The EU plans to approve Pfizer vaccines on December 29 and Moderna on January 12


By CAPosts 01 December, 2020 - 05:05am 44 views

Vial of one of the vaccines that have requested authorization from the EU. Illustrated Service (Automatic) / Europe Press

Europe expects the death toll to reach 400,000 this weekend. Given this situation, the European Medicines Agency (EMA) plans to accelerate the approval processes of the two vaccines that have already requested it: that of Pfizer and the German biotechnology company BioNTech and that of Moderna, both based on RNA. The first could be approved on December 29 and Moderna on January 12, according to the European entity announced today.

The EMA foresees that the Committee for Medicinal Products for Human Use (CHMP, for its acronym in English), the body In charge of giving the go-ahead to the commercialization of the vaccines, conclude its evaluation of the safety and efficiency of the prototypes in an extraordinary meeting that would take place "at the latest" on the indicated dates, an agency spokeswoman has confirmed.

With these forecasts, vaccination campaigns could be launched at the beginning of the year, with the most exposed groups (health workers and the elderly) as a priority. Once they have the approval of the EMA, the Commission is in charge of making the final decision.

The German Ursula von der Leyen , who has completed a year as head of the European Commission (EC) this Tuesday, has warned that the Authorizations will respond only to the criteria of effectiveness and safety of vaccines, although she has been hopeful that these two criteria will be certified in the coming days and another front will begin: building "strong narratives" to fight the anti-vaccine movement and misinformation.

"Vaccination is self-protection and solidarity," said today at the opening of a digital forum dedicated to the European health sector Von der Leyen, who stressed that the development of vaccines has meant "unprecedented progress" and has asked solidarity with initiatives that seek to guarantee "treatments for everyone". “Now we know that defeating this virus is possible, but no country or government can do it alone. This is the case at a global level, within Europe and between the public and private sectors, ”he said.

The alliance of Pfizer and BioNTech presented its request for conditional authorization for its Covid-19 vaccine to the EMA on Tuesday, while it Modern company presented it yesterday. This request to the European Medicines Agency comes after companies have also requested approval from the US with the intention of launching their vaccine as immediately as possible.

Both vaccines are part of the broad portfolio of which it has The European Commission has been gathering together since it launched the so-called European Vaccine Strategy in June, to centrally negotiate doses for all member states. Last week Brussels closed a contract with the Moderna company to acquire 160 million doses (with which 80 people could be vaccinated, since it is double-prick) and sealed an agreement at the beginning of November to acquire up to 300 million doses of the Pfizer / BioNtech prototype (for 150 million people)

Brussels has currently signed agreements to acquire more than 1 billion doses from a diversified portfolio of laboratories, among which are the three most advanced, among which The two for which the EMA has announced approval are included, as well as the British AstraZeneca vaccine

Community distribution of vaccines, which is governed by the principle of solidarity, will take place on a population basis once it has been given the final approval by the Commission.

The European Medicines Agency had already announced that they could issue their opinion on vaccines "if all goes well by the end of this year or early next year ”, in line with what European politicians have also assured. The president of the European Commission, Ursula Von der Leyen, said a few days ago that Moderna and BioNTech could receive approval from the EMA "in the second half of December."

The approval procedure requires that the so-called Committee meet of Medicines for Human Use (CHMP, for its acronym in English), whose members review all the data provided by the laboratories and claim, where appropriate, additional information they deem appropriate. Once all the evidence has been supervised and any doubts that may have arisen are resolved, they express their opinion. This EMA report then reaches the Commission, which is the one who makes a final decision on whether or not to commercialize the vaccine for the entire EU.

Typically, this evaluation process carried out by the EMA is slower. But given the exceptional circumstances caused by the pandemic, mechanisms have been enabled to shorten times. Since the beginning of the coronavirus crisis, they point out from the agency, they have been "available" to vaccine developers, who have been able to address them with any kind of questions. And they have also implemented a specific review procedure, which allows the data to be monitored "continuously" as it has been released. The three most advanced vaccines (Moderna, BioNTech, AstraZeneca) have been used for this specific procedure.

Source: Elpais

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