Pfizer and BioNTech have submitted their final application to the European health authorities for approval of their Covid-19 vaccine, the companies announced Tuesday.
Initial approval could come as early as Dec. 29 when the European Union’s medicine agency plans to meet in an extraordinary session to decide if the data submitted is “sufficiently robust” to show the safety and efficacy of the vaccine.
“Today’s announcement marks another key milestone in our efforts to fulfill our promise to do everything we can to address this dire crisis given the critical public health need,” Dr. Albert Bourla, chief executive of Pfizer, said in a statement.
Last month, Pfizer announced that the vaccine was more than 90 percent effective based on a Phase 3 study involving 43,538 participants, and that it had already submitted an application to the Food and Drug Administration in the United States to authorize it for emergency use.
“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,” said Ugur Sahin, co-Founder of BioNTech, the German start-up that created the vaccine.
The news comes a day after Moderna, the makers of another promising vaccine, announced that it had applied for approval from the European market.
If the applications are approved by the European Medicines Agency, the first doses could be available before the end of the month. The agency is “assessing all the applications for COVID-19 medicines under the minimum time frame necessary to allow for a thorough evaluation of the medicine’s benefits and risks,” it said.
If the agency concludes that the benefits of the vaccine outweigh its risks, it will recommend a conditional marketing authorization, which the European Commission will then fast-track to approve in all European member states within days.
On Tuesday, BioNTech officials, speaking at a news conference, said vaccine doses were waiting for approval to be shipped.
“We have produced a stockpile; everything that we have can really be distributed within a few hours,” said Sierk Poetting, the company’s chief financial officer and chief operating officer.
Source: Read Full Article