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Fnost ten months after the corona pandemic outbreak in Europe, the EU Commission approved the first vaccine in the European Union. The European Medicines Agency (EMA) had the green light this Monday in Amsterdam for the approval of the preparation from the Mainz company Biontech and the US pharmaceutical giant Pfizer. That was the prerequisite for the decision in Brussels.
Federal Health Minister Jens Spahn spoke of a “milestone in the fight against pandemics.” Vaccines pave the way out of the crisis, Spahn said. “And we are doing everything possible to take this route as quickly as possible.” The day after Christmas, the first people who need care should be vaccinated in the hospital care for the elderly. “Because we protect the most vulnerable first,” Spahn said.
“Personal and emotional”
Manufacturers Biontech and Pfizer are on the pillars of delivering the first vaccines to the EU. “We are ready to start administering the first doses of vaccine in the EU as soon as we get the green light,” Biontech chief and co-founder Ugur Sahin said on Monday.
“Today’s decision is particularly personal and emotional for all of us at Biontech,” Sahin said. “As a company based in the heart of the EU, we are especially pleased to be one step closer to the possible delivery of the first vaccine against this devastating pandemic in Europe.”
Germany will receive the first delivery of vaccination doses from Biontech on December 26. The Berlin health administration announced Monday that 151,125 doses of the vaccine are expected. Consequently, the Federal Minister of Health, Jens Spahn (CDU), had previously informed the Conference of Ministers of Health. According to the announcement, 521,625 additional doses of vaccines will be delivered on December 28, followed by 672,750 on December 30. 672,750 doses of vaccine are expected in the first calendar week of 2021. The conference took note and endorsed the Minister’s expert recommendation that half of the doses should be vaccinated initially. Two vaccines are planned for each person.
Without compromising safety
The vaccine is already approved in the United Kingdom, the United States and Canada, among others. According to the EMA, it is around 95 percent effective and is recommended for people over 16 years of age. According to the EMA, around 270,000 people have already been vaccinated with the substance and so far only isolated cases of allergic reactions have been recorded, mostly mild.
EMA experts had been verifying the manufacturers’ data and clinical test results for weeks. Conditional approval in all 27 EU states requires manufacturers to also transmit long-term effect data to the EMA at a later time. Information on possible side effects or allergic reactions will also continue to be verified.
The experts confirmed that the data had not been verified in any way in terms of safety. Clearly there are concerns about the speed of approval, said Harald Enzmann, chairman of the Committee for Medicinal Products for Human Use. But: “The analyzed data meets the standards of reliability and quality.” Last but not least, it was one of the largest vaccine trials in history.
Presumably on January 6, the EMA also wants to clear the way for the approval of the second vaccine, the preparation of the American company Moderna.
