EU’s EXCLUSIVE decision on Russia’s Sputnik V is ‘impossible’ this year – source – .

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EU’s EXCLUSIVE decision on Russia’s Sputnik V is ‘impossible’ this year – source – .


Doses of the Sputnik V vaccine against coronavirus disease (COVID-19) are seen at a vaccination center in Zilina, Slovakia on June 7, 2021. REUTERS / Radovan Stoklasa

October 21 (Reuters) – The European medicines regulator is unlikely to decide whether or not to approve Russia’s Sputnik V coronavirus vaccine until at least the first quarter of 2022, as some data needed for the review is still missing, said a source with knowledge of the matter.

“A decision by the EMA by the end of the year is now absolutely impossible,” said the source, referring to the European Medicines Agency.

If the required data is received by the end of November, “then regulators may well decide in the first quarter of next year,” he said. He declined to be identified due to the sensitivity of the matter.

The EMA, which launched its formal review of the Russian vaccine in March, was previously scheduled to decide in May or June whether or not to approve the vaccine for use in the block.

Phase III trial results published in The Lancet in February showed it to be almost 92% effective. Russia later said Sputnik V was around 83% effective against the Delta variant. Read more

The vaccine is widely used in Russia and approved for use in more than 70 countries. The source said there was no reason to doubt its effectiveness or safety.

The Gamaleya Institute, which is overseen by the Russian Ministry of Health, developed the vaccine and oversaw clinical trials, while the Russian sovereign wealth fund, the Russian Direct Investment Fund (RDIF), markets Sputnik V to the foreigner.

RDIF declined to comment and the Department of Health did not respond to requests for comment.

The EMA said in an email that the vaccine remains under review until sufficient evidence is available for a formal application for marketing authorization.

“The EMA will be in a better position to comment on the possible timelines for an authorization of Sputnik V once a marketing authorization application has been submitted to the agency,” he said.

He said on September 9 that he was waiting for more data on Sputnik V before he could continue his review.

“The EMA asked for a more complete production dossier, details on how the vaccine is produced. When they have this file, they will also be able to figure out where to request inspections, ”the source said.

Those details concerned both the production of the active ingredient and the bottling of the finished product, the source said.

The slowness in approval is the latest blow to Moscow, which hopes support from an international regulator will allow it to compete with vaccines made by US drugmakers Pfizer and Moderna which have become dominant in the global market.

Manufacturers told Reuters they had struggled to produce the second dose of the vaccine, hampering efforts to increase home production. Read more

The EU approval would also be a major relief for Russians wishing to visit the region, as it only recognizes vaccines authorized by the EMA or the World Health Organization.

WHO’s review of the process of including shot in its program for sourcing the poorest countries also encountered pitfalls. Read more

Reuters reported in July that the developers of Sputnik V had repeatedly failed to provide data that regulators consider standard requirements in the approval process. Read more

SLOW PROGRESS

A second source involved in the manufacturing process told Reuters the review was slow because Gamaleya was not used to dealing with an international drug regulator.

The first source said the developers had also repeatedly changed the production sites for vaccine doses for the EU, another reason for the delays.

“They keep changing the location of vaccine production sites that are supposed to be destined for Europe,” he said.

The EMA examines each installation involved in the production process. The chairman of Russian drug maker R-Pharm Alexey Repik said his factories would be included in the EMA bid, but he did not provide more details.

A third source involved in the production of the snapshot in Russia said EMA inspectors visited at least two sites operated by R-Pharm in the western Yaroslavl region. The EMA did not make any critical remarks on these sites, he said.

A third R-Pharm site in Moscow would also produce snapshots for the EU, but it was included in the regulatory submission after the EMA review began, he said.

The inspection was expected before the end of the year, he said.

The EU ambassador to Moscow said on October 8 that Russia has repeatedly delayed EMA inspections needed to certify its vaccine. Read more

The first source with knowledge of the matter said there was no reason to doubt Sputnik was safe and effective.

“But with this incomplete data, the EMA really doesn’t have the material to pass judgment on,” he said.

“The ball is in their court. They have to decide what they want to do. “

Reporting by Emilio Parodi and Polina Nikolskaya in Moscow; additional report by Francesco Guarascio in Brussels, edited by Josephine Mason and Nick Macfie

Our Standards: Thomson Reuters Trust Principles.

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