The US Food and Drug Administration is aiming to give full approval to Pfizer’s COVID-19 vaccine on Monday, the New York Times reported on Friday.
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 Times said, citing people familiar with the planning who were not authorized to speak publicly about it.
The agency declined to comment.
It had set an unofficial deadline for approval of around Labor Day on Sept. 6, the report said.
The vaccine was authorized for emergency use in December and more than 203 million people in the US have so far received it. But none of the three authorized COVID-19 vaccines have received full FDA approval.
The approval could give the vaccination campaign a boost by convincing more unvaccinated Americans that Pfizer’s shot is safe and effective and also make local officials more comfortable in implementing vaccine mandates.
Vaccine hesitancy has been a major hurdle to the White House’s goal of getting all eligible Americans vaccinated against the novel coronavirus.
Pfizer and US listed shares of partner BioNTech SE were up more than 1 percent in extended trading.