By Michel Rose and Polina Ivanova and Emilio Parodi
PARIS (Reuters) – The developers of the Russian Sputnik V coronavirus vaccine have failed to provide data that regulatory agencies consider standardized requests for the approval process several times, according to five people familiar with European efforts to evaluate the vaccine, giving new evidence of the vaccine. country’s difficulty in obtaining foreign approval for its product.
Last month, Reuters reported that the European Medicines Agency (EMA) assessment of the safety and efficacy of the immunizer was delayed because a June 10 deadline for submitting data from the vaccine’s clinical trials was not met, according to one of the sources heard, who is close to the agency, and another person familiar with the matter.
The obstacles go beyond the missed deadline, said the source close to the agency. As of early June, the EMA had barely received production data, and the clinical data it received was incomplete, the source said.
The EMA, which began its formal review of the Russian vaccine in March, was previously expected to decide in May or June whether it would approve the drug’s use in the European Union.
The source close to the EMA said that among the missing clinical information notable during the agency’s review is case report forms that record any adverse effects experienced by trial participants after receiving the vaccine. It is common practice for developers to provide such forms, the source added. Nor was it clear how scientists working on the vaccine tracked the results of people given a placebo, the source said.
The EMA ranks such data gaps on a scale ranging from “critical” – the most severe – to “major” and “minor”. The source said nothing reached the critical threshold, “but there were several ‘majors’”, indicating problems that can be remedied but require a lot of work. The source added that the analysis is only expected to be completed after the northern hemisphere summer.
Several people interacting with Russia’s Gamaleya Institute, which developed Sputnik V and oversaw the clinical trials, attributed the repeated inability to provide any information to lack of experience in dealing with foreign regulatory agencies.
Gamaleya is subordinate to the Russian Ministry of Health. Neither Gamaleya nor the ministry responded to questions for this report. The Kremlin declined to comment.
Sputnik V is traded abroad by Russia’s sovereign wealth fund, the Russian Direct Investment Fund (RDIF).
RDIF said the Reuters report contained “false and inaccurate statements” based on anonymous sources that are trying to harm Sputnik V as part of a disinformation campaign. RDIF suggested that the vaccine could be under attack from the “Western pharmaceutical lobby” without providing evidence of such a campaign.
RDIF added that the vaccine is registered in more than 60 countries and that studies from countries like Argentina, Mexico and Hungary, which are already using the vaccine, show that it is safe and effective. The fund said there were no “serious adverse events reported”.
RDIF also said it is working closely with the EMA, whose inspectors visited Sputnik V’s production facilities. “From the completed inspections, we received no critical critical comments and none of the issues raised doubted the safety and efficacy of the vaccine.” said the RDIF.
The situation in Europe is one of several stumbling blocks for Sputnik V’s developers in dealing with overseas drug regulatory bodies reviewing the vaccine, which have identified lack of data, insufficient documentation of methodology, and non-compliance with what they see as standard protocol .
In Brazil, the National Health Surveillance Agency (Anvisa) initially rejected requests for imports from Sputnik V because technical teams highlighted “inherent risks”, citing the lack of data to guarantee its safety, quality and efficacy.
Last month, Anvisa gave a conditional approval to imports of Sputnik V. The conditions imposed “are intended to overcome the information gaps in the process and ensure minimum conditions of safety and quality of the vaccine,” Anvisa told Reuters, adding that Sputnik V is not being managed in Brazil.
(By Michel Rose in Paris, Polina Ivanova in Moscow and Emilio Parodi in Rome; additional reporting by Matthias Blamont in Paris, Lisandra Paraguassu in Brasília, Stephen Eisenhammer in São Paulo and Marton Dunai in Budapest)
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