Russia suspended investigation into Sputnik V vaccine combination with AstraZeneca

Russia decided slow down clinical research on its territory of the association of vaccines against the coronavirus of AstraZeneca and Sputnik V, as reported this Friday the portal “Pharmatsepticheski Vestnik”.

The Russian site, specializing in news from the pharmaceutical industry, cited a document from the Russian Ministry of Health, according to which the Ethics Committee gave a negative opinion of the first two test phases AZD1222 and rAd26-S vaccines, codes corresponding to the two drugs.

Russian vaccine developers and their British colleagues have been advocating since the end of 2020 the possibility of studying the effects of the combination of the two drugs, to offer “more flexible immunization schedules“and improve immunity long-term.

For its part, the Ministry of Health said in a statement that it is not a categorical refusal to this proposal, and indicated that the decision will be taken after the parties concerned have provided the information requested by the health authorities.

He explained that the negative opinion was due to “the absence of a series of documents and data in the application”, necessary to assess the “ethical and clinical aspects of the investigation”.

The research will be sponsored by AstraZeneca, with support from Russian company R-Pharm, Russian Direct Investment Fund (FIDR) and Gamaleya Center, creator of Sputnik V.

The study foresees the participation of two groups of volunteers: the first will be inoculated initially with a dose of AstraZeneca, and 28 days later, with a dose of the first component of Sputnik V, and the second group, with the same drugs, but in reverse order.

A spokeswoman for AstraZeneca’s Moscow office said that to date “no official confirmation has been received from the Ethics Committee on the decision regarding the investigation.”

“This information does not mean that the research is not approved. The questions asked by the ethics committee refer to the first package of documents. The Russian Ministry of Health has asked us for additional data as part of the process of ‘research approval,’ added.

AstraZeneca has indicated that it is currently preparing “an updated set of documents“, which will soon be sent to the Ministry of Health.

“In addition to Russia, this research is taking place in Azerbaijan and has already been approved by regulators in the United Arab Emirates and Belarus,” he added.

Source: EFE