Background The results of a randomised trial showed the safety and efficacy of Gam-COVID-Vac against COVID-19. However, compared to other vaccines used across the globe, the real-world data on the effectiveness of Gam-COVID-Vac, especially against the disease caused by the Delta variant of concern, was limited. We aimed to assess the effectiveness of vaccination mainly conducted with Gam-COVID-Vac in St. Petersburg, Russia. Methods We designed a case-control study to assess the vaccine effectiveness (VE) against referral to hospital. Self-reported vaccination status was collected for individuals with confirmed SARS-CoV-2 infection who were referred for initial low-dose computed tomography (LDCT) triage in two outpatient centres in July 3–August 9, 2021, in St. Petersburg, Russia. We used logistic regression models to estimate the adjusted (for age, sex, and triage centre) VE for complete (14 days or more after the second dose) vaccination. We estimated the VE against referral for hospital admission, COVID-19-related lung injury assessed with LDCT, and decline in oxygen saturation. Results In the final analysis, 13,893 patients were included, 1291 (9.3%) patients met our criteria for complete vaccination status, and 495 (3.6%) were referred to hospital. In the primary analysis, the adjusted VE against referral to hospital was 81% (95% confidence interval: 68–88) for complete vaccination. The VE against referral to hospital was more pronounced in women (84%, 95% CI: 66–92) compared to men (76%, 95% CI: 51–88). Vaccine protective effect increased with increasing lung injury categories, from 54% (95% CI: 48–60) against any sign of lung injury to 76% (95% CI: 59–86) against more than 50% lung involvement. A sharp increase was observed in the probability of hospital admission with age for non-vaccinated patients in relation to an almost flat relationship for the completely vaccinated group. Conclusions COVID-19 vaccination was effective against referral to hospital in patients with symptomatic SARS-CoV-2 infection in St. Petersburg, Russia. This protection is probably mediated through VE against lung injury associated with COVID-19.

Background Monitoring vaccine effectiveness (VE) remains a priority for epidemiological research throughout the COVID-19 pandemic. VE against infection declines with the emergence of new SARS-CoV-2 variants of concern (VOC), but VE against the severe disease remains high. Therefore, we aimed to estimate the effectiveness of COVID-19 vaccines used in Russia against lung injury during Delta and Omicron VOC surges. Methods We designed a case–control study (test-negative design) to estimate VE against any (any volume of involved lung parenchyma) and severe (>50% of involved parenchyma) lung injury detected on computer tomography and associated with COVID-19 between October 1, 2021–April 28, 2022 (Delta VOC dominance period followed by Omicron dominance period). We included the data of patients with symptomatic confirmed SARS-CoV-2 infection referred to the low-dose computer tomography triage centres. Results Among 23996 patients in the primary analysis, 13372 (55.7%) had any lung injury, and 338 (1.4%) had severe lung injury. The adjusted for age, sex and triage centre VE estimates against any lung injury were 56% (95% confidence interval 54–59) for two-dose Gam-COVID-Vac (Sputnik V), 71% (68–74) for three-dose Gam-COVID-Vac (booster), 2% (−27 to 24) for EpiVacCorona, and 46% (37–53) for CoviVac. VE estimates against severe lung injury were 76% (67–82) for two-dose Gam-COVID-Vac (Sputnik V), 87% (76–93) for three-dose Gam-COVID-Vac, 36% (−63 to 75) for EpiVacCorona, and 80% (45–92) for CoviVac. Conclusions Gam-COVID-Vac remained effective against lung injury associated with COVID-19 during Delta and Omicron VOC surges, and one Gam-COVID-Vac booster could be seen as an appropriate option after a two-dose regimen. CoviVac was also effective against lung injury. EpiVacCorona use in population-based vaccination should be halted until effectiveness and efficacy evidence is provided. Trial registration The joint study of COVID-19 vaccine effectiveness in St. Petersburg was registered at ClinicalTrials.gov (NCT04981405, date of registration—August 4, 2021).

Background Studies of mRNA and vector-based vaccines used in different countries report acceptable levels of effectiveness against SARS-CoV-2 infection caused by the Delta variants of SARS-CoV-2. No studies estimated vaccine effectiveness (VE) of Gam-COVID-Vac and other vaccines used in Russia against symptomatic infection with Delta variant. In this population-based case-control study, we aimed to estimate the effectiveness of the Russian COVID-19 vaccines against symptomatic SARS-CoV-2 during the recent outbreak caused by the Delta VOC in October 2021 in St. Petersburg, Russia. Methods Cases were symptomatic patients with confirmed SARS-CoV-2 (using polymerase chain reaction (PCR) test) referred to low-dose computed tomography (LDCT) triage in two outpatient centres between October 6 and 14, 2021 during the Delta variant outbreak. We recruited the controls during the representative survey of the seroprevalence study conducted during the same period in St. Petersburg using random digit dialling. In the primary analysis, we used logistic regression models to estimate the adjusted (age, sex, and history of confirmed COVID-19) VE against symptomatic SARS-CoV-2 resulted in a referral to triage centre for three vaccines used in Russia: Gam-COVID-Vac, EpiVacCorona, and CoviVac. Results We included 1,254 cases and 2,747 controls recruited between the 6th and 14th of October in the final analysis. VE was 56% (95% CI: 48 to 63) for Gam-COVID-Vac (Sputnik V), 49% (95% CI: 29 to 63) for 1-dose Gam-COVID-Vac (Sputnik V) or Sputnik Light, -58% (95% CI: -225 to 23) for EpiVacCorona and 40% (95% CI: 3 to 63) for CoviVac. Without adjustment for the history of confirmed COVID-19 VE for all vaccines was lower, except for one-dose Gam-COVID-Vac (Sputnik Light). The adjusted VE was slightly lower in women — 51% (95% CI: 39 to 60) than men — 65% (95% CI: 5 to 73). Conclusions Our preliminary results show that in contrast to other Russian vaccines, Gam-COVID-Vac is effective against symptomatic SARS-CoV-2 infection caused by Delta VOC. Effectiveness is likely higher than the estimated 56% due to bias arising from high prevalence of the past COVID-19 in St. Petersburg.