By LAUREN MORELLO, POLITICO
Pfizer has become the first coronavirus vaccine developer to seek emergency authorization from the Food and Drug Administration.
The company and its German partner, BioNTech, said Friday that they had filed paperwork with the agency, which is expected to issue a decision within weeks.
The companies said their submission includes safety data on 8,000 people over age 18, and 100 in the 12-15 age range — potentially setting the vaccine up for use by teenagers. Data the companies released this week also showed the shot was 94 percent effective in the elderly, whose immune systems are generally weaker than those of younger adults or children.
Pfizer and BioNTech announced earlier this week that the shot was safe and 95 percent effective in a late-stage trial with nearly 44,000 participants. That result held true across age, gender, racial and ethnic categories.
The companies also said that side effects from the vaccine were mild, with the most common including fatigue and headache.
But the pair had to wait to seek FDA permission to begin marketing the vaccine until they had accumulated two months of safety data on at least half of their trial participants.
What’s next: The FDA’s independent vaccine advisory group is expected to review the data on Pfizer and BioNTech’s vaccine at a meeting in early December.
The agency is not obligated to follow the recommendations of the advisory panel, but it normally does. The FDA could decide whether to grant the emergency authorization soon after.
Another vaccine developer, Moderna, is expected to soon seek FDA authorization for its Covid shot, which was 94.5 percent effective in preliminary data.