The European Medicines Agency (EMA) approved today, December 21, the use of the Pfizer-BionNTech vaccine against Covid-19, which could thus begin to be administered in the European Union this year.
“I am pleased to announce that the EMA scientific committee met today and recommended a conditional EU market authorization for the vaccine developed by BioNTech and Pfizer. Our scientific opinion paves the way for the first market authorization for a vaccine against Covid-19 in the EU», announced the executive director of the body that regulates the approval of medicines in the EU Emer Cooke.
At a press conference from Amsterdam, Cooke pointed out that the decision "is valid for all 27 Member States at the same time" and commented that it constitutes "a significant step forward in the fight against this pandemic".
In order for this vaccine to begin to be marketed and administered in the EU, approval by the European Commission now remains, which should take place within 48 hours, thus allowing the vaccination campaign to start in the Member States from 27 February December, as the president of the community executive, Ursula von der Leyen, had announced.
Referring to the "intense debate in recent months in the public arena" on the development of vaccines against covid-19, "with some asking for faster approval and others expressing fear that the process is being accelerated", the director -executive of the EMA insisted on leaving the guarantee that the agency acted autonomously, orienting itself "by the strength of scientific evidence and nothing else".
“Let me say this very clearly: while we made every effort to speed up our evaluation process, ensuring vaccine safety was our 'number one' priority. These vaccines will be administered to millions of people in the EU, and we are well aware of the enormous responsibility we have,” he said.
Cooke pointed out that today's conclusion, which is "based on clinical trial data on more than 40 participants and takes into account additional information [provided by US pharmaceutical companies Pfizer and German BioNTech], including over the weekend." , is that "the vaccine meets the stringent EMA standards" and "convincingly shows that the benefits outweigh the risks".
Noting that the new variant of SARS-CoV-2 that has appeared in the UK still needs to be further studied, the EMA pointed out, however, that "it is highly likely that this vaccine will also be effective against the new strain" of the virus.
The vaccine developed jointly by the Pfizer and BioNTech laboratories (Germany) is thus the first to be approved for use in the EU. This same vaccine has already started to be administered in several Western countries, such as the United Kingdom and the United States.
In addition to this vaccine from Pfizer and BioNTech, the European Commission already has a portfolio of six other potential vaccines, developed by AstraZeneca, Sanofi-GSK, Johnson & Johnson, CureVac and Moderna.
The latter should be the next to receive 'green light' from the EMA, with the opinion of the European agency provisionally scheduled for 6 January, revealed today Emer Cooke.
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