May 16, 2021

Brussels reminds Ayuso that it has no powers to buy Sputnik V and that it is outside the EU vaccination strategy


The president of the Popular Party, Pablo Casado, often boasts that the president of the European Commission, Ursula von der Leyen, former Minister of Defense of Angela Merkel, is from his family politics. A few days ago, the president of the Community of Madrid, Isabel Díaz Ayuso, wanted to use the visit of a community vice president, the Greek Margartis Schinas, also from his family politics (New Democracy), against the Government of Pedro Sánchez. But this Tuesday asked the Community Executive about the efforts of the regional government To test the purchase of the Russian vaccine Sputnik V, he replied that it is not Diaz Ayuso’s competence and that, furthermore, it places him outside the European Union’s strategy.

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“Member States can distribute vaccines outside the EU vaccine strategy”, replies the spokesman for the Community Executive for health affairs, Stefan De Keersmaecker, to elDiario.es in reference to the Russian vaccine: “It can be done with a authorization for emergency use [como ha aprobado el Gobierno de Viktor Orbán en Hungría]But it is national competence and the responsibility derived from this type of use and authorization rests with the Member States “.

That is, it is the Government of Pedro Sánchez that would have to approve this type of authorization and on which the responsibility of doing so would fall, while Sputnik still does not have the authorization of the European regulator, the European Medicines Agency (EMA ), for use in the European Union.

The Community of Madrid investigated in February the possibility of buying Sputnik V vaccines, according to ABC has advanced and confirmed elDiario.es. According to these same sources, the councilor of the area, Enrique Ruiz Escudero, met up to three times with “intermediaries of the Russian vaccine”, outside the Government of Spain and the European Union, which is the one that centralizes purchases and use authorizations. The meeting was also attended by the Deputy Minister of Public Health and the COVID Plan, Antonio Zapatero.

The president of the Community of Madrid, Isabel Díaz Ayuso, has assured that the will of the regional government is to “study all the scenarios” to “offer answers to all citizens”, while pointing out that “it would not be the first, neither the fifth, nor the tenth time that the Community of Madrid has anticipated the Government of Spain and analyzes all possible scenarios to continue fighting against the virus. ” The Health Minister has also assured that when the European Medicines Agency approves the Russian vaccine, the intention of the Community of Madrid continues to be to buy it on its own: “If we have the option of being able to bring the Sputnik vaccine, we will.”

Brussels: “Needs to be authorized”

“It is crucial for the EU that vaccines are evaluated for their safety, quality and efficacy,” continues the spokesman for the European Commission: “Vaccination safety is of an extraordinary priority. Therefore, any vaccine needs to be licensed accordingly. with the favorable opinion of the EMA before it is marketed in the EU. ”

The European Commission, after the approval of the EMA, has so far granted conditional marketing authorization to the vaccine developed by BioNTech and Pfizer on December 21, to that developed by Moderna on January 6, to AstraZeneca on January 29, and that of Janssen (Johnson & Johnson) on March 11, although the distribution of the latter, the only single dose, is not expected until the second half of April.

“As part of the EU strategy for COVID-19 vaccines and technical discussions between national drug agencies, Member States agreed to opt for centralized marketing authorizations for COVID-19 vaccines. Therefore , the vaccines covered by our vaccination strategy have to be evaluated by the EMA to ensure their safety and provide a solid follow-up “, explains Brussels:” Thus, the decision to acquire other vaccines, such as Sputnik, and grant approval for its use is outside the EU vaccination strategy. ”

The European Commission adds: “There are currently no talks to integrate the Sputnik V vaccine into the vaccination strategy. We are confident that our providers will allow us to reach the goal of vaccinating 70% of the adult population in summer.”

Brussels has signed contracts with AstraZeneca (400 million doses, although no more than 100 are expected for the first half of the year), Sanofi-GSK (300 million doses), Johnson & Johnson (400 million doses), BioNTech- Pfizer (600 million doses), CureVac (405 million doses) and Moderna (460 million doses). The European Commission has also held exploratory talks with the pharmaceutical company Novavax with a view to acquiring up to 200 million doses and with Valneva with a view to acquiring up to 60 million doses.

“That said,” says the spokesman for the Community Executive, “the EMA is making a continuous review of the Russian vaccine.” Indeed, in March the EU took the first step to authorize the Russian vaccine by starting the preliminary analysis of the vaccine developed by the Russian epidemiology center Gamaleya. Whenever the European Commission has been asked about it, it has answered that an almost essential step for a joint purchase agreement is that it be produced in a plant within the European Union, which seems to be resolved with a factory in Italian territory.

“The fact that the EMA authorizes the vaccine does not oblige the European Commission to close a joint preferential purchase contract”, said the spokesman for the Community Executive, Eric Mamer: “When the time comes, if the Commission and the Member States decide negotiate a contract with the manufacturers of Sputnik V, we will communicate it. We are in negotiations with Novavax or Valneva, we have signed a new agreement with Pfizer to accelerate the delivery of vaccines, but not with the manufacturers of Sputnik. At the moment this is the situation”.

Once the EMA decides that sufficient data is available, the company can submit a formal application. By reviewing the data as it becomes available, the EMA can provide an opinion on the authorization of the medicine.

In any case, a few weeks ago the president of the European Commission, Ursula von der Leyen, made an irony about the Russian vaccine: “I am surprised that they are offering so much their vaccine when so few people are vaccinated in Russia.”

“In any case,” Brussels continues, “the EU vaccination strategy is a joint strategy between the European Commission and the Member States, so that the Commission and the States can always decide jointly to expand the vaccine portfolio later” .

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