Posted 16 февраля 2022,, 07:13

Published 16 февраля 2022,, 07:13

Modified 24 декабря 2022,, 22:38

Updated 24 декабря 2022,, 22:38

Gamaleya Center did not find children aged 6-11 without antibodies for testing Sputnik M in Moscow

Gamaleya Center did not find children aged 6-11 without antibodies for testing Sputnik M in Moscow

16 февраля 2022, 07:13
Gamaleya Center of the Ministry of Health of the Russian Federation could not find children in Moscow who had never encountered the coronavirus. Because of this, the protocol for clinical trials of the Sputnik M vaccine in this age category needs to be changed, said Alexander Gintsburg, head of the center.
Moscow region

"When we started the first pre-screening of this age group of children, there are simply no children negative for antibodies to COVID-19 in this age group. Because this is now the background in this population of children in terms of antibodies. It is impossible to find those who have not experienced the coronavirus. There were ideas to look for them somewhere far away from Moscow, from big cities, but, you know, organizationally it is simply unrealistic", - he said.

Therefore, at present, the center urgently submits an amendment to the protocol. Scientists hope that soon they will be given permission to change the lower limit of antibodies from zero to at least a hundred international units.

The study will start as scheduled: a competition is being held for CRO - a contact research organization - which will last about 20 days, for which an amendment will be received.

It's worth reminding that in January the Russian Ministry of Health approved the trial of the Sputnik M vaccine on children. During the study, the safety of the drug for children, its tolerability and immunogenicity will be assessed.

It was assumed that 2.2 thousand volunteers would be recruited to participate in the study, and the studies would be carried out in the Morozov Children's Clinical Hospital, the Children's City Clinical Hospital named after. Bashlyaeva and at the Sechenov Medical University.

The Sputnik M vaccine was registered in November 2021. It was allowed to be used by teenagers aged 12 to 17 years. Now in the Gamaleya Center specialists intend to study the possibility of using the vaccine on children from six to 11 years old.