ROMA – L’European Medicines Agency will meet on December 21 to decide on vaccino Pfizer-BioNTech. The tight schedule – four days before Christmas – was made official at the end of a morning characterized by German pressing, when the picture online had relaunched December 26 as a useful date for the first administrations (with a go-ahead granted on 23 instead of 29, the date indicated previously). The EMA said it had made the decision after receiving additional data from the drug’s manufacturers. If necessary – says the European Medicines Agency – the appointment of 29 December will be maintained anyway.
In case of advance approval by the European Agency, the company Pfizer announced that it was ready to deliver the vaccine doses envisaged in the EU. The company will use means of transport by land and by air to deliver the serum directly to the points of use within three days of the shipment’s departure from the factories. Pfizer, together with BioNTech, plans to supply up to 50 million doses by the end of 2020 and approximately 1.3 billion doses by the end of 2021 globally. With Europe, the agreement is for 200 million doses, plus optional 100 million, starting from the end of the year.
First vaccinations probably by the end of the year
“The Committee for Medicinal Products for Human Use – specify the EMA – will conclude its evaluation as soon as possible and only once the data on the quality, safety and efficacy of the vaccine are sufficiently solid and complete to determine whether the benefits of the vaccine exceed its risks “. Once the CHMP has given the authorization, “the European Commission will speed up the decision-making process in order to grant a marketing authorization valid in all Member States within a few days”.
On Twitter the immediate applause of the President of the European Commission, Ursula von der Leyen: “Every day – he writes in the post – counts” in the fight against time “to authorize safe and effective vaccines for Covid 19” and the EU is working “at full speed”. For this reason “I welcome the news of the EMA” which “anticipates its meeting before Christmas to discuss the Pfizer / BioNTech vaccine”. “Probably the first Europeans will be vaccinated by the end of 2020!”.
Guido Rasi, former executive director of EMA, confirms the time schedule: “The planned transition to the European Commission for definitive approval of the Pfizer-BionTech anti-Covid vaccine could in all likelihood take place within 48 hours of the green light of theMom“At that point,” the vaccine would be usable from the next day in EU countries – he says – and if the distribution machine and logistics are ready, and with the contextual and immediate validation by Aifa, the vaccination campaign in Italy could start already on 28-29 December “.
The wishes from Italy
“My hope is that the EMA, in compliance with all safety procedures, will be able to approve the Pfizer Biontech vaccine earlier than expected and that vaccinations can also begin in the countries of the European Union as soon as possible”. Roberto Speranza, Minister of Health, is lobbying to speed up the timing and start vaccination against Covid as soon as possible.
Walter Ricciardi, a consultant to the ministry, stresses that “if health workers do not get the vaccine, I am for a form of obligation”. The professor explains that this year the vaccination campaign against the flu “has gone very well, in some regions we have exceeded 70%, the same result can be achieved for Covid with a mix of promotion. But if this has no effect. it is important to insert a clause that obliges health personnel, who are in close contact with the public and protect themselves but also others, to make the vaccine compulsory “.
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Cts and restrictions
Meanwhile, today the technicians of the Technical Scientific Committee met to develop the indications on a possible new tightening in view of the Christmas holidays. Two requests emerged: “” Strengthen the measures and increase controls according to the indications contained in the Dpcm of 3 December, modulating them as deemed appropriate “. Now he first Giuseppe Conte it will have to convene a new summit with the ministers and heads of delegation of the majority forces and decide on a crackdown that now appears unavoidable. Afterwards, probably between tomorrow and Thursday, the government will see the Regions for a discussion on the decisions taken.
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by Michele Bocci
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The idea of closing everything, during the high days of the holidays, on the model of what is happening in Germany, Holland and other European countries is becoming more and more evident at Palazzo Chigi. The whole of Italy could therefore become a red or orange zone on holidays and days before holidays: December 24-27, December 31-January 3, January 5-6. A hypothesis already advanced during another summit that took place on Sunday evening: we therefore go to a further tightening to keep the gatherings, contagion and displacements under control. Which could also concern, as mentioned, the next weekend, that of 19-20 December, considered to be at high risk for the movements planned by millions of Italians.
coronavirus
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Ricciardi: “Lockdown at Christmas to lower the infection”
Ricciardi also sides in favor of the lockdown. “If it continues like this – he says – everything must be closed. When only recommendations are made – he explains – people do everything that is allowed, and this reduces the infection by only 3%. With this rate we will never succeed, not only in flattening the epidemic curve, but to decrease it. Instead – he observes – the lockdown reduces by 15%, and with other interventions we come to halve the infections “. Then he adds: “In view of the Christmas holidays, clear measures are needed to limit mobility and gatherings, and avoid unsustainable pressure on health services”.
The hard line
The Minister of Health shares these positions and in the government he is the supporter of the “hard” line that should lead to the Christmas closure. Backed by the Scientific Technical Committee. The “tough” position also emerged from yesterday’s meeting between the premier Giuseppe Conte, the Minister of the Interior Luciana Lamorgese, the heads of delegation of the majority and some members of the Scientific Technical Committee. “The decision has not yet been taken. Last night during the discussion there was talk of very strict measures that serve to stop people’s movements much more. Measures like that of the red and orange areas”, he explains however Sandra Zampa, Undersecretary of Health. “The effort that was asked of the CTS yesterday is of utmost clarity – he adds – A new lockdown is not a red zone. Certainly, while in the other countries they went in this direction with us they did not, but the curve has not lowered sufficiently it is necessary”.
Coronavirus, Galli: “Europe closes, we continue the push and pull. Too many have not understood”
by Michele Bocci
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