https://sputnikglobe.com/20210715/ema-official-says-criteria-for-assessing-sputnik-v-same-as-for-other-vaccines-1083392518.html
EMA Official Says Criteria for Assessing Sputnik V Same as For Other Vaccines
EMA Official Says Criteria for Assessing Sputnik V Same as For Other Vaccines
Sputnik International
MOSCOW (Sputnik) - The criteria being used by the European Medicines Agency (EMA) to assess Russia’s Sputnik V COVID-19 vaccine are the same that have been... 15.07.2021, Sputnik International
2021-07-15T14:30+0000
2021-07-15T14:30+0000
2021-07-15T14:30+0000
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At a press briefing, Sweeney noted that Sputnik V was currently undergoing the EMA’s rolling review process, which sees the manufacturer submit data and address questions and comments put forward by agency experts.On Tuesday, the Reuters news agency published an article alleging that there were data gaps in the material submitted by Sputnik V’s developers to the EMA.The Russian Direct Investment Fund (RDIF) strongly denied the claims published by Reuters, alleging that the "fake news" article included "false comments by anonymous sources".Kirill Dmitriev, the head of the RDIF, told the India Today portal on Wednesday that he expects the World Health Organisation to approve Sputnik V by September or October.
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EMA Official Says Criteria for Assessing Sputnik V Same as For Other Vaccines
MOSCOW (Sputnik) - The criteria being used by the European Medicines Agency (EMA) to assess Russia’s Sputnik V COVID-19 vaccine are the same that have been used to judge the safety and effectiveness of all vaccines against the disease, Fergus Sweeney, head of the EMA's clinical studies and manufacturing taskforce, said on Thursday.
At a press briefing, Sweeney noted that Sputnik V was currently undergoing the EMA’s rolling review process, which sees the manufacturer submit data and address questions and comments put forward by agency experts.
"We are in that process at the moment [with Sputnik V], it's ongoing. All vaccines are treated equally in that respect and we look forward to the outcome", Sweeney said.
On Tuesday, the Reuters news agency published an article alleging that there were data gaps in the material submitted by Sputnik V’s developers to the EMA.
The Russian Direct Investment Fund (RDIF) strongly denied the claims published by Reuters, alleging that the "fake news" article included "false comments by anonymous sources".
Kirill Dmitriev, the head of the RDIF, told the India Today portal on Wednesday that
he expects the World Health Organisation to approve Sputnik V by September or October.
