The U.S. Food and Drug Administration is poised to fully approve Pfizer Inc.’s coronavirus vaccine early next week as President Joe Biden’s administration tries to woo more Americans to get the shot.

The approval likely will come on Monday or Tuesday, according to one official familiar with the plans, speaking on condition of anonymity ahead of the announcement. Pfizer’s vaccine has been in use in the U.S. based on an emergency authorization.

The White House referred questions to the FDA, which didn’t immediately respond to requests for comment. The development was first reported by Politico.

The New York Times reported Friday that regulators were aiming to complete the process by Friday, but were still working through "a substantial amount of paperwork and negotiation with the company," the report said, citing people familiar with the planning who were not authorized to speak publicly about it.

It had set an unofficial deadline for approval of around Labor Day on Sept. 6, the report said.

The U.S. military is expected to require that service members get vaccinated soon after Pfizer's shot is authorized and other major U.S. employers could follow suit.

Biden has called for FDA approval. He believes it will ease doubts about the vaccine and also give firmer footing for companies and schools to require inoculations, officials familiar with his thinking say.

"My plea is that for those who are not vaccinated: Think about it,” Biden said earlier this month. "God willing, the FDA is going to be coming out in a reasonable time frame to say this vaccine is totally safe.”

Biden has yet to nominate a permanent head of the FDA. The administration has privately decided against nominating the acting commissioner, Janet Woodcock, people familiar with the plans have said.

In a time of both misinformation and too much information, quality journalism is more crucial than ever.
By subscribing, you can help us get the story right.