1980N-0208 Biological Products; Bacterial Vaccines and Toxiods
FDA Comment Number : EC36
Submitter : Dr. Muhiuddin Haider Date & Time: 04/04/2005 07:04:13
Organization : The Partnership for Anthrax Vaccine Education
Category : Health Professional
Issue Areas/Comments
The Partnership for Anthrax Vaccine Education (henceforth, the Partnership), a coalition of public and private organizations, submits this comment to Docket No. 1980N-0208 in support of the Category I classification of the Anthrax Vaccine Adsorbed (AVA) manufactured by BioPort Corporation. The Partnership and its member organizations agree with the Panel finding that AVA is safe, effective and properly labeled. The Partnership further supports the Panel?s decision to classify AVA based on the body of scientific knowledge summarized in detail by the Institute of Medicine report ?The Anthrax Vaccine: Is It Safe? Does It Work?? (cited in the docket as reference 2).

The Institute of Medicine report is the current definitive exploration of the safety and efficacy of the Anthrax Vaccine Adsorbed. Drawn from case reports, research studies, and the expert testimonies from stakeholders, the IoM report is an exhaustive survey of the questions and answers that surround AVA. Having pulled together the vast array of data, facts and opinions on the vaccine, the committee was ultimately able to conclude with confidence that AVA was an effective vaccine against all forms of anthrax. The committeee also found the vaccine to be reasonably safe in adults and that there was no evidence to suggest that vaccination increased the risk of life-threatening or permanently disabling events as compared with the general population. Furthermore, the labeling has remained consistent with what is widely regarded as a safe and effective immunization schedule. On these grounds, the Partnership firmly supports the Panel in classifying the Anthrax Vaccine Adsorbed as a Category I product.

The Partnership, an organization that advocates for vaccine education and promotion based on sound science, lends its support to the Panel finding on behalf of its many member organizations. The Partnership is a broad coalition of organizations including military and security personnel, law enforcement, first responders, consumer and patient groups, vaccine manufacturers, educational institutions, public health officials and health care providers. These organizations include the American Medical Association, American Nurses Association, American College of Emergency Physicians, Society for Public Health Education, and the George Washington University?s School of Public Health and Health Services, among many other distinguished private and public institutions. The primary goals of the Partnership are to clarify myths and correct misinformation regarding anthrax and anthrax vaccines using current science-based information, raise awareness and knowledge about anthrax and anthrax vaccines, and advocate for the development of a comprehensive national anthrax preparedness plan. Further information about the Partnership can be found online at http://www.anthraxinfo.org/.