Pfizer/BioNTech ask EU to approve vaccine
Berlin, Dec 1 (efe-epa).- United States pharmaceutical giant Pfizer and its German research partner BioNTech have asked the European Union for authorization to market their Covid-19 vaccine candidate, the companies said in a statement Tuesday.
The European Medicines Agency confirmed the request for conditional marketing authorization.
BioNTech CEO and co-founder Ugur Sahin said: “As a company located in the heart of Europe, today’s milestone is important to us as we continue to seek to enable a worldwide supply upon potential approval of BNT162b2.
“We will continue to work with regulatory agencies around the world to enable the rapid distribution, should the vaccine receive the approval, contributing to the joint efforts to let the world heal and regain its normal pace of life.”
Pfizer and BioNTech said in the joint statement that they hoped the vaccine could be put into use in Europe by the end of the year.
“If EMA concludes that the benefits of the vaccine outweigh its risks in protecting against COVID-19, it will recommend granting a conditional marketing authorisation,” the EMA said.
“The assessment of BNT162b2 (vaccine) will proceed under an accelerated timeline. An opinion on the marketing authorisation could be issued within weeks, depending on whether the data submitted are sufficiently robust and complete to show the quality, safety and effectiveness of the vaccine.”
Pfizer and BioNTech said they applied for the green-light in Europe on Monday, the same day as US company Moderna amid a race to find a vaccine during a second wave of Covid-19 around the world.
Both companies have also filed for emergency authorization with the US Food and Drug Administration, which is set to meet on 10 December to discuss the request.
To fast-track the vaccine approval process, the EMA has taken part in rolling reviews whereby manufacturers can periodically present partial results from their studies.