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 A panel of outside advisers to the FDA overwhelmingly endorsed the
emergency use of Moderna's coronavirus vaccine on Thursday,
virtually assuring a second option for protecting against COVID-19
for a pandemic ravaged nation.
The committee voted 20-0 with one abstention that the benefits of
the vaccine outweighed its risks in people aged 18 and older.
A week ago, the same panel backed a vaccine from Pfizer Inc and
German partner BioNTech SE, leading to an FDA emergency use
authorization (EUA) a day later.
Following Hahn's comments, the Financial Times reported that the FDA
had decided to approve Moderna's vaccine candidate on an emergency
basis. It cited people close to the process and added that the
emergency approval will be granted in coming days.
The FDA and Moderna did not immediately respond to requests for
comment on the Financial Times report.
The FDA is expected to grant EUA late on Thursday or Friday.
It would provide more hope to a nation that has lost more than
300,000 lives to COVID-19 - including a one-day high of 3,580 deaths
on Wednesday - while record numbers of patients threaten to
overwhelm U.S. hospitals and healthcare workers.
"To go from having a (genetic) sequence of a virus in January to
having two vaccines available in December is a remarkable
achievement," said Dr. James Hildreth, chief executive of Meharry
Medical College, who voted to recommend the vaccine for emergency
use.
The one abstention came from Dr. Michael Kurilla, who works at the
National Institutes of Health and felt blanket authorization for
those 18 and older was too broad.
"I'm not convinced that for all of those age groups the benefits do
actually outweigh the risk. And I would prefer to see it more
targeted towards people at high risk of serious and life threatening
COVID disease," he said.
Health and Human Services Secretary Alex Azar told CNBC on Thursday
that 5.9 million doses of the Moderna vaccine have been allotted for
states and large cities and were ready to ship nationwide.
The vaccines are not a panacea, however, as they will take months to
roll out to a nation where the virus is running rampant and public
health measures such as social distancing and mask wearing are being
rejected by large parts of the population.
EASIER TO TRANSPORT AND STORE
Moderna's vaccine does not require specialized ultra-cold freezers
or vast quantities of dry ice, unlike Pfizer's vaccine which needs
to be shipped and stored at -70 Celsius (-94 F), making it easier to
supply rural and remote areas.
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 Moderna said on Thursday it had
expanded the vaccine's handling guidance to
allow it to be moved locally in a liquid state
at standard refrigerated temperatures. In some
cases, Moderna said, this could be the only
practical way to move it to clinics or remote
locations.
U.S. officials have said they expect to have 40
million doses of the Pfizer/BioNTech and Moderna
vaccines by the end of the year - enough to
inoculate 20 million people. Both vaccines were
about 95% effective at preventing illness in
pivotal clinical trials with no serious safety
issues. The first wave of doses
are expected to be earmarked for healthcare workers who treat
COVID-19 patients and vulnerable residents and staff of nursing
homes. The Moderna vaccine, based on new synthetic messenger RNA
(mRNA) technology, is administered in two shots about 28 days apart.
The Pfizer/BioNTech shot is also an mRNA vaccine.
Documents prepared by FDA scientists and released ahead of the
meeting, said a two-dose regimen of the Moderna vaccine was highly
effective in preventing COVID-19 and did not raise any specific
safety issues.
There were no cases of severe COVID-19 among those who got the
vaccine in the trial versus 30 such cases in the placebo group,
which could be significant as hospital intensive care units fill up
with infected patients.
The United States in August entered a $1.5 billion pact with Moderna
to acquire 100 million doses of its vaccine.
About 20 million doses are expected to be delivered this month, with
the rest of the initial purchase coming in the first quarter of next
year. Last week, Moderna agreed to deliver an additional 100 million
doses in the second quarter.
In the global race to produce highly effective vaccines against the
coronavirus, the Massachusetts-based biotech company is reaching the
finish line ahead of some much larger rivals such as AstraZeneca Plc
and Johnson & Johnson.
 An emergency meeting of a U.S. Centers for Disease Control and
Prevention advisory panel is expected to follow the FDA's
authorization of Moderna's vaccine with its official recommendation
of its use for the U.S. public.
Following that, state and local public health authorities will begin
administering the first doses.
(Reporting by Manas Mishra and Manojna Maddipatla in Bengaluru and
Michael Erman in New Jersey; Additional reporting by Shubham Kalia;
Editing by Caroline Humer and Bill Berkrot)
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