Sputnik V: Russia changes its quality assessment methods to gain European approval

“The developers of Sputnik V are striving to replace methodologies involving the use of animals, by in vitro methods, so that the vaccine can receive authorization from the European Medicines Agency “, noted the director of the Center of Scientific Expertise of the Ministry of Health, Valentina Kósenko, at the annual BioTechMed biotechnology forum.

The official’s statements were reproduced by the official website of the Sputnik V vaccine funded by the Russian Direct Investment Fund (RDIF).

According to Kósenko, “some of the methods still in force in Russia are not accepted in other countries at the level of pharmaceutical production, and this is what is happening in the European Union.“. The official added that “today everyone is looking for more precise and specific quality assessment methods. The EMA launched the authorization process for Sputnik V for Europe in early March ”.

The use of fetal bovine serum detected in the development of the vaccine has become an obstacle to its approval, After the outbreak of mad cow disease in 1986, European and American regulators demanded that developers document that the drugs came from safe sources, according to the EFE agency.

At the beginning of September, the EMA reported that the dialogue with the developers of Sputnik V and the Chinese preparation Sinovac was “constructive”, but more information is still needed on the safety, efficacy and quality of these vaccines, so it is still difficult to establish a precise timetable to finalize the review.

The vaccine, developed by the Nikolai Gamaleya Center for Epidemiology and Microbiology in Moscow, was registered in Russia in August 2020. The two-dose compound is approved in 70 countries, including Argentina, with a total of 4,000 million inhabitants, more than half of the world’s population.

WHO approval

This week, Russian Health Minister Mikhail Murashko referred to the authorization of Sputnik V by the World Health Organization (WHO): “All obstacles to the authorization of Sputnik V by the WHO have been removed, only minor administrative procedures remain to be resolved. This has been confirmed by the Director General of WHO, Tedros Adhanom Ghebreyesus ”. This was reported by the official Russian vaccine Twitter account on Saturday.

It is expected that WHO delegation visits Russia in October to unlock the final seal. WHO approval of Russian vaccine is key for millions of people subjected to this development because it is not yet on the list of the 7 vaccines approved by the World Health Organization which have obtained the approval: Pfizer / BioNTech, AstraZeneca-SK Bio, Covishield, AstraZeneca EU, Janssen, Moderna, Sinopharm and Sinovac.

It is important to stress that The Sputnik V vaccine has been shown to be effective and safe (91.6% without adverse effects) thanks to the publication of phase III results in The Lancet – reviewed by international peers. And despite the episodes of shortages experienced by its deliveries, it undertakes production and distribution on a global scale, sustained over time throughout the world. The Sputnik V vaccine has been acquired and distributed in more than 70 countries around the world, representing 50% of the world’s population.

The specific gravity of those inoculated with one and two doses of Sputnik V is very important because they form a large block around the globe to be overlooked. and all the more so since its complete vaccination schedule against COVID is not recognized in the world. In this sense, the Argentine case deserves a clarification to understand the local expectation that exists vis-à-vis the vaccine of Russian origin.

What is the main objection raised by the world health body on Sputnik V? WHO has identified deficiencies related to the implementation of adequate measures to mitigate the risks of cross-contamination.

This definition occurred during a visit by WHO staff with their technicians to a factory in the Russian city of Ufa, and was what led to the suspension of approval progress pending further inspection.

With information from EFE

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