Flu vaccine shortage anticipated after Brits nix company's supply

| 10/5/2004

The United States is facing a certain shortage of flu vaccine after Britain temporarily suspended a company’s license to produce the vaccine.

Chiron, which makes between 46 million and 48 million doses of vaccine for use in the United States, announced recently that the British Medicines and Healthcare Products Regulatory Agency had revoked its flu vaccine license.

According to the U.S. Department of Health and Human Services, the U.S. had planned to have 100 million doses available, with Chiron producing almost half of it. The agency anticipates that 56 million doses made by two other companies will still be available here.

Last year, 87 million people in the United States received flu shots.

Meanwhile, U.S. officials are working on a contingency plan.

“Our immediate focus will be on making sure that the supply we do have reaches those who are most vulnerable,” Health and Human Services officials said in a news release. “The Centers for Disease Control and Prevention is convening its Advisory Committee on Immunization Practices to prioritize its recommendations on who should get the flu vaccine for this season based on the new vaccine supply information.”

U.S. officials are also checking to see if companies such as Aventis can make more vaccine for this year this late in the process.

Chiron did not say why its license was revoked, and U.S. officials indicated they were seeking more detailed information. Meanwhile, the company did hint at reasons in a statement.

The company said in a news release that the British agency “asserted that Chiron’s manufacturing process does not comply with UK Good Manufacturing Practices regulations.”

“Our manufacturing and quality staff have worked hard to resolve what we viewed as a problem limited in scope to a few batches, and we believe our quality assurance confirmatory testing demonstrates that the Fluvirin doses we anticipate releasing are safe,” John Lamber, president of Chiron Vaccines, said in a statement.

– By Mark H. Reddig, associate editor