BERLIN – BioNTech, a German biotechnology firm, has applied for the approval of a potential vaccine for coronavirus disease 2019 (Covid-19) by the European Medicines Agency (EMA).
Dr. Ugur Sahin, a Turkish scientist and co-founder of BioNTech, along with American medicine firm Pfizer, is expecting a license from the EMA for the Covid-19 vaccine candidate BNT162b1 they have been developing.
“It is our duty to ensure that while we are working to develop a potential vaccine at unprecedented speed to help address this pandemic, we do so with the highest ethical standards while adhering to sound scientific principles,” Sahin said on BioNTech’s official website.
He added that they will be in open dialogue with the EMA during the approval process.
Peter Honig, the senior vice president of Pfizer, said: “We are making every effort to develop a safe and effective vaccine following the guidance of regulatory agencies and are proud to take this historic step with the European Medicines Agency for our Covid-19 vaccine candidate, BNT162b2,” on the website.
BioNTech and Pfizer plan to work with the EMA’s Committee for Medicinal Products for Human Use to complete the rolling review process to facilitate the final Marketing Authorization Application.
The US has implemented Operation Warp Speed in hopes of getting and delivering millions of doses of a vaccine by the end of this year, as it agreed in July to pay Pfizer and BioNTech USD1.95 billion for 100 million doses of their vaccine if it proves safe and effective. It also announced a USD1.6-billion agreement with Novavax to manufacture and deliver 100 million doses by January 2021.
The EU has secured 300 million doses of Covid-19 vaccine from medical firms BioNTech and Pfizer. (Anadolu)