"Russia's Sputnik V Possible WHO Approval Within This Year"

[Image source=Yonhap News]

[Asia Economy Reporter Cho Hyun-ui] The World Health Organization (WHO), which had suspended the emergency use approval review of the Russian-made COVID-19 vaccine Sputnik V, indicated on the 12th (local time) that there is a possibility the vaccine could be approved within this year.

WHO senior researcher Soumya Swaminathan expressed this outlook in an interview with the Russian news agency RIA Novosti, stating that legal documents necessary for the emergency use approval of the vaccine will soon be signed by both Russia and WHO.

Swaminathan said, "There are several legal documents that both sides need to sign before the (WHO emergency use approval) evaluation work can resume," adding, "The Russian side has assured that these documents can be signed soon." She continued, "Once this procedure is completed, the evaluation of the (vaccine) report and dialogue between both sides will resume, followed by an on-site inspection (in Russia). The inspection is expected to take place before the end of the year, making it possible for the evaluation work to be completed within the year."

Previously, the WHO had announced that the evaluation work on the Sputnik V vaccine was temporarily suspended due to the lack of a series of legal documents, including vaccine report materials. WHO inspected four of the seven Sputnik V vaccine production facilities in Russia in mid-year and raised issues with one of them.

The WHO inspection team reportedly found violations related to environmental protection and waste disposal regulations at the Sputnik V production plant located in Ufa, a city in the southern Ural region of Russia. The Russian Ministry of Industry and Trade stated that after the company rectifies the issues, WHO experts will conduct a re-inspection of the production facility.

WHO has also reportedly requested additional data related to the vaccine from the Russian side.

Russia submitted an approval application for its domestically developed Sputnik V vaccine to WHO in the second half of last year, being the first in the world to do so, but approval has not yet been granted. The European Medicines Agency (EMA), the EU’s regulatory body for medicines evaluation and supervision, has also shown no signs of approving Sputnik V, aligning with WHO’s stance.

Unlike the conventional vaccine development process, Sputnik V received Russian government approval for use based only on Phase 1 and 2 clinical trial results before completing Phase 3 trials, which sparked controversy over the vaccine’s efficacy and safety. However, in February, Phase 3 results showing a preventive efficacy of 91.6% were published in the prestigious medical journal The Lancet, and with the number of approving countries increasing to 70, the evaluation of the vaccine has shifted positively.

This content was produced with the assistance of AI translation services.