GSK’s Bird Flu Vaccine Might Need An Outbreak To Get Full Approval
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.
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FDA’s Vaccines and Related Biological Products Advisory Committee recommended 8 to 5 with one abstention that Dynavax acquire more safety data pre-licensure for its hepatitis B vaccine.
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.
Gathering more data to assuage concerns about possibly lower efficacy in black patients will be key to converting the accelerated approval to full approval for the tuberculosis drug, FDA’s Anti-Infective Drugs Advisory Committee concludes.