Pfizer, BioNTech File for Covid-19 Vaccine Approval in Europe

Pfizer Inc.
and partner
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 efficacy, according to people familiar with the discussions.

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.

The EMA declined to comment on the application. The agency has been reviewing early data from the main frontrunning 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.

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 [email protected] and Drew Hinshaw at [email protected]

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