Russian Vaccine 'Sputnik V' Applies for European Approval

Russian COVID-19 vaccine 'Sputnik V'
[Image source=Yonhap News]

[Asia Economy Reporter Cho Hyun-ui] Russia has announced that it has applied to the European Medicines Agency (EMA) for approval to use the COVID-19 vaccine 'Sputnik V.' If approved, it could be supplied uniformly to the European Union (EU) market.

According to Russian state news agency RIA Novosti on the 9th (local time), the Russian Direct Investment Fund (RDIF), responsible for supporting the development, overseas production, and supply of the Sputnik V vaccine, submitted the vaccine registration application to the EMA on the 29th of last month.

Vaccines approved and recommended for emergency use by the EMA are supplied to the European market after approval by the EU Commission. So far, three vaccines have received EMA supply approval: Pfizer, Moderna, and AstraZeneca. RIA Novosti reported, "The EMA conducted a scientific advisory procedure, a preliminary approval step, for Sputnik V on the 19th of last month," adding, "Whether it will be supplied to Europe depends on the EMA's decision."

Sputnik V was the world's first COVID-19 vaccine approved by Russia on August 11 last year. Approval was granted before completing all clinical trials, raising ongoing concerns about its safety.

However, a 'turnaround' occurred within six months. According to the Phase 3 clinical trial results published on the 2nd in the international medical journal The Lancet, Sputnik V's efficacy rate is 91.6%. This is comparable to the U.S.-made COVID-19 vaccines Pfizer (95%) and Moderna (94.1%).

Amid recent skepticism worldwide about the effectiveness of the AstraZeneca vaccine in the elderly, Sputnik V showed a 91.8% efficacy rate for those aged 60 and above.

Skeptical views on the Russian vaccine are turning into calls for use. With Pakistan and Mongolia granting emergency approval for this vaccine on the same day, the number of countries approving its use has increased to 23. RDIF stated, "These countries approved emergency use based on clinical data from Russia without separate clinical trials."

Russia is continuing negotiations to include Sputnik V in the supply list of the international vaccine joint purchase and distribution project led by the World Health Organization (WHO), the 'COVAX Facility.' The WHO also expressed hope on the same day that Sputnik V will be included in the list of vaccines supplied to countries participating in the COVAX project.

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