FDA said to fast-track Pfizer shot full approval

WASHINGTON -- 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 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 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 by the FDA late last year -- could help increase inoculation rates at a moment when the highly transmissible delta variant 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 May 7.

"I just have not sensed a sense of urgency from the FDA on full approval," Dr. Ashish Jha, dean of the Brown University School of Public Health, said Tuesday. "And I find it baffling, given where we are as a country in terms of infections, hospitalizations and deaths."

Recent polls by the Kaiser Family Foundation, which has been tracking public attitudes during the pandemic, have found that 3 of every 10 unvaccinated people said 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 justification not to get a shot.

Moderna, the second most widely used vaccine in the United States, filed for final approval of its vaccine 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.

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