Flu shots now open to all; officials fear fake Tamiflu

Oct 24, 2005 (CIDRAP News) – Seasonal influenza shots are not just for high-risk groups anymore, and everyone interested in a shot should go ahead and seek one out, federal health officials said today.

At a news briefing, officials also warned that the threat of a flu pandemic may spur the sale of fake versions of the antiviral drug oseltamivir (Tamiflu). To make sure they get the genuine article, officials said, people should seek the drug through their physician.

"Starting today, October 24th, we're making influenza shots available to everyone," said Health and Human Services Secretary Mike Leavitt. "There's no reason for anyone to delay or go without their seasonal flu shot."

He added that people seeking a flu shot should make an appointment, because some providers may not have received their vaccine yet.

In early September, the Centers for Disease Control and Prevention (CDC) had recommended that flu shots be reserved for people at risk for serious flu complications until today. (The recommendation did not apply to MedImmune's live-virus vaccine [FluMist], which is licensed only for healthy people between ages 5 and 49.) Despite some scattered shortages caused by delayed vaccine deliveries, the CDC stuck to that timetable.

CDC officials repeated their estimate that at least 71 million doses of flu vaccine will be available in the United States this season, compared with about 60 million last year, when the loss of 48 million doses expected from Chiron triggered shortages.

The CDC still expects 60 million doses from Sanofi Pasteur, 3 million from MedImmune, and 8 million from GlaxoSmithKline, said CDC spokeswoman Christina Pearson. She said the agency also expects up to 18 million doses from Chiron, which until last week was projecting 18 million to 26 million.

CDC Director Dr. Julie Gerberding said the flu season is just beginning. "We're seeing very sporadic activity in seven states, and local activity in one state."

Some localized vaccine shortages have been reported as a result of delayed deliveries, but they are expected to clear up soon, Gerberding said.

"Providers in areas with sufficient flu vaccine already should open up their programs to the expanded group of people" not at high risk for complications, she said. She recommended that clinicians who have an ample supply of vaccine inform local public health officers so the latter can help shift surplus doses to providers who need them.

Gerberding said people who experience flu symptoms and have not been vaccinated, especially if they are in a high-risk group, should call their physician promptly to find out if treatment with an antiviral drug would be appropriate. Preventive treatment with an antiviral may be indicated n some cases, such as for people who can't be vaccinated because of an egg allergy.

Leavitt observed that oseltamivir has been "much in the news" because of the chance that H5N1 avian flu will lead to a human flu pandemic. Many countries, including the United States, are trying to build stockpiles of oseltamivir, but the drug takes a long time to produce.

Because demand for the drug far exceeds the supply, said Leavitt, "We're concerned about the threat of counterfeiting of Tamiflu."

In response to questions, Leavitt and Andrew von Eschenbach, acting commissioner of the Food and Drug Administration (FDA), said they had seen no evidence of counterfeiting to date. But Leavitt said, "It's a situation that's ripe for counterfeiting. The WHO [World Health Organization] now indicates that counterfeit drug making is a $34 billion–a-year industry. We're seeing it in many other instances."

The best way to avoid fake oseltamivir is to get it from state-licensed pharmacies, said von Eschenbach. "We feel strongly that the best protection for patients is to avail themselves of the drug in the context of a doctor-patient relationship."

Gerberding said that right now she does not expect a shortage of oseltamivir for use against seasonal flu. "The manufacturer still has several million doses in the pipeline," she said. "The doses that haven't been distributed yet exceed the number prescribed last year by a significant amount. At this point there's no evidence of a shortage that's going to result in any clinical impact on patients. We'll monitor that."

Von Eschenbach announced that the FDA is forming a "rapid response team" of experts to help make sure antiviral drugs are available in the event of a flu pandemic.

In a news release issued this afternoon, he said, "Using the Rapid Response Team approach, we believe we could review a complete drug application in six to eight weeks."

See also:

FDA news release
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2005/ucm108502.htm

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