HHS Awards $428M Smallpox Vaccine Contract To Acambis-Baxter Joint Venture

HHS Secretary Tommy Thompson on Nov. 28 announced the signing of a $428 million contract for 155 million doses of smallpox vaccine by next fall, which combined with other orders and existing stocks, "should be enough to protect every American against the deadly virus," the New York Times reports (Stolberg/Petersen, New York Times, 11/29). Acambis, a British biotechnology company with U.S. headquarters in Massachusetts, was awarded the contract, and will work with Baxter International to produce the vaccine (Sanders, Los Angeles Times, 11/29). Thompson announced the plan to purchase enough vaccine for every American last month, but it originally called for the government to buy 300 million doses. Instead, the contract for 155 million doses will supplement previous orders with Acambis for 54 million doses. In addition, the NIH is conducting experiments to test whether the nation's current stockpile of 15.4 million doses can be diluted to increase that supply to 77 million, which would bring the total number of available doses to 286 million. Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said the dilution tests, which will be completed in February, "have been very gratifying." The government does not plan to immunize all Americans against the disease, but instead will stockpile the vaccine in the event of a bioterrorist attack involving smallpox (New York Times, 11/29). "While the probability of an intentional release of the smallpox virus is low, the risk does exist and we must be prepared," Thompson said ( HHS release, 11/28).

Price and Speed
The final competitors for the new contract were Acambis, Merck and GlaxoSmithKline. Thompson said he chose the small British firm because it will charge less for the vaccine and will be able to deliver the doses more quickly than the other companies, the Boston Globe reports. The agreed price of $2.76 a dose that Acambis will receive was "substantially less" than the two competitors sought, Thompson said, and means that the government will have to pay less than the $509 million initially proposed by the administration for the contract (Kowalczyk, Boston Globe, 11/29). Under the new contract, Baxter, a global drug and medical products conglomerate that owns a stake in Acambis, will produce the vaccine at one of its facilities in Austria, and then ship it to Acambis in the United States, where it will be placed into vials (Connolly/Gillis, Washington Post, 11/29). Thompson said the FDA would "carefully monitor" the production process of the vaccine, and "test individual lots to ensure safety and effectiveness," (Loyd, Philadelphia Inquirer, 11/28).

Questioning a Single Contract
Despite Acambis' offer of a lower price for a vaccine and its promise to deliver the doses within 12 months, the Wall Street Journal reports that awarding a single contract "rais[es] fears that the government's previous bad luck producing bioterrorism vaccines will be repeated," as Acambis and Baxter are less experienced in the vaccine business than GSK and Merck -- "two of the largest vaccine producers in the world." The Journal reports that none of the doses from Acambis' original order has been delivered, and the company doesn't produce any other vaccines. The Journal cited the government's "troubled" experience with manufacturing anthrax vaccine, in which the vaccine's sole maker, BioPort, has had difficulty meeting FDA safety requirements (Harris, , 11/29). Said one "national vaccine expert" who asked not to be identified: "For something with national security importance, I'd want to diversify the supply and not rely on one company. I would have bet you almost any amount that they would have picked two or three companies in case something goes wrong at one of them" (Kowalczyk, Boston Globe, 11/29).

Thompson Responds
Nevertheless, Thompson said that Acambis' prior research and development of the smallpox vaccine as a result of its first contract "was such that we felt very comfortable with them" (New York Times, 11/29). He added that Acambis will produce the 155 million doses using a different cell line than the original 54 million doses, "giving the government some protection if there are problems growing the virus in one of the cell lines." Thompson also said that the NIH would help conduct clinical trials of both versions of the vaccine in humans (Kowalczyk, Boston Globe, 11/29). Acambis spokesperson Lyndsay Wright said the company's partnership with Baxter will also provide some insurance. "The fact that both Acambis and Baxter are working on the manufacturing is helping to allay some of the risk," she said (Washington Post, 11/28). Daniel Hoffman, a pharmaceutical industry consultant, also expressed confidence in HHS' decision. "Acambis certainly meets the specs required by the FDA for production capability, and the price is right. Those are both established companies. I don't see it as going with the untested or untried, not at all" (Loyd, Philadelphia Inquirer, 11/29). In any case, the "sudden infusion of cash" to Acambis -- which is now responsible for delivering 209 million doses of smallpox vaccine to the U.S. government by the end of next year -- will make it profitable "for the first time in its history." Wright said, "It means a lot to us," adding, "But we are not delighted to be profiting off this particular area. It's such a worry for people" (Aoki, Boston Globe, 11/29). For comprehensive public health information from the CDC on anthrax and other bioterrorism issues, please visit www.bt.cdc.gov.