The Russian adenovirus vaccine against coronavirus infection, developed by the Gamalei Center, is officially registered – it is the first COVID-19 vaccine in the world to pass Registration. The relevant record appeared in the State Register of Medicines (GRLS).
At the end of July, the Gamalei Center, together with Sechenov University and Burdenko Military Hospital, completed the combined phase I-II of clinical trials involving 76 Volunteers. As a result of these tests, as previously stated by the Ministry of Health, a decision can be made on the “conditional” registration of the vaccine, which will allow the use of the vaccine for at-risk groups, and the decision to confirm the registration and put it into mass circulation will be taken at the end of Phase III.
As published on the GRLS website, the Gam-COVID-Vac vaccine is registered under the registration procedure for drugs intended for use in an emergency and based on limited clinical data. Therefore, its use is permitted “only in medical organizations that have the right to provide vaccine prevention to the population.”
Only one form of vaccine has been registered – a solution for intramuscular injection, there is no record of registration of the second form – a vaccine in a lyophilized form – yet.
“This morning a vaccine against the new coronavirus was registered for the first time in the world,” said the Kremlin chief in a meeting with the Cabinet of Ministers.
According to the president, the Russian vaccine is “effective”, has passed all the necessary tests and allows achieving a “stable immunity” against Covid-19.