Pfizer and BioNTech seek approval of coronavirus vaccine in Europe


US pharmaceutical giant Pfizer and its German partner BioNTech said they had applied to the European Medicines Agency for conditional marketing authorization for their vaccine against the coronavirus.
If permission is granted, it could potentially allow the use of the Pfizer and BioNTech vaccine in Europe before the end of 2020, BioNTech said in a press release.

Such an authorization, known as CMA, is granted to drugs “which meet the unmet medical needs of patients on the basis of less complete data than those normally required”, the EMA says on its website.

“In the interest of public health, applicants may be granted conditional marketing authorization for these medicinal products when the benefit of immediate availability outweighs the risk of less complete data than is normally expected. required, ”he adds. However, the candidate must be able to provide complete clinical data in the future.

“Today’s announcement marks another key milestone in our efforts to deliver on our pledge to do all we can to address this serious crisis given the critical public health need,” said Dr Albert Bourla, Chairman and CEO of Pfizer in the press release.

“We have known from the start of this journey that patients are waiting and we are ready to ship doses of the Covid-19 vaccine as soon as potential authorizations allow.

The news comes nearly two weeks after Pfizer and BioNTech said final analysis of data from the advanced clinical trial of their coronavirus vaccine showed it to be 95% effective in preventing infection. at Covid-19.

The vaccine, called BNT162b2, becomes highly effective against the virus 28 days after the first dose, drug makers said in mid-November, and its effectiveness was consistent across ages, races and ethnicities.

In addition, older people, who are at higher risk of serious illness from Covid-19, have seen the vaccine’s effectiveness of over 94%, the companies said.

Pfizer and BioNTech applied for emergency use authorization from the United States Food and Drug Administration for their coronavirus vaccine on November 20, with the FDA process expected to take a few weeks and an advisory committee meeting to review the vaccine tentatively scheduled for early December.

In addition to submissions to the EMA, the US Food and Drug Administration (FDA) and the UK Medicines and Health Products Regulatory Agency (MHRA), BioNTech noted on Tuesday that it and Pfizer ” had launched successive submissions around the world, including Australia, Canada and Japan, and plans to submit submissions to other regulatory bodies around the world. ”

Rival drugmaker Moderna said on Monday it would seek emergency clearance from the FDA for its coronavirus vaccine after new data confirmed the vaccine was over 94% effective in preventing Covid-19 and was sure.

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

– CNBC’s Berkeley Lovelace contributed reporting for this story.


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