Panel: Skip Most Safety, Efficacy Tests to Get Swine Flu Vaccine in September

July 17, 2009 -- Pandemic swine flu vaccine should be fast-tracked, with vaccinations starting in mid-September -- soon after schools open.

That recommendation came today in a unanimous vote by the National Biodefense Safety Board (NBSB), an influential board of outside advisors to Health and Human Services Secretary Kathleen Sebelius.

Getting swine flu vaccine by September means skipping all but the most preliminary clinical tests of vaccine safety and effectiveness. But it means getting some 60 million to 80 million doses nearly at the same time the CDC expects the next wave of the pandemic to hit the U.S.

"We cannot wait beyond mid-August [to make a decision] if vaccine is to be in supply by mid-September," the panel's pandemic influenza working group states in its recommendations. "A critical goal is to have some [standalone] novel H1N1 vaccine available by mid-September 2009, should it be needed."

Why rush through a swine flu vaccine? The first wave of the swine flu pandemic is only just starting to ebb in the U.S. But the virus spreads quickly among children -- and the nation's schools begin opening in late August.

"A second wave is likely to occur, as soon as fall 2009," the recommendations state. "Best estimates suggest that infection rates will be two to three times higher than expected with seasonal influenza. The second wave could peak in October, but we must anticipate onset as early as September."

Initial doses likely will go to those most severely hit by the pandemic so far: infants, toddlers, school-age children, pregnant women, and adults with risk factors for severe flu disease. Next week, the CDC's vaccine advisory board will recommend a priority list for exactly who will first get the vaccine.

The NBSB recommendation puts into words a fear that government officials have so far expressed only privately.

"Having vaccine only after the peak [of the pandemic] may be worse than having no vaccine at all: It incurs all of the risk and cost with no potential benefit," the recommendation reads.

The National Biodefense Science Board advises Sebelius on emergency preparedness for biological threats. Whether to act on the NBSB's decision is up to her -- and, ultimately, to President Barack Obama.

Why deploy a vaccine that hasn't completed safety and efficacy testing? Because we already have a lot of experience with similar vaccines, concluded the NBSB flu vaccine working group, led by University of Utah flu expert Andrew Pavia, MD.

Pandemic swine flu is a type A, H1N1 flu virus. For decades, a type A H1N1 vaccine has been part of the regular seasonal flu vaccine, and the new vaccine is made exactly the same way.

Fast-tracking the vaccine will mean guessing at the best dose, but that's an educated guess based on the well-established dosage for the seasonal H1N1 vaccine.

A more critical guess is whether people will be protected against the new flu bug with only one shot of vaccine. The NBSB working group suggests that previous exposure to H1N1 virus and H1N1 vaccine will prime virtually the entire population so that only one dose is needed -- even though the seasonal vaccine does not protect against pandemic swine flu.

Fast-tracking the vaccine would also mean deciding who's first in line. Robin Robinson, PhD, director of BARDA, the Health and Human Services agency responsible for the logistics of emergency medical supplies, says 60-80 million doses could be available in mid-September -- if vaccine makers start packaging their products in mid-August. Similar quantities would follow in each subsequent month until demand was met.

Voting members of the NBSB include experts from universities, the pharmaceutical industry, and medical groups. NBSB chairwoman Patricia Quinlisk, MD, MPH -- who was absent from today's telephone-based meeting -- is director of the Iowa health department. Non-voting members of the NBSB include representatives of the White House, the Health and Human Services Department, national security agencies, the FDA, and NASA.

[link to www.webmd.com]