Federal Activity – National Vaccine Program Office
Advisory Commission on Childhood Vaccines Meeting (June 10-11, 2010)
The quarterly Advisory Committee of Childhood Vaccines (ACCV) meeting was held June 10 and 11 in Rockville, Maryland. For those not familiar with the ACCV, it is the committee responsible for advising and making recommendations to the Secretary of Health and Human Services on issues relating to the operation of the National Vaccine Injury Compensation Program (VICP). The ACCV meetings are fascinating because the fundamentals of the VICP are presented.
National Vaccine Advisory Committee (NVAC) meeting June 2-3, 2010
NVAC held their quarterly meeting earlier this month in Washington D.C. NVAC’s main purpose is to advise the director of the National Vaccine Program (NVP) on the promotion of immunization and preventing adverse reactions to vaccines. NVAC is compromised of seventeen members who are either physicians, scientists, researchers or members of parent organizations concerned with immunizations.
The main focus of the June meeting was the flu vaccine. NVAC heard presentations that both evaluated the response to last year’s H1N1 pandemic and provided information on the upcoming flu vaccine for the 2010-2011 flu season.
SafeMinds Public Comment on National Vaccine Program
Top US Panel: Some Vaccine-Autism Research is “Appropriate,” “Worthwhile” and “Warranted”
June 5, 2009 by David Kirby for The Huffington Post
On Tuesday, the Federal Government’s leading immunization advisory panel unanimously approved a sweeping list of vaccine safety research recommendations for the US Department of Health and Human Services, including several that are directly or indirectly linked to the vaccine-autism debate. The endorsement, from the highly influential National Vaccine Advisory Committee, will surely intensify the argument. Read more.
The National Vaccine Plan
The National Vaccine Plan is being developed by the National Vaccine Program Office of HHS and will guide U.S. vaccination activities for the next 10 years. The draft Plan fails on many points. To paraphrase Jenny McCarthy’s slogan from the Green the Vaccines rally last June [“Too many, too soon”], the Plan calls for “More, Sooner.” And rather than a “Safety First” approach, the Plan reflects the same “Safety Last” perspective of the existing global vaccine enterprise, giving far more weight to vaccine development and promotion than to safety considerations.
The current draft introduction to the NVP and strategic plan are an update of the plan first published in 1994. The NVP is required by the 1986 Vaccine Injury Compensation Act.
The Plan sets forth five general goals and each goal has a series of outcomes (“indicators”) and objectives underpinning it:
Goal 1: Develop new and improved vaccines.
Goal 2: Enhance the safety of vaccines and vaccination practices.
Goal 3: Support informed vaccine decision-making by the public, providers, and policy-makers.
Goal 4: Ensure a stable supply of recommended vaccines, and achieve better use of existing vaccines to prevent disease, disability, and death in the United States.
Goal 5: Increase global prevention of death and disease through safe and effective vaccination.
Safety must pervade all 5 goals. Money should not be invested in vaccine development unless assurance is given that existing as well as new vaccines are truly safe, individually and as part of the ever expanding vaccine regimen. Honest communication requires a clear statement that the safety of the vaccine schedule has never been demonstrated; therefore the schedule must be regarded as an unethical experiment and true informed decision-making weighing risks and benefits is not possible. The world will increasingly reject vaccines not perceived as safe in developed countries.
In short, the Plan must propose and implement an aggressive “safety first” safety system that contains the following components:
1. Sound science.
3. Meaningful oversight.
6. Honesty and integrity.
7. Adequate safety net.
A meeting of the National Vaccine Advisory Committee for “stakeholder input” was held on February 6 in Washington. Summaries from that meeting can be viewed here. A “stakeholder input” meeting was held by NVAC’s Vaccine Safety Working Group on March 16 to review a parallel vaccine effort by the CDC’s Immunization Safety Office. A “consensus group” developed a very good vaccine safety research agenda which you can review here . Sallie Bernard, Vicky Debold, Peter Bell, and Barbara Loe Fisher represented the “safety concerned” advocates that also included representatives from public health, pediatricians, federal agencies, NVAC members, parental vaccine advocacy organizations, and members of the public.
