Pfizer, Moderna Request Covid-19 Vaccine Authorization in Europe--2nd Update
By Bojan Pancevski and Drew Hinshaw
BERLIN -- Pfizer Inc. partner BioNTech and U.S. drugmaker
Moderna Inc. both applied for their coronavirus vaccines to be
approved in the European Union, the EU's chief medicines regulator
said Tuesday, with officials expected to make a decision on at
least one of the vaccines by the end of the month.
The announcement brings hope that the EU will soon be able to
start vaccinating its 448 million people against a disease that has
done some of its earliest and worst damage on the continent, in
places like northern Italy, Belgium and France.
The European Medicines Agency said its officials will work
through Christmas to review whether data from trials show
sufficient proof of the two vaccines' safety and effectiveness. If
so, the vaccines could be marketed as soon as this month, according
to people familiar with the discussions. The EMA is set to make a
judgment on the BioNTech vaccine first, by Dec. 29 at the latest,
giving that candidate a two-week edge in the vaccine race over
Moderna's candidate. The agency will then decide whether to
authorize the Moderna vaccine by Jan. 12, officials said.
The submission marked a milestone in the race to supply the
world with a working vaccine to end the pandemic, said Ugur Sahin,
the chief executive of BioNTech.
"We will continue to work with regulatory agencies around the
world to enable the rapid distribution, should the vaccine receive
the approval, contributing to the joint efforts to let the world
heal and regain its normal pace of life," Dr. Sahin said.
Albert Bourla, Pfizer's chairman and CEO, said: "We have known
since the beginning of this journey that patients are waiting, and
we stand ready to ship Covid-19 vaccine doses as soon as potential
authorizations will allow us."
BioNTech and Pfizer said their vaccine demonstrated an overall
efficacy rate of 95%, or 94% for people over 65.
The companies have already filed similar submissions with the
U.S. Food and Drug Administration and Britain's Medicines and
Healthcare Products Regulatory Agency. Their vaccine is being
reviewed in other countries, including Canada, Japan and
The EMA says it has been reviewing early data from the main
front-running vaccine candidates since October. But to be
authorized for use, a vaccine must be formally submitted to the
agency, and critically, that submission must then be validated by
EMA regulators. BioNTech says its candidate is the first to cross
that threshold. Moderna on Monday said it was requesting approval
from the EMA, but the agency said that Moderna's submission had not
yet been validated.
On Tuesday, the EMA said that it validated BioNTech's
submission. It later said that it had received and validated
Moderna's submission and that its scientific committee for human
medicines expected to reach a decision on BioNTech's vaccine
Data from Johns Hopkins University on Tuesday show world-wide
more than 62.25 million people have been infected with Covid-19 and
nearly 1.47 million have died since the start of the outbreak.
Write to Bojan Pancevski at email@example.com and Drew
Hinshaw at firstname.lastname@example.org
(END) Dow Jones Newswires
December 01, 2020 08:15 ET (13:15 GMT)
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