Federal Government May Purchase Large Amounts of New Smallpox Vaccine for National Stockpile
The federal government may purchase large amounts of a new form of smallpox vaccine to supplement the national stockpile and help "resuscitate the floundering" national smallpox vaccination campaign, the Washington Post reports. Safety concerns have limited efforts to use the three vaccines currently included in the national stockpile -- which use a live virus to cause an immune system response -- to immunize health care and emergency workers who would respond in the event of a biological attack. The new vaccine, called Modified Vaccinia Ankara, or MVA, also uses a live virus. However, the vaccine does not effectively replicate in humans and as a result, is less likely to cause adverse effects, according to researchers. The vaccine will enter human clinical trials in the United States in the next few weeks, with samples provided by British biotechnology company Acambis and Danish company Bavarian Nordic. The United States expects to award a contract for several million doses of the vaccine later this year. Anthony Fauci, director of National Institute of Allergy and Infectious Diseases, said that the government could begin to include the vaccine in the national stockpile within the next two years (Witte, Washington Post, 4/15).
In related news, officials for Acambis on Tuesday announced that the company has suspended a human clinical trial of ACAM2000, in which researchers sought to compare the effectiveness of ACAM2000 and Dryvax. Three of the 1,132 participants in the trial who received either ACAM2000 or Dryvax developed heart inflammation. Acambis will not enroll new participants in the trial until the completion of a review by company, CDC and FDA officials. According to the Washington Post, the Acambis announcement "reopened debate over the safety of one of the government's primary defenses" against potential smallpox attacks (Witte/Gillis Washington Post, 4/14). In November 2001, the government awarded Acambis a $428 million contract to supply as many as 250 million additional doses of the vaccine to the national stockpile (California Healthline, 11/29/01). Acambis has sent more than 200 million doses of ACAM2000 to the government. CDC spokesperson Tom Skinner said that he was unaware whether the Acambis announcement would affect government plans to use ACAM2000 in the event of a smallpox attack (Washington Post 4/14).
Meanwhile, FDA plans to reduce restrictions on safety reviews of medications developed to treat serious adverse effects caused by smallpox vaccine, Long Island Newsday reports. FDA to date has approved no such medications. Under new guidelines, FDA on May 4 will begin to limit reviews of such medications to six months. Eligible medications will treat such adverse effects as heart and brain inflammation, serious rashes and eye infections. Pharmaceutical companies can either develop new medications or study new uses for approved treatments. Former FDA Commissioner Mark McClellan said, "Bioterrorism is one of the most profound new public health threats facing the U.S. and our agency intends to identify all possible steps to help minimize or eliminate the potential risks of bioterrorism to Americans" (Kerr, Long Island Newsday, 4/15).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.