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 percent 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."
At this point, however, there's no indication that the MHRA overreacted.
"It would be premature to say now what we will find," Goodman said at the news conference. "We want to see detailed reports and see what they based their decision on. Then we will assess what we want to do with respect to those findings. ... We would take seriously any safety concerns raised by the MHRA and assess that with the safety of U.S. consumers in mind."
Expecting to have 100 million doses of flu vaccine on hand, the CDC has been telling everybody to get a flu shot. Now the public health agency has come up with new recommendations.
The Chiron vaccine is not approved for children under the age of 4, so pediatric vaccine doses may not be as severely affected as those for adolescents and adults.
A third manufacturer, MedImmune, makes the FluMist nasal-spray flu vaccine. But it wasn't a big seller last year. This year, MedImmune is making only 1 million to 2 million doses. Aventis Pasteur is expected to deliver 52 million doses of vaccine.
This means the U.S. will have about 54 million flu shots available.
Getting the Vaccine to Most at Risk
"Everyone take a deep breath," CDC Director Julie Gerberding, MD, MPH, said at the HHS news conference. "Recognize this is not an emergency. We will work through this shortage as we have worked through flu vaccine shortages in the past."
That means getting the vaccine to the people who need it the most:
"Healthy people who are not household contacts of high-risk people should defer vaccination until we determine whether we have relief in the vaccine supply line," Gerberding said. "Today I am here to say we will do everything possible to redistribute the vaccine so those at the highest risk get vaccinated. We don't want everyone to rush out and seek flu vaccination today. We have enough now to meet demand without creating a rush."
Flu expert John Treanor, MD, urges all Americans to heed Gerberding's advice. Treanor is professor and director of the vaccine evaluation unit at the University of Rochester in New York.
"With judicious planning, we can get through this with relatively small impact on public health," Treanor tells WebMD. "It will be a lot of work, but we can target the doses we have to those at most risk and prevent most of the impact."
At the HHS news conference, National Institutes of Health Director Anthony Fauci, MD, said studies suggest healthy adults under age 50 may get full flu protection from half doses of vaccine.
"That is something we will at least consider -- no promises on that, but it is one of many ways we are looking at to expand [available vaccine supplies during] the situation we are in now," Fauci said.
SOURCES: Howard Pien, CEO, Chiron Corp., Chiron news conference, Oct. 5, 2004. Tommy Thompson, Secretary Health and Human Services; Jesse Goodman, MD, MPH, director, Center for Biologics Evaluation and Research, FDA; Julie Gerberding, MD, MPH, director, CDC; Anthony Fauci, MD, director, National Institutes of Health; HHS news conference, Oct. 5, 2004. Harry Keyserling, MD, professor and director, division of pediatric infectious diseases, Emory University, Atlanta. John Treanor, MD, professor and director, vaccine evaluation unit, University of Rochester, New York.
By Daniel J. DeNoon
Reviewed by Michael W. Smith, MD
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