Health
Russian COVID-19 vaccine shows early potential in Lancet report
According to a report published in Russia, the Russian controversial COVID-19 vaccine showed signs of generating an immune response in early tests Lancet September 4.
The report includes details of two early phase 1/2 studies on vaccines. Sputnik V, In two hospitals in Russia.
The researchers enrolled 76 participants in the two studies, with 38 participating in each study between June and August. Participants were between the ages of 18 and 60 and were monitored for 42 days after the first dose of vaccine candidates.
During this closely monitored period, the researchers said that all vaccinated participants developed antibodies to the SARS-CoV-2 virus that provoke COVID-19 within 3 weeks.
Several side effects have been reported, the most common being injection site pain and fever, but the vaccine has proven to be safe and well tolerated.
Sputnik V is composed of two strains of adenovirus that normally cause colds and carry the gene for the SARS-CoV-2 spike protein.
This method AstraZeneca and Oxford UniversityThe vaccine candidate uses a modified chimpanzee adenovirus.
A large Phase 3 trial will enroll 40,000 volunteers of different ages and risk groups, with the first results of the study scheduled for October or November.
Despite the lack of solid evidence from a large confirmatory study, Russia granted regulatory approval for Sputnik V in August.
There was widespread response around the world as health care professionals warned that approval should not preempt the completion of Phase 3 testing.
next Lancet Scientists say early results are promising, but it’s important to remember that there are too few data to be sure of efficacy, the report says
“We are very pleased to meet with you,” said Naor Bar-Zeev, associate professor at Johns Hopkins Bloomberg School of Public Health. ..
“Safety is a top priority, as the vaccine will be given to healthy people, and potentially to everyone during the COVID-19 pandemic, after post-trial approval in Phase 3,” he added.
Russian President Vladimir Putin said last month that one of his daughters had volunteered for vaccination, adding that “she feels good and has a high number of antibodies,” after receiving the injection.
Sputnik V was developed by the Gamalya Institute in Moscow. Researchers and directors faced criticism after injecting prototypes a few months ago, bypassing the usual human trial process.
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