The European Medicines Agency (EMA) announced on Thursday the start of the review of the Russian Sputnik V vaccine. IN a statement, the Amsterdam-based agency has reported that its committee for human medicines (CHMP in its acronym in English) has started what is known as rolling review a process to buy time if Later, a formal request arrives from Moscow, with much more complete scientific information, for its commercialization in the European Union.
Sputnik V is a product of the Gamaleya National Center for Epidemiology and Microbiology, but the application to the EMA was filed by R-Pharm Germany GmbH, a German subsidiary of the Russian pharmaceutical company R-Pharm. Until now, despite rumors and misinformation, neither the Russian center nor any subsidiary had started the procedures, so the European Agency could not pronounce itself or take a step ex officio.
With this step, the Sputnik V vaccine is placed on the same plane as that of CureVac or Novavax. The CHMP’s decision to start the review is based on the results of laboratory studies and clinical studies in adults that the Russians have already carried out, and that indicates that Sputnik V activates the production of antibodies and immune cells that attack Sars -Cov-2 coronavirus and that perhaps can protect against Covid19.
From now on, the EMA will evaluate the data as they arrive to decide if the benefits outweigh the risks in this vaccine. The ‘rolling review’ will continue until there is enough evidence available to activate a formal marketing authorization, says the community body. That intermediate step cannot anticipate the result, but it is a way to save time if formal authorization is requested. The process, which has sped up dramatically since the summer, could take at least a few months when all the necessary information has been submitted.
At the moment, two EU countries, Hungary and Slovakia, have chosen to break the unity of the 27 and have authorized, through their national agencies and taking advantage of the flexibility of European legislation in case of emergencies such as the current one, the use of Sputnik. Hungary is administering it and Slovakia has bought two million doses. The first 200,000 units arrived in Bratislava this week on a Russian military plane, but they have not yet been managed.
The European Commission has not yet signed an agreement with the Russian pharmaceutical company for the advance purchase of doses, linked to future approval. It is the step that was made with Pfizer, Moderna, AstraZeneca (which are already being administered throughout the EU). and with Johnson and Johnson. Precisely, the EMA has set March 11, in just one week, to pronounce on the authorization for marketing the Johnson and Johnson vaccine, for which Brussels has an immediate distribution agreement of 200 million doses, extendable up to 400 million.