Sputnik V's developer may request permission to study the drug in children in March
Director Center. Gamalei noted that the study itself will not begin until the completion of the third phase of drug trials in adults, which is scheduled for April-May
/NOVOSTIVL/ Center them. Gamalei can submit documents to the Ministry of Health of the Russian Federation in two months to obtain permission to study the Sputnik V coronavirus vaccine in children. However, the study itself will not begin before the completion of the third phase of trials of the drug in adults, which is scheduled for April-May, said the director of the center, Alexander Gintsburg.
"Regarding the study of the vaccine in children: the work on the preparation of documents is very actively carried out, I hope that within one and a half to two months it will be completed in terms of writing. In two months, at best, we will submit documents to the Ministry of Health for consideration for obtaining permission ", - said the scientist.
"Even if we get permission, it will be possible to start only after all the studies on adults are completely completed. That is, the results of observations of the third phase will be officially entered into the marketing authorization [of the vaccine]. It will be sometime in May-April," - explained Gunzburg.
The vaccine against coronavirus, which the Russian Federation registered the first in the world on August 11, 2020, was named "Sputnik V". The drug was developed by the National Research Center for Epidemiology and Microbiology named after N.F. Gamaleya. Post-registration studies of the drug began in Moscow on September 7. In total, 40 thousand people were supposed to take part in the program, 10 thousand of whom would receive a placebo instead of a vaccine. However, the Ministry of Health of the Russian Federation decided to stop attracting volunteers, having recruited about 31 thousand people. The department noted that the recruited group of participants allows to fully investigate the safety profile and preventive efficacy of the vaccine over a long period of time.