Almost ten months after the outbreak of the corona pandemic in Europe, vaccinations can now also start in the European Union. The EU Commission approved the vaccine from Mainz-based company Biontech and its US partner Pfizer on Monday.

“Today we add to the battle against Covid – 16 added an important chapter “, said Commission President Ursula von der Leyen in Brussels. The European Medicines Agency (EMA) had previously given the green light for approval. This means that nothing stands in the way of the start of vaccinations in the EU.

Vaccination start soon In Germany, the first doses should be on the coming Sunday (27. December). Until then, the federal Paul Ehrlich Institute should check and approve the vaccine batches. The first delivery of vaccination doses from Biontech is to arrive in Germany on Saturday (26. December). Expected are 151. 125 vaccination doses, as the Berlin health administration announced after Health Minister Jens Spahn (CDU) had informed the Health Ministers Conference.

According to the notification, on 28. December further 521. 625 vaccination doses will be delivered on 30. December then 672. 750. In the first calendar week 2021, 672. 750 Vaccination doses expected. There are two vaccinations per person. First of all, those over 80 – year-olds, staff and residents of nursing homes as well as health workers with a very high risk of infection should be vaccinated. According to the clinical studies, Biontech indicates the effectiveness of the vaccine with 95 percent.

The manufacturer Biontech and Pfizer are in the starting blocks by their own account: “We are ready to start delivering the first vaccine doses in the EU as soon as we get the green light,” said Biontech boss and co-founder Ugur Sahin on Monday before the decision of the EU Commission. Spahn spoke of a “milestone in fighting pandemics”. Vaccination paves the way out of the crisis. “And we are doing everything we can to take this path as quickly as possible.”

EMA Director Emer Cooke said in Amsterdam: “This is really a historic scientific achievement.” However, she warned that the turning point of the pandemic has not yet been reached. However, the authority expects that the vaccine will also be effective against the newly emerged coronavirus variant. “At this point there is no evidence to suggest that the vaccine might not work against the new variant,” said the director. More information needs to be gathered about this.

The vaccine has already been approved in Great Britain, the USA and Canada, among others. According to the EMA, it has an effectiveness of around 80 percent and is used for people from 16 years recommended. According to the EMA, around 270. 000 people vaccinated with the substance, and so far there have only been isolated cases of allergic reactions, mostly mild.

Reviews The EMA experts had been checking the data and results of the manufacturers’ clinical tests for weeks. The conditional approval in all 26 obliges the manufacturers to send data to the EMA afterwards, for example about the long-term effect to submit. Information on possible side effects or allergic reactions will also continue to be examined.

The experts confirmed that the examination of the data had not made any compromises in terms of safety. It is clear that there are concerns about the speed of approval, said Harald Enzmann, chairman of the committee for human medicines. But: “The analyzed data meet the standards of reliability and quality.” Last but not least, it was one of the largest vaccine tests in history.

According to the Federal Ministry of Health, three to four million doses could be available in January. In the first quarter, Spahn expects 000 to 13 Millions of vaccine doses. Since the preparation has to be administered twice, this amount would be sufficient for approximately 5.5 to 6.5 million people. In total, the federal government has secured more than 300 million cans – from Biontech and other manufacturers – via an EU-wide key and national agreements.

In other countries such as the USA or Great Britain, the preparation from Biontech / Pfizer is already used on the basis of an emergency approval. Presumably on January 6th, the EMA wants to clear the way for the approval of the second vaccine, the preparation of the US company Moderna.

( olb)