Sputnik V vaccine is one of the vaccines more effective and at the same time is the more controversial. Its authorization process in the World Health Organization (WHO) began at the beginning of this year and even today there is no news.
From the Russian Fund for Direct Investment there is no new information on the progress of this process, which according to the international health organization is virtually suspended.
The vaccine is used in 70 countries, including Argentina, and does not have WHO approval, as other vaccines such as Pfizer, Moderna, AstraZeneca, Janssen, Sinopharm y Sinovac. In our country, more than 15 million Russian vaccines have already been used, of which almost 11 million correspond to component 1 and the rest to component 2.
The warning about suspending the process of homologation It was given by Jarbas Barbosa, deputy director of the Pan American Health Organization (PAHO), WHO regional office. It was a statement in the last press conference that the agency gave: “The authorization process for the emergency use of the Sputnik V vaccine by the WHO is suspended since June, ”said the official.
WHO asked more information to the Gamaleya Institute to continue with the administrative and health process. The independent group of experts on vaccines of the WHO is responsible for analyzing the information from clinical trials and also verifying the production conditions of the vaccine.
WHO Director General Tedros Adhanom.
–
The problem arose when the WHO inspected the facilities of the Gamaleya Institute and found some deficits. Dmitry Peskov, Kremlin spokesman, had assured at the time that there were “some identified deficiencies by the inspection team. They were taken into account and everything that had to be changed was changed ”.
But according to PAHO things are not so simple. Barbosa explained that “this suspension occurred because it was found in a plant that produces Sputnik vaccines conditions that are not suitable for good production practices. Then, it is suspended (the process) waiting for the producer take the necessary measures so that another inspection can go and certify that the conditions are adequate “.
WHO approval it is not an indispensable requirement for a vaccine to be used in a country. But there are nations that take the WHO recommendations, the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to grant emergency permits.
That the vaccine is approved in other countries is key so that those who are immunized with Sputnik V obtain the immune endorsement to circulate freely. Otherwise they may arise obstacles and inconveniences. In Europe, for now only Hungary and Slovakia they approved it on their own, beyond the approval of the European Medicines Agency (EMA).
Barbosa added that “until now, the Sputnik vaccine cannot be acquired by the PAHO revolving fund or by the Covax mechanism. There are countries that made the decision to certify the vaccine, it is a decision of each country. Until now we don’t have a date when this process is going to take place ”.
Kirill Dmitriev, president of the Russian Fund for Direct Investment. Photo: EFE
–
An article published by The Moscow Times, last Friday, stressed that the WHO and the EMA are still awaiting the requested information in order to move forward with a eventual authorization.
The “conflict” dates back to January, when the world health body said it had identified certain problems in the implementation of adequate measures to “mitigate the risks of cross contamination”, As well as the“ proper sterile filtration validation ”of the Sputnik V vaccine.
The inspection was carried out to assess whether the factory was operating in accordance with the so-called Good Manufacturing Practices (GMP), a set of regulatory guidelines that dictate the standards that must comply with the sites involved in the manufacture of pharmaceutical products.
The Pharmstandard plant, where the WHO made its inspection, explained that the questions were “technical problems, mainly related to one of the filling lines“.
The spokesmen added that the plant is responsible for filling the vaccine liquid into vials, and that the antigen is produced in a different facility. The company clarified that the WHO “did not raise any questions about the safety and efficacy of the vaccine produced and finished,” nor did it “identify any critical issues with the actual production of the vaccine, quality, clinical studies, or possible side effects.” .
In South America, Sputnik V had had problems in Brazil. At the end of April, the Anvisa health agency had issued a negative opinion, from the request of ten states to import the Russian vaccine. He pointed out technical flaws in the studies and in the production of the vaccine.
These issues, it was claimed, could pose risks to the safety and quality of the immunizing agent. Finally, in June, the Brazilian Ministry of Health paved the way for the inoculant to enter the country, after a new technical report of Anvisa and the Ministry of Health of Russia.
PS
