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Children, pregnant women won’t participate in Phase III of Vector vaccine trials

Pregnant women and children will not participate in post-registration trials of a vaccine against the coronavirus developed by the Vector State Research Center of Virology and Biotechnology, the press service of the Federal Service for Surveillance on Consumer Rights Protection and Human Wellbeing told TASS on Friday.

“Post-registration trials of the EpiVacCorona vaccine in pregnant women and children are not planned. <…> Clinical trials with the participation of children are possible only after clinical trials on adult volunteers are completed. When studying the preparation, it is necessary to implement a staged research, beginning with the oldest age group: 15-17 years of age, 10-14 years of age, 6-9 years of age, 2-5 years of age, 7-24 months, first 6 months of life,” the statement said.

Therefore, six clinical trials with the participation of children, decreasing the age of volunteers, can be conducted successively only after the vaccine is approved for use on adults.

In order to conduct trials in pregnant women it is necessary to finish the studies of reproductive toxicity on animals first. According to the agency, they will be completed this December.

“To date, no toxic effect of the EpiVacCorona vaccine after single and double injection in animal trials has been detected,” the agency noted.

The Vector Research Center on July 24 obtained the Healthcare Ministry’s permit to conduct clinical trials of its vaccine on volunteers. The first volunteer was inoculated on July 27. The final group of 20 volunteers was discharged from an inpatient facility on September 8. Top sanitary doctor Anna Popova has also reported that clinical trials of the vaccine were completed on September 30.

The registration procedure of the vaccine is planned to be completed by October 15.

Post-registration trials of a vaccine against the coronavirus developed by the Vector State Research Center of Virology and Biotechnology will begin in November-December, the press service of the Federal Service for Surveillance on Consumer Rights Protection and Human Wellbeing told TASS on Friday.

“Post-registration clinical trials of the EpiVacCorona vaccine with participation of 5,000 volunteers will begin after the first batch of preparation is obtained, that is, in November-December 2020. The duration of these trials is six months,” the press service said.

Trials will begin in the Siberian region on 5,000 volunteers aged 18-60, and then will continue in other regions. The list of institutions participating at this stage is now being formed.

The sanitary watchdog’s press service added that the first batch of the vaccine of 10,000 doses is planned to be released at the end of October. General population will obtain access to the vaccine after its mass production is launched. “Deliveries of the EpiVacCorona vaccine for post-registration trials will begin after its registration and the release of the first post-registration batch,” the agency specified.

The volume of hospital beds prepared in Russia to provide medical aid to patients with the novel coronavirus infection is currently sufficient, Russian Healthcare Minister Mikhail Murashko reported on Friday.

“[The amount] prepared during the spring period is fully oriented at the possibility of double use. As we say, beds have dual designation both for treatment of admitted infectious patients and for return to scheduled and emergency care for patients of other types. I would like to note that today in the country the hospital bed capacity is sufficient,” he told journalists.

The minister urged citizens not to neglect the existing measures of protection against the coronavirus infection. “In my opinion, today the behavior of population is crucially important in order to protect themselves against the disease and, among other things, preserve our usual way of life. For this it is [necessary] to protect [oneself] using certain small measures,” he said in response to the question by TASS whether one should expect a growth similar to the one in spring.

To date, 1,194,643 coronavirus cases have been confirmed in Russia, with 970,296 patients having recovered from the disease. Russia’s latest data indicates 21,077 fatalities nationwide. Earlier, the Russian government set up an Internet hotline to keep the public updated on the coronavirus situation.

Header: SOCHI, RUSSIA – MARCH 27, 2020: People wearing face masks in a street amid the COVID-19 coronavirus pandemic. On March 27, 2020, Russia’s Prime Minister Mikhail Mishustin ordered to halt services at resorts, health centers, and public eating spaces for the period from March 28 till June 1, 2020, as a measure to contain the spread of the COVID-19 coronavirus infection. Dmitry Feoktistov/TASS

Source: TASS