# 3507
Yesterday the NBSB (National Biodefense Science Board) held a public meeting on the production and distribution of a pandemic vaccine for this fall.
Robert Roos of CIDRAP brings us details on the the proceedings. This is an important article, and as always with something out of CIDRAP, well worth following the link to read in its entirety.
HHS advisors urge full speed on H1N1 vaccine production
Robert Roos
News Editor
Jul 17, 2009 (CIDRAP News) – An expert panel that advises the Department of Health and Human Services (HHS) today supported the idea of moving quickly on pandemic H1N1 vaccine production with a goal of having "tens of millions of doses" available in September instead of October.
Discussing vaccine issues during a public teleconference today, the 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.
Last week, HHS Secretary Kathleen Sebelius said it was expected that the first H1N1 doses would be ready for distribution in mid-October. HHS has yet not made a formal decision to go ahead with a vaccination campaign, but Sebelius said the step was likely.
Dr. Robin Robinson, director of HHS's Biomedical Advanced Research and Development Authority (BARDA), told the NBSB that 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, he said.
To make vaccine available in mid-September, filling and finishing would have to start Aug 15, Robinson said. "Certainly the department, including FDA, is seriously considering how this can be done," he said.
<snip>
In other comments, Robinson said:
- 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," he said.
