Russia registers COVID-19 vaccine
By Monitoring DeskWednesday – August 12, 2020
According to an official statement, he continued, the pharmacovigilance experts involved in the drug quality and clinical research discussion have helped develop trial programmes and address regulatory issues of drug safety.
The preclinical trials of the vaccine were carried out at the Gamaleya Centre (GC) and the 48th Central Scientific Research Institute (CSRI) of the defence ministry.
The clinical trials took place at two locations: the Sechenov University of the healthcare ministry and a branch of the Burdenko Military Hospital.
According to the results, the vaccine has shown high effectiveness and safety. All volunteers developed high titres of COVID-19 antibodies, while none of them had any serious complications or side effects.
Based on the analysis of clinical trials data, experts from the healthcare ministry issued a conclusion, and a decision was made on granting state registration for the vaccine to prevent the novel coronavirus, developed by the GC of the Russian healthcare ministry.
It is one of the first registered vaccines in the world that has proven its effectiveness and safety.
The vaccine is registered in accordance with the procedure for market access for medicines to prevent COVID-19, adopted by the Russian government.
We have already reported that a number of medicines were previously released for treatment and are now effectively used by medical institutions.
The vaccine developers have prepared documents for further clinical trials involving several thousand people.
For emergency monitoring of the health status of those vaccinated and to control effectiveness and safety, the healthcare ministry is developing a single digital system that makes it possible to monitor the safety and quality of the medication at all stages of the life cycle.
This includes a registry of the vaccinated patients, and on July the first, Russia launched a system for monitoring the circulation of medicines, including an individual code on each package.
Vaccine production will now begin at two sites: the GC of the Russian healthcare ministry and the company Binnopharm.
At the same time, with the assistance of the industry and trade ministry and the Sberbank project office, technical regulations are prepared to increase production at the sites of a number of domestic manufacturers, which exist in our country.
Following your instruction, the Russian Direct Investment Fund (RDIF) is investing in the production and promotion of the vaccine abroad. A number of countries are already showing interest in it.
At the same time, the vaccine will be gradually introduced among civilians, and, first of all, we consider it necessary to offer vaccination to those whose work involves dealing with infected people — medical workers — as well as our teachers, whom the health of children depends on.
One of the most striking examples of the use of the GC platform was the creation of a vaccine against Ebola fever, and another type of coronavirus, MERS.
A huge contribution has been made to the victory of humankind over the novel coronavirus.
Russian president Putin questioned, “You said this is one of the first registered vaccines. Are there similar vaccines registered anywhere around the world?”
Russian healthcare minister Murashko answered, “There is our Chinese colleagues’ research that is undergoing the registration process now. There are similar developments in other countries as well, but clinical tests are still underway. In fact, Russia has the first full registration certificate.”
Russian president Putin said, “I hope the work of our foreign colleagues will also make progress, and there will be a lot of medicines and vaccines on the global market that can be used.
“I know this vaccine, as you have said, is based on adenoviral vectors, but I think its advantage is that it is based on human adenoviral vectors. It works more precisely and forms stable antibody and cellular immunity.
“I know this very well, too, because one of my daughters has got this vaccination.
“I think that in this sense she has taken part in the experiment.
“After the first shot, she had a fever of 38 degrees, but the next day it went down to just over 37, and that was it. After the second shot, her temperature went up a little, but then came down again. She feels well, and the titres are high.
“I know that many people have no symptoms or fever after the shot. In fact, they feel as if nothing happened. The main thing is to ensure unconditional safety and effectiveness of this vaccine in the future. I hope this will happen.”