The European Medical Agency (EMA) still considers data on the Russian Sputnik V coronavirus vaccine insufficient and is unlikely to approve its use until the first quarter of 2022, Reuters reported, citing sources.
“It is impossible for EMA to make this decision by the end of the year,” a source told Reuters. However, he noted that if the missing data are received by the end of November, “regulators may well make a decision in the first quarter of next year.”
The reason for the delay, he said, may be that the developers changed the place of production of the vaccine several times. However, as noted by another source, EMA inspectors visited at least two facilities owned by R-Pharm in the Yaroslavl region and there were no criticisms about them.
According to another source of the agency, the vaccine verification process is slow, as the center has. Gamaleya has no experience of working with an international drug regulator.
Earlier, the Russian Direct Investment Fund (RDIF) expressed hope that EMA representatives would return to Russia this autumn to continue the procedures for registering Sputnik V in the EU. Yesterday, October 20, the World Health Organization (WHO) resumed the vaccine recognition procedure.
About how the Russian vaccine is recognized in the world – in the material of Kommersant FM, “Sputnik V is preparing for recognition.”