Chiron Will Deliver No Doses of Flu Vaccine Manufactured in Germany Over Contamination Problems
Officials for California-based Chiron on Wednesday announced that testing of the company's German manufacturing facility showed that bacterial contamination of the flu vaccine Begrivac is more widespread than previously believed, and as a result no doses will be delivered in the next flu season, the Wall Street Journal reports. Expected production of Begrivac, which is sold in non-U.S. markets, had been 12 million doses (Hamilton, Wall Street Journal, 7/21).
Chiron last week announced that production of Begrivac would be scaled back by about eight million doses because of contamination. The company also said it might delay shipments of the vaccine until early October.
The U.S. experienced a flu vaccine shortage last flu season after the British Medicines and Healthcare products Regulatory Agency in October 2004 suspended the license of a Chiron manufacturing facility in Liverpool, England, because of contamination issues. In late February, MHRA ended the suspension, a move that will allow the facility to manufacture flu vaccine for the U.S. market for the 2005-2006 season, contingent on FDA approval. However, Chiron last month announced plans to manufacture only 18 million to 26 million doses of its U.S. flu vaccine Fluvirin for the 2005-2006 season, down from an April estimate of 25 million to 30 million doses.
Chiron sells flu vaccines Agrippal S1, Fluad and Begrivac outside the U.S. (California Healthline, 7/18).
News of the contamination "couldn't come at a worse time" for Chiron as FDA is evaluating the company's Liverpool plant, the Journal reports. Chiron representatives have said that the contamination incidents at the Liverpool and German plants are unrelated. Chiron said the company has informed FDA of the Begrivac contamination, over which FDA holds no jurisdiction.
Chiron also has said it will attempt to boost production of Fluad and Agrippal. However, the company "hasn't said how much more vaccine it can reasonably produce," the Journal reports (Wall Street Journal, 7/14).
CDC spokesperson Lance Rodewald, speaking about the prospects for Chiron's U.S. flu vaccine manufacturing, said, "We're still in this uncertain period. We haven't seen any red flags that are showstoppers, but they have hurdles to overcome, and we won't know whether they've overcome them until the inspection is done." Rodewald added that he expects Chiron will win FDA approval (Manning, USA Today, 7/21).
Sanford Bernstein analyst Geoffrey Porges said, "It's just interesting to see how a company can continue to shoot themselves in the foot, in the same location, and just keep doing it over and over again." Some analysts predict that Chiron might fail to ship any doses of Fluvirin for the second year in a row. Porges said there is a 20% to 30% chance of that scenario (Wall Street Journal, 7/21).
Deutsche Bank analyst Jennifer Chao said the latest announcement "calls into question management credibility as well as potential systemic vaccine manufacturing issues." Chao added that she expects FDA to grant Chiron approval to sell Fluvirin in the U.S. (Gellene, Los Angeles Times, 7/21).