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Sputnik V, the story of a vaccine
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04 March 2021 The Committee for Human Medicines (CHMP) of the European Medicines Agency (EMA) has started the ongoing review of Sputnik V (Gam-COVID-Vac), the vaccine against Covid-19 developed by Gamaleya, the Center Russian National Institute 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 soon as they are 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 EMA will assess the compliance of Sputnik V with the usual EU standards in terms of 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.