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 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.
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.
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.
[to top of second column] |
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.
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.
(Reporting by Katanga Johnson, Michael Erman and
Manojna Maddipatla; Editing by Arun Koyyur,
Daniel Wallis and Chris Reese)
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