The Russian Direct Investment Fund (RDIF) has refuted the information from Reuters about the failure to meet time constraints for the registration of Sputnik V vaccine in the EU. The Fund stated this in its Telegram channel.
This concerns the agency’s June article, which states that the manufacturers of the Russian vaccine failed to submit all the documents to EMA by June 10. Now the outlet adds that at the beginning of June, the regulator received almost no information about the production of the vaccine, and the data on its clinical trials were incomplete.
The agency notes that the developers of the vaccine have failed to provide evidence to the French side that the master cell bank complied with EU regulations. According to the same sources, the EMA rates such data shortcomings on a scale that goes from “critical” – the most serious – to “major” to “minor.”
The RDIF claims that “the article by the Reuters’ Paris office concerning registration of the Sputnik V vaccine in the EU is based on false comments of anonymous sources and is an example of fake news and the disinformation campaign against the Russian vaccine, organized by the Western pharmaceutical lobby.”
“The Reuters report contains glaring errors and misleads readers regarding the Sputnik V vaccine, its characteristics and interaction between the developers of the pharmaceutical and EMA specialists, and RDIF highlighted this to the Reuters editorial board before the publication. The RDIF refutes the information published by Reuters on the basis of anonymous sources,” the fund said in its statement.
The Fund notes that it is continuing to cooperate with the EMA for the registration of the vaccine in the EU.
“In particular, EMA inspectors have completed an assessment of compliance of the vaccine with the standards of clinical trial and conducted an inspection of the production sites as part of the assessment of the good manufacturing practice in respect of the product,” the RDIF reported.
They also noted that as a result of the inspection, the EMA specialists did not provide any critical comments and gave a positive feedback in their evaluation of the Sputnik V clinical trial. RDIF expects that the registration of the vaccine by the EMA may occur in the coming months.
The RDIF was particularly critical in respect of the fact that Reuters’ article is mainly based on anonymous sources. The only expert named not anonymously, Cecil Czerkinsky, officially denied his citation made by Reuters concerning the fact that the French team was “disheartened”.
“These rumors have been scientifically refuted since that time, and I note that our exchange of opinions of May 2 was reflected in your publication only 2 months later, and, apparently, the material is aimed at undermining confidence in Sputnik V,” Czerkinsky wrote.
RDIF also thanks Reuters for including the Fund’s position in the publication, but asks “to conduct an internal investigation in the Reuters Paris office and take measures against agency employees who spread deliberately false and incorrect information.”