Production problems in a vaccine factory in Liverpool, U.K., have derailed U.S. plans to prepare for this year's flu season and focused new attention on the fragile supply of essential vaccines. Yesterday, vaccinemaker Chiron, based in Emeryville, California, announced that it will not be able to deliver any flu vaccine this year because British regulatory authorities have shut down vaccine production at its Liverpool plant for 3 months. As a result, the United States will have to make do with about 50 million doses of flu vaccine--just over half of what health authorities had hoped to have on hand.
Chiron had warned in August that part of its annual flu vaccine production, the vast majority of which is sold to the United States, would be held up while a contamination problem in its facility was investigated. While providing few details about the snafu, Chiron announced yesterday that the U.K. Medicines and Healthcare Products Regulatory Agency had suspended the company's license to produce flu vaccine because Chiron does not comply with Good Manufacturing Practices regulations in the United Kingdom. As a result, the company won't release any flu vaccine at all this season.
In the United States, the flu vaccine is recommended for anyone over age 50, children between 6 and 23 months, pregnant women, health care workers, people with chronic diseases, and a few other risk groups. Many others also take the shots; some 87 million doses were used last year. Yesterday, the Centers for Disease Control and Prevention issued new vaccination guidelines, recommended by a hastily convened meeting of the Advisory Committee on Immunization Practices. The guidelines raise the recommended age to 65 and ask that anyone not in any of the risk groups forgo vaccination this season.
Influenza sickens between 5% and 20% of the U.S. population each year, killing more than 35,000. "Flu is no joke," says health policy expert Frank Sloan of Duke University. The affair once again underlines how fragile the vaccine market is, Sloan says: Because of high risks and low profits, many companies have given up making vaccines in favor of more lucrative drugs. To remedy that situation, an Institute of Medicine panel chaired by Sloan last year proposed a radical overhaul of the vaccine system that would give the federal government a stronger role and guarantee manufacturers a higher price.
The new flu vaccination guidelines
Chiron press release about the problems
Flu information from the Centers for Disease Control and Prevention
Press release about last year's IOM report, with a link to the full report