Pfizer and BioNTech on Friday announced that they have applied for emergency authorization for their COVID-19 vaccine.
The application comes just two days after the companies unveiled final efficacy data on the vaccine, showing it to be 95 percent effective “against COVID-19 beginning 28 days after the first dose.”
The companies said that they could potentially receive authorization for the vaccine in high-risk populations by the end of December.
Health and Human Services Secretary Alex Azar first announced the companies would file for emergency approval in a rare White House appearance on Thursday.
In addition to the U.S., the companies have already begun submissions in Europe and the U.K., and intend to submit more “in the coming days.” The companies said they would be ready to distribute the vaccine immediately upon authorization.
Pfizer CEO Albert Bourla said in a statement that the filing is a “critical milestone in our journey to deliver a COVID-19 vaccine to the world,” adding that the recent safety and efficacy data on the vaccine give “confidence in its potential.”
The filing from Pfizer and BioNTech is followed by data from a vaccine from Moderna, which showed similar efficacy. Azar said that he expects the company to file for emergency use shortly.
Depending on how long the review process takes, the extremely limited doses could be available for people like front-line health care workers and other essential workers before the end of the year. However, there will likely be enough doses for widespread distribution by next spring or summer.
Azar said on Thursday that between the two vaccine candidates, the U.S. expects to have 40 million doses by the end of the year, which is enough to vaccinate roughly 20 million people.
Updated at 7:56 a.m.