With Europe already crossing the tragic threshold of 400,000 deaths from covid-19, 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 have the go-ahead on December 29 and Modern on January 12, as announced by the European entity today.
The EMA expects that the Committee for Medicinal Products for Human Use (CHMP), the body in charge of giving the go-ahead to the commercialization of vaccines, conclude its evaluation on the safety and efficiency of the prototypes in a meeting extraordinary event that would occur “at the latest” on the dates indicated, an agency spokeswoman has confirmed.
Once they have the approval of the EMA, the European Commission is in charge of making the final decision on their launch on the European market. Given the urgency, this authorization will be taken quickly. “It will probably be a matter of days,” said a spokesman for the Community Executive this afternoon. With these forecasts, vaccination campaigns could be launched at the beginning of the year, with the most exposed groups (health and elderly) as a priority.
Ursula von der Leyen, who has served a year at the head of the European Commission (EC) this Tuesday, has warned that the authorizations will respond only to the criteria of effectiveness and safety of the vaccines, although she has been hopeful that these two criteria get certified in the next few days and start another front: build “strong narratives” to fight the anti-vaccine movement and misinformation.
“Vaccination is self-protection and solidarity,” said Von der Leyen this Tuesday at the opening of a digital forum dedicated to the European Health sector. The president of the European Commission stressed that the development of vaccines has meant “unprecedented progress” and has asked for 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 so on 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 the Moderna company presented it on Monday. This request to the European regulatory body comes after the companies have also requested US approval with the intention of launching their vaccine as soon as possible.
Both vaccines are part of the broad portfolio that the European Commission has been collecting 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 million people could be vaccinated, since it is double-prick) and sealed an agreement at the beginning of November to acquire up to 300 million dose of the Pfizer / BioNtech prototype (for 150 million people).
At the moment Brussels has signed agreements to acquire more than 1 billion doses from a diversified portfolio of laboratories, among which are the three most advanced: the two for which the EMA has announced approval, and also the British vaccine from AstraZeneca.
The community distribution of vaccines, which is governed by the principle of solidarity, will be carried out on a population basis once the final approval has been given by the Commission.
The European Medicines Agency had already announced that they could issue their opinion on vaccines “if everything goes well at 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 the meeting of the so-called Committee for Medicinal Products for Human Use (CHMP), whose members review all the data provided by the laboratories and demand, where appropriate, additional information they deem appropriate. Once all the evidence is 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 assessment 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 put in place a specific review procedure, which allows the data to be monitored “continuously” as it comes out. The three most advanced vaccines (Moderna, BioNTech, AstraZeneca) have been used for this specific procedure.