Today sees the end of what is traditionally known as “Good Friday.”
In Christian tradition, Good Friday is the day the crucifixion of Jesus Christ is remembered, as is his resurrection. In many countries, it’s also tradition to reenact the Via Crucis (also known as the Via Dolorosa or the 14 stations of the cross.)
Along his path to his crucifixion Christ encountered good people who did good deeds. The two most renowned are Simon helping him to carry his cross and Veronica wiping his face. Let’s not forget that Christ’s death and resurrection, in Christian tradition, represents hope for salvation.
Here in Madeira for one group of people, and for one family in particular, it certainly was a Good Friday in terms of good deeds. It was a day when people came together to truly give life to the meaning of the spirit of Christ.
In their own way, one small group of volunteers gave hope and ignited a little light for salvation in the hearts of a family who became homeless after the freak flood of the 20th February 2010: a single mother and her two young children, who have been living in rented accommodation for 6 weeks now, because their house filled with mud and became inhabitable.
Today, on this special day of good deeds, this group of volunteers gave up their free time; precious time with their loved ones and their friends to clean up the mud filled house. Some even brought their friends along to the locality in Curral das Freiras.
They worked all day. They worked in the blazing sun. They walked up and down the side of a mountain countless times. They didn’t take a lunch break. They were called communists for working on a day when everyone else wasn’t working. They were called sinners for working on a Holy day. Yet, they sang, cleaned up mud, laughed and carried on giving hope to a lady and her two children who are desperately trying to get their lives back.
I was one of the volunteers. I watched the lady of the house’s motivation and enthusiasm grow with every inch of mud that was being removed. I saw the light at the end of the tunnel shine in her eyes. Her glimpse of salvation from doom and gloom was to know she wasn’t alone in her plight. We were there for her and with her.
I’m not a Catholic, but surely that is the true spirit of Christ, and it reassures me to know there are still human beings on this earth willing to give their time and their energy to help perfect strangers; no matter what the time or the day.
Friday, 2 April 2010
Wednesday, 17 March 2010
Projecto Coração da Madeira - The Heart of Madeira
The project “The HEART OF MADEIRA” is a non profit project, which offers physical and psychological support to the community of Madeira; wherever necessary. A task force of specialist volunteers has come together from different backgrounds and from various non government organisations; all with one purpose - to show social solidarity.
The purpose of the project is to:
1) Provide voluntary services in the areas of clean up, reconstruction and building advice; on a structural and architectural level - where privately owned houses were damaged during the freak flood of the 20th February 2010.
2) Distribute clothes and other material goods on behalf of and in collaboration with other organisations and institutions; including Caritas of Funchal.
3) Offer free specialised psychological support to people who have not yet received it
4) Investigate and determine other ways in which “The HEART OF MADEIRA” may more efficiently be able to help people who need it the most at this moment in time.
5)Collaborate with as many varied organisations as possible with a view to: maximising volunteer corroboration, efficiently receiving, handling and distributing material goods in order to distribute to benefit as many people as possible; as quickly as possible.
6) With this intent in mind, “The HEART OF MADEIRA” has already created partnerships with: AURA, Acreditar and The Buddhist Union of Funchal.
7) Publicly announce and advertise what material goods are needed in order to call upon Madeira’s sense of solidarity; and the solidarity of foreign contributors.
8) Collaborate with Madeira´s army, any and or all government institutions, any and or all non government organisations, local fire-brigades including the voluntary sector, any and or all social solidarity groups etc, with the intent to collaborate and not work in conflict or opposition.
We are not politically motivated. Our only motivation is to help our island and it’s people.
The project coordinators are volunteer psychologists who have been working in the army barracks since the 20th and 21st February 2010; Drª Isabel Rodrigues, Drª Carmo Aragão and Drª Venerina Conti.
If anyone wishes to donate furniture or other material goods, or if anyone knows of anyone who needs anything: please contact us.
Please note: We are not handling cash donations but you can donate through the English church in Funchal.
The purpose of the project is to:
1) Provide voluntary services in the areas of clean up, reconstruction and building advice; on a structural and architectural level - where privately owned houses were damaged during the freak flood of the 20th February 2010.
2) Distribute clothes and other material goods on behalf of and in collaboration with other organisations and institutions; including Caritas of Funchal.
3) Offer free specialised psychological support to people who have not yet received it
4) Investigate and determine other ways in which “The HEART OF MADEIRA” may more efficiently be able to help people who need it the most at this moment in time.
5)Collaborate with as many varied organisations as possible with a view to: maximising volunteer corroboration, efficiently receiving, handling and distributing material goods in order to distribute to benefit as many people as possible; as quickly as possible.
6) With this intent in mind, “The HEART OF MADEIRA” has already created partnerships with: AURA, Acreditar and The Buddhist Union of Funchal.
7) Publicly announce and advertise what material goods are needed in order to call upon Madeira’s sense of solidarity; and the solidarity of foreign contributors.
8) Collaborate with Madeira´s army, any and or all government institutions, any and or all non government organisations, local fire-brigades including the voluntary sector, any and or all social solidarity groups etc, with the intent to collaborate and not work in conflict or opposition.
We are not politically motivated. Our only motivation is to help our island and it’s people.
The project coordinators are volunteer psychologists who have been working in the army barracks since the 20th and 21st February 2010; Drª Isabel Rodrigues, Drª Carmo Aragão and Drª Venerina Conti.
If anyone wishes to donate furniture or other material goods, or if anyone knows of anyone who needs anything: please contact us.
Please note: We are not handling cash donations but you can donate through the English church in Funchal.
Tuesday, 9 March 2010
Madeira clean up puts the world to shame!
Ladies and Gentleman, if I ever had any doubts that I was living in the wrong place, let me tell you that over the last week and a half those doubts have been completely erased. Madeira may be a small island but heck, when it comes to getting its ass into gear, (excuse the expression) by God, it surely shifts it.
As you all know, Madeira was hit by a freak flooding on the 20th February. I live on the island. Not everywhere was affected, but the areas that were suffered great loss and serious damage.
Everywhere else in the world, clean up operations are carried out solely by the military. Not here! I have never seen so many people volunteer to help out in the clean up of anywhere. Adults, children, the more mature in age; everyone who is able bodied and can chip in in some way. In the barracks where I've been volunteering, I even had a french lady (who was on holiday here) show up and lend a hand. Goodness knows how many tourists helped out along the seafront.
The fact of the matter is, on friday I tried to go into the city and couldn’t. The roads were all still closed. Last night, when I went to work, I could drive all the way from home right through the city, along the seafront, into the old town. Admittedly, one of the dual carriage ways is still closed but I bet any money that by tomorrow or the day after that will be open too.
The bars, cafés, restaurants and shops are now going back to normal. Tourists were sat admiring the marina. People were standing at the bus stops and life almost seemed completely normal. This is just 11 days after the terrible event. The extent of the work carried out made my jaw drop in utter amazement as I was driving and constantly repeating to myself: “wow.”
Even the road that completely collapsed in the famous footage out on the Internet has been completely rebuilt. One final coat of tarmac and it will be as good as new, open and ready for daily business. Anywhere else in the world clean up operations like this take months and months. Not here!
Villages that were left isolated without water, electricity and other amenities are all accessible in some way. They all have their amenities back in addition to supplies of food, clothes and other essentials. Schools and businesses are all back to normal.
Every day, people who have been staying in the barracks are being re-housed into temporary accomodation until they can be re-housed permanently. The government has promised to build 400 new homes.
The people who didn’t lose their houses completely have started rebuilding with bricks and cement. Neighbours are helping out. Communities are coming together. Someone cleans, someone digs, someone mixes cement and someone else lays bricks. It’s truly incredible.
The tourists we have here are even more amazed than I am. Talking to them, some admit they were a little anxious about coming here at first. Yet, seeing with their own eyes, they all end up telling me, they are so glad they came because if they hadn’t they wouldn’t have believed all this was possible in such a short space of time.
I can hardly believe it and I live here, and I feel so proud!!! Proud to be a part of a community of people who doesn’t just sit on their asses waiting for things to happen or for the government to bail them out. They’re making it happen!
I see small miracles every day and huge events taking place on the island all because of the dedication and hard work of its people; people just like you and I. The rest of the world could learn a thing or two from Madeira about how you really roll up your sleeves and just get on with it without waiting for others to do it for you.
If there are any doubting Thomas’ out there who thought the flower festival wouldn’t go ahead, think again! Then again, you don’t have to take my word for it, you could just come and see for yourself.
As you all know, Madeira was hit by a freak flooding on the 20th February. I live on the island. Not everywhere was affected, but the areas that were suffered great loss and serious damage.
Everywhere else in the world, clean up operations are carried out solely by the military. Not here! I have never seen so many people volunteer to help out in the clean up of anywhere. Adults, children, the more mature in age; everyone who is able bodied and can chip in in some way. In the barracks where I've been volunteering, I even had a french lady (who was on holiday here) show up and lend a hand. Goodness knows how many tourists helped out along the seafront.
The fact of the matter is, on friday I tried to go into the city and couldn’t. The roads were all still closed. Last night, when I went to work, I could drive all the way from home right through the city, along the seafront, into the old town. Admittedly, one of the dual carriage ways is still closed but I bet any money that by tomorrow or the day after that will be open too.
The bars, cafés, restaurants and shops are now going back to normal. Tourists were sat admiring the marina. People were standing at the bus stops and life almost seemed completely normal. This is just 11 days after the terrible event. The extent of the work carried out made my jaw drop in utter amazement as I was driving and constantly repeating to myself: “wow.”
Even the road that completely collapsed in the famous footage out on the Internet has been completely rebuilt. One final coat of tarmac and it will be as good as new, open and ready for daily business. Anywhere else in the world clean up operations like this take months and months. Not here!
Villages that were left isolated without water, electricity and other amenities are all accessible in some way. They all have their amenities back in addition to supplies of food, clothes and other essentials. Schools and businesses are all back to normal.
Every day, people who have been staying in the barracks are being re-housed into temporary accomodation until they can be re-housed permanently. The government has promised to build 400 new homes.
The people who didn’t lose their houses completely have started rebuilding with bricks and cement. Neighbours are helping out. Communities are coming together. Someone cleans, someone digs, someone mixes cement and someone else lays bricks. It’s truly incredible.
The tourists we have here are even more amazed than I am. Talking to them, some admit they were a little anxious about coming here at first. Yet, seeing with their own eyes, they all end up telling me, they are so glad they came because if they hadn’t they wouldn’t have believed all this was possible in such a short space of time.
I can hardly believe it and I live here, and I feel so proud!!! Proud to be a part of a community of people who doesn’t just sit on their asses waiting for things to happen or for the government to bail them out. They’re making it happen!
I see small miracles every day and huge events taking place on the island all because of the dedication and hard work of its people; people just like you and I. The rest of the world could learn a thing or two from Madeira about how you really roll up your sleeves and just get on with it without waiting for others to do it for you.
If there are any doubting Thomas’ out there who thought the flower festival wouldn’t go ahead, think again! Then again, you don’t have to take my word for it, you could just come and see for yourself.
Tuesday, 16 February 2010
Another vaccine warning for young people and parents - Gardasil.
It’s bad enough not being fully active and able when you suffer any form of life debilitating condition. It’s even worse when you are (were) a healthy young person, with your whole live ahead of you, and a simple vaccine takes it all away from you.
You see your friends out playing. Mentally, you think about joining them but all the body can do is lay down. You haven’t got any energy, you can hardly breath, you’re in pain, you can’t stand for too long and the list goes on.
So, today, I’m back with another scandal for you and another warning for young people, parents, grandparents, guardians and anyone who cares about someone dear.
This time my warning is about a vaccine called: Gardasil.
Many of you may remember Gardasil from a few years ago when, a celebrity talk show host announced to the world, there would soon be a time mothers would be able to vaccinate their daughters against cervical cancer.
At the time, I, for one, having had cervical cancer twice now, remember thinking what a blessing it would be for young women not to have to go through what I have. As it turns out, thousands of young girls, young women, and counting, are going through much worse; not because of cervical cancer but because of the “so say” preventative vaccine they received.
Worst of all, it seems that young women might not be the only ones who will continue to suffer. Merck now produce a vaccine for young men and boys as well.
Gardasil, which is also known as Siligard, (produced by Merck), was suppose to be the miracle vaccine that would protect young girls from human papillomaviruses (HPV.) What are these? These are viruses that can cause cervical, vaginal, anal and penile types of cancers as well as genital warts.
26 million vaccines of Gardasil were distributed in the USA. On the 1st September 2009, the VAERS (Vaccine Adverse Event Reporting System) reported that in 15,037 people who received the vaccine, 93% had (what were considered non serious side effects whilst the remaining 7% suffered what were considered serious side effects; including death.
It is worth mentioning here that in the non serious side effect category young adults reported fainting, which caused more serious injuries sustained to the head. I would just like to say here that an injury sustained to the head can be very serious and sometimes fatal, so how this can be considered not serious is beyond me.
However, as the packaging now states, preventative measures such as “close monitoring” after injection of the substance can help to reduce the risk of accidents that might occur due to fainting.
Yet is it enough? I question this because of the aluminum ingredient contained in the vaccine, which I will cover a little further down in the report.
An interesting fact worth noting is the way VAERS compiles its data for events; not just for adverse effects to this vaccine but to any vaccine.
Anyone can file an adverse reaction to a vaccine; either directly to VAERS (online) or via a health adviser. However, the majority of data VAERS receives comes from the vaccine manufacturers, at a staggering 37%; compared to only a 7% from parents/guardians. So, I have to question how accurate any of its data truly is.
It would seem to me that there is a bias in data in favour of the pharmaceutical companies who are behind the products they are manufacturing and selling.
8,000 deaths were reported in 2008. I couldn’t find any up to date figures for 2010 but then I didn’t really go digging deep enough. I’m sure if someone wanted to really find them, they could.
So, what are the ingredients? Know them in detail:
Amorphous Aluminum
We all know that aluminum is a metal. Amorphous comes from the Greek amorphos, which means “without shape.” You probably know a great deal about aluminum. It’s the stuff aircraft structures are made of. Aluminum is naturally resistant to corrosion. It is also a great catalyst, which means it increases the speed at which a chemical agent reacts.
It’s been dubbed the new mercury in vaccines. How safe is it? Nobody quite knows yet. However, all the accounts I’ve read online, which you can read too if you search Aluminum don’t have anything to say in its favour.
How toxic is it to humans and in what quantities? Again, it’s an unanswerable question. There have never been sufficient clinical trials carried out to test its safety. Let’s just say that what we know so far makes aluminum about as toxic to humans as mercury.
Another very important question we should be asking here is, what are the effects of aluminum on the brain? Because, ultimately, when we’re injected with it, that’s where it will end up as well.
Hydroxyphosphate Sulfate
Hydroxyphosphate Sulfate is an adjuvnt of aluminum. It’s used in vaccines to “so say” stimulate the immune system. However, I quote: -
Animal and human studies have shown that aluminum can cause nerve cell death [1] and that vaccine aluminum adjuvants can allow aluminum to enter the brain, [2,3] as well as cause inflammation at the injection site leading to chronic joint and muscle pain and fatigue.
- end quote -
sodium chloride - salt
L-histidine - an amino acid
Polysorbate 80
Polysorbate 80 is the drug known as Tween 80, used in the H1N1 vaccine I covered in one of my last posts. It’s a drug used to trick the blood brain barrier to open up so that nano-drugs can be carried through into the brain. However, in 2005, it was discovered that this drug can cause hives, breathing problems and a sharp enough drop in blood pressure to actually be fatal. Aside from this, it was found to cause infertility in mice.
For a fuller description of Polysorbate 80 (Tween 80) you can refer to my article: H1N1 Vaccine - Know it in detail (Part 2.)
Sodium borate
Sodium borate is also known as Borax. It’s an interesting ingredient, in my opinion, to have in a vaccine since it is primarily used as an agent in detergents, ceramics, pottery, enamels, insecticides for cockroaches, ants and such likes. It’s also used as inks for dip pens, a treatment for thrush in horses’ hooves and as a buffering agent to control the Ph in swimming pools.
Packaging Information - Courtesy of the FDA website
6 ADVERSEREACTIONS
Overall Summary of Adverse Reactions
Headache, fever, nausea, and dizziness; and local injection site reactions (pain, swelling, erythema, pruritus, and bruising) occurred after administration with GARDASIL.
Syncope, sometimes associated with tonic-clonic movements and other seizure-like activity, has been reported following vaccination with GARDASIL and may result in falling with injury; observation for 15 minutes after administration is recommended. [See Warnings and Precautions (5.1).]
Anaphylaxis has been reported following vaccination with GARDASIL.
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
GARDASIL has not been evaluated for the potential to cause carcinogenicity or genotoxicity.
GARDASIL administered to female rats at a dose of 120 mcg total protein, which is equivalent to the recommended human dose, had no effects on mating performance, fertility, or embryonic/fetal survival.
The effect of GARDASIL on male fertility has been studied in male rats at an intramuscular dose of 0.5 mL/rat/occasion (120 mcg total protein which is equivalent to the recommended human dose). One group of male rats was administered GARDASIL once, 3 days prior to cohabitation, and a second group of male rats was administered GARDASIL three times, at 6 weeks, 3 weeks, and 3 days prior to cohabitation. There were no treatment-related effects on reproductive performance including fertility, sperm count, and sperm motility. There were no treatment-related gross or histomorphologic and weight changes on the testes.
End quote -
For full packaging detail, I’ve provided the link below.
Please note: Infertility tests were carried out on rats at intervals of 3 days, 3 weeks and 6 weeks prior to mating. My question is, what about the long term effects? Given the Polysorbate 80 (Tween 80) content, what do we know about how it will affect reproductivity in the future? Where are the long term study results of its effects on reproductivity?
