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Russia announced last month that its vaccine, named “Sputnik V” in honor of the Soviet-era satellite that was the first to be launched into space in 1957, had already received approval.
LONDON – Patients taking part in the first trials of a Russian coronavirus vaccine developed antibodies without “serious adverse effects,” according to research published in The Lancet on Friday, but experts said the trials were too small to prove safety. and effectiveness.
Russia announced last month that its vaccine, named “Sputnik V” in honor of the Soviet-era satellite that was the first to be launched into space in 1957, had already received approval.
This raised concern among Western scientists about a lack of safety data, with some caveats that moving too fast on a vaccine could be dangerous.
Russia denounced the criticism as an attempt to undermine the Moscow investigation.
In the Lancet study, the Russian researchers reported on two small trials, each involving 38 healthy adults ages 18 to 60, who received a two-part immunization.
Each participant was given one dose of the first part of the vaccine and then boosted with the second part 21 days later.
They were monitored for 42 days and all developed antibodies within the first three weeks.
The report said the data showed the vaccine was “safe, well tolerated, and does not cause serious adverse events in healthy adult volunteers.”
The trials were open-label and non-randomized, meaning there was no placebo and the participants knew they were receiving the vaccine and were not randomized to different treatment groups.
The researchers stressed that larger and longer trials, including a comparison to placebo, would be needed to establish the long-term safety and efficacy of the vaccine in preventing COVID-19 infection.
The report said that the 76 participants in these trials would be monitored for up to 180 days, adding that a more rigorous phase 3 clinical trial involving 40,000 volunteers “of different age and risk groups” was planned.
‘SAFETY IS PARAMOUNT’
Naor 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 any data on effectiveness among older age groups. , who are particularly vulnerable. to COVID-19.
“Showing safety will be crucial with COVID-19 vaccines, not only for vaccine acceptance, but also for overall vaccination confidence,” he said in a comment in The Lancet.
“Given that vaccines are administered to healthy people and, during the COVID-19 pandemic, potentially to all people after approval after phase 3 trials, safety is paramount.”
The pandemic has seen an unprecedented mobilization of funds and research to rush a vaccine that can protect billions of people around the world.
This week, the US urged states to prepare for a possible COVID-19 vaccine launch two days before the November presidential election, raising concerns that President Donald Trump’s administration is accelerating the investigation to adapt to a political calendar.
Russia has said that industrial production of its version is expected from September.
President Vladimir Putin said in early August that the vaccine provided “sustainable immunity” and that one of his own daughters had been inoculated, although Russia’s Health Ministry said clinical trials were not yet complete.
The World Health Organization has urged Russia to follow established guidelines and go “through all the stages” necessary to develop a safe vaccine.
Sputnik V was developed by the Gamaleya epidemiology and microbiology research institute in Moscow in coordination with the Russian defense ministry.
It uses a cold-causing adenovirus, which is then modified and combined with a part of the new coronavirus, SARS-CoV-2.
The report’s lead author, Denis Logunov of Gamaleya, said the adenovirus vaccine enters people’s cells and delivers the genetic code for the SARS-CoV-2 spike protein, helping the immune system to “recognize and attack “the virus.
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