The Russian Federation has Not Yet Provided All the Data for the Approval of "Sputnik V" in WHO
“Work continues there. There really is some information that needs to be provided for certification, we have not yet provided, because we had a different understanding of what information should be and how it should be provided. Therefore, we are gradually moving towards these requirements and hope for a positive result of this work, ”he told reporters.
Earlier, on Tuesday, Deputy Head of the Research Center for Epidemiology and Microbiology. N.F. Gamalei Denis Logunov said that the center expects the arrival of a WHO delegation as part of the approval of Sputnik V in January.
On December 4, WHO announced that it plans to conduct an inspection in Russia to evaluate the Sputnik V drug no earlier than January 2022. The organization stressed that the inspection cannot be carried out before the data on the quality and safety of the vaccine are presented and evaluated.
Earlier, on December 3, the head of RDIF Kirill Dmitriev said that WHO does not approve of the Russian Sputnik V vaccine solely because of bureaucratic obstacles. He noted that the effectiveness and safety of the vaccine has been confirmed by clinical trials and real data in many countries of the world. More than 70 countries have approved the use of Sputnik V, Dmitriev stressed.
On the same day, the director of the Research Center for the Prevention and Treatment of Viral Infections, immunologist-allergist-infectious disease specialist Georgy Vikulov told Izvestia that there is a political aspect in the delay in the WHO's recognition of Sputnik V. Commenting on the words of the head of the RDIF, he noted that bureaucracy may be the reason, but the main, in his opinion, aspect is political.