With a new surge of Covid-19 infections ripping through much of the United States, the Food and Drug Administration has accelerated its timetable to fully approve Pfizer-BioNTech’s coronavirus vaccine, aiming to complete the process by the start of next month, people involved in the effort said.
President Joe Biden said last week that he expected a fully approved vaccine in early fall. But the FDA’s unofficial deadline is Labor Day or sooner, according to multiple people familiar with the plan. The agency said in a statement that its leaders recognized that approval might inspire more public confidence and had “taken an all-hands-on-deck approach” to the work.
Giving final approval to the Pfizer vaccine — rather than relying on the emergency authorization granted late last year by the FDA — could help increase inoculation rates at a moment when the highly transmissible delta variant of the virus is sharply driving up the number of new cases.
A number of universities and hospitals, the Defense Department and at least one major city, San Francisco, are expected to mandate inoculation once a vaccine is fully approved. Final approval could also help mute misinformation about the safety of vaccines and clarify legal issues about mandates.
Federal regulators have been under growing public pressure to fully approve Pfizer’s vaccine ever since the company filed its application on May 7.
“I just have not sensed a sense of urgency from the FDA on full approval,” Dr. Ashish K. Jha, dean of the Brown University School of Public Health, said in an interview Tuesday. “And I find it baffling.”
Although 192 million Americans — 58 per cent of the total population and 70 per cent of the nation’s adults — have received at least one vaccine shot, many remain vulnerable. The country is averaging nearly 86,000 new infections a day, an increase of 142 per cent in just two weeks.
Moderna filed for final approval of its vaccine on June 1. But the company is still submitting data and has not said when it will finish. Johnson & Johnson, the third vaccine authorized for emergency use, has not yet applied but plans to do so later this year.