http://www.fda.gov/downloads/Advisor.../UCM172424.pdf
Check "Safety Monitoring" on pg. 7 of that doc. Then in the same doc there is this:
Quote:
"The following considerations for clinical studies are based on the premise that clinical trials can be completed in time to inform policy decisions regarding widespread use of novel influenza A (H1N1) virus vaccines. However, because surveillance and epidemiologic data may indicate that vaccination should be initiated before data from such clinical trials are available we recognize that the regulatory approach needs to be flexible and that policy decisions regarding vaccine formulation and use may have to be based on results from incomplete or smaller clinical studies or even in the absence of clinical data with novel influenza A (H1N1) virus vaccine.
The last swine flu vaccine injected in the masses (1970's) had neurological side effects - the Guillain-Barré Syndrome. There were 500 cases of GBS—25 of which resulted in death from severe pulmonary complications. It looks like the CDC is preparing for reports of GBS as related to the vaccine: http://www.eurekalert.org/pub_releas...-acw083109.php"The following considerations for clinical studies are based on the premise that clinical trials can be completed in time to inform policy decisions regarding widespread use of novel influenza A (H1N1) virus vaccines. However, because surveillance and epidemiologic data may indicate that vaccination should be initiated before data from such clinical trials are available we recognize that the regulatory approach needs to be flexible and that policy decisions regarding vaccine formulation and use may have to be based on results from incomplete or smaller clinical studies or even in the absence of clinical data with novel influenza A (H1N1) virus vaccine.
According to this site http://www.nvic.org/vaccines-and-dis...swine-flu.aspx :
Quote:
"The Secretary of Health and Human Services announced on July 9, 2009 that school children, pregnant women and health workers will be the first to be given swine flu vaccines in the fall. Plans are being made by the government to give children swine flu vaccine in schools. Currently, government officials maintain that the swine flu vaccination program will be voluntary."
Now, what all this looks like to me, is that they don't really know if it is safe, but are going to use the above as "guinea pigs". Will this be like one of those drugs where a year or two (or more) down the road, the FDA says, oopsie.. that wasn't safe. Sorry about that. And in the meantime, lots of people (and children no less) have gotten serious complications? Furthermore, now that the U.S. has declared (as of April this year) a public health emergency, the pharmaceutical companies and anyone administering the vaccine cannot be held responsible for the complications resulting from the vaccine. I have also read in a few places that there are nurses & doctors.. and even some of the vaccine creators that will be refusing to take the vaccine. Wonder why? I am thinking I can guess why."The Secretary of Health and Human Services announced on July 9, 2009 that school children, pregnant women and health workers will be the first to be given swine flu vaccines in the fall. Plans are being made by the government to give children swine flu vaccine in schools. Currently, government officials maintain that the swine flu vaccination program will be voluntary."
Right now, it appears to be voluntary. But then there is this - Massachusetts passed the "Massachusetts Pandemic Act of 2009". Read it here if you want to take a look:
http://www.mass.gov/legis/bills/sena...02/st02028.htm
Part of it says this:
Quote:
(b) Furthermore, when the commissioner or a local public health authority within its jurisdiction determines that either or both of the following measures are necessary to prevent a serious danger to the public health the commissioner or local public health authority may exercise the following authority:
(1) to vaccinate or provide precautionary prophylaxis to individuals as protection against communicable disease and to prevent the spread of communicable or possibly communicable disease, provided that any vaccine to be administered must not be such as is reasonably likely to lead to serious harm to the affected individual; and
(2) to treat individuals exposed to or infected with disease, provided that treatment must not be such as is reasonably likely to lead to serious harm to the affected individual.
An individual who is unable or unwilling to submit to vaccination or treatment shall not be required to submit to such procedures but may be isolated or quarantined pursuant to section 96 of chapter 111 if his or her refusal poses a serious danger to public health or results in uncertainty whether he or she has been exposed to or is infected with a disease or condition that poses a serious danger to public health, as determined by the commissioner, or a local public health authority operating within its jurisdiction.
So.. let's say I live in Mass. and a person a block or two down the street gets this swine flu and the commissioner wants to vaccinate within a certain number of blocks. If I don't comply, it's quarantine for me. Even if there is no evidence that I have been exposed. And who is to say other states will not follow suit with similar laws? With the current state of things in Washington, who's to say the federal government won't soon declare this mandatory for certain at-risk groups (that includes children)? I understand wanting to control an outbreak. But honestly, this vaccine sounds like a crap shoot with my health (and more importantly with my children's health) right now.(b) Furthermore, when the commissioner or a local public health authority within its jurisdiction determines that either or both of the following measures are necessary to prevent a serious danger to the public health the commissioner or local public health authority may exercise the following authority:
(1) to vaccinate or provide precautionary prophylaxis to individuals as protection against communicable disease and to prevent the spread of communicable or possibly communicable disease, provided that any vaccine to be administered must not be such as is reasonably likely to lead to serious harm to the affected individual; and
(2) to treat individuals exposed to or infected with disease, provided that treatment must not be such as is reasonably likely to lead to serious harm to the affected individual.
An individual who is unable or unwilling to submit to vaccination or treatment shall not be required to submit to such procedures but may be isolated or quarantined pursuant to section 96 of chapter 111 if his or her refusal poses a serious danger to public health or results in uncertainty whether he or she has been exposed to or is infected with a disease or condition that poses a serious danger to public health, as determined by the commissioner, or a local public health authority operating within its jurisdiction.
Opinions? Thoughts? I'm interested in thoughtful responses in any direction here - not looking to start any heated disagreements.