for WHO, vaccine approval is on hold and it is not known until when

The Sputnik V vaccine is one of the vaccines more efficient and at the same time is the more controversial. Its clearance process with the World Health Organization (WHO) began earlier this year and there is still no news today.

From the Russian Direct Investment Fund, there is no new information on the progress of this process which, according to the international health organization, is practically suspended.

The vaccine is used in 70 countries, including Argentina, and does not have WHO approval because other vaccines such as Pfizer, Moderna, AstraZeneca, Janssen, Sinopharm and 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 regarding the suspension of the approval It was given by Jarbas Barbosa, Deputy Director of the Pan American Health Organization (PAHO), WHO Regional Office. It is a statement during 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, ”the official said.

Who asked more information at the Gamaleya Institute to continue the administrative and health process. The WHO Independent Expert Group on Vaccines is responsible for analyzing information from clinical trials and also verifying the manufacturing conditions vaccine.

The problem arose when the WHO inspected the facilities of the Gamaleya Institute and found deficits. Dmitry Peskov, a spokesman for the Kremlin, assured at the time that there were “some deficiencies identified by the inspection team. They were taken into account and everything that needed to be changed was changed ”.

But according to PAHO, things are not that simple. Barbosa explained that “this suspension occurred because it was found in a factory that produces Sputnik vaccines. unsuitable conditions 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 a necessary condition 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.

Getting the vaccine approved in other countries is essential for those who are immunized with Sputnik V to gain immune approval to circulate freely. Otherwise, obstacles and inconveniences may arise. In Europe, for now only Hungary and Slovakia they approved it themselves, beyond the approval of the European Medicines Agency (EMA).

Barbosa added that “so far the Sputnik vaccine cannot be procured through PAHO’s revolving fund or through the Covax mechanism. There are countries that have made the decision to certify the vaccine, it is a decision of each country. Until we don’t have an appointment when this process is going to take place ”.

An article published by The Moscow Times last Friday pointed out that the WHO and EMA were still awaiting the requested information in order to move forward with a possible authorization.

The “conflict” dates back to January, when the world health body said it had identified certain problems in implementing adequate measures to “mitigate the risks of cross contaminationAs well as the “appropriate validation of sterile filtration” of the Sputnik V.

The inspection was carried out to assess whether the plant was operating in accordance with Good Manufacturing Practices (GMP), a set of regulatory guidelines that dictate the standards to which the sites involved in the manufacture of pharmaceutical products must respond.

The Pharmstandard factory, where the WHO carried out its inspection, explained that the issues were “technical problems, mainly related to one of the filling lines“.

Spokesmen added that the factory is responsible for filling the vaccine liquid into the vials and that the antigen is produced. in another establishment. The company clarified that the WHO “has not raised any questions about the safety and efficacy of the produced and finished vaccine,” nor “has identified critical issues with the actual vaccine production, quality, clinical studies or possible side effects. . “.

In South America, Sputnik V had fought in Brazil. At the end of April, the Anvisa health agency issued a negative opinion, of 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 problems were alleged to 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 Russian Ministry of Health.

PS