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The European Union has approved the Pfizer / BioNTech coronavirus vaccine, opening the door to the first vaccinations in the 27 member countries after Christmas. The European Medicines Agency (EMA) cleared the product for commercialization and, hours later, the EU’s executive arm, the Commission, gave it the final green light. Faced with concern over the highly contagious new strain of covid-19 that has emerged in southern England, the EMA said “there is no evidence” that this antidote is ineffective against this variant .
The Amsterdam-based EMA’s Committee for Medicinal Products for Human Use (CHMP) has postponed the meeting originally scheduled for December 29 by one week, under pressure from Germany and other countries, who wanted to see the a decision quickly.
“This is an important step in the fight against this pandemic, which is causing so much suffering and hardship,” said EMA Director General Emer Cooke. “It is truly a historic scientific achievement, in less than a year a vaccine against this disease has been developed and authorized.”
Donald Trump’s government was the driving force behind this acceleration in vaccine research and approval, and the UK the first country to use Pfizer-BioNTech’s government.
The head of the European Commission, Ursula Von der Leyen, clarified that the first applications of the vaccine will take place between 27 and 29 December. France has already announced that the first vaccinations will take place on Sunday. Countries like the United States, United Kingdom, Canada, Mexico, Costa Rica, Ecuador, Saudi Arabia, Israel, Singapore and Switzerland are among the fifteen states that have already authorized the Pfizer vaccine. -BioNTech, giving the starting signal to vaccination campaigns.
The EMA originally planned to make a decision on Moderna’s competing vaccine on January 12, but also brought it forward by a week, as it did with Pfizer-BioNTech. The vaccine developed by the American giant Pfizer and the German company BioNTech has shown an efficacy of 95% in international clinical trials in which two doses were administered three weeks apart.
The regulator has performed a “continuous review” of laboratory and clinical trial data as it arrives. Normally, the agency does not review the data until it has been fully collected. Pfizer-BioNTech submitted a clearance request on December 1, and the EMA responded that it would make its decision on December 29 at an expert meeting.
But the UK, US and Canada have given the go-ahead for an emergency procedure, which has allowed vaccination campaigns to start earlier. Several states complained about the slowness in reaching a decision. Polish and Hungarian leaders called for an acceleration at the last EU summit last week, assisted by Berlin.
The European regulator also suffered a cyberattack in which data on Pfizer / BioNTech and Moderna was stolen, although this had no impact on the schedule, according to the EMA. The EU ensures that it has put in place a coordinated vaccination program in the 27 member countries to allow equitable access to vaccine doses.
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