- The first results for Russia’s coronavirus vaccine candidate are encouraging but limited by the small size of the trials.
- Russian researchers published the initial data Friday in The Lancet. It comes nearly a month after Russian officials touted a provisional approval of the shot.
- Two studies found the vaccine was generally safe and produced immune responses in a group of 76 young and healthy volunteers.
- Despite the early approval, the authors of the study acknowledged the need to run a larger study. They said Russia was planning a 40,000-volunteer trial to determine if the vaccine prevents infection or disease.
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A Russian coronavirus vaccine candidate was generally safe and produced encouraging immune responses in early studies involving 76 young and healthy volunteers.
The data, published Friday in The Lancet, is the first glimpse at clinical results for Russia’s leading vaccine. Nearly a month ago, Russian officials issued a provisional approval for the shot, and President Vladimir Putin said one of his daughters had received the vaccine.
While the data is encouraging, it comes from early and small trials. The Russian authors of the report acknowledged that more studies would be needed to determine if the vaccine works. The country is now planning a 40,000-volunteer phase-three trial that will include a wider variety of people, they said.
All observed side effects from the vaccine were mild or moderate, with the vast majority being mild, according to the study. The most common side effects were pain at injection site (58%), increase in body temperature (50%), headache (42%), tiredness or weakness (28%), and muscle and joint pain (24%).
And while the studies recorded encouraging immune responses, it’s still not clear which type of immune response might protect people from infection or disease. The researchers said levels of neutralizing antibodies, virus-fighting proteins that play a critical role in warding off invading germs, were lower in the Russian study than in reports from other leading vaccine candidates developed with different technologies.
Two public-health experts at Johns Hopkins University, who were not involved in this study, called the results “encouraging but small.”
“The immunogenicity bodes well, although nothing can be inferred on immunogenicity in older age groups, and clinical efficacy for any COVID-19 vaccine has not yet been shown,” Dr. Naor Bar-Zeev and Dr. Tom Inglesby wrote in a related comment in The Lancet.