Feds May Offer BioPort
Anthrax Vaccine To Some Exposed
By Lisa Richwine

(Reuters) - The U.S. government may offer anthrax vaccinations to some people exposed to the biowarfare agent in mail attacks so they would not get sick once they stop taking antibiotics, officials said on Saturday. People exposed to high doses may still have potentially deadly anthrax spores in their lungs after taking the recommended 60-day course of antibiotics. As many as 3000 people are at the highest risk of having lingering spores and might be candidates for an anthrax vaccine, officials said.
The government's top experts said they would make a recommendation early next week to Tommy Thompson, the Secretary of Health and Human Services, on whether to make the vaccine available to some people who were exposed. [This was approved 18 Dec 2001; see < - Mod.JW]
The vaccine, which Bioport Corp. makes for the U.S. military, is approved for preventing anthrax before exposure. Giving it after someone comes in contact with the biological warfare agent would be done on an experimental basis only, with patients' informed consent, officials said. The doses of the vaccine available to health officials have not received Food and Drug Administration clearance for use, but one top FDA official said they would be appropriate for an emergency, stressing that patients would be informed of their status.
Alternatives to vaccination include advising people to watch for symptoms and to keep in close touch with their doctors after their 60- day course ends or extending antibiotic treatment to 90 days.
The Atlanta-based Centers for Disease Control and Prevention held a meeting with anthrax experts in Washington on Saturday to discuss data and evaluate options for preventing any new illnesses in people who inhaled anthrax bacteria spores. Experts have little experience with anthrax to guide their decisions.
About 10 000 people were urged to take the 60-day treatment because they were exposed to anthrax through tainted letters sent to media outlets and 2 US senators. Antibiotic therapy started as early as 8 Oct 2001, so many people have completed their courses. Others did not start until 25 Nov 2001. No one who has finished the 60-day therapy has developed anthrax, "an extremely reassuring piece of information,'' said Julie Gerberding, acting deputy director for the CDC's infectious disease center.
One animal study showed giving a vaccine together with antibiotics offered no benefit over giving antibiotics alone. [But this is because the veterinary Sterne vaccine is a "live" vaccine derived from a culture that is deficient in the pX02 plasmid. The Russians have successfully explored the possibility of producing STI vaccines resistant to various antibiotics that would be given simultaneously with the vaccine. The STI vaccine is similar to the Sterne vaccine. - Mod.MHJ]
Vaccines ... would be given in 3 injections at 2-week intervals. Antibiotic therapy would continue until immunity built up at about 4 weeks after the first shot.
People who were in the room where an anthrax-tainted letter to Senate Majority Leader Tom Daschle was opened have been urged to extend antibiotic treatment to 90 days, said Dr. Gregory Martin, chief of infectious diseases at Walter Reed Army Medical Center.
Some members of the military have alleged that the vaccine caused chronic health problems. Health officials said on Saturday that the vaccine had not been linked to any long-term side effects, but that studies were continuing. The most common side effects are injection- site reactions, such as swelling and tenderness.
The Defense Department is transferring 10 000 doses of the vaccine to the Department of Health and Human Services and has offered to make more doses available, said Dr. Kathy Zoon, head of the FDA's Center for Biologics Research and Evaluation. The 10 000 doses are from a lot that Bioport has made at a renovated plant that is awaiting regulatory approval. Other doses could come from another batch of 209 000 made in 1992. Preservative levels in those doses are lower than required for regulatory approval, Zoon said, but she added that either batch would be suitable for emergency use. ___
ProMED-mail <
[If the USDA/APHIS or AVMA had recommended putting thousands of cattle on cipro for 60 or 90 days, we would have been roundly criticised by our physician brethren, and correctly so.
If these people were vaccinated now and the antibiotics discontinued after a week, when the antibody system had begun to be primed [by the vaccine] -- or after 2 shots had been given, to be more cautious -- they are then adequately protected against any late-germinating spores, especially if they later get a third shot. The trials at USAMRIID many years ago demonstrated the good protection provided by 2 or 3 shots of the US human vaccine against massive exposures. Similarly, over time the lungs clear out many if not all of the spores deposited there.
If I were to predict anything, it would be that in future similar exposures, the putatively exposed people would be started promptly on a vaccination series and simultaneously be given a limited but adequate amount of a suitable oral antibiotic. - Mod.MHJ]

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