First PDUFA date missed on RFK Jr.’s watch
FDA has at least seven more target action dates coming up in April
FDA’s deadline to complete review of Novavax’s COVID-19 vaccine came and went Tuesday with no response from the agency. Sources told BioCentury that the BLA for full approval of the vaccine, which previously had emergency use authorization, was ready for approval on the April 1 PDUFA date, but Principal Deputy Commissioner Sarah Brenner held the decision pending sign-off from HHS Secretary Robert F. Kennedy Jr., in an unprecedented political intervention.
Novavax Inc. (NASDAQ:NVAX) announced Wednesday that the April 1 PDUFA date had been missed. The vaccine uses a protein base and adjuvant, more traditional technology than in the approved mRNA vaccines. Some politicians have used the novelty of mRNA technology to justify their skepticism of COVID vaccines. ...