The packaging says: - and I quote -
Because these events were reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or to establish a causal relationship to vaccine exposure.
End quote -
Is it not fairer to say that the pharmaceutical companies were in such a hurry to get their product on the market to make money, that, instead of spending more money, time and energy on doing another “more thorough test, they decided to seek FDA approval with fancy wording and do a live test on a much larger population? i.e. the general public.
Let me just say here that I am not against pharmaceutical companies in any way and I am not against vaccinations in any way. What I am against is pharmaceutical companies using the general population as live guinea pigs for products that have been insufficiently tested in clinical trials.
I also feel that the old methods of scientific research are outdated. The controlled methods of testing versus the placebo groups just don’t work anymore. They’re fast and they’re convenient and statistics are drawn from means calculations.
In some countries, doctors and health officials get kick backs (commissions) from pharmaceutical companies for prescribing their drugs. If you didn’t know that, there’s an interesting thought for you to ponder on.
I wonder if reports on studies are subject to such biases as well in certain countries where product tests are carried out. We already know that research is funded by companies who have an invested interest in seeing their product on the market.
One last thought I will leave you with is this. A product maybe tested in 7, 13, 25 or however many different countries. In some countries it is unethical to pay volunteers to participate. However, in others it is not. For some people, being clinical volunteers is an only way to survive and feed a family.
In some countries, that are considered third world, participants are considered less than human. In fact, they are probably considered less than laboratory rats. If they suffer serious side effects, and they’ve been paid, do you honestly think the results would make it into the study reports? I’ll leave you to draw your own conclusions.
Be Safe! Be informed and Proceed with Caution!
Resources & Further reading:
http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM111263.pdf
http://vaers.hhs.gov/about/index
http://www.armycorrosion.com/past_summits/summit2009/09Presentations%5CDay2%5CBenGauthier.pdf
http://www.ageofautism.com/2008/07/is-aluminum-the.html
http://www.novaccine.com/vaccine-ingredients/results.asp?sc=164
http://en.wikipedia.org/wiki/Borax
You see your friends out playing. Mentally, you think about joining them but all the body can do is lay down. You haven’t got any energy, you can hardly breath, you’re in pain, you can’t stand for too long and the list goes on.
So, today, I’m back with another scandal for you and another warning for young people, parents, grandparents, guardians and anyone who cares about someone dear.
This time my warning is about a vaccine called: Gardasil.
Many of you may remember Gardasil from a few years ago when, a celebrity talk show host announced to the world, there would soon be a time mothers would be able to vaccinate their daughters against cervical cancer.
At the time, I, for one, having had cervical cancer twice now, remember thinking what a blessing it would be for young women not to have to go through what I have. As it turns out, thousands of young girls, young women, and counting, are going through much worse; not because of cervical cancer but because of the “so say” preventative vaccine they received.
Worst of all, it seems that young women might not be the only ones who will continue to suffer. Merck now produce a vaccine for young men and boys as well.
Gardasil, which is also known as Siligard, (produced by Merck), was suppose to be the miracle vaccine that would protect young girls from human papillomaviruses (HPV.) What are these? These are viruses that can cause cervical, vaginal, anal and penile types of cancers as well as genital warts.
26 million vaccines of Gardasil were distributed in the USA. On the 1st September 2009, the VAERS (Vaccine Adverse Event Reporting System) reported that in 15,037 people who received the vaccine, 93% had (what were considered non serious side effects whilst the remaining 7% suffered what were considered serious side effects; including death.
It is worth mentioning here that in the non serious side effect category young adults reported fainting, which caused more serious injuries sustained to the head. I would just like to say here that an injury sustained to the head can be very serious and sometimes fatal, so how this can be considered not serious is beyond me.
However, as the packaging now states, preventative measures such as “close monitoring” after injection of the substance can help to reduce the risk of accidents that might occur due to fainting.
Yet is it enough? I question this because of the aluminum ingredient contained in the vaccine, which I will cover a little further down in the report.
An interesting fact worth noting is the way VAERS compiles its data for events; not just for adverse effects to this vaccine but to any vaccine.
Anyone can file an adverse reaction to a vaccine; either directly to VAERS (online) or via a health adviser. However, the majority of data VAERS receives comes from the vaccine manufacturers, at a staggering 37%; compared to only a 7% from parents/guardians. So, I have to question how accurate any of its data truly is.
It would seem to me that there is a bias in data in favour of the pharmaceutical companies who are behind the products they are manufacturing and selling.
8,000 deaths were reported in 2008. I couldn’t find any up to date figures for 2010 but then I didn’t really go digging deep enough. I’m sure if someone wanted to really find them, they could.
So, what are the ingredients? Know them in detail:
Amorphous Aluminum
We all know that aluminum is a metal. Amorphous comes from the Greek amorphos, which means “without shape.” You probably know a great deal about aluminum. It’s the stuff aircraft structures are made of. Aluminum is naturally resistant to corrosion. It is also a great catalyst, which means it increases the speed at which a chemical agent reacts.
It’s been dubbed the new mercury in vaccines. How safe is it? Nobody quite knows yet. However, all the accounts I’ve read online, which you can read too if you search Aluminum don’t have anything to say in its favour.
How toxic is it to humans and in what quantities? Again, it’s an unanswerable question. There have never been sufficient clinical trials carried out to test its safety. Let’s just say that what we know so far makes aluminum about as toxic to humans as mercury.
Another very important question we should be asking here is, what are the effects of aluminum on the brain? Because, ultimately, when we’re injected with it, that’s where it will end up as well.
Hydroxyphosphate Sulfate
Hydroxyphosphate Sulfate is an adjuvnt of aluminum. It’s used in vaccines to “so say” stimulate the immune system. However, I quote: -
Animal and human studies have shown that aluminum can cause nerve cell death [1] and that vaccine aluminum adjuvants can allow aluminum to enter the brain, [2,3] as well as cause inflammation at the injection site leading to chronic joint and muscle pain and fatigue.
- end quote -
sodium chloride - salt
L-histidine - an amino acid
Polysorbate 80
Polysorbate 80 is the drug known as Tween 80, used in the H1N1 vaccine I covered in one of my last posts. It’s a drug used to trick the blood brain barrier to open up so that nano-drugs can be carried through into the brain. However, in 2005, it was discovered that this drug can cause hives, breathing problems and a sharp enough drop in blood pressure to actually be fatal. Aside from this, it was found to cause infertility in mice.
For a fuller description of Polysorbate 80 (Tween 80) you can refer to my article: H1N1 Vaccine - Know it in detail (Part 2.)
Sodium borate
Sodium borate is also known as Borax. It’s an interesting ingredient, in my opinion, to have in a vaccine since it is primarily used as an agent in detergents, ceramics, pottery, enamels, insecticides for cockroaches, ants and such likes. It’s also used as inks for dip pens, a treatment for thrush in horses’ hooves and as a buffering agent to control the Ph in swimming pools.
Packaging Information - Courtesy of the FDA website
6 ADVERSEREACTIONS
Overall Summary of Adverse Reactions
Headache, fever, nausea, and dizziness; and local injection site reactions (pain, swelling, erythema, pruritus, and bruising) occurred after administration with GARDASIL.
Syncope, sometimes associated with tonic-clonic movements and other seizure-like activity, has been reported following vaccination with GARDASIL and may result in falling with injury; observation for 15 minutes after administration is recommended. [See Warnings and Precautions (5.1).]
Anaphylaxis has been reported following vaccination with GARDASIL.
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
GARDASIL has not been evaluated for the potential to cause carcinogenicity or genotoxicity.
GARDASIL administered to female rats at a dose of 120 mcg total protein, which is equivalent to the recommended human dose, had no effects on mating performance, fertility, or embryonic/fetal survival.
The effect of GARDASIL on male fertility has been studied in male rats at an intramuscular dose of 0.5 mL/rat/occasion (120 mcg total protein which is equivalent to the recommended human dose). One group of male rats was administered GARDASIL once, 3 days prior to cohabitation, and a second group of male rats was administered GARDASIL three times, at 6 weeks, 3 weeks, and 3 days prior to cohabitation. There were no treatment-related effects on reproductive performance including fertility, sperm count, and sperm motility. There were no treatment-related gross or histomorphologic and weight changes on the testes.
End quote -
For full packaging detail, I’ve provided the link below.
Please note: Infertility tests were carried out on rats at intervals of 3 days, 3 weeks and 6 weeks prior to mating. My question is, what about the long term effects? Given the Polysorbate 80 (Tween 80) content, what do we know about how it will affect reproductivity in the future? Where are the long term study results of its effects on reproductivity?
The packaging says: - and I quote -
Because these events were reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or to establish a causal relationship to vaccine exposure.
End quote -
Is it not fairer to say that the pharmaceutical companies were in such a hurry to get their product on the market to make money, that, instead of spending more money, time and energy on doing another “more thorough test, they decided to seek FDA approval with fancy wording and do a live test on a much larger population? i.e. the general public.
Let me just say here that I am not against pharmaceutical companies in any way and I am not against vaccinations in any way. What I am against is pharmaceutical companies using the general population as live guinea pigs for products that have been insufficiently tested in clinical trials.
I also feel that the old methods of scientific research are outdated. The controlled methods of testing versus the placebo groups just don’t work anymore. They’re fast and they’re convenient and statistics are drawn from means calculations.
In some countries, doctors and health officials get kick backs (commissions) from pharmaceutical companies for prescribing their drugs. If you didn’t know that, there’s an interesting thought for you to ponder on.
I wonder if reports on studies are subject to such biases as well in certain countries where product tests are carried out. We already know that research is funded by companies who have an invested interest in seeing their product on the market.
One last thought I will leave you with is this. A product maybe tested in 7, 13, 25 or however many different countries. In some countries it is unethical to pay volunteers to participate. However, in others it is not. For some people, being clinical volunteers is an only way to survive and feed a family.
In some countries, that are considered third world, participants are considered less than human. In fact, they are probably considered less than laboratory rats. If they suffer serious side effects, and they’ve been paid, do you honestly think the results would make it into the study reports? I’ll leave you to draw your own conclusions.
Be Safe! Be informed and Proceed with Caution!
Resources & Further reading:
http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM111263.pdf
http://vaers.hhs.gov/about/index
http://www.armycorrosion.com/past_summits/summit2009/09Presentations%5CDay2%5CBenGauthier.pdf
http://www.ageofautism.com/2008/07/is-aluminum-the.html
http://www.novaccine.com/vaccine-ingredients/results.asp?sc=164
http://en.wikipedia.org/wiki/Borax
Wednesday, 10 February 2010
Tibetan Losar - New Year -
As I mentioned in an earlier post this week, Sunday the 14th February 2010 that traditionally marks St. Valentine’s day, this year will mark Losar; the Tibetan New Year. It will be the year 2137; the year of the Tiger of Iron. It is believed to be a time for renewal, for hope and for change; especially for Tibet and Tibetan people.
Losar is a celebratory tradition that pre-dates Buddhism to the Bon period, which is one of the earliest faiths in Tibet. In fact, it was Tibet’s first emperor, Songtsen-gampo (Srong-btsan sgam-po, r. 617 – 649 C.E.), who introduced Buddhism into Tibet.
Although two very distinct religions, Bon and Buddhism shared much in common. However, Bon was not really an organised religion. Many of its practices had closer ties with popular Tibetan traditions and culture. Buddhism, however, was very much organised and patroned by the Emperor and many of his allies in Nepal and Bhutan.
The Losar celebrations use to last up to 15 days. During Bon times, people would burn large amounts of incense to ward off evil spirits. Since they were unfamiliar with the lunar cycles that were introduced by an old lady called Belma and now determine the Tibetan calendar, celebrations usually coincided with harvesting and planting time. In fact, Losar was originally considered a farmer’s festival.
Nowadays, Losar celebrations last about 3 days. In the monasteries, religious practices start on the 29th day of the 12th month; equivalent to the Tibetan New Year’s Eve. Offerings are made for the long life of His Holiness the Dalai Lama. Pujas, meditations, prayers and chants are carried out for global peace, and love among all beings.
On this day, the 14th February 2010, Tibetans everywhere will be “Honouring” their culture, their religion and their history; proud of who they are and where they come from; hoping to one day return to their mother land, and in some cases to be reunited with what remains of their friends and loved ones.
Yet, this does not necessarily mean that all Tibetans will be celebrating Losar. Many have decided to mourn the deceased, the executed and the slaughtered. Many have decided to abstain from all celebrations in solidarity and homage to those still imprisoned; being tortured.
1.2 million Tibetans dead and more die every day. If you can’t imagine that figure, think of it as wiping out the whole population of Dallas or Harare or Salt Lake City or Karaj or even Florida. Can you imagine that? That’s what it’s equivalent to.
More and more Tibetans disappear every day. More and more Tibetans try to flee Tibet in search of a better life in exile. Some make it and some don’t.
For 51 years, Tibetan people have been forced to live in exile or under the Chinese regime. This same regime now is trying to bribe Tibetans to celebrate Losar against their will; offering them free gifts and offering to pay for their celebrations in Tibet.
Yet what price, I ask, can the Chinese government put on human life? On each and every human life lost? What price can the Chinese government pay for the suffering endured by those left behind to mourn? What possible amount of money can the Chinese Government pay for each child that can longer run to the loving arms of their mother or father in times of need?
What sum of money can bring back peaceful sleep to those who awake at night haunted by the horrific events that took place in Tibet?
Why pay any money at all? It’s obvious this is just another attempt at putting on a show for global vision. It’s another distorted propaganda stunt to try and raise the Chinese Government’s image in affairs of public relations.
It’s completely contradictory to recent events as well. In fact, just recently, the Ministry of Education removed the University of Calgary (USA) from their list of accredited institutions. Why? Because the University bestowed his Holiness the Dalai Lama with an Honorary Degree.
Let me just say here that when I talk about the Chinese Government, I am not talking about the Chinese people. I have many beautiful Chinese friends. I lived and worked in China. I had first hand experience of Chinese politics (in reality - on a day to day living basis) and how it affects the Chinese people themselves, and it’s not much better for the people in less fortunate positions.
For 51 years now, Tibetan people have stood resilient in their beliefs from generation to generation. For 51 years now, Tibetan people have been true to themselves and their culture. For 51 years now, everyone who has said something, or says something, is silenced in some way. I wrote an article in November that you can find here if you haven’t read it already. http://www.facebook.com/note.php?note_id=178894765875
For 51 years now, Tibetan people have shown they can bend like a cane in the wind but they cannot be broken. Tibet, the land, may not be free from Chinese rule but Tibetans have shown that their hearts and their spirit are very much strong and free.
If the Chinese Government really want to do something for Tibet and Tibetans, for Losar, then they could start by releasing some of the imprisoned. Then, they could go back to the negotiating table and identify (among themselves) how they could return Tibet to its people without losing face. These two simple gestures would be worth more than they could ever offer in monetary compensation to pay for any celebration.
Here in Madeira, our small but zealous Buddhist community will Honour Tibetans everywhere by commemorating Losar, on Sunday, at our modest meditation centre.
To all my Tibetans friends at Kopan Monastery, (who welcomed me into their home and made it my home), Kopan Nunnery, (my beautiful ladies who touched the very heart of me), Hengja Tibetan Refugee Camp, (who gave me a piece of their heart and accepted a piece of mine), Pokhara, Lakeside, Kathmandu, (I couldn’t have wished to meet nicer people), India & Tibet (I’ll get there one day - I promise) and Lisbon (Um dia vou regressar!) - although I can't be there in person, I am there in spirit. - Tashi Delek Losar -
Further reading:
http://www.berzinarchives.com/web/en/archives/study/history_buddhism/buddhism_tibet/details_tibetan_history/history_early_period_buddhism_tibet/Part_1.html
http://www.search.com/reference/Losar
http://www.phayul.com/news/article.aspx?id=26558&article=Losar+bringing+Tibetans+closer
http://ca.news.yahoo.com/s/cbc/100204/canada/canada_calgary_calgary_university_chinese_dalai_lama
Monday, 1 February 2010
Naturopathic and Homeopathic alternatives for the H1N1 Virus and Vaccine
Since I investigated and posted my research report with reference to the H1N1 vaccine and its effects, I felt it my responsibility to also research and post a report about Homeopathic and Natural remedies and their effects.
Firstly, to understand how any medication can be effective in the treatment of any condition, we have to understand the condition itself, how it operates within the body and where it strikes the most. The tendency of any Influenza virus is to affect the respiratory areas, which is why most of us, when we have the flu, suffer with coughing, bronchitis, sneezing etc.
The H1N1 virus (Influenza A, Gripe A or Swine flu) is no different. It behaves pretty much like a normal flu. It enters through the nose and mouth. It affects the upper respiratory areas; causing bronchial syndromes and is spread by coughing and sneezing. However, it does not go deep enough into the lungs to cause anything that could potentially kill us like pneumonia - unlike the H5N1 (Avian flu virus) that does and could. You can find a comparative report on the following site. - http://news.bbc.co.uk/2/hi/8028371.stm
As I stated in my last report, the only time any human is in imminent danger of death, with any Influenza, would appear to be if the body has what is known as a Cytokine response. Please refer to my H1N1 vaccine report if you need clarification of what the Cytokine response is.
There seems to be a general lack of scientific data regarding the swine flu behaviour in humans, which leads me to two conclusions: a) there is an insufficiency of medical studies being carried out at this time and/or b) it was never considered dangerous enough to conduct such detailed studies in the first place. Of course, there is also the hypothesis that research is being conducted as I type this, and has not yet become public property.
Working with what we know:
Firstly: we need to (obviously) avoid further contaminations. You all know what to do. Publicity is everywhere. Respect it. Be informed in order to protect yourselves, your loved ones and other people around you.
Secondly: we need to protect our lungs. We can do this in a number of relatively inexpensive and easy ways.
