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UPDATE 1-Moderna gets nod to speed up virus vaccine output with bigger vials

Fri, 02nd Apr 2021 04:25

(Adds details, background)

April 1 (Reuters) - The U.S. drug regulator gave Moderna Inc
clearance to speed up output of its COVID-19 vaccine by
letting it fill a single vial with up to 15 doses, with the
United States banking on rapid immunisation to stem the spread
of the deadly virus.

The U.S. Food and Drug Administration (FDA) also authorized
vaccinators to extract a maximum of 11 doses from the current
vials, instead of the ten previously permitted.

In a statement, Moderna said its vaccine can now can be
supplied in vials containing 11 or 15 doses, and it expected to
begin shipping 15-dose vials in coming weeks.

"Both of these revisions positively impact the supply of
Moderna COVID-19 Vaccine, which will help provide more vaccine
doses to communities and allow shots to get into arms more
quickly," Peter Marks, director of FDA's Center for Biologics
Evaluation and Research, said.

However, the regulator also warned that without proper
syringes and needles it may not be possible to extract more that
13 doses from Moderna's 15 dose vials, and more than 10 doses
from the current vials.

Moderna has supplied 100 million doses of its vaccine to the
United States as of March 29. Pfizer/BioNTech
and Johnson & Johnson's shots are the other two vaccines
approved in the country.

With rising cases and several states even lifting mask
mandates and with more infectious variants also spreading,
health authorities are hoping that the contracts it struck with
the currently approved vaccine makers will be enough for its
entire population.

U.S. top infectious diseases doctor Anthony Fauci told
Reuters on Thursday that the country may not need AstraZeneca's
COVID-19 vaccine even if it wins U.S. regulatory
approval.
(Reporting by Radhika Anilkumar and Shubham Kalia in Bengaluru;
editing by Uttaresh.V & Simon Cameron-Moore)

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