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Pfizer, BioNTech apply for approval of coronavirus vaccine in Europe



The volunteer was injected with a vaccine while participating in a coronavirus vaccination study (COVID-19) at the American Research Centers in Hollywood, Florida, USA, September 24, 2020.

Marco Belo Reuters

The American pharmaceutical giant Pfizer and its German partner BioNTech have stated that they have applied to the European Medicines Agency for a conditional authorization to place their coronavirus vaccine on the market.

If granted, it could potentially allow the use of the Pfizer and BioNTech vaccine in Europe before the end of 2020, BioNTech said in a statement.

Such an authorization, known as a CMA, is given to drugs or vaccines “that meet the unmet medical needs of patients on the basis of less comprehensive data than is usually required,”

; the EMA said on its website. The available data should indicate that the benefits of the medicine outweigh the risks and the applicant should be able to provide comprehensive clinical data in the future.

The news comes almost two weeks after Pfizer and BioNTech said analysis of final data from the final phase of a clinical trial of their coronavirus vaccine showed it was 95% effective in preventing Covid-19 infection.

The vaccine, called BNT162b2, is becoming highly effective against the virus 28 days after the first dose, drug manufacturers said in mid-November, and its effectiveness has been consistent across all ages, races and ethnicities.

In addition, the elderly, who are at higher risk of severe Covid-19 disease, have seen the vaccine’s effectiveness at more than 94%, the companies said. On November 20, Pfizer and BioNTech applied for an emergency use permit from the US Food and Drug Administration for their coronavirus vaccine.

A rival to drugmaker Moderna said Monday it would seek approval from the FDA for the coronavirus vaccine following new data confirming that the vaccine was more than 94% effective in preventing Covid-19 and was safe.

This is groundbreaking news, please check back later for more.

– Berkeley Lovelace of CNBC contributed to the reporting of this story.


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