H1N1 Vaccine Production, Availability Increasing Slowly

By David Mitchell
10/30/2009

Vaccine manufacturers are expected to fall well short of having 40 million doses of novel influenza A (H1N1) vaccine available by the end of October, but HHS Secretary Kathleen Sebelius recently told the Senate's Homeland Security and Governmental Affairs Committee that the target likely will be reached in early November.

Photo of young girl receiving H1N1 vaccine as a nasal spray

A 2-year-old girl receives the novel influenza A (H1N1) vaccine. CDC officials said Oct. 30 that 26.6 million doses of the vaccine had been made available. The agency expects availability to increase significantly in the next few weeks.

At an Oct. 21 hearing to update the public on federal efforts to manage the spread of H1N1 influenza, Sebelius said problems with vaccine production yield have been resolved and production is increasing.

The U.S. government has ordered 250 million doses of the H1N1 vaccine. During an Oct. 30 media briefing, CDC Director Thomas Frieden, M.D., said that 26.6 million doses of the vaccine have been made available, and production and distribution should increase dramatically during the next few weeks.

FDA Authorizes Emergency Use of Antiviral Peramivir

The FDA announced Oct. 23 that it has issued an emergency use authorization for the investigational antiviral drug peramivir, which is administered intravenously, in certain adult and pediatric patients with confirmed or suspected novel influenza A (H1N1).

The agency said (42-page PDF; About PDFs) that peramivir may be used for the following reasons in hospitalized patients:

the patient is not responding to either oral or inhaled antiviral therapy;
when drug delivery by a route other than an intravenous route -- enteral or inhaled -- is not expected to be dependable or feasible; or
for adults only, when the clinician judges intravenous therapy is appropriate because of other circumstances.

Peramivir, a neuraminidase inhibitor manufactured by BioCryst Pharmaceuticals Inc., is an unapproved drug being evaluated in phase three clinical trials. No other intravenously administered antiviral drugs have been approved by the FDA for treatment of influenza.

Anne Schuchat, M.D., director of the CDC's National Center for Immunization and Respiratory Diseases, said during an Oct. 16 media briefing that influenza-like illness accounts for 6.1 percent of doctors visits nationwide. She also said that as many as 20 percent of patients being hospitalized with H1N1 require intensive care.

With the virus continuing to spread, President Obama signed a National Emergency Declaration on Oct. 24 that allows health care systems to implement disaster plans if they become overwhelmed. The declaration will allow health care facilities to submit waivers to establish alternate care sites and to modify patient triage protocols and patient transfer procedures.

Earlier this month, the Agency for Healthcare Research and Quality, or AHRQ, released two online tools to help emergency planners select and run alternate care sites. One worksheet helps users select sites and identify what is required to prepare those sites for use. Another tool matches a hospitalized patient's clinical needs with the capabilities of alternate care facilities to determine which patients might be eligible for transfer in the event of a surge.

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