Sebelius vows supply of H1N1 vaccine will soon improve

Oct 21, 2009 (CIDRAP News) – Health and Human Services (HHS) Secretary Kathleen Sebelius promised a Senate committee today that the flow of pandemic H1N1 influenza vaccine doses will greatly improve in November, following its slow start this month.

Speaking to the Senate Committee on Homeland Security and Governmental Affairs, Sebelius blamed production problems for the meager early supplies of vaccine and promised that eventually there will be enough for all Americans who want to be vaccinated.

HHS officials had predicted that 45 million doses would be ready for distribution in mid October, followed by about 20 million more each week after that. But as of yesterday, only 12.8 million doses had become available for ordering, the Centers for Disease Control and Prevention (CDC) said.

Low yields, start-up problems
Sebelius blamed two problems for the low early production numbers: low yields from the eggs used to grow the vaccine virus—which were reported when pharmaceutical companies started production in the summer—and difficulties in starting up new production lines.

"We have some new production lines that have been put in place by the manufacturers; there were glitches in some of these production lines," she told the committee.

"Those two issues have been corrected, so we anticipate that number [of doses] growing exponentially as we move into the season," she added. "By early November we're confident that vaccine will be far more widely available. There'll be enough vaccine so every American who wants to can be vaccinated."

The government has ordered a total of about 250 million doses of H1N1 vaccine from five manufacturers. The expectation is that vaccine deliveries will be completed in December. But the slow start to the vaccine deliveries has complicated planning by state and local health departments and other groups involved in vaccination efforts.

Echoing what a CDC official said yesterday, Sebelius also promised today that the availability of seasonal flu vaccine will improve in coming weeks. Public health agencies had encouraged the public to get their seasonal flu immunizations early, before the rollout of the H1N1 vaccine. But supplies of the seasonal vaccine have run short in some areas.

"We've been assured that production is ramping up," Sebelius told the committee. "Manufacturers are backfilling that, and it'll be much more widely available."

IV antiviral authorization expected
In other comments, Sebelius said HHS will soon issue an emergency use authorization (EUA) for an antiviral drug that can be given intravenously to help critically ill H1N1 patients. The two mainstay antivirals, oseltamivir and zanamivir, are not available in IV formulations.

In her written testimony, Sibelius said, "Physicians treating critically ill patients with H1N1 influenza will soon have access to new antviral drugs supported by HHS/BARDA [the Biomedical Advanced Research and Development Agency] and administered intravenously under a CDC sponsored emergency use authorization."

Under questioning by Sen. Joe Lieberman, committee chairman, she said issuance of an EUA is "imminent" but didn't give a date.

Last week a Food and Drug Administration official said a decision was expected soon on an EUA for IV peramivir, an antiviral that's in the same class as oseltamivir and zanamivir but is not yet licensed.

School closures continuing
Also at today's hearing, Education Secretary Arne Duncan reported that the H1N1 virus has prompted many school closures so far this fall but that the numbers have been below what they were in the spring wave of the pandemic.

So far this fall, 628 schools have closed for at least a day, affecting 219,000 students, Duncan told the committee. As of yesterday, 88 schools were closed, affecting 28,000 students and 1,800 teachers, he said.

By comparison, in the spring, from Apr 27 through Jun 12, more than 1,350 schools in 35 states closed, affecting 824,966 students and 53,217 teachers, Duncan reported. The peak day was May 5, with 980 schools closed.

At the beginning of the H1N1 outbreaks, the CDC recommended that schools close if they had any confirmed or suspected H1N1 cases. But soon afterward, when it became evident that the virus wasn't as virulent as first feared, the agency advised that schools should focus on identifying and isolating sick students and should close only if they had large numbers of cases. Duncan said schools have been heeding the CDC guidance.

He noted that the Education Department, with the CDC and state and local agencies, developed a new school dismissal monitoring system over the summer. The system used earlier didn't work well, he said.

See also:

Senate committee hearing page, with links to testimony:

http://hsgac.senate.gov/public/index.cfm?FuseAction=Hearings.Hearing&Hearing_id=cbe5331e-19ab-41d5-bffe-7610f97708f0

Oct 16 CIDRAP News story "US H1N1 vaccine delayed as cases and deaths rise"

http://www.cidrap.umn.edu/cidrap/content/influenza/swineflu/news/oct1609vaccine.html

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