Pfizer and BioNTech apply for EU approval of Covid-19 vaccine

Pfizer and BioNTech apply for EU approval of Covid-19 vaccine
Credit: Belga

The US company Pfizer and the German company BioNTech have applied for conditional market authorisation for their Covid-19 vaccine with the European Medicines Agency (EMA).

The EMA now has to assess the application. According to Pfizer and BioNTech, it is possible that, with rapid conditional approval, the vaccines could come into circulation this month.

During clinical trials, the Pfizer and BioNTech candidate vaccine showed 95% efficacy in preventing Covid-19.

Both companies expect to produce up to 50 million doses this year, and up to 1.3 billion by the end of 2021. The vaccine is produced at Pfizer's Puurs plant in Belgium, among other plants.

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On Monday, the American pharmaceutical company Moderna also announced that it would submit its candidate vaccine - which is also said to have an efficacy of almost 95% - for approval by the EMA and the United States Food and Drug Administration (FDA).

Pfizer and BioNTech already submitted their applications in the United States on 20 November.

Mid-November, European Commission President Ursula von der Leyen already said that, if all goes well, Pfizer-BioNTech and Moderna's vaccine candidates could obtain conditional market authorisation in Europe in the second half of December, and that the first Europeans could be vaccinated by the end of the year.

Maïthé Chini

The Brussels Times

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