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EMA Says Sputnik V Still Under Review, Gives No Comments on Assessment Timeline

© AP Photo / Pavel GolovkinIn this Thursday, Dec. 10, 2020 file photo, a vial with Russia's Sputnik V coronavirus vaccine in a medical room rests on a table prior to a vaccination in Moscow. The South African drug regulator has rejected the Russian-made coronavirus vaccine Sputnik V, citing some safety concerns the manufacturer wasn't able to answer. In a statement on Tuesday, the country's regulator, also known as SAHPRA, said the request for Sputnik V to be authorized could “not be approved at this time,” referring to past failed HIV vaccines that used a similar technology.
In this Thursday, Dec. 10, 2020 file photo, a vial with Russia's Sputnik V coronavirus vaccine in a medical room rests on a table prior to a vaccination in Moscow. The South African drug regulator has rejected the Russian-made coronavirus vaccine Sputnik V, citing some safety concerns the manufacturer wasn't able to answer. In a statement on Tuesday, the country's regulator, also known as SAHPRA, said the request for Sputnik V to be authorized could “not be approved at this time,” referring to past failed HIV vaccines that used a similar technology. - Sputnik International, 1920, 21.10.2021
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MOSCOW (Sputnik) – The Russian-made Sputnik V COVID-19 vaccine is still undergoing examination at the European Medicines Agency (EMA), and no forecasts on the timeline can yet be made, an expert of the agency said Thursday.
"Regarding the evaluation of the Sputnik V vaccine, that remains under review, we are continuing the assessment and interactions with the company and I can’t comment on the timeline and how we will progress at this point," Dr Fergus Sweeney, the head of the clinical studies and manufacturing task force at the EMA, told a briefing.
Regarding another Russian vaccine, Sputnik Light, the producer has not applied for certification from the EMA yet, another expert said.
"We have seen the discussion taking place on Sputnik Light, at this stage we don’t have really any understanding if the company intends to submit an application for this vaccine in the EU, but we will continue the dialogue to have more clarity on this," Dr Marco Cavaleri, the head of Biological Health Threats and Vaccines Strategy at the EMA, said.
Earlier in the day, Russia’s Assistant Health Minister Alexey Kuznetsov said that experts from the EMA will visit Russia this year for inspection.
Since early March, Sputnik V has been under review by the EMA. Hungary and Slovakia approved the vaccine without waiting for EMA authorization.
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