Posted: 4/16/2010 1:08:50 AM
Washington, D.C. April, 16th 2010 – The National Vaccine Information Center (NVIC) participated in a meeting sponsored by the federal National Vaccine Advisory Committee (NVAC) and facilitated by The Keystone Center April 11-13 in Salt Lake City to discuss strengthening the U.S. vaccine safety system. Invited attendees represented a diverse group of government and private stakeholders, who agreed an effective vaccine safety system would benefit from both internal and independent, external assessment and a focus on detection, prevention and reduction of vaccine adverse events.
Representatives at the meeting included NVIC Co-founder and President Barbara Loe Fisher; NVIC Director of Research and Patient Safety, Vicky Debold, PhD, RN, who is also the consumer representative on the FDA Vaccines & Related Biological Products Advisory Committee (VRBPAC); and NVIC Director of Government Relations, Tawny Buck, who is the consumer representative on the National Vaccine Advisory Committee and co-chair of the NVAC Vaccine Safety Working Group.
NVIC has long supported the creation of an independently operated and funded vaccine safety agency that reports directly to the President. NVIC President, Barbara Loe Fisher said, “It was encouraging that a diversity of perspectives were brought to the table. Acknowledgement of the importance of independent external assessment and reducing vaccine risks for individuals is an excellent starting point for improving confidence in the integrity of the vaccine safety system.” On June 1, a public meeting sponsored by NVAC will be held in Washington, D.C. to obtain further public input on strengthening the vaccine safety system.
The federal public engagement initiative occurred against the backdrop of an emerging vaccine safety issue related to vaccine contamination. The Food and Drug Administration’s (FDA) vaccine licensing advisory committee (VRBPAC) will meet May 7th to discuss vaccine contamination following the FDA’s March recommendation to suspend use of Rotarix vaccine after pig virus DNA was discovered in the vaccine’s seed stock. As the VRPBAC consumer representative, Dr. Debold cast the only dissenting vote during the 2008 FDA pre-licensure hearings on Rotarix safety. Additionally, during VRBPAC’s November 2009 meeting , NVIC’s Fisher questioned the potential for insect virus contamination of an experimental H1N1 vaccine grown in caterpillar cells.
In 2009, NVAC reviewed the federal vaccine research agenda and NVIC, as a participant of that public engagement initiative, supported creating a robust national vaccine safety research agenda including a study comparing health outcomes in highly vaccinated and unvaccinated individuals. In June 2009, NVAC unanimously recommended expansion of the federal vaccine safety research agenda and the feasibility of conducting a study to evaluate health outcomes among vaccinated and unvaccinated individuals.
About Us: NVIC is a non-profit charitable organization that has advocated reform of the vaccine safety system since 1982. Dedicated to preventing vaccine injuries and deaths through public education and defending the informed consent ethic in medicine, NVIC does not advise against, or promote use of, vaccines. Over the past three decades, NVIC has been recognized by government agencies for its expertise and responsible vaccine safety advocacy through federal committee appointments and invited participation in public engagement initiatives to give voice to the vaccine safety concerns of health care consumers. For more information, visit www.NVIC.org.
Posted: 4/16/2010 1:08:50 AM | with 3 comments