Pfizer, BioNTech apply for coronavirus vaccine approval in Europe

Pfizer, BioNTech apply for coronavirus vaccine approval in Europe

PUBLISHED TUE, DEC 1 20205:37 AM ESTUPDATED 17 MIN AGOHolly Ellyatt@HOLLYELLYATT

A volunteer is injected with a vaccine as he participates in a coronavirus disease (COVID-19) vaccination study at the Research Centers of America, in Hollywood, Florida, U.S., September 24, 2020.

A volunteer is injected with a vaccine as he participates in a coronavirus disease (COVID-19) vaccination study at the Research Centers of America, in Hollywood, Florida, U.S., September 24, 2020.Marco Bello | Reuters

LONDON — U.S. pharmaceutical giant Pfizer and its German partner BioNTech said they have applied to the European Medicines Agency (EMA) for the conditional marketing authorization of their coronavirus vaccine.close dialogStream live CNBC TV from around the world.START FREE TRIAL

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If the authorization is granted, it could potentially enable use of Pfizer and BioNTech’s vaccine in Europe before the end of 2020, BioNTech said in a press release.

Such authorization, known as a CMA, is granted to medicines “that address unmet medical needs of patients on the basis of less comprehensive data than normally required,” the EMA says on its website.

“In the interest of public health, applicants may be granted a conditional marketing authorisation for such medicines where the benefit of immediate availability outweighs the risk of less comprehensive data than normally required,” it adds. The applicant should be in a position to provide comprehensive clinical data in the future, however.

“Today’s announcement marks another key milestone in our efforts to fulfill our promise to do everything we can to address this dire crisis given the critical public health need,” Dr. Albert Bourla, Pfizer chairman and CEO said in the press release.

“We have known since the beginning of this journey that patients are waiting, and we stand ready to ship Covid-19 vaccine doses as soon as potential authorizations will allow us.”

The news comes almost two weeks after Pfizer and BioNTech said that final data analysis from the late-stage clinical trial of their coronavirus vaccine showed it was 95% effective in preventing Covid-19 infection.The vaccine, called BNT162b2, becomes highly effective against the virus 28 days after the first dose, the drugmakers said in mid-November, and its effectiveness was consistent across all ages, races and ethnicities.

Additionally, the elderly, who are at a higher risk of severe illness from Covid-19, saw vaccine effectiveness of more than 94%, the companies said.

Pfizer and BioNTech applied for an emergency use authorization from the U.S. 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, U.S. Food and Drug Administration (FDA) and U.K. Medicines and Healthcare Products Regulatory Agency (MHRA), BioNTech noted on Tuesday that it and Pfizer “have initiated rolling submissions across the globe including in Australia, Canada and Japan, and plan to submit applications to other regulatory agencies around the world.”

Rival drugmaker Moderna said Monday it will request emergency clearance from the FDA, and its European equivalent (the EMA), for its coronavirus vaccine after new data confirmed the vaccine was more than 94% effective in preventing Covid-19 and was safe.

Later on Tuesday, Reuters reported that the EMA said if its experts have received enough data from Pfizer and Moderna about their candidate vaccines, it would complete its reviews by Dec. 29 and Jan. 12, respectively, at the latest.

– CNBC’s Berkeley Lovelace contributed reporting to this story.TRENDING NOW

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