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

Frankfurt: Pfizer Inc and BioNTech have applied to the European drugs regulator for conditional authorisation 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 US approval on Nov. 20, taking them a step closer to launching their vaccine.

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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.

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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.

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

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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).