Possibility Of A Pandemic Helped GSK’s Q-Pan H5N1 Flu Vaccine Get Panel Support
This article was originally published in The Pink Sheet Daily
FDA’s Vaccines and Related Biological Products Advisory Committee said in twin 14-0 votes that immunogenicity and safety data are sufficient to support approval.
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The company stressed that because the government will have control of the vaccine stockpile, a partnership is necessary to evaluate the efficacy of the Q-Pan H5N1 vaccine during a pandemic.
FDA will ask its Vaccines and Related Biological Products Advisory Committee to talk about how to verify and describe the clinical benefit of the vaccine under the accelerated approval regulations.
The pandemic influenza situation is leaving the biopharmaceutical industry in a healthy state - with early reports of vaccine sales having notable impact on manufacturers' bottom lines, revitalization for waning antiviral products and accelerated pathways for novel products