MRNA Moderna Inc

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 Australia.

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 first.

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 bojan.pancevski@wsj.com and Drew Hinshaw at drew.hinshaw@wsj.com

(END) Dow Jones Newswires

December 01, 2020 08:15 ET (13:15 GMT)

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