The delay follows leadership changes within the FDA. Dr. Scott Steele has been appointed acting director of the agency’s vaccine division.

But with FDA action, it would be the third vaccine against Covid-19 to receive full FDA approval ... process for the Novavax vaccine, like all vaccines is based solely on ensuring safety and efficacy, ...

But full FDA approval would allow the vaccine to ... alternative to mRNA COVID-19 vaccines for the US,” Novavax added. The delay comes as the FDA is undergoing leadership changes.

Novavax said in a statement that it can confirm the delay in decision and that as of Tuesday, "we had responded to all of the FDA’s information requests and we believe that our BLA is ready for ...

“As of Tuesday, April 1, we had responded to all of the FDA’s information requests and we believe that our [Biologics License Application] is ready for approval,” Novavax said in a ...

Novavax's COVID-19 vaccine received FDA Emergency Use Authorization, but full approval faces delays as regulators request ...