Russia’s proposed Covid-19 vaccine induced an antibody response in all participants in the early trials and found no serious adverse effects, according to early peer-reviewed data on studies from the controversial project.
The vaccine also produced a response in T cells, a type of white blood cell that helps the immune system destroy infection, according to preliminary results from phase 1 and 2 trials published Friday in the Lancet medical journal. Russian officials had previously made very similar claims about the shooting, before it was reviewed by outside experts.
Russia has been seeking to gain international credibility after health officials elsewhere harshly criticized the country’s regulatory approval of the vaccine last month, before it underwent larger phase 3 trials. Russian President Vladimir Putin hailed Sputnik V, named after the Soviet Union’s 1957 launch of the world’s first satellite into space, as the world’s first vaccine to be licensed.
The trials, which took place in two Russian hospitals and involved 76 healthy adults ages 18 to 60, used a two-part vaccine with two different human adenoviruses, pathogens related to the common cold, to carry the antigen. to the body. All participants received the vaccine, without a control group, one of several limitations of the trials cited in the report.
The researchers took convalescent plasma from 4,817 people who had recovered from mild or moderate Covid-19 to compare post-vaccination immunity with natural immunity. Antibody responses were higher in those vaccinated, according to the data.
Wider use
The government has announced plans to begin administering the vaccine more widely to medical personnel and teachers in the coming weeks, ahead of a broader national campaign scheduled for later this year. The move has raised concerns that political pressure could prevail over security considerations and put public health at risk as the world seeks an end to the pandemic.
The Russian researchers tested two forms of the vaccine: frozen and lyophilized. The phase 1 participants received one of the two-part injections, while the phase 2 groups also received a second injection 21 days after the first. All 40 participants in the phase 2 trial produced antibodies, with levels higher in those who had received the frozen vaccine. Neutralizing antibody responses were found in all phase 2 patients, while only 61% of phase 1 participants produced them with a single injection.
All phase 2 participants showed T-cell responses within 28 days of vaccination, and frozen injections were again shown to be more effective than lyophilized ones.
The researchers said the study’s limitations include its size, the short 42-day follow-up time, and the fact that some parts of the phase 1 trial used only male volunteers. Despite the age range for the study, the trial also mainly focused on younger people in their 20s and 30s.
Russia has also been administering the vaccine to officials and other prominent individuals outside the test groups for months without waiting for the full results of the study. On Friday, Moscow Mayor Sergei Sobyanin, 62, told Putin in a televised video conference that he had received the injection and that he was only feeling minor discomfort at the time. Putin said last month that one of his daughters also received the vaccine and was feeling fine. The Kremlin has not revealed whether Putin has been vaccinated.
Phase 3 trial
On August 26, a phase 3 trial was approved for 40,000 volunteers of different ages and risk groups.
“Immunogenicity bodes well, although nothing can be inferred about immunogenicity in older age groups, and the clinical efficacy of any Covid-19 vaccine has not yet been demonstrated,” said Naor Bar-Zeev, associate professor at the Johns Hopkins Bloomberg School of Public Health, in a linked comment in The Lancet. “Showing safety will be crucial with Covid-19 vaccines, not only for vaccine acceptance, but also for confidence in vaccination in general.”
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