Read and report vaccine reactions, harassment and failures.
An inactivated, injectable swine flu vaccine is being created by Novartis, Sanofi Pasteur and GlaxoSmithKline and a live attenuated virus nasal spray vaccine is being created by MedImmune. A limited supply (about 60 to 80 million doses) may be available in September or mid-October. The government reportedly has contracted with vaccine manufacturers to produce a total of 193 million doses of swine flu vaccine (and also has ordered 119 million doses of MF-59 and AS03 adjuvant).
Below are topics with additional information about H1N1 2009 swine flu vaccine.
Oil-in-water adjuvants (squalene) have not been licensed in the U.S., although they are used in some inactivated vaccines marketed in Europe and other countries (live virus vaccines do not contain adjuvants). Many inactivated vaccines in the U.S. contain licensed aluminum-based adjuvants added to increase production of antibodies in an effort to make vaccines more effective at preventing infection.
Oil-based adjuvants (MF-59 and AS03) manipulate and hyper-stimulate the immune system to mount a stronger immune response to the lab-altered virus or bacteria contained in vaccines. However, the use of squalene type vaccine adjuvants, which were allegedly added to experimental anthrax vaccines and made Gulf War soldiers sick, is controversial.
Oil based adjuvants may increase the risk for vaccine-induced chronic inflammation and autoimmunity in some children and adults genetically predisposed to atypical inflammatory responses and autoimmunity. No published scientific studies have examined whether those already suffering with chronic inflammation associated with brain and immune system dysfunction may be at special risk.
U.S. health officials are expected to by-pass normal FDA licensing procedures and include oil-in-water adjuvants in some swine flu vaccines released for public use. The legal ability for the FDA to approve unlicensed vaccines and drugs whenever a national “public health emergency” has been declared was given to the FDA by Congress under an Emergency Use Authorization (EUA) provision included in 2004 Project Bioshield legislation (see below for more information on Bioshield and the EUA).
Thimerosal, which is a mercury-based preservative added to multi-dose vials of inactivated annual influenza vaccines and other vaccines, has been associated with brain and immune system dysfunction, including autism.
Thimerosal, which is a mercury-based preservative added to multi-dose vials of inactivated annual influenza vaccines and other vaccines, has been associated withbrain and immune system dysfunction, including autism. Thimerosal WILL be added as a preservative in multi-dose vials of most inactivated (injected) H1N1 swine flu vaccines, although there reportedly will be a limited supply of single dose vials of inactivated swine flu vaccine that do not contain thimerosal.
The live virus nasal spray H1N1 vaccine being created by MedImmune will not contain the preservative thimerosal (and live virus swine flu vaccine will not contain an unlicensed adjuvant that may be added to inactivated H1N1 vaccines).
According to the FDA, candidate swine flu vaccines will be tested for one to three weeks on a few hundred children and adults before being released for public use in the fall.
There are indications by CDC officials may recommend that children receive annual influenza shots as well as one or two doses of swine flu vaccine. There will be little or no time between now and October to test the safety and efficacy of giving children two to four doses of different kinds of influenza vaccine.
Food & Drug Administration (FDA). Vaccines & Related Biological Products Advisory Committee. July 23, 2009 Meeting Presentations on H1N1 Influenza.
FDA. Vaccines & Related Biological Products Advisory Committee. Transcript of July 23, 2009 VRBPAC meeting on H1N1 influenza virus vaccines and copies of CDC, vaccine manufacturer and other presentations.
Product inserts have been released by the following manufacturers:
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.
Yes. In 2005, Congress passed the Public Readiness & Emergency Preparedness Act (PREP Act). Congress took away liability for experimental drugs and vaccines that are released for public use under an Emergency Use Authorization (EUA) whenever a national public health emergency is declared by the Secretaries of the Department of Human Health & Services or Homeland Security in the federal government. A federal compensation program was discussed in the PREP Act but, as of 2009, there has been no funding of a compensation program for children or adults injured or killed by vaccines or drugs used under an EUA. A report for Congress by the Congressional Research Service discussed legal issues involved in the 2009 H1N1 outbreak and the declaration of a national public health emergency.