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Is FDA Interested in the Safety of Anthrax Vaccine?

Wednesday, August 27, 2008

Is FDA Interested in the Safety of Anthrax Vaccine?

FDA answered a Freedom of Information Act request for me today. I asked how many adverse event reports had been filed for anthrax vaccine (5,931 reports through July 22, 2008) and how many FDA had designated as SERIOUS (618 reports). Serious reports are those indicating an event requiring hospitalization, a life-threatening event, permanent disability, or loss of life.

I further asked whether FDA has performed any studies to assess causality (i.e., were adverse outcomes a result of the vaccination?) or if FDA has required the manufacturer to do so. The answer was 'No' to both questions.

FDA referred me to CDC. CDC began a clinical trial of anthrax vaccine in 1,564 people in 2002. Subjects were enrolled for 43 months, which theoretically should yield excellent long-term data. But no report from the study has been made public, despite early promises that a preliminary report would be released in 2004, and a final report in 2007.

The CDC's Advisory Committee on Immunization Practices met February 27-28, 2008 and discussed anthrax vaccine and this trial. Slides from every talk except the anthrax vaccine talks were posted by the CDC here. But the slides from each of the 4 talks on anthrax vaccine are listed as "coming soon."

However, I did manage to find this tidbit (see page 155 of the report): in CDC's clinical trial of 1,564 subjects, there were 229 reports of serious adverse events! That means, if you entered the anthrax vaccine trial, you had a greater than 1 in 7 chance of suffering a serious adverse event within the next 43 months. Yet despite failing to cite quantitative data, CDC thought the vast majority of serious events were not related to the vaccine. (But something bad was happening to this cohort of subjects, about 85% of whom received anthrax vaccine.)

Over 2 million people have received more than 7.5 million doses of the Bioport (now Emergent BioSolutions/ EBS) anthrax vaccine since 1998, and all deploying soldiers and most contractors must be vaccinated as a condition of employment. Yet no federal public health agency is anxious to release definitive safety/injury data. Wonder why?

Meryl Nass, MD
Mount Desert Island Hospital
Bar Harbor, Maine 04609
W 207 288-5081 ext. 1220
C 207 522-5229
H 207 244-9165
pager 207 818-0708