Pfizer (NYSE:PFE) and BioNTech (NASDAQ:BNTX) will apply Friday for an emergency use authorization from the Food and Drug Administration for their coronavirus vaccine.
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.
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.
PFE shares began Friday up $1.01, or 2.8%, to $37.24, while in BioNTech accelerated $5.85, or 6.3%, to $100.89.
