3.4 Million H1N1 Vaccine Doses Expected in Early October, CDC Says

Kate Traynor

BETHESDA, MD 18 September 2009—MedImmune's intranasal vaccine is expected to be the first of the recently licensed monovalent 2009 H1N1 influenza virus vaccines to be distributed in the United States, Centers for Disease Control and Prevention (CDC) officials announced today.

Jay Butler, chief of CDC's 2009 H1N1 Vaccine Task Force, told reporters that about 3.4 million doses of the live attenuated vaccine should be shipped to providers during the first week of October.

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"Additional vaccine may be available as well...but that information is still forthcoming from the manufacturers," he said.

FDA this week approved the licensing of MedImmune's H1N1 vaccine along with inactivated H1N1 vaccines from CSL Limited, Novartis, and Sanofi Pasteur.

Butler said CDC expects increasing amounts of the vaccines to become available in the months ahead. The federal government has purchased 195 million doses of H1N1 influenza vaccines in all.

As FDA clears vaccine lots for release, the products will be turned over to McKesson Corporation for distribution to as many as 90,000 state-designated sites, Butler said.

He explained that health care providers will transmit their requests for vaccines to their state health department, which will decide where to direct vaccine within the state.

"The state health department immunization coordinator, each day, will know the allocation of vaccine available to that state," which will help guide distribution decisions, Butler said.

Vaccine orders are then transmitted to CDC for collation by the agency and forwarded to the distributor early the next morning. Butler said orders would begin to be filled within three business days of receipt.

" When the order is filled, it will be shipped by overnight express from the distributor to the provider," Butler said. No shipments will be made on Friday or Saturday to minimize the potential for spoilage or loss of vaccine if no one is available to receive it.

Daniel Jernigan, deputy director of CDC's Influenza Division, said today that the number of outpatient visits for influenza-like illness is about twice as high as normal for this time of year. Hospitalizations for influenza-like illness among children and young adults are rising but have not yet reached the level seen during the a normal influenza season, he said.

He said 21 states are reporting widespread influenza, and all 50 states are reporting at least some influenza activity.

"It's a very strange thing for us to see that amount of influenza at this time of year," Jernigan said.

The 2009 H1N1 strain continues to be the predominant influenza strain currently circulating in the United States.

Jernigan said circulating H1N1 viruses continue to be genetically similar to the viruses used to develop the licensed vaccines.

CDC plans to look for changes in the virus that might indicate increased virulence as the influenza season progresses but has seen no signs yet that the virus is becoming more dangerous, he said.