By Jared S. Hopkins and Thomas M. Burton
A Covid-19 vaccine from Pfizer Inc. and partner BioNTech SE was
the first to gain the federal government's permission to go into
use in the U.S., a landmark step in efforts to beat back the raging
pandemic.
The U.S. Food and Drug Administration's authorization of the
shot on Friday, following its record-setting swift development,
sets the stage for administration of inoculations to begin within a
day or two.
The decision clears use of the shots in people 16 years and
older, including the elderly.
President Trump, in a video posted on Twitter Friday night,
called the vaccine a "medical miracle."
"This is one of the greatest scientific accomplishments in
history," he said, speaking from the Oval Office. "It will save
millions of lives and soon end the pandemic once and for all."
The president said the vaccine is safe and would be free for all
Americans.
The FDA's first green light for a Covid-19 vaccine comes little
more than a week after a similar authorization in the U.K. It
follows a 44,000-person study, which found that the shot was 95%
effective at preventing symptomatic Covid-19 and was generally
safe.
Now, the U.S. begins its largest vaccination campaign ever,
bringing together governments, small and big hospitals, as well as
retail pharmacy chains with the goal of vaccinating hundreds of
millions of people swiftly.
The daunting task will include distributing a vaccine that must
be stored at extremely cold temperatures, and since inoculation
requires two doses three weeks apart, the challenge of ensuring
people return for a booster shot. It also means convincing the
large numbers of Americans hesitant to get vaccinated that the shot
is safe to take.
Initial supplies will be limited. Pfizer plans to distribute
about 25 million doses in the U.S. by the end of the year,
potentially enough for 12.5 million people because the vaccine
requires two doses. The people first in line will have to wait at
least until Monday to get vaccinated, because the shots must be
shipped to hospitals and other sites.
Most Americans wouldn't be able to get vaccinated before spring
or summer, because Pfizer needs time to make enough doses.
If enough people eventually take the shots, schools, businesses
and restaurants could start fully reopening. A vaccine's impact
comes not only if it is effective in an individual but also if it
is widely taken.
"The FDA's authorization for emergency use of the first Covid-19
vaccine is a significant milestone in battling this devastating
pandemic that has affected so many families in the United States
and around the world, " said FDA Commissioner Stephen Hahn.
In announcing the authorization, the FDA cautioned that the
vaccine may not protect everyone who gets it.
The agency also said doctors and nurses administering the shot
should keep on hand treatments for managing immediate allergic
reactions. And the FDA's materials for doctors and nurses said the
vaccine shouldn't be administered to people with known histories of
a severe allergic reaction to any components of the vaccine.
U.K. health authorities recently warned against giving the
vaccine to people with a history of serious allergic reactions,
after two health-service workers suffered the reactions after
getting vaccinated.
The FDA also said the vaccine might not be as strong in people
with compromised immune systems, including those taking drugs that
weaken the immune system.
Since Covid-19 swamped hospitals and sank the economy, health
authorities, government officials and business leaders have awaited
the arrival of vaccines and their potential to stamp out the
virus.
Vaccines typically take years to create, test and bring to
market. Pfizer and BioNTech were among dozens of drugmakers that
raced into action.
Not far behind are Moderna Inc., which has a shot on track for
FDA authorization in as little as a week, and several other
drugmakers with candidates in the later stages of development.
Shots developed in China and Russia have already gone into use
in those countries and in others.
The development and authorization of Pfizer and BioNTech's
vaccine advanced faster than any shot has ever progressed in the
West, in less than a year. A mumps vaccine previously had been the
fastest to market, taking about four years.
"It's unbelievable how swiftly the authorization went," BioNTech
Chief Executive Ugur Sahin said.
Pfizer and BioNTech moved quickly by turning to a promising but
unproved gene-based technology, known as messenger RNA after the
molecules that carry to cells DNA's instructions for making
proteins.
Moderna's vaccine also employs mRNA technology.
Using the genetic sequence of the coronavirus, BioNTech
researchers synthesized mRNA that would teach cells to make a
version of the spike protein protruding from the coronavirus.
Production of the protein would prompt an immune system to develop
defenses that mobilize against the real virus.
Given the urgent need for a vaccine, the FDA made its decision
within weeks, a fraction of the months it normally takes to
consider an application. Technically, the agency granted a
temporary clearance, known as an authorization for emergency
use.
