Pfizer-BioNTech apply for EU emergency authorization for Covid-19 vaccine
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THURSDAY, MAY 26, 2022
THURSDAY, MAY 26, 2022
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Pfizer-BioNTech apply for EU emergency authorization for Covid-19 vaccine

World+Biz

Reuters
01 December, 2020, 04:30 pm
Last modified: 01 December, 2020, 05:14 pm

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Pfizer-BioNTech apply for EU emergency authorization 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

Reuters
01 December, 2020, 04:30 pm
Last modified: 01 December, 2020, 05:14 pm
Pfizer says it will have 15m doses of its vaccine ready for people in the US by the end of the year, if it is approved. Photo: Reuters
Pfizer says it will have 15m doses of its vaccine ready for people in the US by the end of the year, if it is approved. Photo: Reuters

Pfizer 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 US approval on Nov. 20, taking them a step closer to launching their vaccine.

Moderna to seek US and EU authorization for its vaccine on Monday

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.

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, with no major safety concerns, raising the prospect of US 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 US-German partners had reported the data from their clinical trials to the UK Medicines and Healthcare products Regulatory Agency (MHRA).

Coronavirus chronicle / Top News

Pfizer / BionTech / EU / covid-19 vaccine

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