Healthcare & Pharmaceuticals

Confusion over Russia's EU vaccine approval bid could be result of misdirected application

4 minute read

A view shows boxes containing vials with Sputnik V (Gam-COVID-Vac) vaccine during the vaccination against the coronavirus disease (COVID-19) at a clinic in the town of Domodedovo near Moscow, Russia December 3, 2020. REUTERS/Maxim Shemetov

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MOSCOW, Feb 19 (Reuters) - Russia's submission of its Sputnik V vaccine for approval by the European Union's medicines regulator appears to have been sent to the wrong agency, according to a Russian document and a clarification of the application process by the regulator.

Russia's RDIF sovereign wealth 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 or not.

A confirmation of the submission was shared on the Sputnik V official Twitter feed - but the screenshot showed that it had been sent to the Heads of Medicines Agencies (HMA).

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An EMA spokesperson said the HMA was not part of the process of applying for COVID-19 vaccine approval by the EMA.

"(Applicants) do not need to submit any information to the HMA," the spokesperson said.

RDIF declined to comment on the reasons for its application to the HMA, but said the application process was moving ahead. "The rapporteur has been appointed and we expect the announcement of the rolling review imminently," a spokesperson said.

The possible misstep highlights how many countries and vaccine developers are still getting to grips with the complicated and often convoluted process of vaccine approval.

For most EU members states, EMA approval is a prerequisite. Russia's Sputnik V has been approved by regulators in 29 countries so far, only one of which is in the EU.

EU member Hungary is the outlier. It has ruffled feathers by striking a bilateral supply deal with Russia prior to a decision by the bloc's regulator. read more

In January, the EU denied it had received a submission for Sputnik V but said scientific advice was being exchanged. read more

It echoed this in a statement on Feb. 10.

"The European Medicines Agency has to date not received an application... despite reports stating the opposite," the EMA said then.

In response, RDIF shared the screenshot showing it had submitted paperwork on Jan. 29 to a website portal run by the HMA. The submission was marked "Status: Complete" by the electronic system.

"In response to the EMA statement that they cannot find Sputnik V application for review, we attach the receipt of such application", RDIF said on Twitter.

However, application to the HMA, which brings together the medicines regulatory bodies of the individual countries that make up the European Economic Area, was not part of the vaccine approval process, the EMA spokesperson said.

Regardless, the process of EMA approval is ongoing.

The rolling review of Sputnik V, a process that leads to conditional marketing authorisation, could begin within weeks if no issues are encountered during the review of its production process, Marco Cavaleri, chair of the EMA's vaccine evaluation team, told Reuters last week. read more

The regulator is in constant contact with Sputnik V's developers, Cavaleri said.

"Sputnik V is waiting for EMA to begin the rolling review and announce it officially on its website," RDIF said on Wednesday.

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Writing by Polina Ivanova; Editing by Angus MacSwan

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