The U.S. company Pfizer and its German partner BioNtech applied to the European authorities for authorization for the use in the European Union of the vaccine against COVID-19 that they have jointly developed.
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"For us, as a company based in the heart of Europe, this is an important milestone. We will continue to strive to distribute the vaccine worldwide after a possible authorization", BioNtech president Ugur Sahin said, adding that both companies hope their vaccine could be used before the end of the year.
In the event that the European Medicines Agency (EMA) concludes that the benefits of the coronavirus vaccine are greater than the possible risks, the agency will recommend a conditional release to the market.
A week ago, Pfizer and BioNtech had requested an emergency authorization for their vaccine from the U.S. health authorities, where the Food and Drug Administration ( FDA ) will meet on December 10 to decide on the application.
The EMA has already started a special procedure to speed up the authorization. In the process to obtain this route, vaccine manufacturers can, before submitting the full application, advance data on the efficacy of the vaccine and its safety in relation to its side effects. If these data are sufficient, a conditional authorization can be granted.
The distribution and application of the vaccine will imply a logistical challenge since it has to be kept at a temperature of minus 70 degrees Celsius. In order to guarantee this, Pfizer and BionTech have developed a transport system with their own refrigerators.
The Pfizer and BioNtech vaccine, which has to be applied in two doses, showed 95 percent effectiveness in the third phase of its clinical studies.