Article preview from "The Pink Sheet" July 14, 2009
Efforts are under way to expedite H1N1 vaccine development for a potential voluntary vaccine campaign in the fall, but how registration of the vaccine is handled by FDA depends on whether or not an adjuvant is used. Read on...
If the H1N1 vaccine is similar enough to the seasonal flu vaccine - which does not include an adjuvant - it could gain licensure as a strain change, the same way FDA approves new strains of the seasonal flu vaccine each year, HHS National Vaccine Program Office Director Bruce Gellin explained during the H1N1 Influenza Preparedness Summit held July 9 at the National Institutes of Health.
As a way to speed availability, only submission and review of a prior approval manufacturing supplement is needed for strain changes to an existing license.
But if a broader immune response is needed to vaccinate against H1N1, the new vaccine would part ways from those currently used by including an adjuvant.
"If there is need to use adjuvant, then that would come under what is called an emergency use authorization, which is a less cumbersome process than an IND, but signals that there is a lot of data, but not a sufficient [amount] to be licensed," Gellin said.
The agency already has issued emergency use authorizations for the two antivirals to treat H1N1, Roche's Tamiflu (oseltamivir) and GlaxoSmithKline's Relenza (zanamivir), for use in an outbreak.
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