Overview of SafeMinds Swine Flu Concerns

[neonds13]

Overview of SafeMinds Swine Flu Concerns

In light of the many unknowns concerning the possible Swine Flu Pandemic, SafeMinds is providing the following updates for informational purposes and to raise awareness regarding possible vaccine safety issues, policy decisions and facts regarding the production and possible use of the novel H1N1 vaccine currently being developed.

Our primary goal in raising these concerns it is to promote the production of the safest vaccine possible as our nation develops its strategy with regard to a possible pandemic.  Given past safety failures and vaccine injuries resulting from the 1976 Swine Flu Immunization Program, we believe that lessons from those failures, as documented by Institute of Medicine President Harvey Fineberg, MD, PhD, as well as the draft recommendations made by the National Vaccine Advisory Committee, H1N1 Vaccine Safety Subgroup, must be integrated into the current effort to improve protection for all individuals.  Life is precious and safety a priority in assuring the health of every man, woman and child.  Please visit often for updates and subscribe to our newsletter for current information.

Swine Flu Update - July 23rd

During the FDA's Vaccine and Related Biologic Products Advisory Committee (VRBPAC) meeting of July 23rd convened to address the possible swine flu pandemic, it was revealed that some of the novel (pandemic) H1N1 inactivated vaccine would contain thimerosal (a vaccine preservative containing mercury) - ten years after the vaccine industry was asked by public health agencies and organizations to remove it (see statement at end of page). It was also reported that most manufacturers were having difficulty growing the novel H1N1 virus, suggesting that an adjuvant may be needed to "spare antigen" and to increase vaccine production.  Additionally, the CDC's ferret studies suggest that the novel H1N1 virus is not as contagious as has been reported. 

Notably, the committee was not furnished with any preclinical trial data, or FDA safety analyses, for the novel H1N1 vaccine, or the proposed adjuvants. Of concern is that the proposed adjuvants (AS03 & MF59) are squalene (oil) based and studies suggest that exposure to squalene is associated with production of auto-antibodies and auto-immune disease. Nor were safety analyses on administration the novel H1N1 vaccine with other vaccines, or with mercury-containing vaccines, provided for the committee's review.

The disconnect between CDC media announcements and advisory meeting comments suggest a campaign of "fear mongering" reminiscent of the 1976 swine flu vaccine fiasco.

To date, the H1N1 pandemic appears to be mild and there's no evidence of increased virulence. As such, it seems highly irresponsible to recommend use of potentially dangerous vaccines - especially those with adjuvants combined with thimerosal - which have not been shown to be safe, or effective, by the FDA. 

Information provided by manufacturers during the FDA VRBPAC meeting indicate that In order to get this vaccine to market by the fall, none of the safety studies will be completed. It also appears that pregnant women and young children will be among the first to receive the experimental novel H1N1 vaccine - the same population most vulnerable to vaccine side effects and injury.

Given these concerns, SafeMinds will raise the following questions during the upcoming July 29th meeting of the Advisory Committee on Immunization Practices (ACIP):

• Should squalene-based adjuvants be used, what studies demonstrate that it's safe to combine thimerosal (mercury) with squalene?

• Both CSL and Sanofi-Pasteur have indicated they can make pandemic mercury-free vaccine. Will ACIP state a preference for mercury-free vaccine for pregnant women, young children and vulnerable and special populations such as premies and immunocompromised children?

• How much mercury will be in multi-dose vials and what dose of mercury will be given to premies, infants, pregnant women and adults?

• Given that the National Vaccine Advisory Committee identified a gap in data demonstrating the safety of simultaneous administration of multiple vaccines during a given office visit, will ACIP recommend administration of H1N1 vaccine separately as a precaution and to permit identifying, tracking and analyzing and if necessary, removing a vaccine from the market as was the case in 1976? 

_____________________

In 2000 "The AAFP (American Academy of Family Physicians), AAP (American Academy of Pediatrics), and the PHS (U.S. Public Health Service) in consultation with the ACIP (Advisory Committee on Immunization Practices) reaffirmed the goal set in July 1999 to remove or greatly reduce thimerosal from vaccines as soon as possible for the following reasons:

1. the removal or substantial reduction of thimerosal from vaccines is feasible,

2. the progress in removal which has been made to date is substantial,

3. the discussions between the Food and Drug Administration and the vaccine manufacturers in removing thimerosal are ongoing, and

4. the public concern about the use of mercury of any sort remains high."

The 2006 url where this statement appeared is no longer active for reasons unknown -

www.cdc.gov/nip/vacsafe/concerns/thimerosal/joint_statement.00.htm 

[neonds13]

Aug. 4, 2009 at 11:59 PM

PLEASE VOTE POPULAR & BUMP!!!!

(Original Poster)