The preliminary results of a trial of 20,000 participants showed that the anti-covid efficacy of Sputnik V vaccine was 91.6%, and for people over 60 years old, the proportion rose to 91.8%. The drug has been licensed in Russia and 14 other countries/regions.
Interim analysis of test data The third phase The Russian covid-19 vaccine (Sputnik V) research shows that the two-dose regimen can achieve 91.6% Fight against symptomatic diseases; in people over 60, this protection is very similar, reaching 91.8%.
The preliminary results were published in “LancetBased on data analysis of nearly 20,000 participants, three-quarters of them received the vaccine and one-quarter received a placebo.
The trial included 2144 participants over the age of 60, and the effectiveness of the vaccine in this group was 91.8%: the vaccine was well tolerated, and safety data from 1,369 of these elderly people showed that the most common adverse reactions were flu symptoms and localization. reaction.
These ones Consistent with most reported adverse reactions In other populations, the general situation is also mild; in the placebo group (0.4%) and vaccine group (0.2%), there are few severe cases (patients requiring hospitalization).
not anyThe authors stated that this was believed to be related to vaccination; four deaths were reported in the trial, none of which were considered to be related to the vaccine.
Clear and reliable results
In comments related to this study, Ian Jones of the University of Reading and Polly Roy of the London School of Hygiene and Tropical Medicine (not involved in this study) pointed out that the development of the Sputnik V vaccine has been “in a hurry,” Shortcuts or lack of transparency” have been criticized, but the results presented here are “very clear, and the scientific principles of vaccination have been proven.”
He said: “This means that another vaccine can now be added to reduce the incidence of covid-19.”
Gam-COVID-Vac or Sputnik V is a two-part vaccine, which includes Two adenovirus vectors -rAd26-S and rAd5-S- have been modified to express the S protein of SARS-CoV-2.
Adenoviruses are also weakened, so they cannot replicate in human cells and do not cause disease. This technology has been used before, and its safety has been guaranteed. Proven in multiple studies The clinic reviewed the journal in the notes.
In this trial, participants received a dose of rAd26-S and then a booster dose of rAd5-S 21 days later.
According to the relevant person in charge, the use of different adenovirus vectors for booster immunization can help establish a Strong immune responseBecause it minimizes the risk of immune system resistance to the initial carrier.
“Our interim analysis of phase III randomized controlled trials with participants aged 18 years and older showed high efficacy, immunogenicity, and good tolerability,” comes from the National Epidemiology of Gamaria and Said Inna V Dolzhikova of the National Research Center of Microbiology (Russia). .
Study of symptomatic cases
On the 21st day after receiving the first dose (the day of the second dose), 16 symptomatic COVID-19 cases (0.1%) were confirmed in the vaccine group, and 62 cases (1.3%) in the placebo group were confirmed in the vaccine group. Summarizing the study, a 91.6% curative effect was achieved.
The vaccine’s data from 342 and 44 participants respectively induced a strong humoral response (antibody response) and cellular immune response (T cell response).
The efficacy analysis only includes symptomatic cases, so Need more research Understand the efficacy of the vaccine in asymptomatic patients.
In addition, the average follow-up time is 48 days after the first dose, So the study cannot evaluate the entire protection period.
As part of the secondary analysis, the author explored the efficacy of targeting moderate or severe COVID-19.21 days after the initial vaccination, there were no moderate or severe COVID-19 cases in the vaccine group and no 20 cases in the placebo group, which is equivalent to one 100% efficiency Against covid-19 Moderate or severe.
Although the study was not designed to evaluate the efficacy of a single-dose regimen, the results showed that part of the protective effect will begin early within 16 to 18 days after a single-dose immunization. The team was recently approved to study the efficacy of a single dose.
The author also pointed out that more research is needed to study the vaccine in adolescents, children, and pregnant women. The trial is ongoing and aims to include 40,000 participants.
In addition to Russia, Russian vaccines have been licensed In 14 other countriesIncluding Hungary, Algeria, Serbia, Argentina, Bolivia, Venezuela, Paraguay, Turkmenistan, Belarus, Kazakhstan, United Arab Emirates and Iran. The Czech Republic, Mexico and Sri Lanka are interested in her.
Roy, Polly, etc. “Sputnik V COVID-19 vaccine candidate appears to be safe and effective.” The Lancet, 2020