Prevention:
Just a simple few things will help: avoid direct contact with cold air, wear a scarf and all the usual things you would do in winter time to avoid catching a cold. Plus you can add a couple of drops of lavender oil to your pillow at night. Not only will it help you breathe more easily, it will also help you sleep more restfully. The better the body rests, the better the immune system repairs any damage from outside influences.
Remedy - Mild symptoms:
(Naturopathy, Aromatherapy, Optimum Nutrition, Ayurveda, Homeopathy)
If you feel a little bit of cold, or a chill, coming on you can add 5 drops of eucalyptus oil, 5 drops of lavender oil and 5 drops of peppermint oil to a full bath of hot water (as hot as you can stand it without burning yourself.) Stay in the bath 20 minutes; a) because that’s sufficient enough time for the oils to be absorbed through the skin and b) inhalation of the vapours, produced by the oils in the water, will help to clear the lungs.
Eucalytus oil - is cleansing and balancing. It kills off germs and bacteria and soothes aching muscular pains. It helps with coughs and has long been used in throat lozenges, oils and balms such as Vicks and Olbas because of its soothing properties. You can even burn a few drops in some water in an oil burner to cleanse a room.
Lavender oil - is marketed primarily as a soothing and calming oil. However, what many people don’t know is that this oil is also a very potent anti-viral and anti-bacterial agent. It’s also the oil that is least responsible for causing allergies in people. However, you should still do an allergy test before using it.
Peppermint oil - Peppermint is commonly known to be a great aid in digestion. Yet, what many people don’t know is that peppermint oil is an excellent natural expectorant. It clears the respiratory tract and therefore helps with bronchial infections, coughs, colds and breathing problems in general.
Please note: - Before you use any type of Aromatherapy oils, you should check your tolerance and whether (or not) you have any allergies to them. You can check with your local health shop (or supplier) if you are unsure how to do this. Or, you can consult a Holistic Health therapist in your area.
Take a Vitamin C supplement or, if you are already taking one, increase the dosage to between 1000 - 1500 mgs per day. Take an anti-oxidant supplement. Drink plenty of fluids.
If you have the beginning of a slight fever as well, remember the saying: “feed a cold, starve a fever”
Remedy - Full Influenza symptoms:
(Naturopathy, Aromatherapy, Optimum Nutrition, Ayurveda)
Aside from being able to still use the above, you can also do the following:
During the virally contaminated period, avoid eating dairy products, soya, eggs and any other products that cause an excess production of mucus. This will help the lungs to dry out quicker. Drink plenty of water to help flush all the toxins out of the body.
You can also take Echinea drops - about 10 drops 3 to 4 times a day. Take a zinc supplement. In elevated quantities it can be toxic. So, you don’t want to exceed about 20mg per day. This mineral has also been studied as an anti-carcinogenesis.
In Ayurvedic remedies, it is believed that drinking hot ginger with honey is very effective for bronchial disorders. It’s even more effective when it’s combined with pepper and cloves. Another very effective herb is turmeric. You can add it to your cooking or you can add one teaspoon to half a glass of milk and drink that 2 or 3 times a day. Eat plenty of onions and drink plenty of orange juice. Increase the amount of dark green leaf vegetables you consume. The lighter you eat, the more energy you free up for the body to focus on fighting the disease.
Homeopathy
I did some research to investigate the H1N1 virus (Swine flu, Influenza A, Gripe A) from a Homeopathic point of view and found that a group of Doctors in Mexico have had very successful results with both preventative measures and remedies. I quote: - http://www.naturalnews.com/026839_homeopathy_homeopathic_doctors.html
PROPHYLAXIS (meaning preventive)1. Homeopathic remediesa. BAPTISIA TINCTOREAb. INFLUENZINUMc. ARSENICUM ALBUMFrom the Mexico City Doctors Report"In homeopathy there are no specific medicines for a particular nosological picture (for which the most common symptoms are taken into account). But in epidemics, due to the common causative agent, susceptibility of the population in this particular moment, and the repetition of symptoms, a group of the most useful remedies can be deduced. The remedies determined in this way are called the Genius Epidemicus. They consist of a group of medicines with symptoms most similar to those presented by most patients suffering this flu.""For homeopathic treatment is it necessary to take into account the degree of reaction of the patient and the symptoms with which the disease manifests itself. We considered this and the symptoms observed during the last epidemic (1918) to find the similar remedy."Homepathic Remedies Listed by the Mexican Doctors and Directly Copied Here Which They Successfully Employed Against the 2009 Mexican FluAconitum napellus, Actea racemosa, Allium cepa, Ammonium phosphoricum, Antimonium tartaricum, Arnica montana, Arsenicum album, Baptisia tinctoria, Belladonna atropa, Bryonia alba, Camphora, Carbo vegetabilis, Carbolic acid, Causticum, Chamomilla, China officinalis, Drosera rotundifolia, Eupatorium perfoliatum, Euphrasia, Ferrum phosphoricum, Gelsemium sempervirens, Glonoinum, Hepatica triloba, Hyosciamus niger, Influenzinum (corresponding to the epidemic), Ipecauanha, Lachesis trigonocephalus, Lycopodium clavatum, Mercurius vivus, Natrum sulphuricum, Nux vomica, Opium, Phosphorus, Phytolacca decandra, Pulsatilla, Pyrogenium, Rhus toxicodendron, Sticta pulmonaria, Sepia officinalis, Sulphur.
End quote -
My suggestion is, if anyone is interested in Homeopathic remedies, go and speak to your local Homeopath. As a certified Homeopath, I can tell you that Homeopathic remedies are not toxic to the body within the prescribed guidelines. Even if you have had the H1N1 virus and you have concerns, you can discuss them with a Homeopath.
Tibetan Medicine
I quote: - http://chinatibet.people.com.cn/6658462.html
The Beijing Tibetan Medicine Hospital has developed an upgraded medicament of "nine-flavored murrain-prevention powder," and donated to staff at the A/H1N1 influenza prevention frontline in Beijing and the quake-hit areas in Sichuan and Gansu provinces. The smell of the medicament made of aconite and musk can arouse human's immunity and adjustment systems, thus preventing respiratory infectious diseases. Developed in 2003, the medicine played an important role in fighting against SARS.
End quote -
I have not been able to determine the effectiveness of this particular medicament, since I could not find any medical reports pertaining to it. However, I have seen the effectiveness of Tibetan Medicine in other fields.
I hope this information proves useful to someone out there somewhere.
God Bless and be safe.
Firstly, to understand how any medication can be effective in the treatment of any condition, we have to understand the condition itself, how it operates within the body and where it strikes the most. The tendency of any Influenza virus is to affect the respiratory areas, which is why most of us, when we have the flu, suffer with coughing, bronchitis, sneezing etc.
The H1N1 virus (Influenza A, Gripe A or Swine flu) is no different. It behaves pretty much like a normal flu. It enters through the nose and mouth. It affects the upper respiratory areas; causing bronchial syndromes and is spread by coughing and sneezing. However, it does not go deep enough into the lungs to cause anything that could potentially kill us like pneumonia - unlike the H5N1 (Avian flu virus) that does and could. You can find a comparative report on the following site. - http://news.bbc.co.uk/2/hi/8028371.stm
As I stated in my last report, the only time any human is in imminent danger of death, with any Influenza, would appear to be if the body has what is known as a Cytokine response. Please refer to my H1N1 vaccine report if you need clarification of what the Cytokine response is.
There seems to be a general lack of scientific data regarding the swine flu behaviour in humans, which leads me to two conclusions: a) there is an insufficiency of medical studies being carried out at this time and/or b) it was never considered dangerous enough to conduct such detailed studies in the first place. Of course, there is also the hypothesis that research is being conducted as I type this, and has not yet become public property.
Working with what we know:
Firstly: we need to (obviously) avoid further contaminations. You all know what to do. Publicity is everywhere. Respect it. Be informed in order to protect yourselves, your loved ones and other people around you.
Secondly: we need to protect our lungs. We can do this in a number of relatively inexpensive and easy ways.
Prevention:
Just a simple few things will help: avoid direct contact with cold air, wear a scarf and all the usual things you would do in winter time to avoid catching a cold. Plus you can add a couple of drops of lavender oil to your pillow at night. Not only will it help you breathe more easily, it will also help you sleep more restfully. The better the body rests, the better the immune system repairs any damage from outside influences.
Remedy - Mild symptoms:
(Naturopathy, Aromatherapy, Optimum Nutrition, Ayurveda, Homeopathy)
If you feel a little bit of cold, or a chill, coming on you can add 5 drops of eucalyptus oil, 5 drops of lavender oil and 5 drops of peppermint oil to a full bath of hot water (as hot as you can stand it without burning yourself.) Stay in the bath 20 minutes; a) because that’s sufficient enough time for the oils to be absorbed through the skin and b) inhalation of the vapours, produced by the oils in the water, will help to clear the lungs.
Eucalytus oil - is cleansing and balancing. It kills off germs and bacteria and soothes aching muscular pains. It helps with coughs and has long been used in throat lozenges, oils and balms such as Vicks and Olbas because of its soothing properties. You can even burn a few drops in some water in an oil burner to cleanse a room.
Lavender oil - is marketed primarily as a soothing and calming oil. However, what many people don’t know is that this oil is also a very potent anti-viral and anti-bacterial agent. It’s also the oil that is least responsible for causing allergies in people. However, you should still do an allergy test before using it.
Peppermint oil - Peppermint is commonly known to be a great aid in digestion. Yet, what many people don’t know is that peppermint oil is an excellent natural expectorant. It clears the respiratory tract and therefore helps with bronchial infections, coughs, colds and breathing problems in general.
Please note: - Before you use any type of Aromatherapy oils, you should check your tolerance and whether (or not) you have any allergies to them. You can check with your local health shop (or supplier) if you are unsure how to do this. Or, you can consult a Holistic Health therapist in your area.
Take a Vitamin C supplement or, if you are already taking one, increase the dosage to between 1000 - 1500 mgs per day. Take an anti-oxidant supplement. Drink plenty of fluids.
If you have the beginning of a slight fever as well, remember the saying: “feed a cold, starve a fever”
Remedy - Full Influenza symptoms:
(Naturopathy, Aromatherapy, Optimum Nutrition, Ayurveda)
Aside from being able to still use the above, you can also do the following:
During the virally contaminated period, avoid eating dairy products, soya, eggs and any other products that cause an excess production of mucus. This will help the lungs to dry out quicker. Drink plenty of water to help flush all the toxins out of the body.
You can also take Echinea drops - about 10 drops 3 to 4 times a day. Take a zinc supplement. In elevated quantities it can be toxic. So, you don’t want to exceed about 20mg per day. This mineral has also been studied as an anti-carcinogenesis.
In Ayurvedic remedies, it is believed that drinking hot ginger with honey is very effective for bronchial disorders. It’s even more effective when it’s combined with pepper and cloves. Another very effective herb is turmeric. You can add it to your cooking or you can add one teaspoon to half a glass of milk and drink that 2 or 3 times a day. Eat plenty of onions and drink plenty of orange juice. Increase the amount of dark green leaf vegetables you consume. The lighter you eat, the more energy you free up for the body to focus on fighting the disease.
Homeopathy
I did some research to investigate the H1N1 virus (Swine flu, Influenza A, Gripe A) from a Homeopathic point of view and found that a group of Doctors in Mexico have had very successful results with both preventative measures and remedies. I quote: - http://www.naturalnews.com/026839_homeopathy_homeopathic_doctors.html
PROPHYLAXIS (meaning preventive)1. Homeopathic remediesa. BAPTISIA TINCTOREAb. INFLUENZINUMc. ARSENICUM ALBUMFrom the Mexico City Doctors Report"In homeopathy there are no specific medicines for a particular nosological picture (for which the most common symptoms are taken into account). But in epidemics, due to the common causative agent, susceptibility of the population in this particular moment, and the repetition of symptoms, a group of the most useful remedies can be deduced. The remedies determined in this way are called the Genius Epidemicus. They consist of a group of medicines with symptoms most similar to those presented by most patients suffering this flu.""For homeopathic treatment is it necessary to take into account the degree of reaction of the patient and the symptoms with which the disease manifests itself. We considered this and the symptoms observed during the last epidemic (1918) to find the similar remedy."Homepathic Remedies Listed by the Mexican Doctors and Directly Copied Here Which They Successfully Employed Against the 2009 Mexican FluAconitum napellus, Actea racemosa, Allium cepa, Ammonium phosphoricum, Antimonium tartaricum, Arnica montana, Arsenicum album, Baptisia tinctoria, Belladonna atropa, Bryonia alba, Camphora, Carbo vegetabilis, Carbolic acid, Causticum, Chamomilla, China officinalis, Drosera rotundifolia, Eupatorium perfoliatum, Euphrasia, Ferrum phosphoricum, Gelsemium sempervirens, Glonoinum, Hepatica triloba, Hyosciamus niger, Influenzinum (corresponding to the epidemic), Ipecauanha, Lachesis trigonocephalus, Lycopodium clavatum, Mercurius vivus, Natrum sulphuricum, Nux vomica, Opium, Phosphorus, Phytolacca decandra, Pulsatilla, Pyrogenium, Rhus toxicodendron, Sticta pulmonaria, Sepia officinalis, Sulphur.
End quote -
My suggestion is, if anyone is interested in Homeopathic remedies, go and speak to your local Homeopath. As a certified Homeopath, I can tell you that Homeopathic remedies are not toxic to the body within the prescribed guidelines. Even if you have had the H1N1 virus and you have concerns, you can discuss them with a Homeopath.
Tibetan Medicine
I quote: - http://chinatibet.people.com.cn/6658462.html
The Beijing Tibetan Medicine Hospital has developed an upgraded medicament of "nine-flavored murrain-prevention powder," and donated to staff at the A/H1N1 influenza prevention frontline in Beijing and the quake-hit areas in Sichuan and Gansu provinces. The smell of the medicament made of aconite and musk can arouse human's immunity and adjustment systems, thus preventing respiratory infectious diseases. Developed in 2003, the medicine played an important role in fighting against SARS.
End quote -
I have not been able to determine the effectiveness of this particular medicament, since I could not find any medical reports pertaining to it. However, I have seen the effectiveness of Tibetan Medicine in other fields.
I hope this information proves useful to someone out there somewhere.
God Bless and be safe.
Saturday, 30 January 2010
The H1N1 Vaccine - Know it in detail!
As anyone who knows me or anyone who follows my posts knows, I am not a political person; what I do care about though are human beings, life in general, human rights and our safety. If the days and countless hours spent on this can help someone somewhere; I’ll be very happy.
As you know, I am a member of the British Psychological Society and the British Mensa Society. My background is in Psychology and Natural Medicine but within both fields I had to study a part of conventional science; not enough to be qualified to conduct my own scientific laboratory research, but enough to be able to bring you informed research from reliable medical sources - if there is such a thing nowadays. I say that because most scientific research nowadays has some invested interest somewhere, and results are sometimes dependent on who’s funding it.
Just recently, I’ve been engaged in more conversations about the swine flu (Influenza A or Gripe A) and the H1N1 vaccine than I care to mention. Many of my colleagues have had the vaccine and some have suffered adverse reactions to it; from headaches to vomiting. However, the biggest plea I received was from my mother who has also been vaccinated. She asked me to please prove the vaccine was safe and that it couldn’t cause cancer.
So, I decided to carry out my own independent research a) to see what I could come up with and b) to inform everyone, in simple terms, about the pros and cons of the vaccine and the flu itself.
I’ve tried to put together material from as reliable and accurate sources as possible. Please consider it very carefully and make your own formulated opinion. Please also consider that since I am not a laboratory researcher, I can only give you facts and data collated by third party scientists in their own research environments.
I wish I could be the one to give my mother good news but I’m not sure I can. My conclusion is that the vaccine does contain known cancer causing substances that are toxic to humans. However, there is some discrepancy as to what dosages are considered highly toxic. So, at this point nobody can predict what the long term side effects will be. Furthermore, everybody’s body will react in a different way; just as some people can smoke all their lives and never develop cancer, whilst others can’t.
By the same token, I can say that one of the vaccines being manufactured does contain a substance that, in laboratory rats, has been known to act as an anti-chemical carcinogenesis. Whether this works in humans is still unknown since clinical trials, with humans, have not yet been carried out.
I think, in all honesty, only the future will tell.
I’ve tried to do my best to bring you the breakdown of the chemical ingredients in the vaccine, and what they’re used for. The rest is up to you to get more information, be aware, take responsibility and do your due diligence.
Be safe. I value every living being.
Background Information
There is a wealth of information on the Internet about the Influenza A. I am not going to reiterate here. However, the “so-called” swine flu first appeared in 1918. It was responsible for the death of between 50 - 100 million people worldwide. It primarily claimed the lives of healthy adults between the ages of 20 and 40. Why? Because it caused something called a cytokine response - what is this?
It’s a term used to describe when the body’s immune system goes into overdrive at defending our organism against harmful external viruses. Basically, the more healthy a body is, the harder it fights off external threats. The harder it fights, the more it goes into overdrive until it, basically, send the system into tilt.
Weaker immune systems, as found in younger people, children, babies and elderly people have slower and weaker responses, which placed them out of the common death claiming range.
I didn’t find any documented evidence that suggested the 2009 Influenza A claimed any lives due to the cytokine response. However, I did find evidence that there is a mutated version of the Influenza A, which has claimed the lives of (maybe) 6 people worldwide. Whether these facts, figures and data are correct is unknown; since we cannot rely on the Media nowadays to duly and accurately inform us.
However, there are a lot of factors that need to be considered when we look at the 1918 death toll. It was war time. Hygiene standards, on a global scale, were much lower. People suffered with malnutrition in areas that nowadays don’t. Troops were constantly on the move, and in great numbers on a global scale, hence the contamination process was greatly aided and speeded up. There was less awareness about the contamination process itself. Little was known about viral infections in general. We didn’t have micro-medications we have today. The list could go on.
