Time.news – The Committee for Human Medicines (CHMP) of the European Medicines Agency (EMA) has started the ongoing review of Sputnik V (Gam-COVID-Vac), the Covid-19 vaccine developed by Gamaleya, the Russian National Center for Epidemiology and Microbiology. The revision request came from R-Pharm Germany. This was announced by the EMA.
The CHMP’s decision to initiate the progressive review is based on the results of laboratory studies and clinical trials in adults. These studies 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-19.
The Ema – reads the note – will evaluate the data as it becomes available to decide if the benefits outweigh the risks. The rolling review will continue until sufficient evidence is available for the formal application for a marketing authorization. The agency will assess Sputnik V’s compliance with the usual EU standards for efficacy, safety and quality.
“Although the EMA is unable to predict overall timelines, it should take less time than usual to evaluate a possible application due to the work done during the rolling review.” The European Medicines Agency writes in a note. The EMA will announce when the application for marketing authorization for the vaccine is submitted.
Russia has said it is ready to provide the Sputnik V vaccine to 50 million Europeans since June. The European Medicines Agency (EMA) has announced that it has started the process for the review of the anti-Covid serum developed by Moscow.
EU: “There are still no talks on the Russian vaccine”
“There are no talks underway to include the Sputnik vaccine in the EU vaccine strategy portfolio,” said Stefan de Keersmaecker, the European Commission’s Health spokesperson. “The common strategy is adopted by the Member States and it is up to them to decide whether to add a vaccine to the portfolio,” he added. “It is good to clarify that even if a vaccine is approved by the EMA, there is no obligation for the Commission to include it in its contracts,” said Commission spokesman Eric Mamer.
“It is premature to say whether the manufacturer of the Sputnik vaccine will have the ability to comply with the criteria” set for entering the European vaccination strategy, such as production capacity in the European Union, but “it is not enough to comply with these requirements to enter the portfolio” of EU dose suppliers, added Stefan de Keersmaecker, spokesman for the European Commission, during the daily press conference. The spokesman also explained that the choice of pharmaceutical suppliers “does not rest with the Commission alone, but also with the Member States”.