WHO delegation to visit Russia in October to unlock approval for Sputnik V vaccine

The paradoxes surrounding the Sputnik V vaccine, produced in Russia by the Gamaleya Institute, do not end. At the worst moment of the global pandemic caused by the new SARS-COV-2 coronavirus, it entered the podium of the first global vaccines available against COVID-19, under emergency conditions; but it has not yet obtained final approval from the World Health Organization (WHO), nor from the two most important regulators in the world: the North American FDA and the European EMA. However, this tension could be about to be resolved.

As he could know Infobae, INegotiations between the producers of the Sputnik V vaccine and the WHO regarding the approval of the Russian vaccine are continuing in a constructive manner, and a WHO delegation is expected to visit Russia in October to release the final seal.

Of the seven COVID-19 vaccines approved by the WHO that have already reached what is known as gold standard These include: Pfizer, Moderna, AstraZeneca, Johnson & Johnson / Janssen and vaccines produced in China, Sinopharm and Sinovac.

It should be noted that the Sputnik V vaccine has demonstrated its efficacy and safety (91.6% without adverse effects) thanks to the publication of the Phase III results in The Lancet – reviewed by international peers. And despite the peaks of shortages that have had its deliveries, it has undertaken large-scale, sustained during the vaccine-era production and distribution, around 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.

Therefore, the specific gravity of those inoculated with Sputnik V – with one and two doses – forms an important block across the world to be ruled out and especially since their 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.

This is the first vaccine approved in Argentina against COVID-19. The national state acquired 25 million direct doses to Russia and later added a domestic manufacturer – for components 1 and 2 and for the whole region: Richmond Laboratories, which at first will produce in alliance with Gamaleya and more later – with your own factory .through, you will be a stand-alone supplier of formulas. Thus, Sputnik V has become one of the pillars of the country’s strategic vaccination plan, having inoculated 11 million Argentines.

What is the main objection raised by the world health body on Sputnik V? The WHO was straightforward: it detected flaws related to the “implementation of adequate measures to mitigate the risks of cross-contamination”. This The definition took place during a visit that the WHO itself made with its technicians to a factory in the Russian city of Ufa, and was what led to the suspension of approval progress pending further inspection.

Following the publication of the WHO findings, the Ufa plant said it had already addressed its concerns and that international inspectors had not questioned the safety or effectiveness of the vaccine..

Infobae consulted experts and was able to trace the Sputnik production line inside the laboratory to understand in detail the dimension of the objections: In order for a small bottle (vial, which contains the formulation for making the virus) to be enlarged and reproduce to vaccinate millions of people, it must go through a process of genetic engineering. Thus, a series of processes are carried out: filtration, purification and sterilization of the formulations – with nuclear reactors in between – then it will be ready to be inoculated, to inject a virus which does not reproduce or does not replicate in the vaccinated organism. . Now, if the technicians or the production lab mess up this process, the possibility of a virus being incorporated is there. But if done in a proper, professional manner, and with the scientific rigors of the case, it doesn’t have to happen.

In this regard, the Gamaleya Scientific Institute – the original producer of the vaccine – has so far stood firm on its position before the WHO that the virus does not replicate.

However, consensus between the parties awaits. At a recent press conference for the Pan American Health Organization, a regional arm of the WHO, Deputy Director Jarbas Barbosa said several manufacturing violations of the Sputnik V vaccine were discovered during an inspection of WHO in Russia in May. “Sputnik V’s Emergency Use List (EUL) process was put on hold because, while inspecting one of the factories where the vaccine was being made, they found that the factory did not comply with best manufacturing practices, ”Barbosa said last week. .latest.

I have to say that The Russian population was the first not to place full confidence in the scientific development of Gamaleya. It was even known that the contingents of Russian passengers are multiplying, who in the absence of approval from Sputnik V, decide to travel abroad to be vaccinated with Pfizer and thus access the green pass certificate.

Russia has not registered any vaccines manufactured abroad. It has approved four domestically produced vaccines, including two-dose Sputnik V. None of the Russian vaccines are endorsed by the World Health Organization or the European Union.

Brazil’s first objections

In April of this year, Brazil had already presented scientific objections to the Sputnik V vaccine. It was from the decision taken by the National Health Surveillance Agency (Anvisa, the Brazilian regulatory body) that it took recommended that Brazil stop importing the Sputnik vaccine. .V, for the attribution of complications in the technology used for its production and the quality control of the doses.

The most serious question that regulator Anvisa asked of the Sputnik V vaccine was that from the samples they analyzed, the second injection (the component of adenovirus 5) was “able to replicate.””. This means that once inside the body, the adenovirus can continue to multiply. In this regard and consulted this time by Infobae, Oscar Cinngolani, cardiologist and researcher at Johns Hopkins University, clarified: “The best way for the Russian Scientific Institute Gamaleya to confront this information about its vaccine is to open its research papers which support the discovery and the processes of production of the Sputnik V. vaccine which is already exported to many countries around the world ”.

Secure platform

It should be remembered that the Sputnik V vaccine is a vaccine with two different doses. It uses two different adenoviral vectors to perform this task of protecting the body against the SARS-COV-2 virus: adenovirus type 26 (Ad26) for the first injection and adenovirus type 5 (Ad5) for the second injection. “The platform that uses the Sputnik V vaccine made in Gamaleya is a very safe production technology platform, and it has already been used effectively in the vaccine against the terrible Ebola virus,” Cingolani said.

While talks between WHO and Russian vaccine producers are not interrupted, the WHO clarified that it was still awaiting an update of Pharmaceutical standard – Russia’s leading pharmaceutical company- and suggested that further facility inspections will be required before the agency grants final approval to Sputnik V.

The European Medicines Agency (EMA) and WHO said last week that they were still awaiting a “full data set” from the developers of Sputnik V. The head of the European body’s vaccine strategy, Marco Cavaleri , said the final approval timeline was “uncertain”.

“The policy gap that some vaccines fell into a few months ago now enjoys a period of certainty, as the results are published in proven scientific journals around the world. Knowing that the vaccine has an inexorable impact on the transmissibility of the SARS-COV-2 virus is the greatest hope we have in beating the pandemic, as there are still no drugs that are the panacea for this virus. This hope allows us to ignore the political divide and rely on scientific data.”He said in an interview with Infobae Cingolani of Johns Hopkins Hospital in Baltimore, United States.

Obtaining approval for a vaccine against COVID-19 during a global pandemic is essential not only for the scientific strengthening of the product – in this case Sputnik V or any other to ratify the safety and efficacy – but to legitimize public communication and the importance of the act of vaccination, as a fundamental key to understanding the pandemic effect of the virus.

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