Cold & Flu Health Center
This article is from the WebMD News Archive
U.S. Loses Half Its Flu Vaccine Supply
Oct. 5, 2004 -- Expect flu vaccine shortages again this year. Manufacturing problems mean half the U.S. flu vaccine supply -- some 48 million doses -- won't arrive.
The U.S. gets nearly all its flu vaccine doses from two manufacturers, Chiron Corp. and Aventis Pasteur.
Last August, Chiron announced that manufacturing problems resulted in contamination of some early lots of its vaccine. Correcting these problems, they said, would delay vaccine delivery.
It now turns out that those problems were quite serious. The U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) -- the U.K.'s counterpart to the U.S. FDA -- has found Chiron's manufacturing process unacceptable and has pulled Chiron's flu-vaccine export license for three months. Unless there's a rapid reversal of this action, this means all of the company's 48 million doses of flu vaccine will be destroyed.
"This is a devastating event to us," Chiron CEO Howard Pien said today in a news conference. "I cannot overemphasize how profoundly we regret we will not be able to meet public health needs this season."
No unsafe flu vaccine has been released to U.S. consumers. A small shipment of the Chiron vaccine did reach American shores but was not distributed.
"I say to the American public that there is not a single vial of the flu vaccine in the U.S. that is contaminated," Pien promised.
Public health officials are reacting to the news with dismay.
"This is very disappointing news that poses a significant challenge to our influenza vaccination program," U.S. Secretary of Health and Human Services Tommy Thompson said today in a news conference.
U.S. Sending Team to U.K.
Harry Keyserling, MD, professor and director of the division of pediatric infectious diseases at Emory University, agrees that the news means a setback to flu vaccination efforts.
"This is certainly a significant and shocking problem to find out that one of the major vaccine producers is not going to be able to release any of its vaccine this year," Keyserling tells WebMD.
Pien says unless the MHRA reverses its position, Chiron's entire flu vaccine will be lost.
"Unless we hear something in the next few days from MHRA that the product can be released -- unless they change their mind -- the season is gone and those products will be destroyed," Pien said.
Thompson said the FDA is rushing a high-level team of experts -- led by Jesse Goodman, MD, MPH, head of the FDA division that oversees vaccines -- to London and to Liverpool, where the Chiron plant is located.
"Dr. Goodman will go to England to work with his U.K. counterpart and hopefully release some of the product from Chiron," Thompson said. "My counterpart in the U.K., John Reed, is taking this seriously. It affects not only us, but also 20% of the U.K. flu vaccine supply. ... We cannot make any conclusions until Dr. Goodman and his team go to Liverpool and London and sit down with their counterparts and learn why it was necessary to suspend [Chiron's] license. The first thing the FDA will do is review the MHRA report, then talk to their counterparts, then go to the factory."
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