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Mon, 05/31/2021 - 10:06

Russian Health Ministry to Decide on Sputnik V-AstraZeneca Study Once Relevant Documents Received

MOSCOW (Sputnik) - The decision on the possibility of conducting a joint study of the Sputnik V and AstraZeneca vaccines will be made after the applicant submits the documents, the Russian Health Ministry said. "The decision on the possibility of carrying out this clinical trial will be made by the Russian Health Ministry on the basis of the conclusions of the expert organisation and the ethics council in the prescribed manner after the applicant submits the previously requested documentation", the statement says. At the same time, the information about the impossibility of conducting a joint clinical trial of vaccines does not correspond to reality, the ministry noted. "The previously published opinion of the ethics council was prepared due to the absence of a number of documents and data in the application for a clinical trial necessary to assess the ethical and clinical aspects of the study, as well as to characterize the efficacy and safety of the studied drugs", the ministry explained. The missing information was requested from the applicant, but has not yet been submitted to the ministry, it specified. Earlier, the ministry's ethics council did not approve the joint research of Sputnik V and AstraZeneca coronavirus vaccines. In December, Gamaleya and AstraZeneca signed a memorandum of understanding to test a combination of their vaccine components. AstraZeneca's chimpanzee adenovirus-based vaccine alone demonstrated significantly lower efficacy in clinical trials. Read more: