Posted: Sun Jul 19, 2009 10:47 pm Post subject: HHS Advisors Urge Full Speed for Vax Production
National Biodefense Science Board (NBSB) favored the idea of asking vaccine makers to start the final production steps for their H1N1 vaccines on Aug 15 - before the first data from safety and immunogenicity trials will be available.
HHS should have some data on the immunogenicity of single-dose H1N1 vaccination in September. If filling and finishing (the final production steps) start on Sep 15, the first doses will become available about Oct 15.
Robinson said that about 60 million to 80 million doses could be made available starting in September if the decision were made to go ahead with final production steps Aug 15. He said Aug 15 is a reasonable date when vaccine makers could start those steps, as they are currently still producing their seasonal flu vaccines.
Robinson said HHS has contracted for 193 million doses of vaccine so far, assuming 15 mcg per dose. After 2.5 weeks of production, manufacturers have made 18 million doses worth of bulk vaccine, he said.
Robinson said yields are actually right in line with what HHS had expected from experience with H5N1 vaccines: about 1.4 doses per egg.
MedImmune, Robinson reported. Instead of low yields, the company is getting surprisingly high yields.
They've already actually made a super virus seed that's actually producing 2 logs titer higher than you'd normally see, he said. That means there's going to be more bulk product available than we can actually fill.
He said HHS will look for other vendors to help package the extra product, adding, "We may be able to have more live attenuated vaccine than anticipated earlier, so that's good news."
HHS wants to increase the proportion of zanamivir (Relenza) in the national stockpile relative to oseltamivir (Tamiflu), in light of a few recent instances of H1N1 resistance to the latter. The current split is 80% oseltamivir and 20% zanamivir; the agency would like to move to 50-50, but that will take time.
HHS is considering issuing an emergency use authorization for peramivir, an antiviral drug that is in phase 3 clinical trials but not yet licensed. It's under consideration whether we should have some of that drug available for individuals in desperate need.
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