WHO Regional Director for Europe expects Sputnik V to be approved soon

STOCKHOLM, December 27. /TASS/. World Health Organization (WHO) Regional Director for Europe Hans Kluge hopes that the approval process of the Russian Sputnik V vaccine will be completed soon. He expressed this hope in an interview with TASS. "The Russian Direct Investment Fund (RDIF) signed all the legal agreements necessary for the EUL (Emergency Use Listing — TASS) assessment in October this year. The signing of these agreements is a prerequisite for all applicants to trigger a EUL assessment. WHO and RDIF met in late November to discuss the need for additional data on the quality, safety, and efficacy of the vaccine. The company has committed to presenting a detailed roadmap for data submission so that WHO can expedite the assessment of this vaccine. The submission of data is expected by the end of December 2021, and I hope that the process will be completed speedily following this," he noted. The official denied that such a lengthy approval process of the Russian vaccine was related to this issue being politicized. "WHO is a scientific evidence-based organization. The process of vaccine approval is exactly the same for every manufacturer, which has to meet the same criteria as everyone else," he said. He explained that the EUL is a risk-based procedure for assessing and listing unlicensed vaccines, therapeutics, and in vitro diagnostics with the ultimate goal of speeding up the availability of these products to people affected by a public health emergency. "The procedure is a key tool for companies wishing to submit their products for use during health emergencies. WHO treats all applicants the same, using the same criteria to measure any given product, in this case, COVID-19 vaccines," he concluded. Read more