The FDA said it still held the vaccine to the high standards it
would have demanded if there wasn't a pandemic.
The agency has issued emergency-use authorizations, which are
different than a normal approval, during recent months for several
drugs, though not a vaccine until now.
Peter Marks, director of the FDA division that reviews vaccines,
said "efforts to speed vaccine development have not sacrificed
scientific standards or the integrity of our vaccine evaluation
process."
The U.S. government placed an initial order for 100 million
doses of the Pfizer-BioNTech vaccine for nearly $2 billion, with
the option to purchase 500 million additional doses.
Pfizer has been producing shots at plants in Belgium and
Michigan. To prepare for distributing the doses, the company
shipped about 750,000 vaccines from its Belgium plant to the
U.S.
The federal government decides how much of the vaccine supplies
states will get, based on the size of their populations. States and
other jurisdictions will initially get 2.9 million doses from
Pfizer, with an additional 2.9 million following three weeks later
for the second dose. Weekly shipments of doses would follow.
States, as well as some territories, federal health agencies and
large cities, will determine where the millions of shots will be
delivered, and who should get vaccinated first. Hospitals, health
clinics and certain public-health locations will serve as most
vaccination sites initially. Pharmacies will be able to give
inoculations as more doses are made and more people are able to get
access.
"As Americans get vaccinated, we need to continue taking steps
like washing our hands, social distancing, and wearing face
coverings to protect ourselves, our loved ones, and our
communities," Health and Human Services Secretary Alex Azar said in
a statement.
The U.S. Centers for Disease Control and Prevention recommended
the nation's 21 million health-care workers and three million
nursing-home and other long-term care residents be the first to
receive any Covid-19 vaccine doses. States don't have to follow the
CDC's guidelines.
CVS Health Corp. and Walgreens Boots Alliance Inc. pharmacies
will deliver and administer most vaccine doses for the nation's
approximately 15,600 nursing homes and 29,000 assisted-living
communities, once states give the go-ahead.
McKesson Corp., which will be distributing vaccines other than
Pfizer's, has been shipping to hospitals and other administration
sites kits with syringes, alcohol prep pads and other medical
supplies needed to administer Pfizer's Covid-19 vaccine.
Health authorities don't expect there will be enough supply to
vaccinate the broader, general population until spring or summer
next year. By then, vaccines from AstraZeneca PLC, Johnson &
Johnson and other companies might be cleared and able to augment
supplies.
How soon vaccinations with the initial supplies will start is
unclear. Once a vaccine gets to a hospital, it could start
administering shots within hours, vaccine experts say, though it
could also take days as hospital workers learn how to handle the
containers storing the shots at ultracold temperatures.
A big challenge is persuading millions of people to get
vaccinated. Surveys have found large percentages of people in the
U.S., many of whom are in high-risk categories, are hesitant to get
vaccinated, partly out of concern development of the shots was
rushed.
Fueling some of the hesitancy has been the Trump
administration's own actions and comments, according to the
surveys.
During the presidential campaign, Mr. Trump urged the FDA to
authorize a vaccine by Election Day. He also said, during the first
presidential debate and in a news conference in September, a
vaccine would be available within weeks.
FDA and industry officials made statements seeking to ease any
concerns that political pressure was forcing them to rush out
shots.
The FDA also published detailed guidelines outlining the
agency's requirements for authorizing a vaccine.
It waited for a panel of outside experts to meet, on Thursday,
to review the performance of the Pfizer-BioNTech vaccine in
testing. The committee voted 17 to 4 to recommend
authorization.
Earlier Friday, White House chief of staff Mark Meadows told Dr.
Hahn, the FDA commissioner, that he should look for a new job if
the FDA didn't authorize the vaccine Friday, according to a senior
administration official, prompting the agency to speed up its
plans.
Dr. Hahn, in a statement, had denied his job was threatened on
the call, which was first reported by the Washington Post.
--Bojan Pancevski, Peter Loftus Andrew Restuccia contributed to
this article.
Write to Jared S. Hopkins at jared.hopkins@wsj.com and Thomas M.
Burton at tom.burton@wsj.com
(END) Dow Jones Newswires
December 11, 2020 23:12 ET (04:12 GMT)
Copyright (c) 2020 Dow Jones & Company, Inc.
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