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Coronavirus pandemic

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

In order to conduct trials in pregnant women it is necessary to finish the studies of reproductive toxicity on animals first

© Natalia Fedosenko/TASS

MOSCOW, October 2. /TASS/. 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.

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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.

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