FDA Sets Review Dates For Pfizer, Moderna COVID-19 Shot For Kids, Plus Novavax EUA

The FDA has set up June meeting dates to review COVID-19 vaccine submissions, noting that the dates are tentative as none of the submissions are complete.
The agency reserved June 8, 21, and 22 for virtual meetings of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) to review Moderna Inc MRNA and Pfizer Inc PFE - BioNTech SE BNTX emergency use authorizations for younger age groups.
On Thursday, Moderna submitted its emergency use authorization (EUA) for children aged six months to 6 years to the FDA.
Pfizer/BioNTech have yet to do so.
In February, the FDA pulled back on its plan to authorize the Pfizer vaccine for children aged six months to 4 years as the agency asked for more information.
In addition, the FDA also slated June 7 for the panel to discuss Novavax Inc’s NVAX COVID-19 vaccine emergency use submission.
The FDA set June 28 to discuss whether the SARS-CoV-2 strain composition should be modified. The June meeting follows VRBPAC’s meeting this month that discussed general considerations.
The FDA said that the discussion will include whether the strain should be modified, “and if so, which strain(s) should be selected for Fall 2022.”
Price Action: NVAX shares are up 2.91% at $45.56 during the market session on the last check Friday.