BioNTech, Pfizer file for approval of COVID-19 vaccine in EU: Statement

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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.

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The application to the European Medicines Agency (EMA) comes after the companies applied for U.S. approval on November 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.

US drugmaker Pfizer and Germany's BioNTech reported final trial results on November 18 that showed their vaccine candidate was 95 percent 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 October 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).

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