Post-registration trials of Sputnik V vaccine to be completed in summer 2021
Moscow: Post-registration phase of clinical trials of the Sputnik V vaccine against the coronavirus which has been launched recently should be completed by the middle of next summer.
After that it will be possible to continue the study of the vaccine in children, Director of the Gamaleya National Research Center for Epidemiology and Microbiology of the Russian Healthcare Ministry Alexander Gintsburg said.
“If all goes well, the post-registration phase which is underway now will be completed at some point in the middle of next summer,” he said at a roundtable discussion on the COVID-19 issues.
After this, according to the Russian legislation, the vaccine may be studied in children. “Currently we are preparing a packet of documents in order to obtain a permit to conduct clinical trials in children with our leading medical institutions. <…> Children will be split in different age groups and risk groups, this work is underway now. I hope that during six months we will prepare the paperwork and when the entire cycle of trials on adults is over, we will submit the vaccine to obtain a permit for a study in children,” the developer added.
On August 11, Russia became the first worldwide to register the vaccine against the coronavirus which was named Sputnik V. The preparation was developed by the Gamaleya National Research Center for Epidemiology and Microbiology of the Russian Healthcare Ministry and passed clinical trials in June – July.
It is based on a known platform previously used for other vaccines. The Healthcare Ministry noted that the experience of use of similar preparations shows that they are capable of providing a lengthy immunity of up to two years. On September 9, Russian Healthcare Minister Mikhail Murashko reported on the beginning of Phase Three clinical trials of the Sputnik V vaccine.