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Pfizer, BioNTech apply for EU approval of vaccine

December 1, 2020

Pfizer and BioNTech have lodged their COVID-19 vaccine with the European Medicines Agency for conditional approval. The companies have already taken similar steps in the US and UK.

A syringe in front of a sign of the BioNTech logo
Image: Jakub Porzycki/NurPhoto/picture alliance

Pfizer and BioNTech have applied to the European drugs regulator for conditional authorization of their coronavirus vaccine, the companies said on Tuesday.

The submission to the European Medicines Agency (EMA) comes after the US pharma giant and its German partner applied for emergency approval in the US

Clinical tests showed their vaccine, named BNT162b2, was 95% effective against COVID-19. BioNTech has said it could be made available in Europe before the end of the year.

"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,'' Pfizer's chief executive, Albert Bourla, said in a statement.

Read more: When will we have a COVID-19 vaccine?

The companies are competing with rival US firm Moderna, which announced on Monday that it had also applied to EU and US regulators to allow the emergency use of its coronavirus vaccine.

The Amsterdam-based EMA said that, if the data sufficed, it would complete an assessment of the BioNTech-Pfizer vaccine by December 29 at the latest, and of the Moderna vaccine by January 12.

While Moderna's drug can be kept in long-term storage at minus 20 degrees Celsius (minus four degrees Fahrenheit), Pfizer's must be kept at minus 70 degrees Celsius.

Germany aims to start vaccinating in January 

Meanwhile, German Health Minister Jens Spahn said the government was aiming to have the first at-risk people vaccinated against the coronavirus in January. 

"It remains true, and we have always said, that the cold winter months, in which we spend more time indoors, will be the harder part. That actually applies until the end of winter," Spahn told public broadcaster Deutschlandfunk.

He added that the vaccine would be administered by health workers in mobile teams and at special vaccination centers. Vulnerable people, as well as nurses and doctors, will likely get the drug first.

Last month, Spahn said Germany was expected to get up to 100 million doses of the BioNTech-Pfizer vaccine.

Germany's vaccination challenge

nm/dr (Reuters, AP, dpa)