WHO waits for full data from Russia to continue Sputnik V EUL assessment process

GENEVA, October 21./TASS/. The World Health Organization (WHO) welcomes the signing by the Russian Direct Investment Fund (RDIF) of the documents necessary for the assessment of Sputnik V for the EUL (emergency use listing) status and is waiting for the full set of data for analysis, a WHO Media Relations’ statement said on Thursday. "WHO welcomes RDIF’s signing of all the legal agreements necessary for the EUL assessment. We look forward to receiving the full data for analysis and for the continuation of the assessment process," the press service told TASS. On Wednesday, the WHO confirmed that the decision on including the Russian Sputnik V COVID-19 vaccine in the Emergency Use Listing (EUL) would be taken after "the last inspection" in Russia, the WHO’s official website said. The document entitled ‘Status of COVID-19 Vaccines within WHO EUL/PQ evaluation process,’ indicates that "the process has restarted" and the organization is "awaiting the completion of rolling submission" and "the last inspection." The WHO emphasized that the decision on Sputnik V would be made "once all data was submitted and a follow-up of inspection observations completed." As the Russian Direct Investment Fund (RDIF) said earlier, "the WHO has confirmed that the procedure for Sputnik V approval continues and is undergoing its last stage." "A group of the WHO inspectors is going to visit Russia soon to collect all the necessary data on the jab," the statement read. CEO of the RDIF Kirill Dmitriev expressed hope that the vaccine would be authorized by the WHO in the next couple of months. "We expect a group of [the WHO] inspectors in Russia soon, and we are hoping for the approval of Sputnik V in the next couple of months," Dmitriev noted. Talks between the Russian Health Minister and the WHO Director General After talks with Director General of the WHO Tedros Adhanom Ghebreyesus in Geneva on October 1, Russian Health Minister Mikhail Murashko said that all barriers hampering emergency use authorization for Sputnik V by the WHO had been removed. The WHO press service told TASS on September 27 that it was waiting for additional information about Sputnik V from Moscow. It said that only after this data was studied would it be possible to organize an inspection trip to Russia by international experts. Earlier this year, the WHO inspected four production facilities in Russia as part of the preliminary assessment of Sputnik V and issued recommendations to one of them. To date, seven coronavirus vaccines have been recommended for emergency use by the WHO, and applications for 13 more vaccines, including Russia’s Sputnik V and EpiVacCorona, are at various stages of assessment. Read more