Of course, there would also be conspiracy theorists who would have us believe the H1N1 was a laboratory manufactured virus, as a type of biological warfare; specifically designed to eliminate a certain age group of the population in order to end, and win, the war. Personally, I do not believe this as there were too many casualties on all sides.
The 1918 Influenza A didn’t just disappear as many would have us believe. It apparently weakened itself over time, as many viruses do, but lay dormant somehow; somewhere. It reappeared again in 1937.
The scandalous facts about the 1937 outbreak is that scientists in the UK and the United States used patients, they describe as “feebleminded” at various psychiatric institutions as human guinea pigs for live anti-viral testing. Yes, you read it correctly. Scientists injected about a third of the patients, across various institutions at various locations, with a vaccine containing “live” Influenza A virus; no doubt without written consent. http://aje.oxfordjournals.org/cgi/pdf_extract/35/1/55
If you follow the link above, to the article written in 1941, what amazes me is how scientists report patients were inoculated, and I quote, 5 to 10 weeks before the onset of an Influenza epidemic. We have two choices here: a) we can think that any serious Influenza, at that time was considered an Influenza A, or that somehow the relaunch of the Influenza A (of which by definition of gene content there is only one associated with the Swine flu) was premeditated in a bid to use more humans as guinea pigs.
In 1946/47, there was another outbreak of Influenza that apparently started in Japan. People were inoculated with a milder strain of the H1N1 vaccine but it proved to be a complete failure. Even nowadays, the H1N1 vaccine will not protect you from the swine flu nor any of its mutations thereof.
In 1957, 1968, 1976, 1977 there were more minor outbreaks of various types of Influenza; including the H1N1 that struck people who hadn’t had it previously. Of course, then, closer to the 21st century we’ve had the Avian Influenza and now we have the new H1N1 again.
An interesting fact I came across is that in 2008, in a bid to study the Avian Influenza virus, scientists exhumed the body of a man who died during the 1918/1919 pandemic. He was buried in a lead coffin, which could have very well preserved the H1N1 virus. I’ll leave it to you to think what you will.
So, I come to the modern day 2009 Influenza A. You’ve all heard about it. You all know what it is and how it can affect you. You all know what steps you can take to avoid contamination and spreading. So, I’m not going to go into any details here. What I will say though is that more people have died from a common flu than from the Influenza A.
It’s the Media hype that has blown it out of control and disseminated fear into our minds with a little help from the pharmaceutical companies who have an invested interest in making billion and billions of dollars; not just in the short term, with the vaccines, but in the long term as well, with the potential side effects the vaccines could have in a large proportion of individuals that have it.
Current Manufacturers of the Influenza A (H1N1) vaccine
To date, I have found 5 major manufacturers of the Influenza A vaccine. They are: Sanofi Pasteur, Novartis Vaccines and Diagnostics Limited, CSL Limited, ID Biomedical Corporation of Qebec and MedImmune, LLC. The vaccine produced by ID Biomedical Corporation of Qebec is being distributed by Glaxo Smithkline Beecham.
As a matter of curiosity, I went digging around for financial reports for all the pharmaceutical companies mentioned above. As with all businesses, they suffered losses due to the economic crisis the world has been facing. Stocks had fallen. Yet, they are rising again slowly since the advent of the “hearsay” Influenza A epidemic.
As anyone who deals in stocks and shares will know, the more a rumour is spread, the more likely it is a product will sell. The more likely it is that a product will sell, the more likely it is a company will find investors or the more likely it is prices of stock will go up and the company makes money all round.
Far be it for me to be a sceptic, but in a world where economic growth is at an all time slow and world markets show no sign of immediate recovery, perhaps the banks and the big boys behind wall street, (and most of the global power), found a window of opportunity to increase their bank balances, recover their losses and guarantee an income for the coming years.
How? Simple, develop a vaccine that, theoretically, does little or nothing against the Influenza A, yet injects people with toxic substances that in the long term might have detrimental effects on their health, and ensure they require more medication in the future. More medication equals more guaranteed income for the pharmaceutical companies. I hate to say this but it’s also a way to control the population count.
I’d like to just say here that I am not in any way a conspiracy theorist. I look at the given facts before coming to any conclusions. The facts, in this case, are exemplified by the Polio vaccine first introduce in 1955. By 1961, the vaccine was declared unsafe for human consumption because it was thought to be contaminated with a substance called SV40, a carcinogen that came from infected monkeys.
Yet, that very same vaccine continued to be used well into the year 2000 on a global scale. Hundreds of millions of people worldwide have potentially been exposed to this silent killer. In some, the effects have become apparent. Sufferers in whom cancer has already developed, relatives of people who died and/or some people who have become or became paralysed, because of the vaccine, have carried out lawsuits. You can find more information on the net by searching for links between polio vaccines and paralysis lawsuits.
With the new H1N1 vaccine, as far as I am aware, the pharmaceutical companies have a clause that stipulates they cannot be brought into a court of law should anyone suffer any side effects. This clause alone begs the question: “Why?”
It’s my humble opinion we do not question enough what we allow medics to put into our bodies. We do not investigate enough. We place too much trust in the hands of our doctors and the Media. It doesn’t take a medical degree to ask what something is and what it is used for, and nowadays we have no excuse. Information is everywhere.
Prior to the current manufacturers of the vaccine H1N1, Baxter International Inc. developed a vaccine that contained H5N1 (avian flu virus) and H3N2 (seasonal flu viruses.) In experiments, ferrets were found to die from the vaccine, which suggested the H5N1 virus was live. If this substance had been injected into humans it could have had disastrous consequences.
Human beings could have acted as incubators for a new crossbreed virus that could have then been transmitted from one being to another. The vaccine went out. It was discovered by pure accident. However, it is now said that all known batches of the Baxter vaccine have been recalled.
Human errors happen. Accidents happen. Researchers, scientists, doctors, nurses; nobody is infallible. It’s our responsibility to safeguard ourselves from others’ errors.
H1N1 Vaccine - “Known” Ingredients
This is the list of ingredients contained within the vaccines that I’ve been able to find so far. As you will see, different pharmaceutical companies are using slightly different ingredients. I have no idea if there are other “unmentioned” ingredients as I cannot get my hands on all the packaging labels that come with the actual vaccines (as of yet.)
Sanofi Pasteur
Formaldehyde, Gelatin, Sucrose, Thimerosal, Sodium chloride, Sodium phosphate, Chick embryo cells, Triton X-100, Polyethylene glycol.
Novartis Vaccines and Diagnostics Limited,
Beta-propiolactone, Neomycin, Polymyxin B, Thimerosal, Mercury, Chick embryo cells, Egg protein, Nonylphenol ethoxylate.
CSL Limited,
Beta-propiolactone, Polymyxin B, Sucrose, Thimerosal, Mercury, Sodium chloride, Sodium phosphate-monobasic, Ovalbumin (egg), Chick embryo cells, Neomycin sulphate, Calcium chloride, Sodium phosphate- dibasic anhydrous, Potassium phosphate- monobasic, Sodium taurodeoxycholate, Triton X-100.
ID Biomedical Corporation of Qebec
Formaldehyde, Thimerosal, Mercury, Ovalbumin (egg), Egg protein, Virus: Influenza virus antigens, Sodium deoxycholate.
MedImmune, LLC.
Gentamicin Sulfate, Gelatin, Monosodium Glutamate (MSG), Sucrose, Potassium phosphate, Chick embryo cells, Potassium phosphate- monobasic, Arginine.
Please note that anyone suffering with egg allergies should not go anywhere near the vaccine.
Know these ingredients - What are they?
I am not going to describe every ingredient in detail, as I am sure you know what many of them are; like sucrose (sugar), gelatin (which can cause allergies in some people), ovalbumin (egg or egg protein), sodium (salt) and so on. However, I am going to bring to your attention the most important ones that need very careful reflection.
Formaldehyde
As many of you probably already know, Formaldehyde is a colourless and odourless substance that was once used in building materials; in resin form for insulating foam, as an adhesive and to treat textiles. Its primary function was to act as a fungicide, sterilizer and germicide. It’s also used in morgues and laboratories (in liquid form) as embalming fluid and to preserve bodies. Formaldehyde is actually naturally present in the atmosphere in very small quantities because every living organism produces and emits a tiny amount of it.
Different people have different reactions to over-exposure to Formaldehyde and, of course, the severity of symptoms depends on the amount of exposure.
According to the U.S Goverment’s National Cancer Institute website information and the International Agency for Research on Cancer (World Health Organization) - http://www.cancer.gov/cancertopics/factsheet/risk/formaldehyde - http://monographs.iarc.fr/ENG/Monographs/vol88/index.php - studies have been carried out, on a global scale, since the 1980s to see just what the effects of Formaldehyde are.
In 1980, Formaldehyde was found to cause nasal cancer in rats. In 1987 Formaldehyde was declared a cancer causing substance for humans (carcinogen) and found to be associated with different types of cancers. In fact, in 1988 and again in 2003, scientists in the United States and the United Kingdom found a serious relationship between over-exposure to Formaldehyde and deaths caused by lung cancer in industries where Formaldehyde was being used as a chemical agent. (http://monographs.iarc.fr/ENG/Monographs/vol88/mono88-6B.pdf) - In Denmark, Formaldehyde was associated with lung, kidney, colon and nasal cancer in a study carried out by Hansen and Olsen. http://www.springerlink.com/content/w632326683541334/ The list and studies go on. I suggest you follow the links if you’re interested in the full research findings.
Pregnant women who were exposed to Formaldehyde have been known to give birth to deformed babies. There were known cases studied in China, UK and US. In fact, just recently I was talking to a friend about the UK being one of the first countries in the world to pay compensation to mothers, of deformed babies through exposure to Formaldehyde, who sought legal action.
Why would the World Health Organization, any Government or any Health organisation knowingly approve that we be injected with a substance, (no matter in how much of a small dosage), that they themselves officially declared as a carcinogen?
Tween 80 (also known as Polysorbate 80)
First of all, Tween 80 is a drug used to trick the blood brain barrier to open up so that nano-drugs can be carried through into the brain. However, in 2005, it was discovered that this drug can cause hives, breathing problems and a sharp enough drop in blood pressure to actually be fatal. Aside from this, it was found to cause infertility in mice.
I quote: http://www.whale.to/v/tween_80.html
According to the World Intellectual Property Organization, which is part of the United Nations, scientists from the organization are developing vaccines specifically to damage fertility as a method of contraception. A suggested ingredient for the vaccine is tween 80 (polysorbate 80): “In a preferred embodiment the vaccine comprises oil, preferably a biodegradable oil such as squalene oil. Typically, the vaccine is prepared using an adjuvant concentrate which contains lecithin in squalene oil. The aqueous solution glycoprotein is typically a phosphate-buffered saline (PBS) solution, and additionally preferably contains Tween 80.” (Fertility Impairing Vaccine And Methods of Use’ This application claims the benefit of U. S. Provisional Application No. 60/070,375, filed January 2,1998, U. S. Provisional Application No. 60/071,406, filed January 15,1998.) Exploring Vaccines
You will see, from what I have highlighted in red and orange that a couple of questions arise:
a) Are the pharmaceutical companies trying to control the number of future births; on a global scale?
b) Or, are they trying to subsequently cash in on fertility treatments? Think about this, with each treatment costing between 2,000 to 5,000 US dollars, just how much would they stand to cash in on if a third of the global population was sterile? After all, is it not nearly every couple’s dream to have a child?
Thimerosal and Mercury
Thimerosal is a type of Mercury used as a preservative. So, I am shocked to find that the H1N1 has both Thimerosal and Mercury contained within the vaccine. Both elements have been declared dangerous to health and linked to autism in children, cardiovascular disease in adults, brain tissue damage and other malfunctions of the nervous system.
For years, the FDA in the United States has admitted that Mercury is toxic. For years, it has been reviewing what quantities can be excreted from the body safely. Yet, regardless of the amount of research carried out, the answer is: we still don’t know. Scientists still don’t know. For years the FDA has been campaigning to remove Thimerosal altogether from vaccines. Yet, pharmaceutical companies are still selling vaccines with Mercury and Thimerosal, and the FDA are still approving them. Why?
You can read full reports on Thimerosal and Mercury here:
http://www.naturalnews.com/011764.html
http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/VaccineSafety/UCM096228
Triton X-100
Commonly used as a spermicide. Also used as a detergent and a solvent for vinyl record cleaning.
Polyethylene glycol
I find the inclusion of this ingredient very interesting. Apparently, to date, it is a known anti-chemical carcinogenesis in laboratory rats. However, whether or not it can prevent the development of cancer in humans is not yet known because, (as far as I could find out), there haven’t been any human clinical trials yet.
I have to wonder, though, if the inclusion of this substance in the H1N1 vaccine is part of a live clinical trial. Think what you will.
Squalene - Although it’s not on the official packaging, we know it’s being used.
Squalene is an oil that derives from sharks’ liver primarily and some plants as well. It’s used in cosmetics because it’s easily absorbed through the skin and doesn’t leave an oily after-feeling. In medicine, it’s added to vaccines to stimulate the immune system’s response because it enhance the production of what are known as CD4 memory cells. However, squalene has never been approved for this usage by the FDA.
I quote: http://www.novaccine.com/vaccine-ingredients/results.asp?sc=27
"Animals injected with squalene always develop painful, incurable, autoimmune diseases like multiple sclerosis, rheumatoid arthritis or systemic lupus according to investigative journalist Gary Matsumoto, former reporter for NBC and Fox News. (Gary Matsumoto, Vaccine A: The Covert Government Experiment That's Killing Our Soldiers and Why GIs Are Only the First Victims, Basic Books, 2004) Dangers of squalene have been known since 1956 when Dr. Jules Freund, creator of this oil-based adjuvant, warned that animals injected with his formulation developed terrible, incurable conditions: allergic aspermatogenesis (stoppage of sperm production), experimental allergic encephalomyelitis (the animal version of MS), allergic neuritis (inflammation of the nerves that can lead to paralysis) and other severe autoimmune disorders. Squalene (MF 59) was added to the anthrax vaccine. This vaccine caused tens of thousands of U.S. Iraq Desert Storm soldiers to suffer permanent neurological damage called “Gulf War Illness.” (Jane Bergermeister, Adjuvants to be added to H1N1 vaccine by Baxter and WHO programme body for “endless loop of self-destruction, 2009) Squalene (MF 59) enzyme is not approved for human consumption but waived for use in the H1N1 vaccine. It also potentially causes “undiscovered side effects” according to Jefferson, Mercola and others. "
Deborah Dupre, Examiner.com -- 8/18/2009
Mono Sodium Glutamate
Mono Sodium Glutamate is known as an excitotoxin. It’s an additive that’s been used in food for centuries; to make it taste better. The truth behind it is, it kills off certain neurons in the brain by overstimulating them.
Russell Blaylock, an American neurosurgeon, has made a very convincing connection between continuous exposure to Mono Sodium Glutamate, in adults, to (and I quote) an accelerated onset and degeneration in Alzheimer's disease, Parkinson's, and ALS as well as headaches, seizures, strokes and AIDS dementia.
http://curezone.com/foods/msg.asp http://www.russellblaylockmd.com/
Polyethylene glycol
Usually used as a laxative or as a substance to coat suppositories with. It is also found in cosmetics because of its lubricant nature.
Nonylphenol ethoxylate
Mainly used in detergents, as emulsifiers and found in some pesticides, Nonylphenol ethoxylate is a man-made chemical that was officially declared dangerous to the environment by the European commission and the WWF. It was found to have serious detrimental effects on the female reproductive organs in aquatic species and also found to lower the sperm count in male species. Just how it affects humans is still relatively unknown.
In 1992 the Paris Commission urged the European parliament to recommend that the use of Nonylphenol ethoxylate be completely phased out of domestic cleaning substances by the year 2000. You can read the full International report here:
http://www.ngo.grida.no/wwfneap/Publication/briefings/Nonylphenol.pdf
As far as I discovered, in 2003, the product was banned in Europe by the European Parliament. Here’s the Directive:
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2003:178:0024:0027:EN:PDF
Gentamicin Sulfate
This is an antibiotic. However, in some people it can cause side-effects of vomiting, nausea, increased salivation, joint pain, visual disturbances, dry eyes, tinitus, vertigo etc.
You can see the full description on the packaging details here:
http://medical-dictionary.thefreedictionary.com/gentamicin+sulfate
Other Internet Sources:
CDC - Emerging Infectious Diseases
http://www.cdc.gov/ncidod/eid/vol12no01/05-1254.htm
United States Government National Cancer Institute
http://www.cancer.gov/cancertopics/factsheet/risk/formaldehyde
International Agency for Research on Cancer (World Health Organization)
http://monographs.iarc.fr/ENG/Monographs/vol88/index.php
(http://monographs.iarc.fr/ENG/Monographs/vol88/mono88-6B.pdf)
United States Department of Labor
Occupational Safety and Health Administration
http://www.osha.gov/SLTC/formaldehyde/
Formaldehyde and cancer morbidity among male employees in Denmark
http://www.springerlink.com/content/w632326683541334/
Warnings: (Courtesy of the following websites:)
http://www.rumormillnews.com/cgi-bin/archive.cgi?read=150745
FLU VACCINE RECOMMENDATIONS FOR ALL PREGNANT WOMEN (CDC)
The Advisory Committee on Immunization Practices (ACIP): Vaccination of pregnant women is recommended by the Centers for Disease Control Advisory Committee on Immunization Practices (ACIP). < http://www.cdc.gov/vaccines/pubs/vis/default.htm#flu > http://www.cdc.gov/vaccines/pubs/vis/default.htm#flu
FDA approved manufacturers package insert: Manufacturers warnings
Sanofi Pasteurs Fluzone package insert, WARNING www.vaccinesafety.edu/package_inserts.htm" TARGET="_blank">http://www.vaccinesafety.edu/package_inserts.htm>www.vaccinesafety.edu/package_inserts.htm>
8.1 Pregnancy Category C: Animal reproduction studies have not been conducted with Fluzone vaccine. It is also not known whether Fluzone vaccine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Fluzone vaccine should be given to a pregnant woman only if clearly needed.
