HHS orders novel H3N2 vaccine for clinical trials

Jan 6, 2012 (CIDRAP News) – The US Department of Health and Human Services (HHS) is taking steps to prepare for clinical trials of a vaccine targeted to a novel H3N2 influenza strain that has infected at least 12 people so far, in case one is needed, a department official said today.

The moves follow the US Center for Disease Control and Prevention (CDC) announcement in November that it had developed a candidate vaccine virus and provided it to manufacturers. The swine-origin H3N2 reassortant strain (H3N2v) includes the M gene from the 2009 H1N1 virus. The 12 infections were all reported in 2011, occurring mostly in children.

The CDC has said that some of the cases, especially those in children, probably involved limited person-to-person spread of the virus. The current seasonal flu vaccine is thought to provide little protection against the H3N2v strain, though people who were infected with or vaccinated against similar H3N2 strains that circulated in the 1990s might have some protection.

Gretchen Michael, a spokeswoman with the HHS assistant secretary for preparedness and response (ASPR), told CIDRAP News that HHS has asked manufacturers to produce enough H3N2v vaccine to launch clinical trials. She said the request to have clinical lots ready is part of its pandemic preparedness program, a strategy that has also been used for other viruses that could have pandemic potential, such as H5N1 and H9N2.

She said HHS has asked Sanofi Pasteur and Novartis to produce the investigational vaccine lots, which would be used in clinical trials by the National Institutes of Health and the manufacturers. The supply of vaccine for the studies will likely be ready by spring, Michael said.

No new novel flu infections were reported today in the CDC's weekly flu update. The agency has asked states to increase their surveillance for the new virus.

See also:

Nov 22 CDC statement

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