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The Biontech / Pfizer vaccine may be about to be approved in the EU. The corresponding application has been submitted, the companies said. The decision must be made no later than December 29.
Following on from the American pharmaceutical manufacturer Moderna, the German-American alliance of Biontech and Pfizer has also applied for the approval of a corona vaccine in the EU. As the companies announced, they have submitted a conditional marketing authorization for their BNT162b2 mRNA vaccine candidate against Covid-19 to the European Medicines Agency (EMA).
The companies have been sharing information from the test series with the EMA since October as part of an ongoing approval process to speed up the testing process. So far a formal subsequent request has been lacking. The EMA approves vaccines and medicines for all EU member states at the same time.
According to Research Minister Anja Karliczek, the EMA will hold a public hearing on December 11 on the request for approval from Biontech and Pfizer. According to the EMA, the test result should be available before December 29.
“Important milestone”
“Today we have reached another important milestone in our efforts to combat this serious crisis. We remain true to our promise to do everything possible to address urgent needs,” said Dr. Albert Bourla, President and CEO of Pfizer.
Mainz-based manufacturer Biontech expressed a similar view: “As a company based in the heart of Europe, today’s milestone is immensely important to us as we continue to strive to enable global distribution following the possible approval of BNT162b2. “said Biontech boss Ugur Sahin.
In the US, Pfizer / Biontech had already applied for an emergency permit on November 20. The United States government promised that approval for the United States could take place in the first two weeks of December.
Delivery of the vaccine is possible “within a few hours” after approval, Biontech announced at a joint press conference with Research Minister Karliczek. “We cut production and everything in there can be distributed in a few hours,” said Biontech CFO Sierk Poetting. Be well prepared for this distribution.
The vaccine is delivered in boxes and can be cooled in boxes with dry ice for up to 30 days at the respective vaccination center or for up to five days in a standard refrigerator. Freezers only become important when it comes to long-term storage.
The EU has ordered millions of cans
BNT162b2 is currently being tested for efficacy and safety in large clinical trials. The companies recently announced that their vaccine prevents the outbreak of corona disease in 95 percent of cases. This would have resulted in tests with tens of thousands of participants.
The preparation is comparatively similar to Moderna’s vaccine in the mode of action and also in its effectiveness of more than 90 percent. A decision on Moderna’s request for approval of her vaccine is expected on January 12.
According to Pfizer / Biontech, their vaccine has been well tolerated during previous studies and there were no serious side effects. The vaccine is given in two doses. The EU Commission had already agreed on a delivery scope of 200 million cans with the two companies, as well as an option for another 100 million cans as soon as approval is available. Biontech and Pfizer expect to be able to produce 50 million doses this year and up to 1.3 billion doses by the end of 2021. These must be distributed fairly. Biontech had announced that “one country would not get everything.”
