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(Adds comments from president-elect, infectious disease expert)
By Michael Erman
Dec 18 (Reuters) - Moderna Inc's coronavirus
vaccine on Friday became the second to receive emergency use
authorization (EUA) from the U.S. Food and Drug Administration,
welcome news to a nation with a staggering COVID-19 death toll
of over 307,000 lives lost.
Millions of doses of the Moderna vaccine are expected to be
added to the U.S. rollout, which began this week with healthcare
workers. Older people in long-term care facilities are next in
line for vaccines, with a U.S. Centers for Disease Control and
Prevention expert panel on Sunday set to recommend what groups
follow, as industries compete to have their workers given
precedence.
The FDA announced the authorization the day after the
agency's panel of outside experts endorsed its use and a week
after the FDA authorized a vaccine from Pfizer Inc and
German partner BioNTech SE.
The vaccine from Pfizer and BioNTech, based on similar
technology, has been put into the arms of thousands of U.S.
healthcare workers this week in a massive nationwide rollout.
Moderna injections are expected to begin in coming days for
adults 18 years old and up.
"With the availability of two vaccines now for the
prevention of COVID-19, the FDA has taken another crucial step
in the fight against this global pandemic that is causing vast
numbers of hospitalizations and deaths in the United States each
day,” FDA Commissioner Stephen M. Hahn, M.D, said in a
statement.
Moderna's shot is expected to be used in harder-to-reach
locations, such as rural hospitals. The vaccine needs to be
stored and shipped frozen, but does not require the ultra-cold
temperatures of the Pfizer/BioNTech shot.
The speed of vaccine development - less than a year from
when the first case of the new coronavirus was found in the
United States - is a stunning scientific success, although there
is some hesitancy among the public.
"It is my hope that all Americans will protect themselves by
getting vaccinated when the vaccine becomes available to them.
That is how our country will begin to heal and move forward,"
top U.S. infectious disease scientist Anthony Fauci said in a
statement.
Moderna said it intended to apply for full U.S. license in
2021.
The FDA decision marks the first regulatory authorization in
the world for Moderna's vaccine and validation of its messenger
RNA technology, shown to be nearly 95% effective with no serious
safety concerns. It came less than a year after the
first COVID-19 case was identified in the United States.
The vaccine, developed in partnership with the National
Institutes of Health, had relatively minor side effects
including pain around the injection site and swelling.
The biotech company has worked with the U.S. government to
prepare for the distribution of 5.9 million shots starting as
early as this weekend.
Once thawed, the Moderna vaccine can be kept at typical
refrigerator temperatures. It is administered in two shots 28
days apart.
Between the two vaccines, the United States is expecting 40
million doses before year end, enough to eventually vaccinate 20
million people, as both require two shots.
"Brighter days lie ahead," responded U.S. President-elect
Joe Biden, who plans to be vaccinated on Monday.
U.S. President Donald Trump on Twitter hailed the
authorization. "Congratulations, the Moderna vaccine is now
available!" he wrote. The vaccine must be transported to
hospitals and other centers before injections begin.
Moderna said it would deliver approximately 20 million doses
to the U.S. government this year and expected to have between
100 million and 125 million globally in the first quarter of
next year, with 85-100 million of those for the United States.
Moderna has deals with the U.S. government to provide a
total of 200 million doses by the end of June 2021. Other
vaccines still are in testing, including a one-shot injection
from Johnson & Johnson, and a two-shot course from AstraZeneca
and Oxford University.
U.S. hospitalizations and deaths have surged, driven by last
month's Thanksgiving holiday gatherings. Authorities have
renewed restrictions and shutdowns across the country.
Public health officials have warned infections from
Christmas and New Year's celebrations could exacerbate a crisis
that already threatens to overwhelm healthcare systems
nationwide.
Even with two highly effective vaccines, practices such as
social distancing and face covering will be needed for months
before enough people are inoculated to curb virus transmission
and eventually end the pandemic.
"With strong federal funding for swift vaccine rollout and
education, and by following the guidance of public health
experts to continue wearing masks and maintaining distance, we
can bring the end of this pandemic closer," Barbara Alexander,
head of the Infectious Diseases Society of America, said in a
statement.
(Reporting by Reporting by Kanishka Singh and Manojna
Maddipatla in Bengaluru, Michael Erman and Rebecca Spalding in
New York, Peter Henderson in Oakland and Julie Steenhuysen in
Chicago; Editing by Caroline Humer, Bill Berkrot and David
Gregorio)
