Sputnik V Vaccine May Obtain Permission to Release for Civilian Use in a Few Days

08 September 2020

GMP News

The Gamaleya Research Institute of Epidemiology and Microbiology under the Russian Health Ministry may be granted permission to release a batch of the newly-developed vaccine Sputnik V against the novel coronavirus for civilian use next week, the institute’s deputy director for research, associate member of the Russian Academy of Sciences, Denis Logunov, said on September 3.

“Its examination is to begin within days. Also, within days we are to obtain permission. There is a certain procedure of authorizing a batch for civilian use. It must pass the quality check of the medical watchdog Roszdravnadzor. Within days, between September 10 and 13, we are to obtain permission to release a batch of the vaccine for civilian use. Respectively, from that moment on the population will begin to be vaccinated,” he said on the Rossiya-24 round-the-clock television news channel.

The vaccine’s distribution will be under the Health Ministry’s purview. Earlier, Health Minister Mikhail Murashko said that at the current stage the term civilian use implied vaccination of people from the risk groups, such as medics and teachers. This procedure will take place alongside post-registration clinical research.

“The vaccine’s registration allows for vaccinating the whole population, but the high-risk groups will come first. There are no restrictions as far as others are concerned, but the Health Ministry has set a task of protecting the risk groups in the first place,” Logunov said.

“The platform [on which the vaccine against the coronavirus has been developed] had been well studied not only by us, but globally, too. It is registered in China, the EU and the United States. The vast evidential base the vaccine is safe was the main pre-requisite for its conditional registration. What does conditional registration allow for? It allows for protecting the risk groups right away without spending two, three, four or five years testing the vaccine on volunteers, during which many people in the high-risk groups may die or be harmed. This resolution allows for starting the protection of the population. That’s what it means,” Logunov said.

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