FDA Rules Hinder Distribution, Production of Vaccines

The new smallpox vaccine that drug maker Acambis PLC plans to have ready by next year -- two to three years ahead of schedule -- will not have won FDA approval when it first appears, Gannett News Service/Detroit News reports. Although it appears "more likely than not," according to Goldman-Sachs, that the vaccine will eventually win "accelerated" FDA approval, a study of Acambis' finances released last week by the investment firm Goldman, Sachs & Co. concluded that that approval will not have come by the end of 2002. Federal health officials say they need to use the smallpox vaccine on civilians before granting final FDA approval. They could get clearance to use the vaccine as an "investigational" drug, similar to experimental cancer treatments that are used on patients even though they do not have full FDA approval. The federal government has 15 million doses of a smallpox vaccine last manufactured in the 1970s, but that vaccine would not meet FDA standards today and may "be of dubious quality because of its age." According to Gannett News Service/Detroit News, the issue illustrates "how difficult it may be to rely on vaccines" in the event of a bioterrorist attack.

In addition to the smallpox vaccine problems, the FDA since 1998 has forced BioPort Corp., which manufactures an anthrax vaccine for the U.S. military, to halt production of the vaccine (Neus, Gannett News Service/Detroit News, 10/9). BioPort stopped manufacturing the vaccine after FDA investigators found "numerous deficiencies" in the company's facility in Lansing, Mich. Kevin Keane, an FDA spokesperson, said that Bioport officials "are working closely to try to get the facility open as quick as possible," but plans to resume production still appear "at least a month away." Sen. Tim Hutchinson (R-Ark.) said that the federal government should "take over" the manufacture of vaccines, such as the anthrax vaccine, that health officials would use to defend against bioterrorism. He inserted a $3 million provision in a defense bill approved in the Senate last month for the design of a facility for the federal government to manufacture anthrax vaccine. In addition, Merck & Co. officials have discussed a plan with the Department of Defense to allow a Merck facility in Whitehouse Station, N.J., to become a supplier for anthrax vaccine. BioPort has received a "floo[d]" of requests for the anthrax vaccine from U.S. civilians in the aftermath of the Sept. 11 attacks on the World Trade Center and the Pentagon (Wall Street Journal, 10/9). However, the federal government has "no plans" to distribute the vaccine to civilians (California Healthline, 10/1). "We're not recommending it to the population," Dr. Scott Lillibridge, a top bioterrorism adviser to HHS Secretary Tommy Thompson, said, adding, "(Soldiers) are in high-risk areas. We don't vaccinate for illnesses not moving through the (civilian) population" (Gannett News Service/Detroit News, 10/9).

Meanwhile, the Washington Post reports that the Dale and Betty Bumpers Vaccine Research Center, a $34 million NIH facility developed to "streamline" vaccine research, production and marketing, has selected HIV as its first "target." Opened last year on the NIH campus in Bethesda, Md., the VRC, with a budget of $40 million in 2002, represents the first federally funded vaccine research facility "devoted entirely" to vaccine research and production. The center will research, develop and manufacture some vaccines, which will allow the federal government to avoid negotiations for licensing partnerships with private drug companies, a process that can "tie up products for years," the Post reports. In conjunction with San Diego-based biotechnology firm Vical, the center has begun tests on VRC-001-VP, a DNA-based HIV vaccine candidate that uses genetically re-engineered pieces of HIV DNA. Although it will not likely stop HIV, researchers predict that the vaccine, combined with an immunity-boosting vaccine to boost white blood cell production, could "thwart" the virus. The VRC plans to develop and test vaccines for additional diseases such as Ebola virus, malaria and tuberculosis (Squires, Washington Post, 10/9).