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Russian scientists have belatedly published the first results of the first trials of the experimental Sputnik V vaccine, which received government approval last month but drew considerable criticism from experts as the injections had only been tested in several dozen people. before being administered more widely.
In a report published in the Lancet on Friday, the vaccine’s developers said it appeared to be safe and elicit an antibody response in the 40 people tested in the second phase of the study within three weeks. However, the authors noted that participants were only followed for 42 days, the study sample was small, and no placebo or control vaccine was used.
One part of the safety trial included only men and the study mainly involved people in their 20s and 30s, so it is unclear how the vaccine might work in older populations at higher risk for the most serious complications of COVID- 19.
International experts remained cautious about the efficacy and safety of the vaccine. However, its Russian developers made some bold claims on Friday after presenting the findings to journalists.
Professor Alexander Gintsburg, director of the Moscow-based Gamaleya Institute that developed the vaccine with the help of the Russian Defense Ministry, told reporters that the vaccine triggers an immune response “sufficient” to counteract any imaginable dose that infects (a a person) with COVID-19. “
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“We are ready to state that the protective effect of this vaccine will be detectable and will remain at an adequate level for 2 years, or maybe even longer,” Gintsburg said, without providing any evidence to support the claim.
According to the Lancet report, the trials were carried out in two Russian hospitals involving healthy adults between the ages of 18 and 60, who had to self-isolate once they registered for the trial. They remained in the hospital for the first 28 days of the study after being vaccinated.
One part of the study involved a frozen formulation of the vaccine while another studied a lyophilized variation. The scientists said the frozen vaccine would be suitable for current global vaccine supply chains, while the freeze-dried version could be used in hard-to-reach areas.
Satellite V / Things
An image of the Sputnik V vaccine in production and samples of the two sera taken. Provided by Sputnik V Media kit.
Both vaccines used a modified version of the adenovirus that causes the common cold to carry genes for the spike protein in the coronavirus, as a way to prepare the body to react if a real virus that causes COVID-19 appears. That’s a technology similar to the vaccines being developed by China’s CanSino Biologics and the University of Oxford and Britain’s AstraZeneca.
The Russian researchers said all 40 participants produced a response of neutralizing antibodies, molecules that are key to blocking infection. The vaccines also appeared to trigger a reaction in the body’s T cells, which help destroy cells that have been invaded by the virus.
The most frequently reported side effects were injection site pain, fever, headache, and muscle or joint pain.
Satellite V / Things
The Sputnik V vaccine is being produced in Russia.
In an accompanying comment, Dr. Naor Bar-Zeev of the Johns Hopkins Bloomberg School of Public Health and colleagues wrote that the studies were “encouraging but small.” They said that the immune reaction elicited by the vaccine “bodes well” but that “the clinical efficacy of any COVID-19 vaccine has not yet been demonstrated.”
Bar-Zeev and his colleagues said that proving the safety of any coronavirus vaccine would be critical.
“The safety results so far are reassuring, but the studies are also too small to address less common or rare serious adverse events,” they said. “Since vaccines are administered to healthy people and during the COVID-19 pandemic, potentially to all people after approval after (advanced) trials, safety is paramount.”
Dr Ohid Yaqub, Senior Lecturer in the Science Policy Research Unit at the University of Sussex, said the limited size of the study was not enough for regulatory approval, which the vaccine received last month.
“In the context of regulatory approval, the design and size of an (initial) study are not sufficient for widely recognized approval standards. The study was not randomized and it was not large enough to detect more rare safety problems, ”Yaqub said.
The vaccine was approved by the Russian government with much fanfare on August 11. President Vladimir Putin personally broke the news on national television and said that one of his daughters had already been vaccinated, experienced mild side effects and developed antibodies. Since then, several high-profile officials also said they had fired, including Moscow Mayor Sergei Sobyanin and Defense Minister Sergei Shoigu.
It is unclear if they were among the volunteers in the clinical trials or if they agreed to the vaccine in some other way.
Russian health authorities announced advanced trials of the vaccine among 40,000 volunteers last month. According to official records, it will be a randomized, double-blind, placebo-controlled study. Officials also mentioned that vaccination of risk groups, such as doctors and teachers, can be carried out “in parallel,” but it is unclear whether it will be done as part of the study.
Michael Head, senior researcher in global health at the University of Southampton in Britain, agreed that the Russian vaccine appeared to be “promising” but that more studies were needed.
“At this stage, we don’t really know if the vaccine works,” he said. Head was not linked to the Russian investigation. “Public confidence in any vaccine is vital,” he said in a statement, saying that suggestions from Russian authorities and elsewhere that a vaccine could be accelerated without proper research are “problematic.”
“Ultimately, we must not pour more fuel on the fires of the anti-vaccine lobby,” he said.
