Health and Human Services Secretary Alex Azar said Friday the
Trump administration has informed Pfizer it intends to authorize
its coronavirus vaccine for emergency use in the coming days.
Azar added that the first doses could be administered by early
next week after federal officials put the finishing touches on
warning labels and factual information for providers.
“The FDA informed Pfizer that they do intend to proceed
towards an authorization for their vaccine,” Azar said on ABC’s
“Good Morning America.” “So in the next couple of days,
probably, as we work to negotiate with Pfizer the information
doctors need to prescribe it appropriately, we should be seeing the
authorization of this first vaccine.”
An independent FDA advisory committee on Thursday
voted to recommend use of the Pfizer vaccine for people aged 16
and older. The panel’s recommendation is nonbinding, but the
agency’s top vaccine official, Peter Marks, has stated that the
FDA could grant its blessing in a matter of days.
Marks issued a statement with FDA Commissioner Stephen Hahn on
Friday morning confirming Azar’s announcement, and saying that
the agency “will rapidly work toward finalization and issuance of
an emergency use authorization.”
The two officials added that they have also notified the Centers
for Disease Control and Prevention and the Trump administration’s
Operation Warp Speed, so that it can gear up for the distribution
effort.
Once granted, the distribution of the first vaccine against
Covid-19 in the United States would be a significant step toward
ending the pandemic, which has killed nearly 290,000 Americans this
year.
The vaccine has shown 95 percent effectiveness at preventing the
disease in a 44,000-person U.S. trial whose
peer-reviewed results were published Thursday in the New England
Journal of Medicine.
Members of the FDA advisory panel supported authorizing the
vaccine, but expressed concern about possible allergic reactions
that were reported in the U.K.
Azar said language related to that issue is one of the items
that the government is finalizing before giving Pfizer the formal
go-ahead. “Really just the last dotting of ‘I’s and crossing
of ‘T’s,” he said.
The vaccine’s imminent authorization is coming at an
astounding pace relative to the rate at which immunizations are
typically approved. But President Donald Trump on Friday
nonetheless hammered the FDA, which has slightly lagged behind
regulators in the United Kingdom and Canada in green-lighting the
Pfizer vaccine.
“While my pushing the money drenched but heavily bureaucratic
@US_FDA saved five years in the approval of NUMEROUS great new
vaccines, it is still a big, old, slow turtle,” the president
tweeted.
“Get the dam [sic] vaccines out NOW, Dr. Hahn @SteveFDA. Stop
playing games and start saving lives!!!”
