American multinational pharmaceutical corporation Pfizer Incorporated applied to U.S. health regulators on Friday for emergency use authorization of its COVID-19 vaccine, the first such application in a major step toward providing protection against the new coronavirus.
The application to the U.S. Food and Drug Administration (FDA) comes just days after Pfizer and German partner BioNTech reported final trial results that showed the vaccine was 95% effective in preventing COVID-19 with no major safety concerns.
Pfizer Chief Executive Officer Albert Bourla confirmed in a video posted on the company's website this afternoon that the application had been made.
The companies expect the FDA to grant the emergency use authorization by mid-December and said they will begin shipping doses almost immediately.
Pfizer has said it expects to have 50 million vaccine doses ready this year, enough to protect 25 million people.
A source told Reuters that an FDA advisory committee tentatively plans to meet December 8 to 10 to discuss the vaccine, though the dates could change.
Of the 170 volunteers who contracted COVID-19 in Pfizer's trial involving over 43,000 people, 162 had received only a placebo, meaning the vaccine was 95% effective, far higher than originally expected.
The U.S. FDA had set minimum bar for efficacy of 50%.
Pfizer said nearly 42% of global participants and 30% of U.S. participants in the Phase 3 study have racially and ethnically diverse backgrounds.
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