WHO, Russia Disagree Over Status of Country's Sputnik V Vaccine

Russian Health Minister Mikhail Murashko said "disagreements" with the World Health Organization (WHO) have been resolved regarding Russia's Sputnik V COVID-19 vaccine status, the Associated Press reported.

But Sputnik V is still under review as administrative issues were among the holdups in the decision-making process, and the WHO on Tuesday said that no approval is near.

After a meeting on Saturday with WHO Director-General Tedros Adhanom Ghebreyesus, Murashko said "all barriers have been removed" for further review of Sputnik.

"Some administrative procedures remained to be completed, but the issues were not about the vaccine itself," he said.

"As with other candidate vaccines, WHO continues to assess Sputnik V vaccines from different manufacturing sites and will publish decisions on their EUL [emergency use listing] status when all the data are available and the review is concluded," WHO said in a statement.

On Monday, Murashko added that the production site and registration company "should submit the entire package of documents within a week or a week and a half" so "the further process will begin."

Approval of Sputnik V by the U.N. health agency for emergency use against coronavirus would show international confidence in Russia's vaccine considering the intense WHO review process. The approval would pave the way for Russia's inclusion in the WHO's COVAX program and partners that ship COVID-19 vaccines to needy countries around the world.

For more reporting by the Associated Press, see below.

Russia’s vaccine under review by the WHO
Administrative issues have caused hold-ups in the WHO's decision-making process about Russia's Sputnik V COVID-19 vaccine. Above, a medical worker administers a Sputnik V shot at a vaccination center in Gostinny Dvor, an exhibition site in Moscow. Pavel Golovkin/AP Photo

In a phone interview, WHO spokeswoman Daniela Bagozzi said Tuesday that only the WHO's technical advisory group on emergency use listings—not the WHO director-general himself—has final say about whether a vaccine obtains emergency approval.

Once WHO receives the full amount of data that it needs, when production sites have been inspected, and when the data is deemed to meet WHO criteria, the group can schedule a meeting to validate a candidate vaccine for an emergency use listing.

"The EUL assessment process aims to speed up equitable access to vaccines in order to save lives and bring the COVID-19 pandemic under control," WHO said in a statement.

No such meeting has been set for Sputnik V. The next vaccine on the group's agenda is one from India's Bharat Biotech, which is expected to be discussed this month.