Thursday, November 29, 2001

U.S. gov’t purchases smallpox vaccine
By Lauea Meckler
Associated Press

WASHINGTON — The Bush administration signed a contract Wednesday to buy 155 million doses of smallpox vaccine from a British firm, preparing for the possibility terrorists would try to spread the deadly virus.

The contract with Acambis Inc. will bring the nation’s stockpile to 286 million doses of the vaccine by the end of next year, promising protection for every American should bioterrorists attack with the all-but-extinct virus.

“The risk does exist and we must be prepared,” said Health and Human Services Secretary Tommy Thompson.

The vaccine can be administered four days after exposure to smallpox and still offer protection. For that reason, and because the vaccine can cause some rare but deadly side effects, officials have no plans to resume the routine vaccinations of Americans that ended in 1972.

Thompson said that buying the new vaccine is sure to prompt demand for the shots by some Americans and debate in Congress and at the White House over whether vaccinations should resume.

The government already has 15.4 million doses of smallpox vaccine on hand, and each of them will be diluted to create five doses, bringing the total to 77 million.

Researchers are studying whether each dose could be further diluted, to get 10 doses from each one.

In either case, the diluted vaccine would only be used if the new doses had not yet been delivered, or if they ran out, said Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Disease.

An additional 54 million doses have already been ordered from Acambis and are expected to be delivered next year.

The new contract will bring another 155 million doses, which are expected by late fall 2000. They will cost the government $428 million, or $2.76 per dose. That’s less than the $509 million that the Bush administration has asked from Congress to pay for the new vaccine.

The initial budget request assumed that the government would need to buy 250 million doses, but new research has found that the existing vaccine can safely be diluted, meaning much less new vaccine is needed.

To make the newest batch of vaccine, Acambis has teamed with Baxter International, which will begin brewing doses immediately at an undisclosed European factory, said Acambis spokeswoman Lyndsay Wright. Acambis’ own manufacturing will begin soon at a factory in Cambridge, Mass., she said.

“Between the two of us, we have the manufacturing capability,” she said.

After the vaccine is manufactured, it must be tested in clinical trials and then approved by the Food and Drug Administration. The FDA promised a sped-up review but promised not to lower its standards.

Smallpox hasn’t occurred in the United States since 1949 and was declared eradicated from the globe in 1980. But the Centers for Disease Control and Prevention in Atlanta and a Moscow laboratory hold stocks of the virus, and experts worry that samples could fall into terrorists’ hands and be brewed into enough to be used as a weapon.

Bioterrorism experts say a smallpox attack is unlikely, but it could overwhelm communities were it to occur. The virus is highly contagious, and nearly a third of its victims die.

“Obtaining the vaccine represents an important insurance policy,” said Dr. D.A.

Henderson, who led the global campaign that eradicated smallpox and is now Thompson’s top bioterrorism adviser. “This is not because of any particular threat or new threat or anything of that sort. It’s simply a prudent thing to do at this point in time.”

Thompson added that while the risk of a release of the virus is low, it is real.

“We hope that increasing our smallpox vaccine stockpile would serve as a deterrent to any individual terrorist who would consider using smallpox as a weapon against us,” he said.

HHS officials have been negotiating for weeks with several drug makers for the new smallpox contract. Two other companies were in the final bidding, Merck & Co. and GlaxoSmithKline.

Final offers were submitted last week. Thompson said Acambis was chosen because of its experience and because its offer was lowest.