Data on Russia's Sputnik V vaccine is still under review for emergency use approval: WHO

The World Health Organization is still reviewing data about Russia’s Sputnik V vaccine as part of hopes that it can be approved by the U.N. health agency for emergency use against coronavirus, but said Tuesday that no decision is imminent. The clarification comes after Russian Health Minister Mikhail Murashko in recent days said that administrative issues were among the main holdups in WHO’s decision-making process about whether to grant an emergency use listing to Sputnik V, as it has for a half-dozen other vaccines. Such approval would be a show of international confidence in the vaccine after a rigorous review process, and could pave the way for its inclusion into the COVAX program organized by WHO and key partners that is shipping COVID-19 vaccines to scores of countries around the world based on need. “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. “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.” The vaccines WHO has approved are Pfizer-BioNTech, AstraZeneca, Johnson & Johnson, Moderna, Sinovac and Sinopharm. After a meeting with WHO Director-General Tedros Adhanom Ghebreyesus, Murashko on Saturday said “all barriers have been removed” for further review of Sputnik V, as quoted by Russian news agencies and the official Twitter page of the Sputnik V vaccine. “Today we see no obstacles to further work,” and this was confirmed by Tedros, Murashko said. Some administrative procedures remained to be completed but the issues were not about the vaccine itself, he said. On Monday, Murashko added that “disagreements” with WHO had been resolved, and the production sites and registering company in Russia “should submit the entire package of documents within a week or a week and a half, and the further process will begin.” 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. 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.