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Pfizer and BioNTech submit an application that could allow the use of their vaccine in Europe by the end of 2020 | CNN

2020-12-01T22:27:47.041Z


BioNTech and Pfizer have submitted an application for their covid-19 vaccine to the European Medicines Agency (EMA) that could allow its use before the end of the year, according to a press release. | Health | CNN


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(CNN) -

BioNTech and Pfizer have submitted an application for their covid-19 vaccine to the European Medicines Agency (EMA) that could allow its use before the end of the year, according to a press release.

"If the EMA concludes that the benefits of the candidate vaccine outweigh its risks in protecting against COVID-19, it will recommend granting a CMA (Conditional Marketing Authorization) that could allow the use of BNT162b2 in Europe before the end of 2020," he said. the statement from the German company BioNTech.

This submission completes an ongoing review process that began on October 6.

The candidate vaccine will now be evaluated according to the EMA's strict normal standards for quality, safety and efficacy, the drug manufacturers said.

"Today's announcement marks another key milestone in our efforts to deliver on our promise to do everything possible to address this serious crisis given the critical need for public health," said Albert Bourla, Pfizer President and CEO.

"We have known from the beginning of this journey that patients are waiting and we are ready to ship the doses of the covid-19 vaccine as soon as potential clearances allow."

Ugur Sahin, CEO and co-founder of BioNTech, said it was an important step "as we continue to seek to enable global supply after possible approval" of the vaccine.

Earlier this month, BioNTech and pharmaceutical giant Pfizer submitted their coronavirus mRNA vaccine candidate to the US Food and Drug Administration (FDA).

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The companies have filed with the EMA, the FDA and the UK Medicines and Healthcare Products Regulatory Agency, and have started ongoing filings in countries such as Australia, Canada and Japan.

Modern pharmaceutical company announced yesterday that it will become the second pharmaceutical company to request authorization from the FDA for the emergency use of its covid-19 vaccine.

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Source: cnnespanol

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