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The European Medicines Agency (EMA) said Wednesday that it needed additional information on the vaccine developed by the University of Oxford and the pharmaceutical company AstraZeneca against covid-19, as part of the approval process for the European Union.
“Additional scientific information on issues related to the quality, safety and efficacy of the vaccine is considered necessary to support the rigor required for an authorization”, which has already been requested from the company, the EMA said in a statement.
The agency received on December 21 a series of data from clinical trials in the United Kingdom, Brazil and South Africa, which are under study, pending additional information that allows the license to be granted to the European Union.
As explained by the EMA, the UK Medical and Health Products Regulatory Agency today approved the temporary use of this vaccine for an emergency, but the procedure followed for the European Union is different, consisting of a “conditional marketing authorization”. “.
The AstraZeneca vaccine is the second to be part of the immunization program against the new coronavirus in the United Kingdom, which began on December 8, which had already approved an emergency authorization for the Pfizer / BioNTech vaccine.
The agency also plans to announce on January 6 the conclusions on the safety and efficacy of the vaccine developed by the modern pharmaceutical company, which, if it receives a positive opinion, will be the second against covid-19 to be approved in the Union European, after the Pfizer / BioNTech drug, which was granted a conditional license on December 21.
The covid-19 pandemic caused at least 1,791,033 deaths as a result of more than 81.9 million cases of infection worldwide, according to a report by the French agency AFP.
In Europe, the highest number of fatalities is registered in Italy (73,604 deaths, plus 2 million cases), followed by the United Kingdom (72,548 deaths, more than 2.4 million cases), France (63,109 deaths and more than 2 , 5 million cases) and Spain (50,122 deaths, more than 1.8 million cases).
The disease is transmitted by a new coronavirus detected at the end of December 2019 in Wuhan, a city in central China.
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