Moderna's coronavirus vaccine faces U.S. FDA expert panel review
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[December 17, 2020]
(Reuters) - A panel of outside
advisers to the U.S. Food and Drug Administration is expected to endorse
emergency use of Moderna Inc's coronavirus vaccine during a meeting on
Thursday, as the nation prepares to roll out a second vaccine.
The panel vote on whether the vaccine's benefits outweigh its risks is
likely to come some time after 3 pm ET (2000 GMT), with an FDA
authorization expected as soon as Friday.
This is the same committee of expert advisers that last week backed the
COVID-19 vaccine from Pfizer Inc and German partner BioNTech SE,
clearing the way for the FDA emergency use authorization (EUA) a day
later.
That vaccine is being distributed throughout the country. A massive
inoculation program began at U.S. hospitals on Monday.

The Moderna vaccine uses similar messenger RNA technology but with less
onerous cold storage requirements than the Pfizer/BioNTech shot, making
it a better option for remote and rural areas. Both vaccines were about
95% effective in preventing illness in pivotal clinical trials.
The FDA advisory committee is likely to discuss Moderna's reports of
side effects from its 30,000-person trial, which were more frequent than
those reported by Pfizer. These were primarily relatively short-lived
reactions to the vaccination rather than serious adverse events.
SVB Leerink analysts said the Moderna vaccine appears less tolerable
than the Pfizer/BioNTech shot, but noted that is not a proper comparison
across trials and unlikely to stand in the way of an EUA.
The FDA staff did not raise any serious concerns about safety in
documents published on Tuesday in preparation for the meeting. It said a
link between Bell's palsy, which causes temporary paralysis of facial
muscles, and the vaccine could not be ruled out after some cases were
reported in trials of both vaccines.
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A small shopping basket filled with vials labeled "COVID-19 -
Coronavirus Vaccine" and a medical sryinge are placed on a Moderna
logo in this illustration taken November 29, 2020. REUTERS/Dado
Ruvic/Ilustration

Pfizer and BioNTech said those cases occurred at the same rate as in
the general population.
Moderna is seeking authorization for people aged 18 and older. That
could sidestep the lively discussion last week among panel members
about whether there was enough data to authorize use of the Pfizer/BioNTech
vaccine in adolescents aged 16 and 17. They ultimately voted to back
that vaccine for those 16 and older.
Initial Moderna vaccine supply would likely go to the United States,
which has signed deals to secure as many as 200 million doses and is
expecting the first 20 million this month. The vaccine is
administered in two doses about four weeks apart.
The company has also signed supply deals with Canada, the European
Union and the UK. The vaccine is undergoing a "rolling review" by
regulators for all three.
(Reporting by Manas Mishra in Bengaluru; Editing by Caroline Humer
and Bill Berkrot)
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