Pfizer seeks emergency use approval for vaccine

A major milestone in the fight against the deadly pandemic: Pfizer said it’ll apply to U.S. health regulators on Friday to permit emergency use of its COVID-19 vaccine. It’s the first such application in the U.S.

The drug maker and its German partner BioNTech expect to get the blessing of the Food and Drug Administration by mid-December. They say they could immediately ship out the vaccines. Pfizer aims to have 50 million doses ready this year. That’s enough for the two-dose regimen to protect 25 million people.

News of the filing drove shares of Pfizer and BioNTech higher in early trading Friday.

The application to the FDA comes just days after the two companies reported that their vaccine was 95% effective in preventing COVID-19 with no major safety concerns. The application includes safety data on about 100 children 12-15 years old. Pfizer says nearly half of its U.S. trial participants are between 56 and 85.

A source tells Reuters an FDA advisory committee tentatively plans to meet December 8-10 to discuss the vaccine.