A Swine Flu Statement of Concerns safe Minds CDC Public Engagement Meeting - Denver, Colorado Serle Aon For ing Weary diced ‘August 8, 2009 Sense Mpegs Deeaen SafeMinds Public Comment Good Morning, | am Theresa Wrangham and | am the President for the Coalition for SafeMinds. During last week’s Vaccine and Related Biologic Products Advisory Committee (VRBPAC) of the FDA it was stated that some of the pandemic HiN1 inactivated vaccine would contain thimerosal - ten years after the vaccine industry was asked by public health agencies to remove it. Also, it was reported that most manufacturers were having difficulty growing H1N1 virus, suggesting that an adjuvant may be needed to “spare antigen” and to increase vaccine production. Additionally, CDC’s ferret studies suggest that the pandemic H1N1 virus is not as contagious as has been reported. The ongoing disconnect between CDC media announcements and advisory meeting comments suggest a campaign of “fear mongering” reminiscent of the 1976 swine flu vaccine fiasco. In order to get this vaccine to market by the fall, none of the safety studies will be completed. We understand that pregnant women and young children will be among the first to receive the experimental H1N1 vaccine and are also the most vulnerable to vaccine side effects and injury. Vaccine safety should always take highest priority in any vaccination effort. Based on current information, the HiN1 pandemic is 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. It also seems that lessons learned from the 1976 swine flu pandemic have been ignored. Questions that remain as a result of July's meetings of the ACIP, FDA VRBPAC and the draft recommendations by the National Vaccine Advisory Committee (NVAC), HIN1 Vaccine Safety Subgroup are as follows - the public awaits answers! ‘+ AS ACIP recommendations have been predicated on non-adjuvanted vaccine scenarios, how will recommendations for use of the currently unlicensed adjuvants under consideration be determined prior to their use? ‘+ How will warnings on possible side effects be identified to the public, and injuries compensated, with no safety data available prior to vaccination? + Currently, the majority of seasonal flu vaccine exceeds the EPA’s safe exposure standard for mercury established in 2000 by the institute of Medicine (IOM). Will pandemic H1N1 vaccine also exceed this guideline for any target population identified? © What safety studies are being carried out, particularly on the currently unlicensed adjuvants under consideration and their effects when combined with thimerosal, and what are their gaps and limitations? * Two manufacturers (CSL and Sanofi-Pasteur) can make pandemic mercury-free vaccine. Will there be a preference for mercury-free vaccine to be administered for pregnant women, young children and vulnerable and special populations such as premies? ‘+ What mechanism has been created to properly monitor adverse events on this vaccine’s new antigen and the possible use of unlicensed adjuvants, given the NVAC’s H1N1 Subgroup’s statement that the current vaccine safety infrastructure is unlikely to be sufficient and may need to be enhanced? 16033 Bolsa Chica St. #104-142, Huntington Beach, CA 92649 - v, 404.994.0777 «f.770 631-9272 + www.safominds.orgUD ‘Swine Flu Statement of Concerns safe Minds CDC Public Engagement Meeting - Denver, Colorado ea ‘August 8, 2009 Sere i eoopelteeden How will long-term health outcomes be determined given that they may not manifest until many years later, as is the case with schizophrenia linked to viral illness during pregnancy, when current monitoring is only planned for 6 months after the second dose of pandemic HIN1 vaccine? Given NVAC's identification of the lack of safety data on simultaneous administration of multiple vaccines, will pandemic HIN1 vaccine be administered separately to permit identifying, tracking and analyzing and if necessary, removal of this vaccine from the market as was the case in 1976? Will the NVAC’s H1N1 Subgroup’s recommendation for a transparent and independent panel of outside experts with no professional or commercial stake in vaccines be assembled to review accumulated data, assess risks and advise on implications of possible side effects be implemented? FDA VRBPAC & ACIP Meeting Statements of July 2009 ‘Mercury containing vaccines will be used; Squalene-based adjuvants under consideration (ASO3 - GlaxoSmithKline and MF-59 -Novartis) are not currently licensed for use in the United States; Growing the pandemic H1N1 virus is proving difficult and suggests the use of adjuvants may be needed, possibly squalene-based (studies suggest that exposure to squalene is associated with production of auto-antibodies and auto-immune disease); No preclinical trial data, or FDA safety analyses, for the H1N1 vaccine or the proposed adjuvants were provided; No safety analyses on administration the novel H1N1 vaccine with other vaccines or with mercury-containing vaccines were provided; Recommendations for pandemic HIN1 vaccine fs based on non-adjuvant scenarios; Data on pregnant women was “scanty”; Adverse events will be tracked and recorded for only 6 months after the second dose of pandemic HiN1 vaccine is administered; Injuries related to pandemic HiN1 vaccine have not been identified and compensation for injuries resulting from this vaccine will be implemented separately from the existing Vaccine Injury Compensation Program (VICP) under a new program being developed. About the HHS National Vaccine Advisory Committee National Vaccine Advisory Committee’s (NVAC) conducted a review of the Centers for Disease Control’s Immunization Safety Office Draft Research agenda. This report identified critical gaps in vaccine safety research and made sweeping recommendations for improvement. This report can be found at http:// www.hhs.gov/nvpo/nvac/documents/NVACVaccineSafetyWGReport041409.pdf . The NVAC also established the HIN1 Vaccine Safety Subgroup to review the current federal plans for safety monitoring for a 2009 HiN1 influenza vaccine on the adequacy, strengths, weaknesses and con: iderations for enhancement. Their draft recommendations can be found at http: //www.hhs.gov /nvpo/nvac/Draft2009H1N1VaccineSafetyMonitoring. html. 16033 Bolsa Chica St. #104-142, Huntington Beach, CA $2649 + v. 404 934-0777 «f. 770 631-9272 « wow-safominds.orgoe. penis ce safe Minds CDC Public Engagement Meeting - Denver, Colorado eciaaeeaeeireee ‘August 8, 2009 Nowelegeal Deore About SafeMinds Mission The Coalition for SafeMinds is a non-profit organization founded to scientifically investigate, support research, raise awareness, change policy and focus national attention on the growing evidence of a link between mercury and neurological disorders such as autism, attention deficit disorder, language delay and learning disabilities. Our mission is to end the health and personal devastations caused by needless exposure to mercury, one of the most neurotoxic substances on earth. Government Agency & Committee Appointments ‘Our reputation of working with government agencies and the scientific community is one we are proud of and is well known. Several of our Board Members hold, or have held various agency/committee appointments such as: ‘+ the NIH Interagency Autism Coordinating Committee (IAC); ‘+ the Centers for Disease Control's (CDC) external Autism-Thimerosal Expert Panel and Blue Ribbon Panel on Vaccine Safety; * the FDA Vaccine and Related Biological Products Advisory Committee (VRBPAC); * the Department of Defense Scientific review panels for the Autism Spectrum Disorder Research Program (ASDRP); + the National Vaccine Advisory Committee (NVAC) Vaccine Safety Working Group (VSWG); and * Vaccine Safety Working Group's (VSWG) Salt Lake City Writing Group; Expert Resource Our history of funding research and service on government agency committees demonstrates that SafeMinds is reliable source of factual information regarding mercury and vaccine safety concerns. For more information regarding mercury and vaccine safety concerns, please contact our Press Manager, Pamela Felice at 251-861-3303. To learn more visit http://www. safeminds.org/news/swine-flu-hin1-vaccine.html 16033 Botsa Chica St #104-142, Huntington Beach, CA 92649 « v, 04 884.0777 « 770 631-9272 « www.safominds. org