Nov 29, 2001 (CIDRAP News) – The US Department of Health and Human Services (HHS) has awarded Acambis Inc. a $428 million contract to produce an additional 155 million doses of smallpox vaccine by the end of 2002, HHS Secretary Tommy G. Thompson announced Wednesday.
Production under the new contract will bring the national stockpile of smallpox vaccine to 286 million doses by the end of next year, enough to vaccinate every American, according to an HHS news release. That number includes the doses under the new contract and 54 million doses that Acambis was already under contract to provide. The government has a stockpile of 15.4 million doses, and HHS expects to be able to dilute those doses by a 5 to 1 ratio, increasing the total to 77 million doses.
The Centers for Disease Control and Prevention's smallpox response plan does not call for nationwide vaccinations, but officials described the vaccine buildup as a prudent preparatory step and a deterrent to bioterrorists. The CDC says the risk of many adverse reactions from mass vaccination outweighs the risk of a smallpox outbreak.
"While the probability of an intentional release of the smallpox virus is low, the risk does exist and we must be prepared," Thompson said. "Expanding our stockpile so there is a smallpox vaccine for every American if needed prepares us to respond aggressively to minimize the spread of the disease should an outbreak occur. Additionally, we hope that increasing our smallpox vaccine stockpile would serve as a deterrent to those who might consider using smallpox as a weapon against us."
Acambis Inc., the US subsidiary of British firm Acambis plc, will produce the vaccine in partnership with Baxter BioScience, part of Baxter Healthcare Corp., according to an Acambis press release. Acambis originally won a $343 million contract from the CDC in September 2000 to produce 40 million doses of smallpox vaccine by 2004. After the terrorist attacks of last Sept 11, the CDC renegotiated the contract to change the delivery date to the end of 2002 and increase the doses to 54 million. The new contract means the company will be producing a total of 209 million doses for HHS. Acambis Inc. is based in Cambridge, Mass.
The new contract specifies a fixed price of $2.76 per dose, HHS reported. HHS has asked for an appropriation of $509 million to pay for smallpox vaccine.
Acambis is one of several drug companies that were reported to have been negotiating with HHS to supply smallpox vaccine. Other companies that have been mentioned in recent news reports include Merck and Co. and GlaxoSmithKline.
"Acambis and Baxter will produce the smallpox vaccine using a purified strain of vaccinia virus grown in live tissue culture," the HHS release states. Acambis said its vaccine is based on the same vaccinia strain that was licensed in the United States and used for routine immunization against smallpox before the disease was eradicated in the 1970s.
HHS officials said Acambis's vaccine will be produced in bulk form in a Baxter plant in Europe and will be shipped to the United States for refinement and processing. The Food and Drug Administration (FDA) will review the manufacturing processes and test individual lots of the vaccine to assure its safety and effectiveness, officials said. Acambis reported that the contract "includes the funding of an accelerated clinical development plan with the objective of obtaining FDA approval of the vaccine as rapidly as possible." The first clinical trials of the vaccine are scheduled to start early in 2002, and the company plans to apply for product approval in mid-2003, Acambis officials said.
Company offiicals said they will be pursuing separate, parallel clinical testing plans to obtain approval for the vaccines being developed under the original contract and the new one.
Concerning the existing vaccine stockpile, the HHS release notes that the National Institute of Allergy and Infectious Diseases has been studying the possibility of diluting the vaccine by a ratio of 5 to 1. "Early results indicate that the diluted vaccine retains the same level of effectiveness as the fully concentrated vaccine, which essentially expands the existing Dryvax vaccine supply to at least 77 million doses," officials said.
Commenting on the new Acambis contract, D. A. Henderson, MD, director of HHS's Office of Public Health Preparedness, said, "Expanding our smallpox vaccine stockpile ensures that we are well prepared in the event of a bioterrorist attack using smallpox. This new contract gives us the insurnace that we will have more than enough vaccine for any outbreak that might occur."
HHS press release of Nov 28