European Union medicines regulator will not approve Russia’s Sputnik V coronavirus vaccine until at least the first few months of 2022, Reuters reported Thursday, citing anonymous sources.
Russia is eager to obtain international clearance for Sputnik V, which Moscow is touting as the world’s first vaccine against Covid-19. The approval of Sputnik V by the EU and the World Health Organization (WHO) would allow vaccine makers to compete with Western drug makers Pfizer and Moderna and facilitate international travel for Russians vaccinated with Sputnik.
The European Medicines Agency (EMA) “may well decide in the first quarter of next year“Whether to approve Sputnik V, Reuters quoted an anonymous source familiar with the matter.
But that depends on whether the Russian manufacturer provides the still missing data needed for the ongoing EMA review by the end of November.
“A decision by the EMA by the end of the year is now absolutely impossible,The quoted source said.
The EMA said in an email that Sputnik V remains under continuous review until a “marketing authorization application has been submitted to the agency,” Reuters reported.
The news agency source said the EMA had asked the Russian manufacturer for a “more complete dossier” on the production of the active ingredient in Sputnik V and the bottling of the finished product.
“When they have this file, they will also be able to figure out where to request inspections,” the source said.
The EMA review was delayed because the Gamaleya Institute, the maker of Sputnik V, has no experience with an international drug regulator and has changed production sites several times for doses vaccine destined for the EU, Reuters said, citing two sources.
The Russian Direct Investment Fund (RDIF), which markets Sputnik V internationally, did not comment on the story.
The WHO, which is also conducting a separate review of Sputnik V, said earlier this month that issues with its suspension of the vaccine approval process had been resolved. RDIF noted that a group of WHO inspectors is due to visit Russia “shortly”.
Sputnik V’s international clearance may face a supply shortage as all but one Russian region has mandated vaccinations for certain categories of the population to fight against the deadliest wave of pandemic in the country.