U.S. FDA aims to give full approval to Pfizer vaccine on Monday -NYT

2 minute read

Doses of the Pfizer-BioNTech coronavirus disease (COVID-19) vaccine are seen at a COVID-19 vaccination centre in Seoul, South Korea, March 10, 2021. REUTERS/Kim Hong-Ji

Register now for FREE unlimited access to Reuters.com

WASHINGTON, Aug 20 (Reuters) - The U.S. Food and Drug Administration is aiming to give full approval to Pfizer's (PFE.N) 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.

Register now for FREE unlimited access to Reuters.com

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

The approval could boost the vaccination campaign by convincing more unvaccinated Americans that Pfizer's shot is safe and effective and also make local officials more comfortable in implementing vaccine mandates. read more

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. read more

Vaccine hesitancy has been a major hurdle to the White House's goal of getting all eligible Americans vaccinated against the coronavirus.

Only around 60% of adults aged 18 and over have been fully vaccinated even as the new Delta variant of COVID-19 has contributed to a surge in cases.

Full approval of Pfizer's shot would also make it easier for physicians to prescribe a third booster shot to people who could benefit from an additional dose.

The FDA has authorized Pfizer's shot as a booster for people with weakened immune systems, but the White House plans to offer them much more widely in the coming months. read more

The White House earlier this week said it plans to give out 100 million booster shots, many supplied by Pfizer, to at-risk Americans, including anyone whose initial inoculation is more than 8 months old, starting in September.

Some experts, including at the World Health Organization say there is not yet enough data be certain boosters are needed.

Pfizer's vaccine was authorized for emergency use in December and more than 203 million people in the United States have so far received it. None of the three authorized COVID-19 vaccines have received full FDA approval.

Register now for FREE unlimited access to Reuters.com
Reporting by Katanga Johnson, Michael Erman and Manojna Maddipatla; Editing by Arun Koyyur, Daniel Wallis and Chris Reese

Our Standards: The Thomson Reuters Trust Principles.