Read SafeMinds Response to National Vaccine Plan of 2008 Draft
These comments were endorsed by the Autism Action Network, Autism One, the National Autism Association, Talk About Curing Autism and the US Autism and Asperger Association.
The Writing Group
SafeMinds Directors Sallie Bernard and Vicky Debold participated in the Writing Group meeting held last month, which helped prepare for the March 16 meeting. The Writing Group consisted of individuals and members of groups with a primary interest in vaccine-related issues, state and local public health and immunization officials, pediatricians, and federal officials. The Writing Group has published a draft joint statement and draft documents on Gaps in the Research Agenda and Criteria for Assessing ISO Research, which address questions around immunization of special populations, specific diseases which might be caused by vaccination, and the health effect of vaccination practices.
Encouragingly, the Writing Group acknowledged the public’s strong desire to study total health outcomes as they relate to the full vaccination schedule. Their consensus recommendation asked that an independent expert panel be convened to review strengths and weaknesses, ethical issues and feasibility of study designs with consideration to be given to research on vaccinated vs. unvaccinated populations. The inclusion of autism as a desired outcome was also recommended along with the need for transparency and broad public and stakeholder involvement in the review process.
Despite the progress made by the Salt Lake City Writing Group, much more is needed to understand potential adverse effects from vaccines. SafeMinds attended the March 16 meeting and submitted a comprehensive analysis of needed vaccine safety reforms for the upcoming NVPO stakeholder meetings focused on the following points:
1. The proposed prioritization scheme for the CDC’s ISO vaccine safety research is sound, however, CDC’s vested interests in vaccine promotion precludes their ability to conduct unbiased vaccine safety research. Vaccine safety research must be overseen by an independent agency, conducted by unbiased researchers and assure parent stakeholder involvement in all aspects of research.
2. The CDC’s ISO lacks the budget and infrastructure to conduct adequate safety research and relies on the flawed and deficient VAERS and VSD databases to detect adverse effects. The funding of safety research must increased and based on sound datasets capturing all potential adverse events.
3. In the interest of transparency, the unrestricted use of CDC’s VAERS and VSD datasets should be made available to outside, independent scientists immediately in a manner that preserves patient privacy.
4. The CDC’s ISO studies vaccine safety only after it has been licensed, relegating safety as secondary to vaccine promotion. Vaccine safety policy should ensure that comprehensive research is transparent to the public and conducted to examine the effects of the total vaccination schedule, not just individual vaccines, before licensure.
5. In fulfilling its Congressional charter to make vaccines as safe as possible, NVPO must ensure that a comprehensive program of vaccine safety research is initiated through the establishment of the expert panel, as recommended by the Writing Group. This panel would be charged with identifying science on health outcomes in vaccinated versus unvaccinated populations. Additionally, this science requires more than one study of on the effects of a single vaccine; it requires an array of cell, animal and human studies with multiple endpoints, from immunological alterations to metabolic dysregulation to brain changes, especially in sensitive subpopulations.
6. The treatment of our children as guinea pigs in the ever expanding and untested vaccine schedule is unethical. Billions of dollars are spent to license, promote and pay for vaccinations, while the CDC shamefully spends only about $20 million annually for safety research. At a minimum, vaccine safety should have the same priority as vaccine development and promotion. The US government needs a “Safety First” agenda for vaccines.
7. Scientists, like Dr. Wakefield, have been endless persecuted for conducting safety research whose findings are viewed as unfavorable by those with vested interests in vaccine uptake. The US government must support scientists currently engaged in much needed safety research; they must not be persecuted for conducting research that closes acknowledged vaccine safety research gaps.