The European Medicines Agency (EMA) has started its study for the authorisation of the Russian Sputnik V vaccine for use among the European Union's 27 member states.
The members of the Committee for Medicinal Products for Human Use will review the data provided by the Russian laboratories and by the Gamaleya Institute in Moscow.
Europe has opted for the express “continuous review” study procedure, in which the experts focus on analysing the international scientific literature on the formula that already exists, even before the laboratories have submitted all the paperwork.
At a similar stage of analysis are two other projects, the Janssen one, which will probably be approved on 11 March, and also the Curevac one.
Just minutes after the EMA announced that it was starting the vaccine review process, the Russian Direct Investment Fund (RDIF), the developer of the 'Sputnik V' vaccine, offered Brussels the possibility of vaccinating up to "50 million Europeans as of June 2021" if the European Medicines Agency finally gives the go-ahead.
In a statement, the EMA stressed that the decision to take the first step to study its "conditional" approval is based on the results of laboratory studies and clinical studies in adults "that the drug developer has shared with European scientists” and that information is already being analysed by its experts at its headquarters in Amsterdam.
The EMA admitted this Thursday that "it cannot predict" how long the process will take until the eventual approval of the vaccine, but given the global health emergency situation, the study "should take less time than normal" despite the fact that Moscow has not yet officially submitted the marketing authorisation application for the vaccine in the EU.
The agency said that the first studies are encouraging because "they indicate that Sputnik V triggers the production of antibodies and immune cells that target the SARS-CoV-2 coronavirus and can help protect against Covid."
"The EMA will evaluate the data as it becomes available to decide whether the benefits outweigh the risks," the agency said.
The Sputnik V vaccine, developed by the Nikolai Gamaleya Centre for Epidemiology and Microbiology, had initially been widely questioned by scientists internationally, because it had not passed the same tests and controls as others. However, according to an analysis of clinical trials published in February in the medical journal The Lancet, the Russian vaccine is “91.6 per cent effective against Covid-19 in its symptomatic manifestations.”
The Russian vaccine is easy to store - in an ordinary refrigerator - and costs only eight euros a dose.
Until recently there had been an obstacle in the way because the EMA cannot legally give its authorisation to the distribution of any drug that cannot be produced, at least in part, in one of the 27 EU member countries. For now, Sputnik V, in addition to in Russia, is manufactured in Brazil, India, South Korea and Kazakhstan. But in February, the Kremlin announced its willingness to increase production of its vaccine in new plants abroad, including the European Union. In fact, the Russian authorities have already contracted the German pharmaceutical company IDT Biologika, to produce Sputnik V.
On 3 February, Spain’s Minister of Health, Carolina Darias, opened the door to the administration of this prophylaxis in Spain saying, “We are going to welcome any vaccine that has the authorisation of the European Medicines Agency (EMA) enthusiastically.”