Russia brought together independent scientists from around the world to study the safety and efficacy of Sputnik V | After confirming the modernization of its controls



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Only a few days after the Gamaleya Center confirmed the modernization of its quality controls to adapt them to the standards of the European Medicines Agency (EMA) and obtain the approval of Sputnik V in Europe, the Russian Direct Investment Fund (RDIF) brought together international researchers and scientific institutions cooperate in studies on the safety and efficacy of this vaccine.

“The Fund is interested in expanding the knowledge of Russian and international scientists, as well as promote public awareness of real-world data on the safety and efficacy of Sputnik V, Sputnik Light and other vaccines, ”the institution said in a letter of invitation.

He then explained some of the technical reasonsThe two-dose Sputnik V vaccine was the world’s first registered coronavirus vaccine and also the first based on a heterogeneous booster or “vaccine combination” approach using human adenovirus serotype 26 as the first component and serotype 5 of human adenovirus as the second component.

“This approach induces stronger immunity compared to vaccines which use the same delivery mechanism for both injections.”, underlined the RDIF. Meanwhile, he added, the single dose Sputnik Light vaccine is the first component (recombinant human adenovirus 26 (rAd26) serotype) of the Sputnik V vaccine.

In January 2021, RDIF and the Gamaleya Center created the International Scientific Advisory Council on Sputnik V. There, the main scientists in virology, microbiology and immunology from Argentina, Great Britain, Croatia, France met. , Germany, India, Sweden, United States. States and Russia.

Studies based on the analysis of the use of the Sputnik V and Sputnik Light vaccines have been published in the main international medical journals Peer review: The Lancet, EClinical Medicine (published by The Lancet), Vaccines, and Cell Reports Medicine.

However, there are countries which have not yet approved its administration, and a good part of them belong to the bloc of the old continent. Certification from the World Health Organization (WHO) is also expected by the end of November.

This is why RDIF is working quite actively in this direction. In fact, just two days ago it was reported that “The developers of Sputnik V are currently working to change their methodologies”. The objective is to obtain the approval of the EMA, recognized the director of the Center of medical expertise of the Ministry of Health, Valentina Kosenko.

The scientist recalled that the Russian vaccine is under review at the EMA, “but some methods used in Russia to control the quality of medicines are no longer used in more developed countries pharmacist, in particular, in Europe ”.

The new methods, he said, will prioritize more modern in vitro technologies over those inherited from the Soviet pharmaceutical company, which used animals. In particular, the use of fetal bovine serum, which has become an obstacle to its approval.

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