Aventis to Donate 70 to 90 Million Doses of 30-Year-Old Smallpox Vaccine to Federal Government
French pharmaceutical company Aventis Pasteur announced last Friday that it will donate to the U.S. government between 70 and 90 million doses of the smallpox vaccine it recently found "after 30 years in cold storage," the AP/Philadelphia Inquirer reports (Caruso, AP/Philadelphia Inquirer, 3/30). The drug maker said the U.S. government still must conduct human clinical trials to confirm the effectiveness of the vaccine, but initial tests by Aventis found the vaccine "still potent and as effective as the 15.4 million doses the United States already has." The NIH will also test the doses to see if they can be diluted, which could "multiply" the amount of available vaccine "fivefold or more" (Lueck, Wall Street Journal, 4/1). HHS Secretary Tommy Thompson said, "What the Aventis supply could give us is an extra layer of protection, a huge insurance policy" (Pear, New York Times, 3/30).
According to Thompson, because the vaccine can cause potentially fatal side effects, the current plan for addressing a bioterrorist attack using the smallpox virus is still ring containment -- a "process of vaccinating only those people who have come in contact with the disease or with others who have been exposed" (California Healthline, 3/29). However, the donation of the Aventis doses "sharply shifted" the debate over whether the government should instead provide mass vaccinations. The New York Times reports that "now the questions are how to decide on a smallpox vaccine plan, and who should be making the decisions." National Institute of Allergy and Infectious Diseases Director Dr. Anthony Fauci is calling for an "open dialogue" on the current plan, but adds that his suggestion is "not an indictment" (Kolata, New York Times, 3/30). D.A. Henderson, head of the HHS Office of Public Health Preparedness, said that "because the current threat of a smallpox attack is low, the risks of vaccination may outweigh the benefits." However, the Washington Post reports that doctors and emergency response personnel say that a "crisis would be the worst time to implement a complicated, massive vaccination program." William Bicknell, a professor at the Boston University School of Public Health, wrote in a New England Journal of Medicine opinion piece, "An epidemic is highly likely to outrun the vaccinators" (Connolly, Washington Post, 3/30). Thompson said that although "there's ongoing discussion at the highest level of government and throughout America about vaccination, there's no change in what the CDC has come up with so far" (Manning, USA Today, 4/1). The Washington Post reports the CDC will hold a conference in May to discuss the current plan and "make recommendations" (Washington Post, 3/30).
If the U.S. government offered "the best possible estimate of the risk" of a smallpox attack and the risk of vaccination, "informed members of the public [could] choose their own medicine," according to a New York Times editorial. The editorial says that the current ring containment plan has "worked well in containing natural outbreaks in the past," but there is no apparent "reason why the vaccine should not be available to those who want it." But the editorial concludes, "People who fear the side effects and think the likelihood of an attack is remote could shun the vaccine, while those willing to accept the risks should be able to get the vaccination" (New York Times, 3/31). A Boston Globe editorial says the current plan, "for the time being, still makes sense," but added that an "open discussion is needed more urgently than ever" with the announcement of the found vaccine. The editorial concludes that "federal officials should hold off" on mass inoculation, especially because "highly publicized deaths" from the vaccine could "deter people from using other vaccines that do not have such complications" in the future (Boston Globe, 4/1).
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