The Government of Madrid considered the purchase of Russian-made coronavirus vaccines known as Sputnik V, as advanced Abc and has confirmed this diary. The Minister of Health, Enrique Ruiz-Escudero, met up to three times last February “with intermediaries of Russian products” to “explore the international market and have all the possibilities open in the future in the fight against the pandemic, always within the national vaccination framework ”, a spokesman for the Ministry of Health pointed out. But this operation of the regional government has little history and no legal or health support. To begin with, because the drug still does not have the endorsement of the European Medicines Agency (EMA, for its acronym in English), condition sine qua non to be dispensed in Spain. And, in addition, the European Union has agreed an authorization and centralized purchase of vaccines against covid through the European Commission, so that the autonomous communities cannot negotiate the acquisition of medicines of this type at their own risk and expense. “None of the autonomous communities could authorize the marketing of this vaccine or its use as a foreign medicine or compassionate use,” insisted a spokeswoman for the Ministry of Health.
The regional president, Isabel Díaz Ayuso, has justified in a press conference that, “even if you do not have the authorization, you cannot avoid exploring all the scenarios to offer answers to the citizens.” “It is true that it is not approved, but with the endorsement of our technicians, we decided to explore this vaccine. It is something that we have the right and the duty to do. We need vaccines, always conditional on the authorization of the European Medicines Agency ”, Ruiz-Escudero explained. As confirmed by the Community of Madrid, the idea of the Ministry of Health was “to facilitate a preliminary purchase agreement beneficial to the entire SNS [Sistema Nacional de Salud]”By the time the drug is approved by the EMA. But that is not the province of autonomy. The EU agreed to manage the authorization and purchase of medicines through a centralized procedure, so that, once the drug is approved, it can be marketed throughout the European territory.
Although some countries, such as Hungary and Slovakia, have bypassed the consensus and bought Russian and Chinese vaccines unilaterally, Spain maintains a coordinated position with the EU and does not contemplate the incorporation of the Russian drug without the approval of the EMA. “The legislation also allows a vaccine to be used with an authorization for use in special situations. This is how it has become accessible in a very small number of EU countries. This authorization in Spain is the exclusive competence of the Spanish Agency for Medicines and Health Products (AEMPS), which has not received any request in this regard, ”says a Health spokesperson.
In video, Isabel Díaz Ayuso justifies the negotiation of the purchase of the Russian vaccine.
Regarding the controversy raised by the negotiations between Madrid and Russian intermediaries, the President of the Government, Pedro Sánchez, has warned: “We are talking about something very serious. All governments have to be responsible, serious, loyal and supportive. One of the main successes of the European strategy is to centralize the purchase in the hands of the European Commission. All I ask is responsibility, loyalty, solidarity and seriousness to all administrations ”.
Sánchez recalled that Spain will only administer the vaccines validated by the EMA, which for now are four: those from Pfizer, Moderna, AstraZeneca and Janssen. The EMA Committee for Medicinal Products for Human Use (CHMP), in which AEMPS technicians participate, has been evaluating laboratory results and clinical studies in adults carried out so far since March 4. with the Sputnik V vaccine. A study published in the scientific journal The Lancet revealed that the effectiveness of the Russian drug was 92%.
For it to be marketed in the EU, the EMA has to issue a positive assessment and, with that opinion, the European Commission has the last word. There is no date for the verdict on the Russian drug, although due to the urgency of the pandemic, the EMA has speeded up the evaluation deadlines for the drugs so that, in less than 150 days, and through the so-called rolling review —An exceptional mechanism by which agencies evaluate data as it arrives — the regulatory body can dictate a position.
In parallel to the study of the drug’s efficacy, confirms the ministry, the EMA is also analyzing whether the trials have complied with the standards of good clinical practice and is inspecting whether the manufacturing sites “comply with Good Manufacturing Practices (GMP, for its acronym in English), essential for the vaccine to be authorized in the European Union “. Kirill Dmitriev, director of the Russian sovereign wealth fund RDIF, which markets Sputnik V in the world, has assured that his fund already has reached agreements with production facilities in Italy, Spain, France and Germany to produce the vaccine, although Health does not have agreements with Russia. In any case, if the Russians found facilities to manufacture their vaccine, the AEMPS would have the last word, which is the one that has to sign the permits for its manufacture within the national territory.
However, according to Health, the criteria for a vaccine to enter the European strategy are, in addition to being authorized, that the company can guarantee the supply of a high number of doses in a short period of time. “Until now, neither because of the quantity available, nor when it could be available, has it been considered a vaccine of interest, since the supply in a small quantity could only come in a period in which there is already a notable volume of doses. provided by other companies, “says a spokeswoman for Health.