Pfizer, BioNTech seek COVID-19 vaccine approval in Europe

By: Noah M.

Pfizer and BioNTech have asked European regulators for conditional approval of their experimental coronavirus vaccine — and officials say they could make a decision by the end of the month.

The companies said they submitted an application to the European Medicines Agency on Monday for a conditional marketing authorization for their COVID-19 shot, which was shown to be 95 percent effective in a late-stage clinical trial.

The European Union drug regulator will hold a meeting no later than Dec. 29 to decide whether to recommend the approval as long as the drugmakers submitted enough data for officials to reach conclusions about the vaccine’s quality, safety and effectiveness, the agency said Tuesday.

The European Commission could grant a formal authorization valid in all EU member states “within days” after the drug agency makes its decision, according to regulators. Pfizer and BioNTech say the process could allow their vaccine to be used in Europe before the end of the year if it goes their way.

The companies called the submission another important milestone in their quest to produce and distribute a vaccine that could bring an end to the deadly COVID-19 pandemic. The application came less than two weeks after the drugmakers asked the US Food and Drug Administration to clear the shot 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,” Dr. Ugur Sahin, BioNTech’s co-founder and CEO, said in a statement.

The European Medicines Agency says it grants conditional marketing authorizations to drugs that fulfill an “unmet medical need” based on less comprehensive data than it normally requires. The data has to show that the benefits of the drug outweigh any risks, officials say.

Massachusetts-based biotech firm Moderna has also asked regulators in Europe and the US to clear its experimental vaccine, which was 94.1 percent effective in a late-stage trial.

European regulators say they will make a decision on Moderna’s application at a meeting scheduled for Jan. 12 at the latest. The company has said the FDA officials plan to review its US submission at a Dec. 17 meeting.