8.2 Nursing Mothers: It is not known whether Fluzone vaccine is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Fluzone vaccine is administered to a nursing woman.
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility: Fluzone vaccine has not been evaluated for carcinogenic or mutagenic potential, or for impairment of fertility.
NOTE: CDC does not require providers to inform pregnant women of the Thimerosal (mercury) content.
Appendix A - Sanofi Pasteur Packaging Insert -
Courtesy of the FDA -
http://www.fda.gov/downloads/biologicsbloodvaccines/vaccines/approvedproducts/ucm182404.pdf
sanofi pasteur 449/454 Influenza A (H1N1) 2009 Monovalent Vaccine
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use Influenza A (H1N1) 2009 Monovalent Vaccine safely and effectively. See full prescribing information for Influenza A (H1N1) 2009 Monovalent Vaccine.
Influenza A (H1N1) 2009 Monovalent Vaccine Manufactured by Sanofi Pasteur Inc. Suspension for Intramuscular Injection Initial US Approval: 1980
----------------------------RECENT MAJOR CHANGES------------------------------ Indications and Usage ( 1 ) [9/2009] Dosage and Administration ( 2.2 ) [9/2009]
----------------------------INDICATIONS AND USAGE------------------------------- Influenza A (H1N1) 2009 Monovalent Vaccine is an inactivated influenza virus vaccine indicated for active immunization of persons 6 months of age and older against influenza disease caused by pandemic (H1N1) 2009 virus. (1)
--------------------------DOSAGE AND ADMINISTRATION------------------------- Based on currently available information the vaccination regimen is as follows:
Children ▪ 6 through 35 months of age (0.25 mL dose, intramuscular injection): - Two 0.25 mL doses approximately one month apart. (2.2) ▪ 36 months through 9 years of age (0.5 mL dose, intramuscular injection): - Two 0.5 mL doses approximately one month apart. (2.2) ▪ 10 years of age and older - A single 0.5 mL dose, intramuscular injection. (2.2) Adults - A single 0.5 mL dose, intramuscular injection. (2.2)
---------------------DOSAGE FORMS AND STRENGTHS--------- Influenza A (H1N1) 2009 Monovalent Vaccine, a sterile suspension for intramuscular injection, is supplied in four presentations: ␣ Prefilled syringe, 0.25 mL, no preservative; distinguished by a pink syringe
plunger rod (3) ␣ Prefilled syringe, 0.5 mL, no preservative (3) ␣ Single-dose vial, 0.5 mL, no preservative (3) ␣ Multi-dose vial, 5 mL, contains thimerosal, a mercury derivative, added as a
10 September 2009_v0.3 LE5860-5862
-------------------------------CONTRAINDICATIONS------------ ␣ Severe hypersensitivity to egg proteins or any component of the vaccine
or life-threatening reactions after previous administration of any influenza vaccine. (4, 11)
-----------------------WARNINGS AND PRECAUTIONS--------------------- ␣ If Guillain-Barré syndrome (GBS) has occurred within 6 weeks of
previous influenza vaccination, the decision to give Influenza A (H1N1) 2009 Monovalent Vaccine should be based on careful consideration of the potential benefits and risks. (5.1)
␣ Immunocompromised persons may have a reduced immune response to Influenza A (H1N1) 2009 Monovalent Vaccine. (5.2)
------------------------------ADVERSE REACTIONS-------------- Adverse reaction information is based on studies conducted with seasonal trivalent Influenza Virus Vaccine. ␣ Most common (≥10%) local reactions were soreness at injection site,
tenderness, pain, and swelling. (6) ␣ Most common (≥10%) systemic events were malaise, headache, and
myalgia. (6)
To report SUSPECTED ADVERSE REACTIONS, contact Sanofi Pasteur Inc., Discovery Drive, Swiftwater, PA 18370 at 1-800-822-2463 (1-800-VACCINE) or VAERS at 1-800-822-7967 or http://vaers.hhs.gov.
------------------------------DRUG INTERACTIONS-------------- ␣ Do not mix with other vaccines in the same syringe or vial. (7.1) ␣ Immunosuppressive therapies may reduce the immune response to
Influenza A (H1N1) 2009 Monovalent Vaccine. (7.2)
-----------------------USE IN SPECIFIC POPULATIONS------- Information in this section is based on seasonal trivalent Influenza Virus Vaccine manufactured by Sanofi Pasteur Inc. (Fluzone vaccine). ␣ Safety and effectiveness of Influenza A (H1N1) 2009 Monovalent
Vaccine have not been established in pregnant women or nursing mothers
or children <6 months of age. (8.1, 8.3, 8.4) ␣ Antibody responses to Fluzone vaccine were lower in the geriatric
population than in younger adults. (8.5) See 17 PATIENT_COUNSELING_INFORMATION.
preservative. Each 0.5 mL dose contains 25 mcg mercury. (3, 11 ) _______________________________________________________________________________________________________________________________________
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION
2.1 Preparation for Administration
2.2 Recommended Dose and Schedule 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS
5.1 Guillain-Barré Syndrome 5.2 Altered Immunocompetence 5.3 Preventing and Managing Allergic Reaction 5.4 Limitations of Vaccine Effectiveness
6 ADVERSE REACTIONS
6.1 Clinical Trial Experience 6.2 Post-Marketing Experience 6.3 Other Adverse Events Associated with Influenza Vaccines
7 DRUG INTERACTIONS
7.1 Concomitant Administration with other Vaccines 7.2 Immunosuppressive Therapies
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy 8.3 Nursing Mothers 8.4 Pediatric Use 8.5 Geriatric Use
11 DESCRIPTION 12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action 13 NON-CLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 14 CLINICAL STUDIES
14.1 Immunogenicity in the Adult and Geriatric Population
14.2 Immunogenicity in Children 15 REFERENCES 16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied
16.2 Storage and Handling 17 PATIENT COUNSELING INFORMATION
*Sections or subsections omitted from the full prescribing information are not listed.
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1 FULL PRESCRIBING INFORMATION:
2 1. INDICATIONS AND USAGE
3 Influenza A (H1N1) 2009 Monovalent Vaccine is an inactivated influenza virus vaccine 4 indicated for active immunization of persons 6 months of age and older against influenza disease 5 caused by pandemic (H1N1) 2009 virus. 6
7 2. DOSAGE AND ADMINISTRATION
8
2.1. Preparation for Administration
9 Inspect Influenza A (H1N1) 2009 Monovalent Vaccine syringes and vials visually for particulate 10 matter and/or discoloration prior to administration. If either of these conditions exist, the vaccine 11 should not be administered. 12
13 Shake the syringe and single-dose vials well before administering the vaccine and shake the 14 multi-dose vial each time before withdrawing a dose of vaccine. 15 16 2.2. Recommended Dose and Schedule
17 Clinical studies are ongoing with Influenza A (H1N1) 2009 Monovalent Vaccine to determine 18 the optimal dosage, number of doses and schedule. 19 20 Available data show that children 9 years of age and younger are largely serologically naive to 21 the pandemic (H1N1) 2009 virus. (1) Based upon these data Influenza A (H1N1) 2009
22 Monovalent Vaccine should be administered as follows:
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1 2 Children 3 Children 6 through 35 months of age should receive two 0.25 mL intramuscular doses 4 approximately 1 month apart. (1) 5 6 Children 36 months through 9 years of age should receive two 0.5 mL intramuscular doses 7 approximately 1 month apart. (1) 8 9 Children 10 years of age and older should receive a single 0.5 mL intramuscular dose. (1)
10 11 The preferred sites for intramuscular injections are the anterolateral aspect of the thigh in infants 12 or the deltoid muscle of the upper arm in toddlers and young children. 13 14 The vaccine should not be injected into the gluteal region or into areas where there may be a 15 major nerve trunk. 16 17 Adults 18 Persons 18 years of age and older should receive a single 0.5 mL intramuscular dose. 19 20 In adults, the preferred site for intramuscular injection is the deltoid muscle. 21
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1 The vaccine should not be injected into the gluteal region or into areas where there may be a 2 major nerve trunk. 3
4 3. DOSAGE FORMS AND STRENGTHS 5 Influenza A (H1N1) 2009 Monovalent Vaccine is a sterile suspension for intramuscular
6 injection. [See Description (11)] 7 8 Influenza A (H1N1) 2009 Monovalent Vaccine is supplied in 4 presentations:
Prefilled syringe, 0.25 mL, no preservative, for 6 through 35 months of age; distinguished by a pink syringe plunger rod; Prefilled syringe, 0.5 mL, no preservative, for 36 months of age and older; Single-dose vial, 0.5 mL, no preservative, for 36 months of age and older;
Multi-dose vial, 5 mL, for 6 months of age and older, contains thimerosal, a mercury derivative, added as a preservative. Each 0.5 mL dose contains 25 micrograms (mcg) mercury.
17 4. 18 Do not administer Influenza A (H1N1) 2009 Monovalent Vaccine to anyone with a known severe hypersensitivity to egg proteins or any component of the vaccine or life-threatening reactions after previous administration of any influenza vaccine. [See Warnings and Precautions 21 (5) and Description (11)]
5. WARNINGS AND PRECAUTIONS
Confidential/Proprietary Information
CONTRAINDICATIONS
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1 5.1. Guillain-Barré Syndrome
2 Recurrence of Guillain-Barré syndrome (GBS) has been temporally associated with the 3 administration of influenza vaccine. The decision to give Influenza A (H1N1) 2009 Monovalent 4 Vaccine to individuals who have a prior history of Guillain-Barré syndrome should be based on 5 careful consideration of the potential benefits and risks. 6 7 5.2. Altered Immunocompetence
8 If Influenza A (H1N1) 2009 Monovalent Vaccine is administered to immunocompromised
9 persons, including those receiving immunosuppressive therapy, the immune response may be 10 diminished. 11 12
5.3. Preventing and Managing Allergic Reaction
13 Appropriate medical treatment and supervision must be available to manage possible 14 anaphylactic reactions following administration of the vaccine. 15 16 5.4. Limitations of Vaccine Effectiveness
17 Vaccination with Influenza A (H1N1) 2009 Monovalent Vaccine may not protect all recipients. 18
19
6. ADVERSE REACTIONS
20 Sanofi Pasteur’s Influenza A (H1N1) 2009 Monovalent Vaccine and seasonal trivalent Influenza
21 Virus Vaccine (Fluzone®) are manufactured by the same process. The following sub-sections
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1 summarize safety data from clinical experience with seasonal trivalent inactivated influenza 2 vaccines, including Fluzone vaccine. 3
6.1. Clinical Trial Experience
4 Adverse event information from clinical trials provides the basis for identifying adverse events 5 that appear to be related to vaccine use and for approximating the rates of these events. However, 6 because clinical trials are conducted under widely varying conditions, adverse event rates 7 observed in the clinical trials of a vaccine cannot be directly compared to rates in the clinical trial 8 of another vaccine, and may not reflect the rates observed in practice. 9
10 Adults and Geriatrics 11 In placebo-controlled studies among adults, the most frequent side effect of vaccination is soreness 12 at the vaccination site (affecting 10%–64% of patients) that lasts <2 days, local pain and swelling. 13 These local reactions typically are mild. Fever, malaise, myalgia, and other systemic symptoms can 14 occur following vaccination and most often affect persons who have had no prior exposure to the 15 influenza virus antigens in the vaccine (e.g., young children). These reactions begin 6–12 hours 16 after vaccination and can persist for 1–2 days. Placebo-controlled trials demonstrate that among 17 older persons and healthy young adults, administration of split-virus influenza vaccine is not 18 associated with higher rates of systemic symptoms (e.g., fever, malaise, myalgia, and headache) 19 when compared with placebo injections. (2) 20
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1 Children 2 The 2003-2004 formulation of Fluzone vaccine was studied in 19 children 6 to 23 months of age 3 and in 12 children 24 to 36 months of age, given in 2 doses one month apart. Local reactions and 4 systemic events were solicited for 3 days after each dose. Most local and systemic reactions were 5 mild. The proportions of local and systemic reactions in children were similar to the proportions 6 in adults. No reported local or systemic reaction required a therapeutic intervention other than 7 analgesics. (3) 8 9
6.2. Post-Marketing Experience
10 The following additional events have been reported during post-approval use of Fluzone vaccine. 11 Because these events are reported voluntarily from a population of uncertain size, it is not always 12 possible to reliably estimate their frequency or establish a causal relationship to vaccine 13 exposure.
14 15 Blood and Lymphatic System Disorders: Thrombocytopenia, lymphadenopathy 16 17 Immune System Disorders: Anaphylaxis, other allergic/hypersensitivity reactions (including 18 urticaria, angioedema) 19 20 Nervous System Disorders: GBS, convulsions, myelitis (including encephalomyelitis and 21 transverse myelitis), facial palsy (Bell’s palsy), optic neuritis/neuropathy, brachial neuritis, 22 syncope (shortly after vaccination), dizziness, paresthesia
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1 2 Vascular Disorders: Vasculitis, vasodilation/flushing 3 4 Respiratory, Thoracic and Mediastinal Disorders: Dyspnea, pharyngitis, rhinitis 5 6 Skin and Subcutaneous Tissue Disorders: Stevens-Johnson syndrome 7 8 General Disorders and Administration Site Conditions: Fever, pain, pruritis, asthenia/fatigue, 9 pain in extremities, chest pain
10 11
6.3. Other Adverse Events Associated with Influenza Vaccines
12 Anaphylaxis has been reported after administration of influenza vaccines. Although Influenza A 13 (H1N1) 2009 Monovalent Vaccine contains only a limited quantity of egg protein, this protein 14 can induce immediate hypersensitivity reactions among persons who have severe egg allergy. 15 Allergic reactions include hives, angioedema, allergic asthma, and systemic anaphylaxis. [See 16 Contraindications (4)]
17 18 The 1976 swine influenza vaccine was associated with an increased frequency of Guillain-Barré 19 syndrome (GBS). Evidence for a causal relation of GBS with subsequent vaccines prepared from 20 other influenza viruses is unclear. If influenza vaccine does pose a risk, it is probably slightly 21 more than 1 additional case/1 million persons vaccinated. 22
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1 Neurological disorders temporally associated with influenza vaccination such as encephalopathy, 2 optic neuritis/neuropathy, partial facial paralysis, and brachial plexus neuropathy have been 3 reported. 4
5 Microscopic polyangitis (vasculitis) has been reported temporally associated with influenza 6 vaccination. 7
8
7. DRUG INTERACTIONS
9
7.1. Concomitant Administration with Other Vaccines
10 There are no data on the concomitant administration of Influenza A (H1N1) 2009 Monovalent 11 V accine with seasonal trivalent influenza vaccines. 12 13 Influenza A (H1N1) 2009 Monovalent Vaccine should not be mixed with any other vaccine in 14 the same syringe or vial.
15 16 If Influenza A (H1N1) 2009 Monovalent Vaccine is to be given at the same time as another 17 injectable vaccine(s), the vaccine(s) should always be administered at different injection sites. 18 19 7.2. Immunosuppressive Therapies
20 If Influenza A (H1N1) 2009 Monovalent Vaccine is administered to immunosuppressed persons 21 or persons receiving immunosuppressive therapy, immunologic response may be diminished. 22
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1
8. USE IN SPECIFIC POPULATIONS 2 Sanofi Pasteur’s Influenza A (H1N1) 2009 Monovalent Vaccine and seasonal trivalent Influenza
3 Virus Vaccine (Fluzone vaccine) are manufactured by the same process. Available information 4 for Fluzone vaccine is provided in this section. 5
8.1. Pregnancy
6 Pregnancy Category C: Animal reproduction studies have not been conducted with Influenza A 7 (H1N1) 2009 Monovalent Vaccine or Fluzone vaccine. It is also not known whether these 8 vaccines can cause fetal harm when administered to a pregnant woman or can affect reproduction 9 capacity. Influenza A (H1N1) 2009 Monovalent Vaccine should be given to a pregnant woman
10 only if clearly needed. 11 12
8.3. Nursing Mothers
13 It is not known whether Influenza A (H1N1) 2009 Monovalent Vaccine or Fluzone vaccine is 14 excreted in human milk. Because many drugs are excreted in human milk, caution should be 15 exercised when this vaccine is administered to a nursing woman. 16
17
8.4. Pediatric Use
18 Safety and effectiveness in pediatric subjects below the age of 6 months have not been 19 established. The immune response and safety of Fluzone vaccine was evaluated in 31 children 20 between the ages of 6-26 months. [See Adverse Reactions (6.1), Clinical Studies (14)] 21 22
8.5. Geriatric Use
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1 Immune response to Fluzone vaccine in subjects older than 61 years of age were lower when 2 compared to immune responses in adults 19-59 years of age. [See Clinical Studies (14)] 3
4
11. DESCRIPTION 5
6 Influenza A (H1N1) 2009 Monovalent Vaccine, an inactivated influenza virus vaccine, for 7 intramuscular use, is prepared from influenza viruses propagated in embryonated chicken eggs. 8 The virus-containing allantoic fluid is harvested and inactivated with formaldehyde. Influenza 9 virus is concentrated and purified in a linear sucrose density gradient solution using a continuous
10 flow centrifuge. The virus is then chemically disrupted using a non-ionic surfactant, polyethylene 11 glycol p-isooctylphenyl ether (Triton® X-100), producing a “split virus”. The split virus is further 12 purified and then suspended in sodium phosphate-buffered isotonic sodium chloride solution. 13
14 Influenza A (H1N1) 2009 Monovalent Vaccine is formulated to contain 15 mcg hemagglutinin 15 (HA) of influenza A/California/07/2009 (H1N1) v-like virus per 0.5 mL dose. Gelatin 0.05% is 16 added as a stabilizer. Each 0.5 mL dose may contain residual amounts of formaldehyde (not 17 more than 100 mcg), polyethylene glycol p-isooctylphenyl ether (not more than 0.02%), and 18 sucrose (not more than 2.0%).
