According to research published in The Lancet Friday, patients involved in the initial tests of the Russian coronavirus vaccine developed antibodies with "no serious adverse events", but experts say that these cases are too strong to prove safety and effectiveness. Were few
Russia announced last month that its
vaccine, known as the "Sputnik V", had already been approved’ after
the Soviet-era satellite was first launched into space in 1957.
This has raised concerns among Western
scientists about the lack of safety data, with some warning that moving too
fast on a vaccine could be dangerous.
Russia denounced the criticism as an
attempt to undermine Moscow's research.
The trials were open-label and not
randomized, meaning there was no placebo and participants knew they were
receiving the vaccine and were not randomly assigned’ to different treatment
groups.
The researchers stressed that larger and
longer trials - including placebo comparisons - would be needed to establish
the long-term safety and efficacy of the vaccine to prevent Covid 19
infections.
The report said 76 participants in the
trials would be monitored’ for 180 days, adding that "more rigorous Phase
3 clinical trials involving 40,000 volunteers from different age and risk
groups." The trial was, planned.
- 'Safety is paramount' -.
Naor Bar-Zeev of
the Johns Hopkins Bloomberg School of Public Health, who did not participate in
the study, said the research was "encouraging but small", adding that
it had no data on the effectiveness in older groups. Given, who are
particularly at risk. Covid-19
"Safety with the Covid 19 vaccine
will be crucial, not only for vaccine acceptance but also for widespread
confidence in vaccination," he said in a comment in the Lancet.
"Because healthy people are vaccinated
and, during the Cove 19 epidemic, possibly after everyone has been approved
after Phase 3 trials, safety is very important."
The epidemic has seen unprecedented
mobilization of funds and research to rush through a vaccine that could protect
billions of people around the world.
This week, the United States urged states
to prepare for the elimination of the vaccine two days before the November
presidential election, which has raised concerns that President Donald Trump's
administration has set a political timetable. Accelerating research to fit.
Russia says industrial production of its
version is expected’ from September.
President Vladimir Putin said in early
August that the vaccine provided "permanent immunity" and that one of
his own daughters had been vaccinated’ although Russia's health ministry said
clinical trials were not yet complete. Were
The World Health Organization (WHO) has
urged Russia to adhere to the guidelines it has established and to "go
through all the steps" to develop a safe vaccine.
The Sputnik V was developed in
collaboration with the Russian Ministry of Defense by the Gamaleya Research
Institute for Infectious Diseases and Microbiology in Moscow.
It uses the cold-causing adenovirus, which
has since been replaced’ with a portion of the new Corona virus, SARS-CoV-2.
Denis Logunov Gamaleya, lead author of the
report, said the adenovirus vaccine enters human cells and provides the
SARS-KO-2 spike protein genetic code, which allows the immune system to
"recognize and attack" the virus. Helps to
In the Lancet study, Russian researchers
conducted 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 dose of the vaccine and then a booster with the second dose 21 days
later.
They were monitored’ for more than 42 days
and all antibodies were ready within the first three weeks.
Statistics show that the vaccine was
"safe, well-tolerated, and does not cause serious adverse events in
healthy adult volunteers," the report said.
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