Pfizer Inc said on Friday it has applied to U.S. health regulators for emergency use authorization (EUA) of its COVID-19 vaccine, a major step toward providing protection against the new coronavirus for pandemic-weary Americans.
The application to the U.S. Food and Drug Administration (FDA) comes just days after Pfizer and German partner BioNTech SE reported final trial results that showed the vaccine was 95% effective in preventing COVID-19 with no major safety concerns.
Pfizer's shares rose 2% and BioNTech climbed 5% on the news that a vaccine could soon be available, raising hopes for the end of a pandemic that has claimed more than a quarter of a million lives in the United States and over 1.3 million worldwide.
The companies expect the FDA to grant the EUA by mid-December and said they 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.
An FDA advisory committee tentatively plans to meet on Dec. 8-10 to discuss the vaccine, a source familiar with the situation told Reuters, though the dates could change.
The final trial data showed the vaccine provided a similar level of protection across different ages and ethnicities - an encouraging result as the disease disproportionately hurts the elderly and minorities.