19
20 There is no thimerosal used in the manufacturing process of the single-dose presentations of
21 Influenza A (H1N1) 2009 Monovalent Vaccine. The multi-dose presentation of Influenza A
22 (H1N1) 2009 Monovalent Vaccine contains thimerosal, a mercury derivative, added as a
23 preservative. Each 0.5 mL dose of the multidose presentation contains 25 mcg mercury.
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449/454 Influenza A (H1N1) 2009 Monovalent Vaccine
LE5860-5862
1 2 Influenza A (H1N1) 2009 Monvalent Vaccine is a sterile clear to a slightly opalescent 3 suspension. 4 5 Antibiotics are not used in the manufacture of Influenza A (H1N1) 2009 Monovalent Vaccine. 6 7 All presentations of Influenza A (H1N1) 2009 Monovalent Vaccine do not contain latex. 8
9
12. CLINICAL PHARMACOLOGY
10
12.1. Mechanism of Action
11 Influenza illness and its complications follow infection with influenza viruses. Global 12 surveillance of influenza identifies yearly antigenic variants. For example, since 1977, antigenic 13 variants of influenza A (H1N1 and H3N2) viruses and influenza B viruses have been in global 14 circulation. Specific levels of hemagglutinin inhibition (HI) antibody titer post-vaccination with 15 inactivated influenza virus vaccines have not been correlated with protection from influenza 16 virus infection. In some human studies, antibody titer of ≥1:40 have been associated with 17 protection from influenza illness in up to 50% of subjects. (4) (5) 18 19 Antibodies against one influenza virus type or subtype confer limited or no protection against 20 another. Furthermore, antibodies to one antigenic variant of influenza virus might not protect 21 against a new antigenic variant of the same type or subtype. Frequent development of antigenic
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1 variants through antigenic drift is the virologic basis for seasonal epidemics and the reason for 2 the usual change of one or more new strains in each year's influenza vaccine. 3
4
13. NON-CLINICAL TOXICOLOGY
5
13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility
6 Neither Fluzone vaccine nor Influenza A (H1N1) 2009 Monovalent Vaccine have been evaluated 7 for carcinogenic or mutagenic potential, or for impairment of fertility. 8
9
14. CLINICAL STUDIES 10 Sanofi Pasteur’s Influenza A (H1N1) 2009 Monovalent Vaccine and seasonal trivalent Influenza
11 Virus Vaccine (Fluzone vaccine) are manufactured by the same process. Data in this section 12 were obtained in clinical studies conducted with Fluzone vaccine. 13 14
14.1. Immunogenicity in the Adult and Geriatric Population
15 In an observational study of the immunogenicity of Fluzone vaccine in a geriatric population 16 (median age: 72.0 range: 61 to 86 years of age) compared with younger adults (median age: 38.0 17 range: 19 to 59 years of age; racial distribution was 2 Asian, 11 Black, 106 Caucasian, and 2 18 other; no gender data were available), the following results were obtained using a single-dose of 19 the year 1999–2000 formulation of Fluzone vaccine. (See Table 1.) Antibody levels were 20 obtained on the day of and just prior to vaccination and approximately 21 days after vaccination. 21 (4)
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1 Table 1: Geometric Mean Titer (GMT) and Percentage (%) Achieving an HI Titer ≥1:40 2 (N = 58-62) in Adults and the Elderly (after vaccination with Fluzone vaccine)
3 N = Number of participants 4 5
14.2. Immunogenicity in Children
6 In a study using 2 doses of Fluzone vaccine (2003-2004) in 31 healthy children 6–36 months of 7 age (3 Black, 23 Caucasian, 2 Hispanic, and 3 other; 15 were male and 16 were female), the 8 following immunogenicity results were obtained on day 0 before vaccination and approximately 9 14 days after dose number 2. (See Table 2.)
1 15. REFERENCES
Centers for Disease Control and Prevention. Serum Cross-Reactive Antibody Response to a Novel Influenza A (H1N1) Virus After Vaccination with Seasonal Influenza Vaccine. MMWR 2009;58(19):521-524.
Centers for Disease Control and Prevention. Prevention and Control of Influenza: Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 2009;58(RR08):1-52.
Sanofi Pasteur Inc. Data on file, 071107.
Hannoun C et al. Immunogenicity and protective efficacy of influenza vaccination. Virus Res 2004;103:133-138
Hobson D, et al. The role of serum hemagglutinin-inhibiting antibody in protection against challenge infection with influenza A2 and B viruses J Hyg Camb 1972;70:767-777.
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1 16. HOW SUPPLIED/STORAGE AND HANDLING
2
16.1. How Supplied
3 Single-dose prefilled syringe, without needle, 0.25 mL, package of 10 prefilled syringes per 4 carton – Product No. NDC 49281-650-25. 5 6 Single-dose prefilled syringe, without needle, 0.25 mL, package of 25 prefilled syringes per 7 carton – Product No. NDC 49281-650-70.
8
9 Single-dose prefilled syringe, without needle, 0.5 mL, package of 10 prefilled syringes per carton 10 – Product No. NDC 49281-650-50. 11 12 Single-dose prefilled syringe, without needle, 0.5 mL, package of 25 prefilled syringes per carton 13 – Product No. NDC 49281-650-90.
14 15 Single-dose vial, 0.5 mL, package of 10 vials per carton – Product No. NDC 49281-650-10. 16 17 Multi-dose vial, 5 mL, one vial per carton. The vial contains ten 0.5 mL doses – Product No. NDC 18 49281-640-15. 19 20 Vial stoppers and syringe plungers do not contain latex. 21 22 16.2. Storage and Handling
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1 Store all Influenza A (H1N1) 2009 Monovalent Vaccine presentations refrigerated at 2° to 8°C 2 (35° to 46°F). DO NOT FREEZE. Discard if vaccine has been frozen. 3 4 Between uses, return the multi-dose vial to the recommended storage conditions at 2o to 8oC (35o 5 to 46oF).
6 7 Do not use after the expiration date shown on the label. 8
9 17. 10 •
PATIENT COUNSELING INFORMATION
Inform vaccine recipients or guardians that Influenza A (H1N1) 2009 Monovalent Vaccine contains killed viruses and cannot cause influenza. Inform vaccine recipients or guardians that there are two influenza vaccine formulations for this influenza season, the monovalent vaccine against influenza disease caused by pandemic (H1N1) 2009 virus and seasonal trivalent influenza vaccine.
Instruct vaccine recipients or guardians to report any severe or unusual adverse reactions to their health care provider.
11 12 • 13 14 15 • 16 17 18 19 20 21 22 23 Manufactured by:
Product information as of September 2009.
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1 2 3 4
5
Sanofi Pasteur Inc.
Swiftwater PA 18370 USA
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Influenza A, Gripe A and H1N1 Vaccine - My research report
As you know, I am a member of the British Psychological Society and the British Mensa Society. My background is in Psychology and Natural Medicine but within both fields I had to study a part of conventional science; not enough to be qualified to conduct my own scientific laboratory research, but enough to be able to bring you informed research from reliable medical sources - if there is such a thing nowadays. I say that because most scientific research nowadays has some invested interest somewhere, and results are sometimes dependent on who’s funding it.
Just recently, I’ve been engaged in more conversations about the swine flu (Influenza A or Gripe A) and the H1N1 vaccine than I care to mention. Many of my colleagues have had the vaccine and some have suffered adverse reactions to it; from headaches to vomiting. However, the biggest plea I received was from my mother who has also been vaccinated. She asked me to please prove the vaccine was safe and that it couldn’t cause cancer.
So, I decided to carry out my own independent research a) to see what I could come up with and b) to inform everyone, in simple terms, about the pros and cons of the vaccine and the flu itself.
I’ve tried to put together material from as reliable and accurate sources as possible. Please consider it very carefully and make your own formulated opinion. Please also consider that since I am not a laboratory researcher, I can only give you facts and data collated by third party scientists in their own research environments.
I wish I could be the one to give my mother good news but I’m not sure I can. My conclusion is that the vaccine does contain known cancer causing substances that are toxic to humans. However, there is some discrepancy as to what dosages are considered highly toxic. So, at this point nobody can predict what the long term side effects will be. Furthermore, everybody’s body will react in a different way; just as some people can smoke all their lives and never develop cancer, whilst others can’t.
By the same token, I can say that one of the vaccines being manufactured does contain a substance that, in laboratory rats, has been known to act as an anti-chemical carcinogenesis. Whether this works in humans is still unknown since clinical trials, with humans, have not yet been carried out.
I think, in all honesty, only the future will tell.
I’ve tried to do my best to bring you the breakdown of the chemical ingredients in the vaccine, and what they’re used for. The rest is up to you to get more information, be aware, take responsibility and do your due diligence.
Be safe. I value every living being.
Background Information
There is a wealth of information on the Internet about the Influenza A. I am not going to reiterate here. However, the “so-called” swine flu first appeared in 1918. It was responsible for the death of between 50 - 100 million people worldwide. It primarily claimed the lives of healthy adults between the ages of 20 and 40. Why? Because it caused something called a cytokine response - what is this?
It’s a term used to describe when the body’s immune system goes into overdrive at defending our organism against harmful external viruses. Basically, the more healthy a body is, the harder it fights off external threats. The harder it fights, the more it goes into overdrive until it, basically, send the system into tilt.
Weaker immune systems, as found in younger people, children, babies and elderly people have slower and weaker responses, which placed them out of the common death claiming range.
I didn’t find any documented evidence that suggested the 2009 Influenza A claimed any lives due to the cytokine response. However, I did find evidence that there is a mutated version of the Influenza A, which has claimed the lives of (maybe) 6 people worldwide. Whether these facts, figures and data are correct is unknown; since we cannot rely on the Media nowadays to duly and accurately inform us.
However, there are a lot of factors that need to be considered when we look at the 1918 death toll. It was war time. Hygiene standards, on a global scale, were much lower. People suffered with malnutrition in areas that nowadays don’t. Troops were constantly on the move, and in great numbers on a global scale, hence the contamination process was greatly aided and speeded up. There was less awareness about the contamination process itself. Little was known about viral infections in general. We didn’t have micro-medications we have today. The list could go on.
Of course, there would also be conspiracy theorists who would have us believe the H1N1 was a laboratory manufactured virus, as a type of biological warfare; specifically designed to eliminate a certain age group of the population in order to end, and win, the war. Personally, I do not believe this as there were too many casualties on all sides.
The 1918 Influenza A didn’t just disappear as many would have us believe. It apparently weakened itself over time, as many viruses do, but lay dormant somehow; somewhere. It reappeared again in 1937.
The scandalous facts about the 1937 outbreak is that scientists in the UK and the United States used patients, they describe as “feebleminded” at various psychiatric institutions as human guinea pigs for live anti-viral testing. Yes, you read it correctly. Scientists injected about a third of the patients, across various institutions at various locations, with a vaccine containing “live” Influenza A virus; no doubt without written consent. http://aje.oxfordjournals.org/cgi/pdf_extract/35/1/55
If you follow the link above, to the article written in 1941, what amazes me is how scientists report patients were inoculated, and I quote, 5 to 10 weeks before the onset of an Influenza epidemic. We have two choices here: a) we can think that any serious Influenza, at that time was considered an Influenza A, or that somehow the relaunch of the Influenza A (of which by definition of gene content there is only one associated with the Swine flu) was premeditated in a bid to use more humans as guinea pigs.
In 1946/47, there was another outbreak of Influenza that apparently started in Japan. People were inoculated with a milder strain of the H1N1 vaccine but it proved to be a complete failure. Even nowadays, the H1N1 vaccine will not protect you from the swine flu nor any of its mutations thereof.
In 1957, 1968, 1976, 1977 there were more minor outbreaks of various types of Influenza; including the H1N1 that struck people who hadn’t had it previously. Of course, then, closer to the 21st century we’ve had the Avian Influenza and now we have the new H1N1 again.
An interesting fact I came across is that in 2008, in a bid to study the Avian Influenza virus, scientists exhumed the body of a man who died during the 1918/1919 pandemic. He was buried in a lead coffin, which could have very well preserved the H1N1 virus. I’ll leave it to you to think what you will.
So, I come to the modern day 2009 Influenza A. You’ve all heard about it. You all know what it is and how it can affect you. You all know what steps you can take to avoid contamination and spreading. So, I’m not going to go into any details here. What I will say though is that more people have died from a common flu than from the Influenza A.
It’s the Media hype that has blown it out of control and disseminated fear into our minds with a little help from the pharmaceutical companies who have an invested interest in making billion and billions of dollars; not just in the short term, with the vaccines, but in the long term as well, with the potential side effects the vaccines could have in a large proportion of individuals that have it.
Current Manufacturers of the Influenza A (H1N1) vaccine
To date, I have found 5 major manufacturers of the Influenza A vaccine. They are: Sanofi Pasteur, Novartis Vaccines and Diagnostics Limited, CSL Limited, ID Biomedical Corporation of Qebec and MedImmune, LLC. The vaccine produced by ID Biomedical Corporation of Qebec is being distributed by Glaxo Smithkline Beecham.
As a matter of curiosity, I went digging around for financial reports for all the pharmaceutical companies mentioned above. As with all businesses, they suffered losses due to the economic crisis the world has been facing. Stocks had fallen. Yet, they are rising again slowly since the advent of the “hearsay” Influenza A epidemic.
As anyone who deals in stocks and shares will know, the more a rumour is spread, the more likely it is a product will sell. The more likely it is that a product will sell, the more likely it is a company will find investors or the more likely it is prices of stock will go up and the company makes money all round.
Far be it for me to be a sceptic, but in a world where economic growth is at an all time slow and world markets show no sign of immediate recovery, perhaps the banks and the big boys behind wall street, (and most of the global power), found a window of opportunity to increase their bank balances, recover their losses and guarantee an income for the coming years.
How? Simple, develop a vaccine that, theoretically, does little or nothing against the Influenza A, yet injects people with toxic substances that in the long term might have detrimental effects on their health, and ensure they require more medication in the future. More medication equals more guaranteed income for the pharmaceutical companies. I hate to say this but it’s also a way to control the population count.
I’d like to just say here that I am not in any way a conspiracy theorist. I look at the given facts before coming to any conclusions. The facts, in this case, are exemplified by the Polio vaccine first introduce in 1955. By 1961, the vaccine was declared unsafe for human consumption because it was thought to be contaminated with a substance called SV40, a carcinogen that came from infected monkeys.
Yet, that very same vaccine continued to be used well into the year 2000 on a global scale. Hundreds of millions of people worldwide have potentially been exposed to this silent killer. In some, the effects have become apparent. Sufferers in whom cancer has already developed, relatives of people who died and/or some people who have become or became paralysed, because of the vaccine, have carried out lawsuits. You can find more information on the net by searching for links between polio vaccines and paralysis lawsuits.
With the new H1N1 vaccine, as far as I am aware, the pharmaceutical companies have a clause that stipulates they cannot be brought into a court of law should anyone suffer any side effects. This clause alone begs the question: “Why?”
It’s my humble opinion we do not question enough what we allow medics to put into our bodies. We do not investigate enough. We place too much trust in the hands of our doctors and the Media. It doesn’t take a medical degree to ask what something is and what it is used for, and nowadays we have no excuse. Information is everywhere.
Prior to the current manufacturers of the vaccine H1N1, Baxter International Inc. developed a vaccine that contained H5N1 (avian flu virus) and H3N2 (seasonal flu viruses.) In experiments, ferrets were found to die from the vaccine, which suggested the H5N1 virus was live. If this substance had been injected into humans it could have had disastrous consequences.
Human beings could have acted as incubators for a new crossbreed virus that could have then been transmitted from one being to another. The vaccine went out. It was discovered by pure accident. However, it is now said that all known batches of the Baxter vaccine have been recalled.
Human errors happen. Accidents happen. Researchers, scientists, doctors, nurses; nobody is infallible. It’s our responsibility to safeguard ourselves from others’ errors.
H1N1 Vaccine - “Known” Ingredients
This is the list of ingredients contained within the vaccines that I’ve been able to find so far. As you will see, different pharmaceutical companies are using slightly different ingredients. I have no idea if there are other “unmentioned” ingredients as I cannot get my hands on all the packaging labels that come with the actual vaccines (as of yet.)
Sanofi Pasteur
Formaldehyde, Gelatin, Sucrose, Thimerosal, Sodium chloride, Sodium phosphate, Chick embryo cells, Triton X-100, Polyethylene glycol.
Novartis Vaccines and Diagnostics Limited,
Beta-propiolactone, Neomycin, Polymyxin B, Thimerosal, Mercury, Chick embryo cells, Egg protein, Nonylphenol ethoxylate.
CSL Limited,
Beta-propiolactone, Polymyxin B, Sucrose, Thimerosal, Mercury, Sodium chloride, Sodium phosphate-monobasic, Ovalbumin (egg), Chick embryo cells, Neomycin sulphate, Calcium chloride, Sodium phosphate- dibasic anhydrous, Potassium phosphate- monobasic, Sodium taurodeoxycholate, Triton X-100.
ID Biomedical Corporation of Qebec
Formaldehyde, Thimerosal, Mercury, Ovalbumin (egg), Egg protein, Virus: Influenza virus antigens, Sodium deoxycholate.
MedImmune, LLC.
Gentamicin Sulfate, Gelatin, Monosodium Glutamate (MSG), Sucrose, Potassium phosphate, Chick embryo cells, Potassium phosphate- monobasic, Arginine.
