Moderna voluntarily withdrew the BLA after consultation with the FDA and will resubmit once it has additional phase 3 efficacy data for its investigational flu shot.
The FDA's new approach to evaluating and approving COVID-19 vaccines will move the US away from a one-size-fits-all approach and closer to policy in other countries.
Nuvaxovid (NVX-CoV2373) is indicated for those aged ≥65 years and aged 12 to 64 years with at least one condition that puts them at high risk for severe infection.