EMA recommended the Pfizer-BioNTech vaccine



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The European Medicines Agency (EMA), the European Union agency for the evaluation of medicines, has recommended that the European Commission authorize the distribution and administration of the coronavirus vaccine developed by Pfizer and BioNTech, already used for a few weeks in the US and UK. The European Commission had already anticipated that in case of a positive recommendation, it would authorize the vaccine before December 23, in order to start the massive administration throughout the European Union between December 27 and 29.

EMA’s decision was taken for granted as the agency decided to move forward the meeting to evaluate the vaccine developed by Pfizer and BioNTech, originally scheduled for December 29. The president of the European Commission, Ursula von der Leyen, announced that the authorization should be granted in the evening.

The recommendation was formally issued by the Commission for the Use of Medicinal Products in Humans (CHMP), composed of 27 members, one for each state of the Union. The President of the Commission is the German Harald Enzmann, while the Italian representative is called Armando Genazzani and is director of the pharmaceutical department of the University of Eastern Piedmont. The CHMP recommendation was accepted by the agency and will shortly be submitted to the European Commission. If, unsurprisingly, the authorization from the Commission arrives during the day, the European Union will in fact have compressed into one day just three steps that usually take several months. Only after official authorization will Pfizer be able to distribute the vaccines throughout Europe.

In general, before being used in the general public, a medicine must receive a series of authorizations from the regulatory authorities. In the European Union this task falls to the EMA. Under a treaty clause decided in 2001, each state can decide to approve the use of a drug or vaccine in an emergency. As for the coronavirus vaccine, the clause was used only by the United Kingdom, which among other things, except for great surprises, will leave the European Union completely on December 31, 2020. All other states have made the symbolic decision and policy of awaiting EMA authorization,

– Read also: How the UK did before with the coronavirus vaccine

Even before the EMA licensed the Pfizer and BioNTech vaccine, the European Commission had anticipated that “vaccine days” would be celebrated across Europe on December 27, 28 and 29, ideally in which all states of the The EU should start the vaccination campaign, at least symbolically. Across the European Union, it has reserved around 300 million doses of the vaccine developed by Pfizer and BioNTech, but it is unclear how many of these will be available in the first weeks of the campaign.

Germany and France appear to be the two countries most willing to start vaccinations immediately: both will start on the 27th. Other countries appear to be further behind in preparations. The Belgian Federal Minister of Health, for example, spoke of a “symbolic” quota of 10,000 doses that should arrive at the end of December, while in the Netherlands the real campaign should only start at the end of January. Also in Italy it is believed that the true mass administration campaign can only begin in mid-January, as the extraordinary commissioner Domenico Arcuri announced in recent days.



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