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ios developer account:FDA aims to give full approval to Pfizer vaccine by early next month

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WASHINGTON — With a new surge of Covid-19 infections ripping through much of the United States, the Food and Drug Administration (FDA) 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.

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United States President Joe Biden said last week that he expected a fully approved vaccine in early fall. But the FDA’s unofficial deadline is Sept 6 or sooner, according to multiple people familiar with the plan. The agency said in a statement that its leaders recognised that approval might inspire more public confidence and had “taken an all-hands-on-deck approach” to the work.

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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.

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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.

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Final approval could also help mute misinformation about the safety of vaccines and clarify legal issues about mandates.

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Federal regulators have been under growing public pressure to fully approve Pfizer’s vaccine ever since the company filed its application on May 7.

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“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 (Aug 3). “And I find it baffling.”

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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.

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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.

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This article originally appeared in The New York Times.

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