Russia’s Sputnik V vaccine finally set for WHO approval following removal of barriers, health minister says

Russia’s Sputnik V vaccine finally set for WHO approval following removal of barriers, health minister says

Russia’s Sputnik V Covid-19 vaccine is finally set to be approved by the WHO after the country’s health minister said only ‘minor administrative procedures’ remain to be finalized following a meeting with the UN agency’s chief.

All outstanding issues that had plagued the registration approval process have been resolved between Moscow and the World Health Organization (WHO), Health Minister Mikhail Murashko told TASS on Saturday.

“Russia’s position on the promotion and registration of the Russian Sputnik V vaccine has been heard. We have completely resolved all the issues to date,” Murashko said.

To date, all the barriers have been removed. Therefore, we do not see any obstacles to further work today. And this was confirmed to us by the WHO director general.

Only minor administrative procedures remain before the approval process can be finalized, Murashko added, noting that the company submitting the application is poised to “sign a bunch of documents [and] produce a number of additional papers.”

The Russian health minister met WHO Director General Tedros Adhanom Ghebreyesus in Geneva on Friday to discuss various issues related to global health. The WHO boss described the meeting was “constructive,” thanking Russia for its “strong leadership” in fighting tuberculosis and non-communicable diseases (NCD).

The world’s first registered vaccine against Covid-19, Sputnik V ran into difficulties getting a green light from the WHO. The approval process has dragged on for months already, with the UN watchdog sending mixed signals about the procedure.

In mid-September, the assistant director of the Pan American Health Organization, a regional arm of the WHO serving the Americas, Jarbas Barbosa, said the approval process had been “suspended” altogether. A WHO spokesperson, however, disputed the claim, telling Russian media that the situation regarding Sputnik V’s approval remained unchanged and the watchdog was still awaiting additional paperwork from the manufacturers.

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A man receives a dose of Sputnik V (Gam-COVID-Vac) vaccine against the coronavirus disease at a vaccination centre in Gostiny Dvor in Moscow, Russia. © Sputnik / Pavel Bednyakov
Russia’s Sputnik V vaccine successfully completes third & final phase clinical trials among elderly, Health Minister reveals

The apparent breakthrough in the approval process comes a day after Russian health authorities announced the completion of the third and final phase of Sputnik V’s clinical trials. The jab was tested among over 23,000 elderly patients, aged 50 and above, showing a “high safety and effectiveness profile,” Murahsko said on Thursday. A full report on the trials is expected to be published shortly.

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