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European efforts to assess Russia's Sputnik V vaccine stymied by data gaps | World


Wednesday, 14 Jul 2021 07:45 AM MYT
In this file photo taken on April 15, 2021 a health worker shows vials of the Russian Sputnik V vaccine against Covid-19, at a vaccination centre at the Tecnopolis park in Villa Martelli, Buenos Aires province, Argentina. AFP pic
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PARIS, July 14 The developers of Russia’s Sputnik V coronavirus vaccine have repeatedly failed to provide data that regulators deem to be standard requirements of the drug approval process, according to five people with knowledge of European efforts to assess the drug, providing new insight into the country’s struggle to win foreign acceptance of its product. ....

United States , Slovak Republic , France General , Buenos Aires , Distrito Federal , Noord Holland , Cecil Czerkinsky , Villa Martelli , Vladimir Putin , Sergio Rezende , European Union , European Medicines Agency , Reuters The Gamaleya Institute , Russia Gamaleya Institute , Russian Direct Investment Fund , Gamaleya Institute , Russian President Vladimir , North American , ஒன்றுபட்டது மாநிலங்களில் , ஸ்லோவாக் குடியரசு , புஏனோஸ் ஐரிஸ் , திஸ்திரிதோ கூட்டாட்சியின் , நூற்த் ஹாலண்ட் , வில்லா மார்டெல்லி , விளாடிமிர் புட்டின் , செர்ஜியோ ரேஜெந்தே ,

sputnik v vaccine: European efforts to assess Russia's Sputnik V vaccine stymied by data gaps


Synopsis
Separately, an assessment of Sputnik V by a French delegation of scientists in advance of the EMA review found that the vaccine developers were unable to document that the so-called master cell bank, the initial building block of the vaccine.
Agencies
The developers of Russia’s Sputnik V coronavirus vaccine have repeatedly failed to provide data that regulators deem to be standard requirements of the drug approval process, according to five people with knowledge of European efforts to assess the drug, providing new insight into the country’s struggle to win foreign acceptance of its product.
Reuters reported last month that the European Medicines Agency (EMA)’s review of the drug’s safety and efficacy was delayed because a June 10 deadline to submit data on the vaccine s clinical trials was missed, according to one of those people, who is close to the agency, and another person familiar with the matter. The ....

United States , Slovak Republic , France General , Noord Holland , Cecil Czerkinsky , Vladimir Putin , Sergio Rezende , European Union , European Medicines Agency , Reuters The Gamaleya Institute , Russia Gamaleya Institute , Russian Direct Investment Fund , Gamaleya Institute , Russian President Vladimir , North American , ஒன்றுபட்டது மாநிலங்களில் , ஸ்லோவாக் குடியரசு , நூற்த் ஹாலண்ட் , விளாடிமிர் புட்டின் , செர்ஜியோ ரேஜெந்தே , ஐரோப்பிய தொழிற்சங்கம் , ரஷ்ய நேரடி முதலீடு நிதி , ரஷ்ய ப்ரெஸிடெஂட் விளாடிமிர் , வடக்கு அமெரிக்கன் ,

Data gaps hinder European efforts to assess Russia's Sputnik V vaccine


Jul 14, 2021
PARIS – The developers of Russia’s Sputnik V coronavirus vaccine have repeatedly failed to provide data that regulators deem to be standard requirements of the drug approval process, according to five people with knowledge of European efforts to assess the drug, providing new insight into the country’s struggle to win foreign acceptance of its product.
Reuters reported last month that the European Medicines Agency (EMA)’s review of the drug’s safety and efficacy was delayed because a June 10 deadline to submit data on the vaccine’s clinical trials was missed, according to one of those people, who is close to the agency, and another person familiar with the matter. The EMA is the European Union’s medicines watchdog. ....

United States , Slovak Republic , France General , Noord Holland , Cecil Czerkinsky , Vladimir Putin , Sergio Rezende , European Union , European Medicines Agency , Reuters The Gamaleya Institute , Russia Gamaleya Institute , Russian Direct Investment Fund , Gamaleya Institute , Russian President Vladimir , North American , ஒன்றுபட்டது மாநிலங்களில் , ஸ்லோவாக் குடியரசு , நூற்த் ஹாலண்ட் , விளாடிமிர் புட்டின் , செர்ஜியோ ரேஜெந்தே , ஐரோப்பிய தொழிற்சங்கம் , ரஷ்ய நேரடி முதலீடு நிதி , ரஷ்ய ப்ரெஸிடெஂட் விளாடிமிர் , வடக்கு அமெரிக்கன் ,