The New York Times
With a new surge of coronavirus 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 familiar with the effort said.
President Biden said last week that he expected a fully approved vaccine in early fall. But the F.D.A.’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 F.D.A. — 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 F.D.A. on full approval,” Dr. Ashish K. Jha, the dean of the Brown University School of Public Health, said in an interview on Tuesday. “And I find it baffling, given where we are as a country in terms of infections, hospitalizations and deaths.”
Although 192 million Americans — 58 percent of the total population and 70 percent of the nation’s adults — have received at least one vaccine shot, many remain vulnerable to the ultracontagious, dominant Delta variant. The country is averaging nearly 86,000 new infections a day, an increase of 142 percent in just two weeks, according to a New York Times database.
Recent polls by the Kaiser Family Foundation, which has been tracking public attitudes during the pandemic, have found that three of every 10 unvaccinated people said that they would be more likely to get a shot with a fully approved vaccine. But the pollsters warned that many respondents did not understand the regulatory process and might have been looking for a “proxy” justification not to get a shot.
Moderna, the second most widely used vaccine in the United States, 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.
Full approval of the Pfizer vaccine will kick off a patchwork of vaccination mandates across the country. Like most other employees of federal agencies, civilians working for the Defense Department must be vaccinated or face regular testing. But the military has held off on ordering shots for 1.3 million active-duty service members until the F.D.A. acts.