Rules relaxed in rush for new smallpox vaccine

Rules relaxed in rush for new smallpox vaccine

Charlotte Denny
Guardian

Thursday October 25, 2001

The US government is to allow drug firms to speed up safety trials in their search for a new smallpox vaccine as fresh evidence emerges that Washington is preparing itself for full-scale biological warfare.

Tommy Thompson, the US health secretary, asked Congress this week for $500m (£350m) to produce enough smallpox vaccine "so every American will be assured there is a dose with his or her name on it if it is needed".

The administration has stepped up its preparations for more biological attacks after the anthrax campaign which has killed three people. Officials disclosed yesterday that three new suspected cases of inhalation anthrax had been reported by a hospital near Washington. All were linked to a contaminated letter sent to Senator Tom Daschle.

Mr Thompson wrote to leading companies asking if they could make a smallpox vaccine available by the end of next year. New drugs normally have several years of safety testing.

Industry observers say Washington is prepared to let firms compress clinical trials into 12 months. The government has promised legal protection for companies. No American producer has made smallpox vaccine since the 1980s and most will have to start from scratch. Vaccination for the disease stopped after smallpox was eradicated in the 1970s, but experts fear it might be used as a biological weapon.

A British company, Acambis, which has developed a new vaccine, said it hoped to complete safety trials in 18 months.

The Acambis vice-president, Thomas Monath, told a Senate committee yesterday that no private insurers would cover a company bringing out a vaccine in record time for potential use on hundreds of millions of people.

Acambis has an existing agreement with the US government to deliver 54m doses of vaccine next year. It plans to begin human safety trials early next year.