Please note that anyone suffering with egg allergies should not go anywhere near the vaccine.
Know these ingredients - What are they?
I am not going to describe every ingredient in detail, as I am sure you know what many of them are; like sucrose (sugar), gelatin (which can cause allergies in some people), ovalbumin (egg or egg protein), sodium (salt) and so on. However, I am going to bring to your attention the most important ones that need very careful reflection.
Formaldehyde
As many of you probably already know, Formaldehyde is a colourless and odourless substance that was once used in building materials; in resin form for insulating foam, as an adhesive and to treat textiles. Its primary function was to act as a fungicide, sterilizer and germicide. It’s also used in morgues and laboratories (in liquid form) as embalming fluid and to preserve bodies. Formaldehyde is actually naturally present in the atmosphere in very small quantities because every living organism produces and emits a tiny amount of it.
Different people have different reactions to over-exposure to Formaldehyde and, of course, the severity of symptoms depends on the amount of exposure.
According to the U.S Goverment’s National Cancer Institute website information and the International Agency for Research on Cancer (World Health Organization) - http://www.cancer.gov/cancertopics/factsheet/risk/formaldehyde - http://monographs.iarc.fr/ENG/Monographs/vol88/index.php - studies have been carried out, on a global scale, since the 1980s to see just what the effects of Formaldehyde are.
In 1980, Formaldehyde was found to cause nasal cancer in rats. In 1987 Formaldehyde was declared a cancer causing substance for humans (carcinogen) and found to be associated with different types of cancers. In fact, in 1988 and again in 2003, scientists in the United States and the United Kingdom found a serious relationship between over-exposure to Formaldehyde and deaths caused by lung cancer in industries where Formaldehyde was being used as a chemical agent. (http://monographs.iarc.fr/ENG/Monographs/vol88/mono88-6B.pdf) - In Denmark, Formaldehyde was associated with lung, kidney, colon and nasal cancer in a study carried out by Hansen and Olsen. http://www.springerlink.com/content/w632326683541334/ The list and studies go on. I suggest you follow the links if you’re interested in the full research findings.
Pregnant women who were exposed to Formaldehyde have been known to give birth to deformed babies. There were known cases studied in China, UK and US. In fact, just recently I was talking to a friend about the UK being one of the first countries in the world to pay compensation to mothers, of deformed babies through exposure to Formaldehyde, who sought legal action.
Why would the World Health Organization, any Government or any Health organisation knowingly approve that we be injected with a substance, (no matter in how much of a small dosage), that they themselves officially declared as a carcinogen?
Tween 80 (also known as Polysorbate 80)
First of all, Tween 80 is a drug used to trick the blood brain barrier to open up so that nano-drugs can be carried through into the brain. However, in 2005, it was discovered that this drug can cause hives, breathing problems and a sharp enough drop in blood pressure to actually be fatal. Aside from this, it was found to cause infertility in mice.
I quote: http://www.whale.to/v/tween_80.html
According to the World Intellectual Property Organization, which is part of the United Nations, scientists from the organization are developing vaccines specifically to damage fertility as a method of contraception. A suggested ingredient for the vaccine is tween 80 (polysorbate 80): “In a preferred embodiment the vaccine comprises oil, preferably a biodegradable oil such as squalene oil. Typically, the vaccine is prepared using an adjuvant concentrate which contains lecithin in squalene oil. The aqueous solution glycoprotein is typically a phosphate-buffered saline (PBS) solution, and additionally preferably contains Tween 80.” (Fertility Impairing Vaccine And Methods of Use’ This application claims the benefit of U. S. Provisional Application No. 60/070,375, filed January 2,1998, U. S. Provisional Application No. 60/071,406, filed January 15,1998.) Exploring Vaccines
You will see, from what I have highlighted in red and orange that a couple of questions arise:
a) Are the pharmaceutical companies trying to control the number of future births; on a global scale?
b) Or, are they trying to subsequently cash in on fertility treatments? Think about this, with each treatment costing between 2,000 to 5,000 US dollars, just how much would they stand to cash in on if a third of the global population was sterile? After all, is it not nearly every couple’s dream to have a child?
Thimerosal and Mercury
Thimerosal is a type of Mercury used as a preservative. So, I am shocked to find that the H1N1 has both Thimerosal and Mercury contained within the vaccine. Both elements have been declared dangerous to health and linked to autism in children, cardiovascular disease in adults, brain tissue damage and other malfunctions of the nervous system.
For years, the FDA in the United States has admitted that Mercury is toxic. For years, it has been reviewing what quantities can be excreted from the body safely. Yet, regardless of the amount of research carried out, the answer is: we still don’t know. Scientists still don’t know. For years the FDA has been campaigning to remove Thimerosal altogether from vaccines. Yet, pharmaceutical companies are still selling vaccines with Mercury and Thimerosal, and the FDA are still approving them. Why?
You can read full reports on Thimerosal and Mercury here:
http://www.naturalnews.com/011764.html
http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/VaccineSafety/UCM096228
Triton X-100
Commonly used as a spermicide. Also used as a detergent and a solvent for vinyl record cleaning.
Polyethylene glycol
I find the inclusion of this ingredient very interesting. Apparently, to date, it is a known anti-chemical carcinogenesis in laboratory rats. However, whether or not it can prevent the development of cancer in humans is not yet known because, (as far as I could find out), there haven’t been any human clinical trials yet.
I have to wonder, though, if the inclusion of this substance in the H1N1 vaccine is part of a live clinical trial. Think what you will.
Squalene - Although it’s not on the official packaging, we know it’s being used.
Squalene is an oil that derives from sharks’ liver primarily and some plants as well. It’s used in cosmetics because it’s easily absorbed through the skin and doesn’t leave an oily after-feeling. In medicine, it’s added to vaccines to stimulate the immune system’s response because it enhance the production of what are known as CD4 memory cells. However, squalene has never been approved for this usage by the FDA.
I quote: http://www.novaccine.com/vaccine-ingredients/results.asp?sc=27
"Animals injected with squalene always develop painful, incurable, autoimmune diseases like multiple sclerosis, rheumatoid arthritis or systemic lupus according to investigative journalist Gary Matsumoto, former reporter for NBC and Fox News. (Gary Matsumoto, Vaccine A: The Covert Government Experiment That's Killing Our Soldiers and Why GIs Are Only the First Victims, Basic Books, 2004) Dangers of squalene have been known since 1956 when Dr. Jules Freund, creator of this oil-based adjuvant, warned that animals injected with his formulation developed terrible, incurable conditions: allergic aspermatogenesis (stoppage of sperm production), experimental allergic encephalomyelitis (the animal version of MS), allergic neuritis (inflammation of the nerves that can lead to paralysis) and other severe autoimmune disorders. Squalene (MF 59) was added to the anthrax vaccine. This vaccine caused tens of thousands of U.S. Iraq Desert Storm soldiers to suffer permanent neurological damage called “Gulf War Illness.” (Jane Bergermeister, Adjuvants to be added to H1N1 vaccine by Baxter and WHO programme body for “endless loop of self-destruction, 2009) Squalene (MF 59) enzyme is not approved for human consumption but waived for use in the H1N1 vaccine. It also potentially causes “undiscovered side effects” according to Jefferson, Mercola and others. "
Deborah Dupre, Examiner.com -- 8/18/2009
Mono Sodium Glutamate
Mono Sodium Glutamate is known as an excitotoxin. It’s an additive that’s been used in food for centuries; to make it taste better. The truth behind it is, it kills off certain neurons in the brain by overstimulating them.
Russell Blaylock, an American neurosurgeon, has made a very convincing connection between continuous exposure to Mono Sodium Glutamate, in adults, to (and I quote) an accelerated onset and degeneration in Alzheimer's disease, Parkinson's, and ALS as well as headaches, seizures, strokes and AIDS dementia.
http://curezone.com/foods/msg.asp http://www.russellblaylockmd.com/
Polyethylene glycol
Usually used as a laxative or as a substance to coat suppositories with. It is also found in cosmetics because of its lubricant nature.
Nonylphenol ethoxylate
Mainly used in detergents, as emulsifiers and found in some pesticides, Nonylphenol ethoxylate is a man-made chemical that was officially declared dangerous to the environment by the European commission and the WWF. It was found to have serious detrimental effects on the female reproductive organs in aquatic species and also found to lower the sperm count in male species. Just how it affects humans is still relatively unknown.
In 1992 the Paris Commission urged the European parliament to recommend that the use of Nonylphenol ethoxylate be completely phased out of domestic cleaning substances by the year 2000. You can read the full International report here:
http://www.ngo.grida.no/wwfneap/Publication/briefings/Nonylphenol.pdf
As far as I discovered, in 2003, the product was banned in Europe by the European Parliament. Here’s the Directive:
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2003:178:0024:0027:EN:PDF
Gentamicin Sulfate
This is an antibiotic. However, in some people it can cause side-effects of vomiting, nausea, increased salivation, joint pain, visual disturbances, dry eyes, tinitus, vertigo etc.
You can see the full description on the packaging details here:
http://medical-dictionary.thefreedictionary.com/gentamicin+sulfate
Other Internet Sources:
CDC - Emerging Infectious Diseases
http://www.cdc.gov/ncidod/eid/vol12no01/05-1254.htm
United States Government National Cancer Institute
http://www.cancer.gov/cancertopics/factsheet/risk/formaldehyde
International Agency for Research on Cancer (World Health Organization)
http://monographs.iarc.fr/ENG/Monographs/vol88/index.php
(http://monographs.iarc.fr/ENG/Monographs/vol88/mono88-6B.pdf)
United States Department of Labor
Occupational Safety and Health Administration
http://www.osha.gov/SLTC/formaldehyde/
Formaldehyde and cancer morbidity among male employees in Denmark
http://www.springerlink.com/content/w632326683541334/
Warnings: (Courtesy of the following websites:)
http://www.rumormillnews.com/cgi-bin/archive.cgi?read=150745
FLU VACCINE RECOMMENDATIONS FOR ALL PREGNANT WOMEN (CDC)
The Advisory Committee on Immunization Practices (ACIP): Vaccination of pregnant women is recommended by the Centers for Disease Control Advisory Committee on Immunization Practices (ACIP). < http://www.cdc.gov/vaccines/pubs/vis/default.htm#flu > http://www.cdc.gov/vaccines/pubs/vis/default.htm#flu
FDA approved manufacturers package insert: Manufacturers warnings
Sanofi Pasteurs Fluzone package insert, WARNING www.vaccinesafety.edu/package_inserts.htm" TARGET="_blank">http://www.vaccinesafety.edu/package_inserts.htm>www.vaccinesafety.edu/package_inserts.htm>
8.1 Pregnancy Category C: Animal reproduction studies have not been conducted with Fluzone vaccine. It is also not known whether Fluzone vaccine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Fluzone vaccine should be given to a pregnant woman only if clearly needed.
8.2 Nursing Mothers: It is not known whether Fluzone vaccine is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Fluzone vaccine is administered to a nursing woman.
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility: Fluzone vaccine has not been evaluated for carcinogenic or mutagenic potential, or for impairment of fertility.
NOTE: CDC does not require providers to inform pregnant women of the Thimerosal (mercury) content.
Appendix A - Sanofi Pasteur Packaging Insert -
Courtesy of the FDA -
http://www.fda.gov/downloads/biologicsbloodvaccines/vaccines/approvedproducts/ucm182404.pdf
sanofi pasteur 449/454 Influenza A (H1N1) 2009 Monovalent Vaccine
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use Influenza A (H1N1) 2009 Monovalent Vaccine safely and effectively. See full prescribing information for Influenza A (H1N1) 2009 Monovalent Vaccine.
Influenza A (H1N1) 2009 Monovalent Vaccine Manufactured by Sanofi Pasteur Inc. Suspension for Intramuscular Injection Initial US Approval: 1980
----------------------------RECENT MAJOR CHANGES------------------------------ Indications and Usage ( 1 ) [9/2009] Dosage and Administration ( 2.2 ) [9/2009]
----------------------------INDICATIONS AND USAGE------------------------------- Influenza A (H1N1) 2009 Monovalent Vaccine is an inactivated influenza virus vaccine indicated for active immunization of persons 6 months of age and older against influenza disease caused by pandemic (H1N1) 2009 virus. (1)
--------------------------DOSAGE AND ADMINISTRATION------------------------- Based on currently available information the vaccination regimen is as follows:
Children ▪ 6 through 35 months of age (0.25 mL dose, intramuscular injection): - Two 0.25 mL doses approximately one month apart. (2.2) ▪ 36 months through 9 years of age (0.5 mL dose, intramuscular injection): - Two 0.5 mL doses approximately one month apart. (2.2) ▪ 10 years of age and older - A single 0.5 mL dose, intramuscular injection. (2.2) Adults - A single 0.5 mL dose, intramuscular injection. (2.2)
---------------------DOSAGE FORMS AND STRENGTHS--------- Influenza A (H1N1) 2009 Monovalent Vaccine, a sterile suspension for intramuscular injection, is supplied in four presentations: ␣ Prefilled syringe, 0.25 mL, no preservative; distinguished by a pink syringe
plunger rod (3) ␣ Prefilled syringe, 0.5 mL, no preservative (3) ␣ Single-dose vial, 0.5 mL, no preservative (3) ␣ Multi-dose vial, 5 mL, contains thimerosal, a mercury derivative, added as a
10 September 2009_v0.3 LE5860-5862
-------------------------------CONTRAINDICATIONS------------ ␣ Severe hypersensitivity to egg proteins or any component of the vaccine
or life-threatening reactions after previous administration of any influenza vaccine. (4, 11)
-----------------------WARNINGS AND PRECAUTIONS--------------------- ␣ If Guillain-Barré syndrome (GBS) has occurred within 6 weeks of
previous influenza vaccination, the decision to give Influenza A (H1N1) 2009 Monovalent Vaccine should be based on careful consideration of the potential benefits and risks. (5.1)
␣ Immunocompromised persons may have a reduced immune response to Influenza A (H1N1) 2009 Monovalent Vaccine. (5.2)
------------------------------ADVERSE REACTIONS-------------- Adverse reaction information is based on studies conducted with seasonal trivalent Influenza Virus Vaccine. ␣ Most common (≥10%) local reactions were soreness at injection site,
tenderness, pain, and swelling. (6) ␣ Most common (≥10%) systemic events were malaise, headache, and
myalgia. (6)
To report SUSPECTED ADVERSE REACTIONS, contact Sanofi Pasteur Inc., Discovery Drive, Swiftwater, PA 18370 at 1-800-822-2463 (1-800-VACCINE) or VAERS at 1-800-822-7967 or http://vaers.hhs.gov.
------------------------------DRUG INTERACTIONS-------------- ␣ Do not mix with other vaccines in the same syringe or vial. (7.1) ␣ Immunosuppressive therapies may reduce the immune response to
Influenza A (H1N1) 2009 Monovalent Vaccine. (7.2)
-----------------------USE IN SPECIFIC POPULATIONS------- Information in this section is based on seasonal trivalent Influenza Virus Vaccine manufactured by Sanofi Pasteur Inc. (Fluzone vaccine). ␣ Safety and effectiveness of Influenza A (H1N1) 2009 Monovalent
Vaccine have not been established in pregnant women or nursing mothers
or children <6 months of age. (8.1, 8.3, 8.4) ␣ Antibody responses to Fluzone vaccine were lower in the geriatric
population than in younger adults. (8.5) See 17 PATIENT_COUNSELING_INFORMATION.
preservative. Each 0.5 mL dose contains 25 mcg mercury. (3, 11 ) _______________________________________________________________________________________________________________________________________
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION
2.1 Preparation for Administration
2.2 Recommended Dose and Schedule 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS
5.1 Guillain-Barré Syndrome 5.2 Altered Immunocompetence 5.3 Preventing and Managing Allergic Reaction 5.4 Limitations of Vaccine Effectiveness
6 ADVERSE REACTIONS
6.1 Clinical Trial Experience 6.2 Post-Marketing Experience 6.3 Other Adverse Events Associated with Influenza Vaccines
7 DRUG INTERACTIONS
7.1 Concomitant Administration with other Vaccines 7.2 Immunosuppressive Therapies
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy 8.3 Nursing Mothers 8.4 Pediatric Use 8.5 Geriatric Use
11 DESCRIPTION 12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action 13 NON-CLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 14 CLINICAL STUDIES
14.1 Immunogenicity in the Adult and Geriatric Population
14.2 Immunogenicity in Children 15 REFERENCES 16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied
16.2 Storage and Handling 17 PATIENT COUNSELING INFORMATION
*Sections or subsections omitted from the full prescribing information are not listed.
