MOSCOW (Reuters) – Russia’s sovereign wealth fund denied on Friday it had made a mistake in its application for European approval for its Sputnik V vaccine for COVID-19, after a document posted online appeared to show it was sent to the wrong address.
Russia’s RDIF fund, which is responsible for marketing the vaccine abroad, has been in a dispute with the European Medicines Agency (EMA) in recent weeks over whether the shot had been submitted for approval.
The spat highlights how countries and vaccine developers are still getting to grips with the complicated and often convoluted process of vaccine approval.
A confirmation of the submission was shared on the Sputnik V official Twitter feed. But the screenshot showed it had been addressed to a body called the Heads of Medicines Agencies (HMA).
An EMA spokesperson said the HMA – which brings together the national regulatory bodies of countries in the European Economic Area (EEA) – was not part of the process of applying for COVID-19 vaccine approval by the EMA.
RDIF declined to comment on the reasons for addressing its application to the HMA, but said the overall application process was moving ahead.
Responding to the initial Reuters report on the address on the application document, RDIF said late on Friday on Twitter that “reports of (a) potentially misdirected application to EMA are inaccurate”.
It said it was working with EMA to start a rolling review for Sputnik V. The EMA had appointed rapporteurs a few days ago to work on the dossier, it added.
The European Union has lagged far behind the United States and former member Britain in vaccinating citizens. Most EU member states have been waiting for EMA approval before rolling out vaccines. Hungary is the only member of the bloc so far to give approval to Sputnik V without waiting for the EMA.
The chair of the EMA’s vaccine evaluation team told Reuters last week that the rolling review of Sputnik V, a process that leads to conditional marketing authorisation, could begin within weeks if no issues are encountered during a review of its production process.
(Writing by Polina Ivanova; Editing by Angus MacSwan, Gareth Jones and Peter Graff)
