Pharmaceutical company Pfizer and its German partner BioNTech applied Friday for an emergency use authorization form from the Food and Drug Administration for their COVID-19 vaccine.
The FDA process is predicted to take several weeks, meaning the vaccine could be available to the public by the end of the year.
"Filing in the U.S. represents a critical milestone in our journey to deliver a COVID-19 vaccine to the world and we now have a more complete picture of both the efficacy and safety profile of our vaccine, giving us confidence in its potential," said Pfizer CEO Dr. Albert Bourla.
The vaccine would be rolled out over the course of several months, with older and at-risk individuals being prioritized for the first available doses. The vaccine is expected to be available to all Americans by April.
Pfizer already has 350 freezers full of its vaccine, reported this week to be 95% effective, at its Michigan plant. Army General Gus Perna has been put in charge of distributing the vaccine, which will be difficult to distribute due to its two required doses and the necessity that it be stored at -94º Fahrenheit.
In comparison, rival company Moderna has announced that its vaccine is stable at -4º for up to six months, meaning it is easier to transport worldwide and can be stored in regular refrigerators for up to 30 days. Despite a 94% effectiveness rate, Moderna has not yet finished its trials or applied for FDA approval.
The Trump administration invested billions in both Pfizer and Moderna earlier this year as part of its Operation Warp Speed initiative. The move was seen as a gamble, with Dr. Anthony Fauci of the National Institute of Allergy and Infectious Diseases saying it would be a waste of "a few hundred million dollars" if it did not work, but would save "four, five, six months of waiting" if it did.