Patients involved in early testing of a Russian coronavirus vaccine developed antibodies with no “serious adverse events,” according to a study published in The Lancet Friday. However, experts said the studies were too small to prove safety and effectiveness.
Russia announced last month that its vaccine, named “Sputnik V” after the Soviet-era satellite that was first launched in 1957, had already received approval.
This raised concern among Western scientists about the lack of safety data and warned that vaccinating too quickly could be dangerous.
Russia denounced criticism as an attempt to undermine Moscow’s research.
In the Lancet study, Russian researchers reported two small studies, each with 38 healthy adults between the ages of 18 and 60 who received a two-part immunization.
Each participant received a dose of the first part of the vaccine and a booster of the second part 21 days later.
They were monitored for 42 days and all developed antibodies within the first three weeks.
According to the report, the data showed that the vaccine “is safe, well tolerated and does not cause serious adverse events in healthy adult volunteers”.
The studies were open-label and not randomized, which meant 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 studies – including a placebo comparison – would be needed to determine the long-term safety and effectiveness of the vaccine in preventing Covid-19 infection.
According to the report, the 76 participants in these studies would be monitored for up to 180 days and a more rigorous Phase 3 clinical trial is planned, involving 40,000 volunteers “from various ages and risk groups.”
“Safety is the top priority”
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 give any data on effectiveness in older age groups who did are particularly at risk after Covid-19.
“Evidence of safety will be vital with Covid-19 vaccines, not only for vaccine acceptance but also for confidence in vaccination in general,” he said in a comment in the Lancet.
“With vaccines being given to healthy people and potentially anyone during the COVID-19 pandemic after approval after Phase 3 trials, safety is of the utmost importance.”
The pandemic has seen an unprecedented mobilization of funding and research to rush through a vaccine that can protect billions of people worldwide.
This week the US called on states to prepare for a possible introduction of Covid-19 vaccines two days before the November presidential election. This raised concerns that President Donald Trump’s administration is speeding up research to meet a policy schedule.
Russia has said that industrial production of its version is expected from September.
President Vladimir Putin said in early August that the vaccine gave “sustained immunity” and that one of his own daughters had been vaccinated, although the Russian Ministry of Health said the clinical trials were still ongoing.
The World Health Organization has urged Russia to follow the established guidelines and go through “all stages” necessary to develop a safe vaccine.
Sputnik V was developed by the Gamaleya Research Institute for Epidemiology and Microbiology in Moscow in coordination with the Russian Ministry of Defense.
A cold causing adenovirus is used, which is then modified and combined with part of the new coronavirus SARS-CoV-2.
The report’s lead author, Denis Logunov from Gamaleya, said that the adenovirus vaccine penetrates people’s cells and provides the genetic code for the SARS-CoV-2 spike protein, which is what enables the immune system to “recognize and attack” the virus.
(Except for the headline, this story was not edited by GossipMantri staff and published from a syndicated feed.)