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Pfizer-BioNTech apply for EU emergency authorisation for Covid-19 vaccine

The application to the European Medicines Agency (EMA) comes after the companies applied for US approval on Nov. 20, taking them a step closer to launching their vaccine.

Topics
Coronavirus Vaccine | Pfizer | European Union

Reuters  |  Frankfurt 

Pfizer-BioNTech apply for EU emergency authorisation for Covid-19 vaccine
US drugmaker Pfizer and Germany's BioNTech reported final trial results on Nov. 18 that showed their vaccine candidate was 95% effective in preventing Covid-19

Inc and BioNTech have applied to the European drugs regulator for conditional authorization of their COVID-19 vaccine, following similar steps in the United States and Britain, the companies said on Tuesday.

The application to the European Medicines Agency (EMA) comes after the companies applied for U.S. approval on Nov. 20, taking them a step closer to launching their vaccine.

In their pursuit of a European launch, potentially this year, the partners are neck-and-neck with rival Moderna, which said on Monday it would ask the EU regulator to recommend conditional approval for its shot.

U.S. drugmaker and Germany's BioNTech reported final trial results on Nov. 18 that showed their vaccine candidate was 95% effective in preventing COVID-19, with no major safety concerns, raising the prospect of U.S. and European approval as early as December.

The European filing completes the so-called rolling review process, which was initiated with the EMA on Oct. 6.

The British government said last week that the U.S.-German partners had reported the data from their clinical trials to the UK Medicines and Healthcare products Regulatory Agency (MHRA).

(Only the headline and picture of this report may have been reworked by the Business Standard staff; the rest of the content is auto-generated from a syndicated feed.)

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First Published: Tue, December 01 2020. 16:10 IST
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