Pfizer Pursuing COVID-19 Vaccine Full Approval This Month

Pfizer said it plans to file for full approval of its COVID-19 vaccine by the FDA later this month — an approval that would allow the companies to market the vaccine directly to consumers and allow the product to stay on the market beyond the pandemic.

The FDA granted Emergency Use Authorization (EUA) for the vaccine, co-developed with BioNTech, on Dec. 11, 2020, for individuals 16 years of age and older, but the authorization is only good through the end of the public health emergency.

For a full approval, the agency will require six months’ worth of supporting data, compared with just two months for an EUA.