The European Union asked for more reports and will not authorize the Sputnik V vaccine before 2022: “Absolutely impossible”

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The European Medicines Agency considers it “impossible” to approve the vaccine against the Russian coronavirus Sputnik V until at least the first quarter of 2022 because some data needed for the review is still missing, a source with knowledge of those negotiations told the news agency Reuters, while the Russian Ministry of Health tries to obtain international recognition, with the WHO front also open.

“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.

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

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

The results of phase III trials published in the medical journal The Lancet in February they have shown that it has a efficiency of nearly 92%. Russia later said that Sputnik V has an efficiency of about 83% against the Delta variant.

The vaccine that It was approved for use in more than 70 countries, including Argentina. The source said that there was no reason to doubt efficacy or safety of the serum developed by the Gamaleya Institute.

However, “the EMA asked for a more complete dossier on production, details on how the vaccine is produced. When they have this file, they will also be able to know where to request the inspections, ”said the source. These details pertain to both the production of the active ingredient and the bottling of the final product, the source said.

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“With these incomplete data, the EMA doesn’t really have the material on which to make a judgment“Said a source to Reuters. “The Ball Is in his field. They have to decide what they want to do ”.

A vaccine with two different components

Vladimir Putin surprised the world in August 2020 when he said that Russia had the first vaccine approved against Covid-19. However, the slow pace of approval by the EMA and the World Health Organization (WHO) prevented it from competing with vaccines manufactured by US pharmaceutical companies. Pfizer and Modern, which have become dominant in the global market.

One of the main difficulties in the production of Russian serum is that, unlike the other two-dose vaccines, its components are not the same. The Gamaleya Institute, creator of the formula for two modified human adenovirus vectors, claims that it gives you greater protection than most vaccines. But the production of the second component is slower and more complicated, which generated severe delays in deliveries, in addition to requiring two different production chains.

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

The statement of the Ministry of Health of Russia and Sputnik V

After the news spread by Reuters, the Russian Ministry of Health said that “currently, the production sites are finalizing the preparation of the additional requested documents necessary to complete the certification process of the vaccine by the European Medical Agency. The coordination of the dates of the inspection trip of the EMA specialists to the companies continues. We are preparing a visit this year ”.

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Meanwhile, Sputnik V developers released the following statement:

“We ask the media not to rely on inaccurate anonymous sources and, on important issues, to use the official position of the regulators. Attacks in the press against the Sputnik V vaccine based on misleading and misleading information from anonymous sources have recently intensified after official studies showed that the efficacy of mRNA vaccines against the Delta strain of COVID-19 falls below 50% in just five months. Meanwhile, real-world analyzes confirmed that Sputnik V exhibits superior efficacy and longer-lasting immunity compared to mRNA vaccines. Additionally, an October study in The New England Journal of Medicine showed that human adenoviral vector vaccines, such as Sputnik Light, induce a 10-fold stronger antibody and T-cell response 8 months after vaccination than mRNA vaccines. .

Rather than attack Sputnik V, we urge Western producers of mRNA vaccines to consider using single-component Sputnik Light as a booster to help them achieve stronger, longer-lasting immunity. “

Russia says WHO is “in the final stage” of approving Sputnik V vaccine

This Wednesday, the developers of the Russian vaccine indicated on their official Twitter account that “WHO confirmed that the prequalification process for Sputnik V is on the right track and is entering its final stage. A group of inspectors will visit Russia shortly to carry out all the necessary inspections and paperwork on one of the safest and most efficient vaccines in the world ”.

Earlier this month, Russian Health Minister Mikhail Murashko met in Geneva with WHO Director General Tedros Adhanom Ghebreyesus to advance this process.“All barriers were removed, only minor administrative procedures remain”, he indicated at the time.

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The WHO has already included in the list of drugs approved for emergency use those of Modern, Pfizer / BioNTech, Johnson&Johnson already the two versions of AstraZeneca, the one made in India (called Covishield) and the one it develops in South Korea. It also granted that authorization to those of Chinese origin from Sinovac (called CoronaVac) and Sinopharm.

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