Moscow: Russia on Tuesday became the first country in the world to register a Covid-19 vaccine jointly developed by the Gamaleya Research Institute and the Russian Defence Ministry.
The vaccine has two separately-injected components. These two components work together to build a long-term immunity against the virus, Sputnik news agency reported.
“The two-stage injection plan helps form a lasting immunity. The experience with vector vaccines and two-stage scheme shows that immunity lasts for up to two years,” the Russian Health Ministry was quoted as saying in the report.
Preclinical tests of the vaccine for toxicity, safety, immunogenicity and protective effectiveness on large and small animals were conducted at the 48th Central Research Institute of the Russian Ministry of Defence.
On June 16, the Russian Health Ministry issued a permit to conduct clinical trials of the vaccine on volunteers at the Burdenko Main Military Clinical Hospital.
Clinical trials of the vaccine started on June 18 and included 38 volunteers.
The volunteers were divided into two main groups – one group consisted of 18 people and the other group had 20.
The experiment started with the first group. Nine volunteers were given one component of the vaccine, and nine more were given the second component.
After receiving initial data on the safety and tolerability of the vaccine based on the results of the survey of the first group of volunteers, the vaccine was inserted into 20 more selected volunteers on June 23.
This group of experimental participants received the drug in a booster version — three weeks after the first vaccination, they were given the second component of the vaccine according to indications.
On August 3, a “final medical examination” of participants in clinical trials of the vaccine took place at the Burdenko Main Military Clinical Hospital, Russian Ministry of Defence said in a statement.
The results clearly showed that all volunteers had a clear immune response resulting from vaccination, the ministry said, adding that there were no side effects or abnormalities in the work of the volunteers.
According to the registration certificate, the vaccine is expected to go into civilian circulation on January 1 next year, Sputnik reported.
According to Russian Health Minister Mikhail Murashko, two sites — the Gamaleya Research Institute and a private company — will be used for producing the vaccine, said the report.
While Russia has claimed that the vaccine has passed “all the necessary inspections”, the country has faced criticism from several quarters for rushing the vaccine development process and for not involving a large number of people in the trial before declaring it safe.
The news of the registration of the world’s first Covid-19 vaccine came at a time when over 20 million people worldwide have tested positive for the disease which has so far caused over 736,000 deaths.
According to the World Health Organization (WHO) there are currently over 165 Covid-19 vaccines in different stages of development.