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1 FULL PRESCRIBING INFORMATION:
2 1. INDICATIONS AND USAGE
3 Influenza A (H1N1) 2009 Monovalent Vaccine is an inactivated influenza virus vaccine 4 indicated for active immunization of persons 6 months of age and older against influenza disease 5 caused by pandemic (H1N1) 2009 virus. 6
7 2. DOSAGE AND ADMINISTRATION
8
2.1. Preparation for Administration
9 Inspect Influenza A (H1N1) 2009 Monovalent Vaccine syringes and vials visually for particulate 10 matter and/or discoloration prior to administration. If either of these conditions exist, the vaccine 11 should not be administered. 12
13 Shake the syringe and single-dose vials well before administering the vaccine and shake the 14 multi-dose vial each time before withdrawing a dose of vaccine. 15 16 2.2. Recommended Dose and Schedule
17 Clinical studies are ongoing with Influenza A (H1N1) 2009 Monovalent Vaccine to determine 18 the optimal dosage, number of doses and schedule. 19 20 Available data show that children 9 years of age and younger are largely serologically naive to 21 the pandemic (H1N1) 2009 virus. (1) Based upon these data Influenza A (H1N1) 2009
22 Monovalent Vaccine should be administered as follows:
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1 2 Children 3 Children 6 through 35 months of age should receive two 0.25 mL intramuscular doses 4 approximately 1 month apart. (1) 5 6 Children 36 months through 9 years of age should receive two 0.5 mL intramuscular doses 7 approximately 1 month apart. (1) 8 9 Children 10 years of age and older should receive a single 0.5 mL intramuscular dose. (1)
10 11 The preferred sites for intramuscular injections are the anterolateral aspect of the thigh in infants 12 or the deltoid muscle of the upper arm in toddlers and young children. 13 14 The vaccine should not be injected into the gluteal region or into areas where there may be a 15 major nerve trunk. 16 17 Adults 18 Persons 18 years of age and older should receive a single 0.5 mL intramuscular dose. 19 20 In adults, the preferred site for intramuscular injection is the deltoid muscle. 21
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1 The vaccine should not be injected into the gluteal region or into areas where there may be a 2 major nerve trunk. 3
4 3. DOSAGE FORMS AND STRENGTHS 5 Influenza A (H1N1) 2009 Monovalent Vaccine is a sterile suspension for intramuscular
6 injection. [See Description (11)] 7 8 Influenza A (H1N1) 2009 Monovalent Vaccine is supplied in 4 presentations:
Prefilled syringe, 0.25 mL, no preservative, for 6 through 35 months of age; distinguished by a pink syringe plunger rod; Prefilled syringe, 0.5 mL, no preservative, for 36 months of age and older; Single-dose vial, 0.5 mL, no preservative, for 36 months of age and older;
Multi-dose vial, 5 mL, for 6 months of age and older, contains thimerosal, a mercury derivative, added as a preservative. Each 0.5 mL dose contains 25 micrograms (mcg) mercury.
17 4. 18 Do not administer Influenza A (H1N1) 2009 Monovalent Vaccine to anyone with a known severe hypersensitivity to egg proteins or any component of the vaccine or life-threatening reactions after previous administration of any influenza vaccine. [See Warnings and Precautions 21 (5) and Description (11)]
5. WARNINGS AND PRECAUTIONS
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CONTRAINDICATIONS
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1 5.1. Guillain-Barré Syndrome
2 Recurrence of Guillain-Barré syndrome (GBS) has been temporally associated with the 3 administration of influenza vaccine. The decision to give Influenza A (H1N1) 2009 Monovalent 4 Vaccine to individuals who have a prior history of Guillain-Barré syndrome should be based on 5 careful consideration of the potential benefits and risks. 6 7 5.2. Altered Immunocompetence
8 If Influenza A (H1N1) 2009 Monovalent Vaccine is administered to immunocompromised
9 persons, including those receiving immunosuppressive therapy, the immune response may be 10 diminished. 11 12
5.3. Preventing and Managing Allergic Reaction
13 Appropriate medical treatment and supervision must be available to manage possible 14 anaphylactic reactions following administration of the vaccine. 15 16 5.4. Limitations of Vaccine Effectiveness
17 Vaccination with Influenza A (H1N1) 2009 Monovalent Vaccine may not protect all recipients. 18
19
6. ADVERSE REACTIONS
20 Sanofi Pasteur’s Influenza A (H1N1) 2009 Monovalent Vaccine and seasonal trivalent Influenza
21 Virus Vaccine (Fluzone®) are manufactured by the same process. The following sub-sections
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1 summarize safety data from clinical experience with seasonal trivalent inactivated influenza 2 vaccines, including Fluzone vaccine. 3
6.1. Clinical Trial Experience
4 Adverse event information from clinical trials provides the basis for identifying adverse events 5 that appear to be related to vaccine use and for approximating the rates of these events. However, 6 because clinical trials are conducted under widely varying conditions, adverse event rates 7 observed in the clinical trials of a vaccine cannot be directly compared to rates in the clinical trial 8 of another vaccine, and may not reflect the rates observed in practice. 9
10 Adults and Geriatrics 11 In placebo-controlled studies among adults, the most frequent side effect of vaccination is soreness 12 at the vaccination site (affecting 10%–64% of patients) that lasts <2 days, local pain and swelling. 13 These local reactions typically are mild. Fever, malaise, myalgia, and other systemic symptoms can 14 occur following vaccination and most often affect persons who have had no prior exposure to the 15 influenza virus antigens in the vaccine (e.g., young children). These reactions begin 6–12 hours 16 after vaccination and can persist for 1–2 days. Placebo-controlled trials demonstrate that among 17 older persons and healthy young adults, administration of split-virus influenza vaccine is not 18 associated with higher rates of systemic symptoms (e.g., fever, malaise, myalgia, and headache) 19 when compared with placebo injections. (2) 20
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1 Children 2 The 2003-2004 formulation of Fluzone vaccine was studied in 19 children 6 to 23 months of age 3 and in 12 children 24 to 36 months of age, given in 2 doses one month apart. Local reactions and 4 systemic events were solicited for 3 days after each dose. Most local and systemic reactions were 5 mild. The proportions of local and systemic reactions in children were similar to the proportions 6 in adults. No reported local or systemic reaction required a therapeutic intervention other than 7 analgesics. (3) 8 9
6.2. Post-Marketing Experience
10 The following additional events have been reported during post-approval use of Fluzone vaccine. 11 Because these events are reported voluntarily from a population of uncertain size, it is not always 12 possible to reliably estimate their frequency or establish a causal relationship to vaccine 13 exposure.
14 15 Blood and Lymphatic System Disorders: Thrombocytopenia, lymphadenopathy 16 17 Immune System Disorders: Anaphylaxis, other allergic/hypersensitivity reactions (including 18 urticaria, angioedema) 19 20 Nervous System Disorders: GBS, convulsions, myelitis (including encephalomyelitis and 21 transverse myelitis), facial palsy (Bell’s palsy), optic neuritis/neuropathy, brachial neuritis, 22 syncope (shortly after vaccination), dizziness, paresthesia
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1 2 Vascular Disorders: Vasculitis, vasodilation/flushing 3 4 Respiratory, Thoracic and Mediastinal Disorders: Dyspnea, pharyngitis, rhinitis 5 6 Skin and Subcutaneous Tissue Disorders: Stevens-Johnson syndrome 7 8 General Disorders and Administration Site Conditions: Fever, pain, pruritis, asthenia/fatigue, 9 pain in extremities, chest pain
10 11
6.3. Other Adverse Events Associated with Influenza Vaccines
12 Anaphylaxis has been reported after administration of influenza vaccines. Although Influenza A 13 (H1N1) 2009 Monovalent Vaccine contains only a limited quantity of egg protein, this protein 14 can induce immediate hypersensitivity reactions among persons who have severe egg allergy. 15 Allergic reactions include hives, angioedema, allergic asthma, and systemic anaphylaxis. [See 16 Contraindications (4)]
17 18 The 1976 swine influenza vaccine was associated with an increased frequency of Guillain-Barré 19 syndrome (GBS). Evidence for a causal relation of GBS with subsequent vaccines prepared from 20 other influenza viruses is unclear. If influenza vaccine does pose a risk, it is probably slightly 21 more than 1 additional case/1 million persons vaccinated. 22
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1 Neurological disorders temporally associated with influenza vaccination such as encephalopathy, 2 optic neuritis/neuropathy, partial facial paralysis, and brachial plexus neuropathy have been 3 reported. 4
5 Microscopic polyangitis (vasculitis) has been reported temporally associated with influenza 6 vaccination. 7
8
7. DRUG INTERACTIONS
9
7.1. Concomitant Administration with Other Vaccines
10 There are no data on the concomitant administration of Influenza A (H1N1) 2009 Monovalent 11 V accine with seasonal trivalent influenza vaccines. 12 13 Influenza A (H1N1) 2009 Monovalent Vaccine should not be mixed with any other vaccine in 14 the same syringe or vial.
15 16 If Influenza A (H1N1) 2009 Monovalent Vaccine is to be given at the same time as another 17 injectable vaccine(s), the vaccine(s) should always be administered at different injection sites. 18 19 7.2. Immunosuppressive Therapies
20 If Influenza A (H1N1) 2009 Monovalent Vaccine is administered to immunosuppressed persons 21 or persons receiving immunosuppressive therapy, immunologic response may be diminished. 22
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1
8. USE IN SPECIFIC POPULATIONS 2 Sanofi Pasteur’s Influenza A (H1N1) 2009 Monovalent Vaccine and seasonal trivalent Influenza
3 Virus Vaccine (Fluzone vaccine) are manufactured by the same process. Available information 4 for Fluzone vaccine is provided in this section. 5
8.1. Pregnancy
6 Pregnancy Category C: Animal reproduction studies have not been conducted with Influenza A 7 (H1N1) 2009 Monovalent Vaccine or Fluzone vaccine. It is also not known whether these 8 vaccines can cause fetal harm when administered to a pregnant woman or can affect reproduction 9 capacity. Influenza A (H1N1) 2009 Monovalent Vaccine should be given to a pregnant woman
10 only if clearly needed. 11 12
8.3. Nursing Mothers
13 It is not known whether Influenza A (H1N1) 2009 Monovalent Vaccine or Fluzone vaccine is 14 excreted in human milk. Because many drugs are excreted in human milk, caution should be 15 exercised when this vaccine is administered to a nursing woman. 16
17
8.4. Pediatric Use
18 Safety and effectiveness in pediatric subjects below the age of 6 months have not been 19 established. The immune response and safety of Fluzone vaccine was evaluated in 31 children 20 between the ages of 6-26 months. [See Adverse Reactions (6.1), Clinical Studies (14)] 21 22
8.5. Geriatric Use
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1 Immune response to Fluzone vaccine in subjects older than 61 years of age were lower when 2 compared to immune responses in adults 19-59 years of age. [See Clinical Studies (14)] 3
4
11. DESCRIPTION 5
6 Influenza A (H1N1) 2009 Monovalent Vaccine, an inactivated influenza virus vaccine, for 7 intramuscular use, is prepared from influenza viruses propagated in embryonated chicken eggs. 8 The virus-containing allantoic fluid is harvested and inactivated with formaldehyde. Influenza 9 virus is concentrated and purified in a linear sucrose density gradient solution using a continuous
10 flow centrifuge. The virus is then chemically disrupted using a non-ionic surfactant, polyethylene 11 glycol p-isooctylphenyl ether (Triton® X-100), producing a “split virus”. The split virus is further 12 purified and then suspended in sodium phosphate-buffered isotonic sodium chloride solution. 13
14 Influenza A (H1N1) 2009 Monovalent Vaccine is formulated to contain 15 mcg hemagglutinin 15 (HA) of influenza A/California/07/2009 (H1N1) v-like virus per 0.5 mL dose. Gelatin 0.05% is 16 added as a stabilizer. Each 0.5 mL dose may contain residual amounts of formaldehyde (not 17 more than 100 mcg), polyethylene glycol p-isooctylphenyl ether (not more than 0.02%), and 18 sucrose (not more than 2.0%).
19
20 There is no thimerosal used in the manufacturing process of the single-dose presentations of
21 Influenza A (H1N1) 2009 Monovalent Vaccine. The multi-dose presentation of Influenza A
22 (H1N1) 2009 Monovalent Vaccine contains thimerosal, a mercury derivative, added as a
23 preservative. Each 0.5 mL dose of the multidose presentation contains 25 mcg mercury.
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1 2 Influenza A (H1N1) 2009 Monvalent Vaccine is a sterile clear to a slightly opalescent 3 suspension. 4 5 Antibiotics are not used in the manufacture of Influenza A (H1N1) 2009 Monovalent Vaccine. 6 7 All presentations of Influenza A (H1N1) 2009 Monovalent Vaccine do not contain latex. 8
9
12. CLINICAL PHARMACOLOGY
10
12.1. Mechanism of Action
11 Influenza illness and its complications follow infection with influenza viruses. Global 12 surveillance of influenza identifies yearly antigenic variants. For example, since 1977, antigenic 13 variants of influenza A (H1N1 and H3N2) viruses and influenza B viruses have been in global 14 circulation. Specific levels of hemagglutinin inhibition (HI) antibody titer post-vaccination with 15 inactivated influenza virus vaccines have not been correlated with protection from influenza 16 virus infection. In some human studies, antibody titer of ≥1:40 have been associated with 17 protection from influenza illness in up to 50% of subjects. (4) (5) 18 19 Antibodies against one influenza virus type or subtype confer limited or no protection against 20 another. Furthermore, antibodies to one antigenic variant of influenza virus might not protect 21 against a new antigenic variant of the same type or subtype. Frequent development of antigenic
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1 variants through antigenic drift is the virologic basis for seasonal epidemics and the reason for 2 the usual change of one or more new strains in each year's influenza vaccine. 3
4
13. NON-CLINICAL TOXICOLOGY
5
13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility
6 Neither Fluzone vaccine nor Influenza A (H1N1) 2009 Monovalent Vaccine have been evaluated 7 for carcinogenic or mutagenic potential, or for impairment of fertility. 8
9
14. CLINICAL STUDIES 10 Sanofi Pasteur’s Influenza A (H1N1) 2009 Monovalent Vaccine and seasonal trivalent Influenza
11 Virus Vaccine (Fluzone vaccine) are manufactured by the same process. Data in this section 12 were obtained in clinical studies conducted with Fluzone vaccine. 13 14
14.1. Immunogenicity in the Adult and Geriatric Population
15 In an observational study of the immunogenicity of Fluzone vaccine in a geriatric population 16 (median age: 72.0 range: 61 to 86 years of age) compared with younger adults (median age: 38.0 17 range: 19 to 59 years of age; racial distribution was 2 Asian, 11 Black, 106 Caucasian, and 2 18 other; no gender data were available), the following results were obtained using a single-dose of 19 the year 1999–2000 formulation of Fluzone vaccine. (See Table 1.) Antibody levels were 20 obtained on the day of and just prior to vaccination and approximately 21 days after vaccination. 21 (4)
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1 Table 1: Geometric Mean Titer (GMT) and Percentage (%) Achieving an HI Titer ≥1:40 2 (N = 58-62) in Adults and the Elderly (after vaccination with Fluzone vaccine)
3 N = Number of participants 4 5
14.2. Immunogenicity in Children
6 In a study using 2 doses of Fluzone vaccine (2003-2004) in 31 healthy children 6–36 months of 7 age (3 Black, 23 Caucasian, 2 Hispanic, and 3 other; 15 were male and 16 were female), the 8 following immunogenicity results were obtained on day 0 before vaccination and approximately 9 14 days after dose number 2. (See Table 2.)
1 15. REFERENCES
Centers for Disease Control and Prevention. Serum Cross-Reactive Antibody Response to a Novel Influenza A (H1N1) Virus After Vaccination with Seasonal Influenza Vaccine. MMWR 2009;58(19):521-524.
Centers for Disease Control and Prevention. Prevention and Control of Influenza: Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 2009;58(RR08):1-52.
Sanofi Pasteur Inc. Data on file, 071107.
Hannoun C et al. Immunogenicity and protective efficacy of influenza vaccination. Virus Res 2004;103:133-138
Hobson D, et al. The role of serum hemagglutinin-inhibiting antibody in protection against challenge infection with influenza A2 and B viruses J Hyg Camb 1972;70:767-777.
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1 16. HOW SUPPLIED/STORAGE AND HANDLING
2
16.1. How Supplied
3 Single-dose prefilled syringe, without needle, 0.25 mL, package of 10 prefilled syringes per 4 carton – Product No. NDC 49281-650-25. 5 6 Single-dose prefilled syringe, without needle, 0.25 mL, package of 25 prefilled syringes per 7 carton – Product No. NDC 49281-650-70.
8
9 Single-dose prefilled syringe, without needle, 0.5 mL, package of 10 prefilled syringes per carton 10 – Product No. NDC 49281-650-50. 11 12 Single-dose prefilled syringe, without needle, 0.5 mL, package of 25 prefilled syringes per carton 13 – Product No. NDC 49281-650-90.
14 15 Single-dose vial, 0.5 mL, package of 10 vials per carton – Product No. NDC 49281-650-10. 16 17 Multi-dose vial, 5 mL, one vial per carton. The vial contains ten 0.5 mL doses – Product No. NDC 18 49281-640-15. 19 20 Vial stoppers and syringe plungers do not contain latex. 21 22 16.2. Storage and Handling
Confidential/Proprietary Information Page 17 of 19
sanofi pasteur 10 September 2009_v0.3 449/454 Influenza A (H1N1) 2009 Monovalent Vaccine LE5860-5862
1 Store all Influenza A (H1N1) 2009 Monovalent Vaccine presentations refrigerated at 2° to 8°C 2 (35° to 46°F). DO NOT FREEZE. Discard if vaccine has been frozen. 3 4 Between uses, return the multi-dose vial to the recommended storage conditions at 2o to 8oC (35o 5 to 46oF).
6 7 Do not use after the expiration date shown on the label. 8
9 17. 10 •
PATIENT COUNSELING INFORMATION
Inform vaccine recipients or guardians that Influenza A (H1N1) 2009 Monovalent Vaccine contains killed viruses and cannot cause influenza. Inform vaccine recipients or guardians that there are two influenza vaccine formulations for this influenza season, the monovalent vaccine against influenza disease caused by pandemic (H1N1) 2009 virus and seasonal trivalent influenza vaccine.
Instruct vaccine recipients or guardians to report any severe or unusual adverse reactions to their health care provider.
11 12 • 13 14 15 • 16 17 18 19 20 21 22 23 Manufactured by:
Product information as of September 2009.
Confidential/Proprietary Information Page 18 of 19
sanofi pasteur 449/454 Influenza A (H1N1) 2009 Monovalent Vaccine
10 September 2009_v0.3 LE5860-5862
5860-5862
1 2 3 4
5
Sanofi Pasteur Inc.
Swiftwater PA 18370 USA
Confidential/Proprietary Information Page 19 of 19
Influenza A, Gripe A and H1N1 Vaccine - My research report
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