If Pfizer's application is approved, the vaccine will likely be limited and rolled out in phases, with health-care workers, the elderly and people with underlying health conditions getting the first inoculations. Essential workers, teachers and people in homeless shelters and prisons would likely be next, followed by children and young adults.
The FDA process is expected to take a few weeks, and an advisory committee meeting to review the vaccine has been tentatively scheduled for early December. Some Americans could get their first dose of the vaccine in about a month.
"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," Pfizer CEO Dr. Albert Bourla said in a statement.
Friday's announcement came two days after Pfizer said a final data analysis found its coronavirus vaccine with BioNTech was 95% effective in preventing Covid, was safe and appeared to fend off severe disease.
The final analysis evaluated 170 confirmed Covid infections among the late-stage trial's more than 43,000 participants. The companies said 162 cases of Covid were observed in the placebo group versus eight cases observed in the group that received its two-dose vaccine. That resulted in an estimated vaccine efficacy of 95%, they said.
Pfizer is the first in the Covid vaccine race to apply for emergency use with the FDA. Its vaccine contains genetic material called messenger RNA, or mRNA, which scientists expect provokes the immune system to fight the virus. The vaccine requires a storage temperature of minus 94 degrees Fahrenheit, potentially posing challenges for widespread distribution. By comparison, Moderna's vaccine must be stored at minus 4 degrees Fahrenheit.
Pfizer announced on July 22 that the U.S. agreed to buy 100 million doses of its vaccine for up to $1.95 billion. The agreement, part of the Trump administration's vaccine program Operation Warp Speed, allows the U.S. to acquire an additional 500 million vaccine doses. Bourla said on Nov. 9 that the company is on track to produce up to 50 million vaccine doses this year and up to 1.3 billion doses in 2021.
It already has initiated rolling submissions with several regulatory agencies around the world, including the European Medicines Agency and the Medicines & Healthcare Products Regulatory Agency in the United Kingdom.
Dr. Anthony Fauci, the nation's leading infectious disease expert, has said a vaccine could be available to all Americans by April or July.
A safe and effective vaccine is seen by investors and policymakers as a solution to get the global economy back on track after the pandemic wreaked havoc on nearly every country. The coronavirus continues to rapidly spread across the United States, infecting more than 11.71 million Americans and killing at least 252,564 as of Friday, according to data compiled by Johns Hopkins University.