Sputnik V, “failed”: why it has not been approved in Europe for five months and does not have the authorization of the WHO

Another controversy splashes Sputnik V: in addition to the delay in the arrival of second doses in the country, the Russian vaccine It has been analyzed for five months and awaiting approval by the European Medicines Agency (EMA). It took the agency more than twice as long to approve other coronavirus vaccines, while Sputnik is the third most international brand.

Oxford-AstraZeneca has been approved in 119 countries; Pfizer, at 97; Sputnik, and 70. Further on, Moderna, cleared at 64, and Sinopharm, at 59. Then Janssen, at 56; Sinovac, at 39; and far behind, Cansino, approved in 8 countries.

// In the absence of second doses, Russia says “it is safe” to combine Sputnik V vaccine with AstraZeneca vaccine

The issue of legitimation isn’t just in EMA: so far, the World Health Organization (WHO) has not approved it either.

At the end of June, the world’s highest health agency expressed concern about the methods used in a facility that produces the Russian vaccine, after Slovakia announced that it would sell or give away 160,000 doses of the 200,000 it had ordered.

WHO then declared to be “concerned about quality control and test results of one of the four production establishments he visited in Russia, that of Pharmstandard-UfaVITA in Bashkortostan ”.

Meanwhile, the company said in a statement that it is working to resolve any issues and is ready for a new inspection. For his part, Kremlin spokesman Dmitry Peskov said “all necessary measures have been taken”.

The Deputy Director of the Pan American Health Organization (PAHO), Jarbas Barbosa, explained that in WHO reviews “on several occasions, and this is the case Sputnik, more information is requested from producers”. “The conclusion of the process depends on the producer, who must provide all the information so that the examination can be completed,” he said.

In other words, Barbosa blamed the delay on the tandem made up of the Gamaleya Center and the Russian Direct Investment Fund (RFID), the developers of Sputnik.

// More countries have problems with Sputnik V: Bolivia analyzes the vaccine combination, Guatemala canceled the contract and Mexico made a turnaround in time

At EMA, meanwhile, they said Bugle that Sputnik, the study of which began on March 4, “is currently under continuous review and will continue until sufficient evidence is available for a formal marketing authorization application, which no ‘has not yet been received “.

“The EMA will be in a better position to comment on possible delays in the authorization of the Sputnik V vaccine once an application for marketing authorization has been submitted to the Agency, which allow a better understanding of the robustness of the available data»Explained Laure Herold, public relations officer at the European Medicines Agency.

He added, adding to the confusion: “The applicant has not submitted a marketing authorization application for the Sputnik V vaccine. Applicants typically submit all data on the efficacy, safety and quality of a drug or vaccine and all the documents required in the context of a marketing authorization application ”.

“An ongoing review is a regulatory tool that the EMA uses to expedite the evaluation of a promising drug or vaccine during a public health emergency (…) Once the Medicines Committee humans decides that sufficient data is available, the company can submit a formal request for marketing authorization, ”he added, in statements collected by the same newspaper.

Anyway, There is no shortage of those who think that authorization depends on a political decisionToo bad that Argentinian tourists who hope to travel to Europe with this vaccination passport are despite this.