According to research published in The Lancet on Friday, patients taking tests for a Russian coronavirus vaccine did not develop antibodies with “serious adverse events”, but experts said there were few trials to prove safety and efficacy.
Russia announced last month that it had already received approval for its first satellite to be launched into space in 1957, called the “Sputnik V” satellite.
This raised concerns Due to the lack of safety data in Western scientists, there are some warnings that growing too fast on a single vaccine can be dangerous.
Russia denounced the criticism as an attempt to undermine Moscow’s research.
In the Lancet study, Russian researchers reported two small trials, each involving 38 healthy adults between the ages of 18 and 60 who were vaccinated in two doses.
Each participant was given a dose of the first portion of the vaccine and then a booster with the second portion 21 days later.
They were monitored for 42 days and antibodies were developed within the first three weeks.
The report states that the statistics show that the vaccine was “safe, well tolerated, and does not cause serious reactions in healthy adult volunteers”.
The trials were open-label and not randomized, meaning there were no placebo and participants knew they were receiving the vaccine and were not given randomized treatment groups.
The researchers emphasize that large and long trials – including a placebo comparison – will require the establishment of long-term safety and efficacy of the vaccine to prevent Kovid-19 infection.
The report said 76 participants would be monitored for 180 days and that another rigorous Phase 3 clinical trial was planned with the participation of 40,000 volunteers from different age and risk groups. Was
“Safety is paramount”
Knorr Bar-Zeev of the Johns Hopkins Bloomberg School of Public Health, who was not involved in the study, said the research was “encouraging but small”, adding that it did not provide data on efficacy in the older age groups, which in particular Weak on the Kovid-19.
“It will be important to show safety with the Covid-19 vaccine, not only for vaccine approval, but also for widespread reliance on vaccination,” Lands said in a comment.
“Because healthy people are vaccinated and, during the COVID-19 pandemic, safety is potentially important after everyone is approved after the Phase 3 trials.”
The epidemic has seen an unprecedented mobilization of funds and research to run through a vaccine that could save people worldwide.
This week, the United States urged states to be prepared for a possible Covid-19 vaccine rollout two days before the November presidential election, raising concerns that President Donald Trump’s administration is looking to adapt to a political timetable. Is accelerating.
Russia says industrial production of the version is expected to begin in September.
President Vladimir Putin said in early August that the vaccine was “immunizable” and that one of his own daughters had been vaccinated, although Russia’s health ministry said a clinical trial had not yet been completed.
The World Health Organization (WHO) has urged Russia to follow the established guidelines and go through “all stages” necessary to develop a safe vaccine.
Sputnik was also developed by the Gamalea Research Institute for Epidemiology and Microbiology in Moscow in coordination with the Russian Ministry of Defense.
It uses a cold-producing adenovirus, which is then modified and added to a portion of the new coronavirus, SARS-COVI-2.
Denis Logunov of Gemalia, lead author of the report, said the adenovirus vaccine enters human cells and provides the Saran-Cove-2 Spike protein genetic code, which helps the immune system identify and attack the virus. .
(Except for the headline, this story has not been edited by NDTV staff and is published from a syndicated feed.)