PARTNERSHIP COMMENDS FDA RULING CONFIRMING SAFETY, EFFICACY OF ANTHRAX VACCINE
WASHINGTON, DC – December 16, 2005 – The Partnership for Anthrax Vaccine Education (PAVE) commends the Food and Drug Administration’s (FDA) Final Rule and Order issued December 15th confirming its previous finding that the anthrax vaccine (Anthrax Vaccine Adsorbed, AVA) is safe and effective.
The ruling stated that AVA is safe and effective for its intended use, including protection against inhalation anthrax.
This decision also confirms the position of the Partnership, which supports the need for public policy based on science, not outside factors.
“We applaud the FDA for using an unbiased, scientific approach to render its findings,” said Dr. James James, director of the AMA’s Center for Public Health Preparedness.
“This ruling is truly in the best interests of the men and women of our country’s defense forces, who may find themselves facing an anthrax attack. AVA is the best available countermeasure with which to protect them, or anyone at risk of being exposed to this potentially lethal disease.”
The FDA findings were the result of a court-ordered review of the vaccine and the second time that the agency has validated AVA as a Category I drug, stating further that it has been legally licensed since November 1970.
“The FDA has once again confirmed what the Partnership and many vaccinology experts have known – that AVA is safe and effective,” said Dr. Muhiuddin Haider, Project Director of the Partnership and Professor at the George Washington School of Public Health.
“These findings should once and for all clear up any myths and misconceptions about the anthrax vaccine and provide peace of mind for anyone receiving this vital, life-saving drug.”
AVA is the only FDA-licensed anthrax vaccine available in the world, with more than 5 million doses administered to more than 1.3 million people. In its Final Rule and Order, the FDA also concluded that there is no causal relationship between AVA and adverse side effects or deaths.
This renewed support further strengthens the Partnership charter of educating the public regarding health preparedness against viable threats, such as anthrax, as a necessary key to vaccine success and effectiveness. Additionally, it urges heightened community awareness regarding prevention through vaccines, whether for anthrax or other diseases as essential to the health, well-being, and protection of the public.
Led by the George Washington University Medical Center’s School of Public Health and Health Services, the Partnership is a coalition of public health, medical and anti-bioterrorism organizations that have united to provide the public with the most comprehensive and current information on anthrax and its vaccine.
To do this, the Partnership created a website: www.anthraxinfo.org. The website is updated regularly and presents information in a clear manner. The Partnership’s members include the George Washington University, the American Medical Association (AMA), the American Nurses Association, the American College of Emergency Physicians, the American Association of Occupational Health Nurses, the American Council on Science and Health, the Global Health Council and the Society for Public Health Education (SOPHE).
# # #
 top
|