22 Nov 2021 21:32

Gamaleya Center ready to submit documents for Sputnik V trials on children 6 to 11 years old - center head

MOSCOW. Nov 22 (Interfax) - The Russian Health Ministry's Gamaleya Center is ready to submit documents, seeking permission to start trials of the Sputnik V Covid-19 vaccine on children 6 through 11 years of age, Gamaleya Center Director Alexander Gintsburg said.

"The package of documents confirming the efficacy and safety of the specific version of the Sputnik V vaccine for use among children in the 12-17 age group has been in the Health Ministry for a certain period of time, and we are awaiting its approval [...] It will allow us to prepare the next ready package of documents which will deal with trials of the Sputnik V vaccine's version diluted to a certain extent on children in the 6-11 age group," Gintsburg told the Rossiya-24 (VGTRK) television channel.

As soon as the center receives approval "for the trials that we conducted for this group of children (12 to 17 years of age), it will make it possible to roll out this vaccine and to use it, naturally with full consent not only from children, but also from their parents," he said.

When commenting on the results of the vaccine's trials on teenagers in the 12-17 age group, Gintsburg said that teenagers "react very well in terms of generating antibodies..., much better than adults react to Sputnik V in its classic version."

It is because children's immune system reacts better to alien antigens, he said.

The only side-effect was a slight fever, up to 37.4 degrees Celsius at the most, the day after receiving a vaccine shot, he said.

"There were no other side-effects among the children who received the vaccine," Gintsburg said.

The Moscow administration's press service on October 28 reported the results of the Phase I trials of the Gam-Covid-Vac M Covid-19 vaccine for teenagers.

Two-shot vaccination of volunteers with Gam-Covid-Vac M with either 1/10 or 1/5 of the adult dosage creates good post-vaccination cell immunity, the press service said. The vaccine demonstrated good levels of safety and immunogenicity, which are even higher than those seen in adults during the Phase I trials. The Phase III clinical trials of the Sputnik M coronavirus vaccine for teenagers began on November 11.