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Second after Modena… Pharmaceuticals can be sold for one year with prior approval.
(Berlin = Yonhap News) Correspondent Lee Yul = The US pharmaceutical company Pfizer and the German Bioentech applied for marketing approval of a new vaccine against coronavirus infection (Corona 19) from the European Medicines Agency (EMA).
If the approval process goes as expected, the vaccination is expected within this month.
(Baltimore Reuters = Yonhap News) On May 24 (local time), a participant in a vaccine clinical trial at the University of Maryland School of Medicine in Baltimore, Maryland, USA Corona 19) We are preparing to receive the candidate vaccine ‘BNT162b2’. [화이자 제공. 재판매 및 DB 금지] [email protected]
Pfizer and Bioentech submitted an application for approval of a corona 19 vaccine to the European Medicines Agency the day before, after Modena, an American pharmaceutical company, according to Germany’s Suddeutsche Chaitung (SZ) on day 1 (local time).
If the European Medicines Agency initiates a review and approves it, the two companies will be able to start their first vaccination in December, SZ predicted.
The conditional sale approval granted by the European Union (EU) is a procedure to respond quickly to emergency situations that threaten public health such as Corona 19. The drug can be marketed for one year in 27 Member States before all is available. the necessary information on its efficacy and side effects.
Pfizer-Bioentech previously announced the final results of a phase 3 clinical trial indicating that the immune effect of the COVID-19 vaccine jointly developed by the two companies was 95%, and then requested emergency use of the vaccine from the US Food and Drug Administration did.
On the 30th of last month, Moderna began a procedure for the emergency use of the Corona 19 vaccine in the United States and Europe simultaneously. Moderna revealed that the final analysis of its phase 3 clinical trial of the vaccine showed a 94.1% preventive effect.
Among the pharmaceutical companies that recently announced the results of the Corona 19 vaccine clinical trial, Pfizer, Biontech and Modena are the most advanced in the approval application process.
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2020/12/01 19:47 Sent
