Acambis' Smallpox vaccine gets FDA consent

After getting its small pox vaccine approved by the US Food and Drug administration, Acambis PLC said the agreement may be looked upon as a major step towards firming up a long-term 'warm-base manufacturing' contract with the US government.

According to experts, the samples of Smallpox virus, capable of killing at least 30 percent of its victims were made into biological weapons in countries such as Iraq and the former Soviet Union, although the disease was completely wiped out in 1979 by worldwide vaccination programs.

The vaccine will be a part of a government stockpile for emergency use in case of a biological attack.

The Vaccines and Related Biological Products Advisory Committee of the FDA, decided in May that the Acambis’ Smallpox vaccine, ACAM2000 is both safe and efficient but should only be used during high risk of exposure to smallpox. The outside experts, that advice the Advisory Committee said further study was required, as there was a risk of heart inflammation in people who were vaccinated.

Another Smallpox vaccine of the company, MVA-3000, was rejected in November, last year, after having reached Phase II clinical trials. It was awarded fast track status, but Acambis could not beat a version offered by Novo Nordisk, and lost out in the tendering process after its vaccine was judged as ‘uncompetitive.’

The loss of $1 billion US government contract caused a financial hysteria in Acambis, and was soon followed by a major reshuffle of its top-level management. The company also slashed its workforce by 15 per cent.

The London-based, biotechnology company said that it is not competing with other companies and the contract is being offered on a 'sole-supplier' basis. The company proclaimed to have invested around $11 million to build up its vaccines manufacturing capacity and it can now contribute up to 190 million doses of vaccine.

Although details are not yet known, the contract is said to be worth up to $30 million per year for between 5 and 10 years, the company said.

Under a 2001 deal Acambis already has supplied millions of doses ACAM2000 vaccine but for the continuation of supplies, it required to win a new contract to be given by the US Department of Defense, for which a formal FDA approval was desired.