COVID-19: Approve Vaccine For Emergency Usage – BioNTech, Pfizer Tell European Regulators

by on December 1, 2020

By Onwuka Gerald

German pharmaceutical company, BioNTech alongside its partner from the United States, Pfizer said they have filed an application with the European Medicines Agency for conditional approval of their COVID-19 vaccines.

Both companies on Tuesday stated that the submission completes the rolling review process that was initiated with the agency on 6, October 2020.

Their decision comes a day after fellow coronavirus vaccine producing rival, Moderna said it asked US and European regulators to approve of emergency use of its COVID-19 vaccine.

According to BioNTech, “If the vaccine, with the name BNT162b2, is approved, Europe might start using it before the end of year 2020.

The two companies, last month stated that clinical trials that involved tens of thousands of volunteers showed the vaccine had an efficacy rate of 95% against the virus.

“The success rate achieved in particularly susceptible older persons was more than 94%.

BioNTech and Pfizer have already submitted a proposal with the U.S. Food and Drug Administration as well as the U.K. regulator MHRA, for emergency approval for their COVID-19 vaccine.

They also made rolling submissions in other countries like Australia, Canada and Japan.

Meanwhile, Pfizer’s Chief Executive, Albert Bourla as contained in a statement said, “We knew from moment we commenced this journey that patients are waiting, and we stand ready to deliver COVID-19 vaccine doses upon approval by authorities”, he said.

Be the first to comment!
Leave a reply »


Leave a Response