Swine Flu Vaccine Fast-Tracked to September?
Panel: Skip Most Safety, Efficacy Tests to Get Swine Flu Vaccine in September
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.