“Absolutely impossible”: the European Union rules out approving the Sputnik V vaccine this year

It is “impossible” for the EU drug regulator to decide whether to approve the vaccine against coronavirus Sputnik V from Russia until at least the first quarter of 2022 because some data needed for the review is still missing, said a source with knowledge of those negotiations, as the Russian Health Ministry tries to gain international recognition, with the WHO front also opened.

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“A decision by the EMA before the end of the year is now absolutely impossible,” said the source, who declined to be identified because of the sensitivity of the matter, referring to the European Medicines Agency.

If the required data is received by the end of November, “then regulators can decide in the first quarter of next year.”

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The EMA, which launched its formal review of the Russian vaccine in March, was previously expected to decide in May or June whether to approve the use of the vaccine.

The results of phase III trials published in The Lancet in February they have shown that the vaccine is almost 92% effective. Russia later said that the Sputnik V It is around 83% effective against the Delta variant.

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

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

In response to the EMA, RDIF said that its vaccine showed superior efficacy and longer-lasting immunity compared to mRNA vaccines and reiterated that its one-dose “Sputnik Light” vaccine could be used as a booster.

RDIF also complained about what it called attacks by the press against the Sputnik V based on what it considered to be incorrect information.

BREAKING | RDIF: Media attacks against Sputnik based on wrong & misleading information from anonymous sources intensified recently after official studies showed mRNA vaccines’ efficacy vs Delta falling to below 50% in 5 months.
READ | Full statement here????https://t.co/H5J8h9SWfq

– Sputnik V (@sputnikvaccine) October 21, 2021

Alexei Kuznetsov, assistant to the Russian health minister, said the ministry was finalizing the paperwork required by the EMA and discussing the dates for the lab visits that it expects to occur this year.

Kremlin spokesman Dmitry Peskov commenting on the EMA certification process for the Sputnik V, said there were technological disagreements between the regulator and the Russian side regarding the integrity of the documents submitted and the information for the record. “Now we are only talking about technical procedures and they will be resolved,” he said.

“The Ball Is in his field”

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

“The EMA requested a more complete dossier on production, details of how the vaccine is produced. When they have this dossier, they will also be able to understand where to request inspections, ”said the source. These details related to both the production of the active ingredient and the bottling of the finished product, he said.

The slow approval is the latest blow for Moscow, which hopes that the backing of an international regulator would allow it to compete with vaccines made by US pharmaceutical companies Pfizer and Moderna, which have become dominant in the global market.

Manufacturers told Reuters they have struggled to produce the second dose of the vaccine, hampering efforts to boost production in the country.

EU approval would also be a huge relief to Russians – and others vaccinated with the Sputnik in the world – who wish to travel to Europe, as it only recognizes vaccines authorized by the EMA or the World Health Organization.

The review of the WHO As part of the process to include vaccines in its program to supply the poorest countries, it has also run into difficulties.

BREAKING: @WHO confirmed Sputnik V pre-qualification process is on track and entering its final stage. A group of WHO inspectors is due to visit Russia shortly to round up all necessary inspections & paperwork on #SputnikV, one of the world’s safest & most efficient vaccines. pic.twitter.com/In48juFhM3

– Sputnik V (@sputnikvaccine) October 20, 2021

Another person involved in the manufacturing process told Reuters that the review was slow because Gamaleya had no experience dealing with an international drug regulator.

The first source said that the developers had also changed production sites of vaccine doses for the EU on several occasions, one more reason for the delays.

The EMA reviews every facility involved in the production process. The chairman of Russian pharmaceutical company R-Pharm Alexey Repik said its factories would be included in the request to the EU, but did not provide further details.

A third source involved in the production of the vaccine in Russia said that EMA inspectors had visited at least two sites operated by R-Pharm in the western region of Yaroslavl. EMA did not comment critically on these sites, it said.

A third R-Pharm plant in Moscow would also produce the drug for the EU, but it was included in the regulatory filing after the EMA review began, he said. And he added that the inspection is expected before the end of the year.

The EU ambassador in Moscow said on October 8 that Russia had repeatedly delayed the EMA inspections necessary for the certification of its vaccine.

One of the sources consulted by Reuters said there was no reason to doubt that the Sputnik was safe and effective. “But with these incomplete data, the EMA he really doesn’t have the material on which to make a judgment, ”he said. “The Ball Is in his field. They have to decide what they want to do ”.

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Deshawn