U.S. Hopes to Stockpile One Million Doses of the Anthrax Vaccine
HHS Secretary Tommy Thompson said yesterday that the U.S. government hopes to stockpile an anthrax vaccine supply "large enough" to inoculate close to one million individuals, the New York Times reports. BioPort Corp., which manufactures an anthrax vaccine for the U.S. military, has a "large" supply of the vaccine, but the FDA has prohibited the company from shipping the vaccine (Wade, New York Times, 10/31). The FDA shut down Bioport's facility in Lansing, Mich., in 1998 after an investigation found "numerous deficiencies" (Kaiser Daily Health Policy Report, 10/4). In October 2000, the FDA found 18 violations of "manufacturing procedures" at the facility (Kaiser Daily Health Policy Report, 10/31/00). BioPort filed documents with the FDA this month to demonstrate that the company has "resolved shortcomings" at the facility (Kaiser Daily Health Policy Report, 10/11). Thompson said that FDA officials will inspect the facility "shortly" and may allow BioPort to begin shipping the anthrax vaccine as early as Nov. 22. According to Thompson, BioPort has five million doses of the vaccine, which means that about 833,000 people could be inoculated. Six doses are necessary for full vaccination. If necessary, health officials could begin vaccinating up to two million individuals "because the shots are spread over 18 months and substantial benefit is obtained after the first two shots." The Department of Defense owns BioPort's vaccine stockpile, and Thompson has asked the department to share the vaccine (New York Times, 10/31). He said that negotiations with the department have moved "along very well" (AP/Milwaukee Journal Sentinel, 10/30).
Target Users
Health officials have considered new federal guidelines on who should receive the anthrax vaccine. CDC Director Dr. Jeffrey Koplan said that department officials "are in discussion as to who would be the target users of that vaccine." The government currently only vaccinates researchers who study anthrax in laboratories, individuals who handle animal products in areas where health officials often find anthrax, veterinarians and the U.S. military (Hostetler,
Richmond Times-Dispatch, 10/31). Health experts have said that those exposed to anthrax should receive the vaccine in addition to antibiotics to prevent overuse of the drugs (New York Times, 10/31). The CDC may also vaccinate individuals who cannot take antibiotics (Richmond Times-Dispatch, 10/31). In addition, the CDC may recommend the vaccine for postal employees "at long-term risk" for anthrax exposure (New York Times, 10/31). CDC epidemiologist Dr. Bradley Perkins said that the guidelines could change as new information emerges (Richmond Times-Dispatch, 10/31).
Government Contracts?
Meanwhile, drug makers have asked the government for contracts to conduct research on drugs to treat biological agents, such as anthrax and smallpox, a request that has led to an "uneasy debate" among company executives, lawmakers and consumer advocates over "how close the industry should be to the government," the New York Times reports. The debate has centered on who should fund the development of new vaccines and antibiotics to protect individuals against bioterrorism. In the past, the government has relied on the drug industry to develop pharmaceuticals and distribute them to the public. However, drug makers have said that the government should contract with them to develop anti-bioterrorism drugs "because the market need is uncertain and pricing is likely to be a sensitive topic." Several drug companies have said they have "no intention to make any profits on bioterrorism," but many executives have said that without the "potential for profits, possibly from government contracts," drug companies will have "no reason to create medicines for which there is no everyday market." Rep. Christopher Shays (R-Conn.) said yesterday that the government should offer drug companies "profitable contracts" to develop anti-bioterrorism drugs. Still, John Calfee, a health care expert at the
American Enterprise Institute, said that government contracts for drug development could "prove inefficient and costly because the government would probably have to cover any costs the companies incurred, plus a profit margin" (Bradsher, New York Times, 10/31). For comprehensive public health information from the CDC on anthrax and other bioterrorism issues, please visit www.bt.cdc.gov.
