Pfizer, BioNTech File for Covid-19 Vaccine Approval in Europe
December 01 2020 - 4:31AM
Dow Jones News
By Bojan Pancevski
BERLIN -- Pfizer Inc. and partner BioNTech SE said they are
seeking approval from the European Union for their coronavirus
vaccine.
The companies, which have already applied for authorization in
the U.S. and U.K., submitted an application on Monday to the
European Medicines Agency. That application was accepted on Tuesday
by the regulator, the companies said.
The vaccine could be marketed later this month if the EMA
concludes that data from trials show sufficient proof of the
vaccine's safety and efficiency, according to people familiar with
the discussions.
The EMA declined to comment on the application.
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."
The companies 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
Australia.
Data from Johns Hopkins University show 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 bojan.pancevski@wsj.com
(END) Dow Jones Newswires
December 01, 2020 05:16 ET (10:16 GMT)
Copyright (c) 2020 Dow Jones & Company, Inc.
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