Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress 2023 EHA Congress 2023 ASCO Annual Meeting
Clinical Collections
Advances in Alzheimer’s

At a glance: The ONWARDS insulin icodec trials

A round-up of the ONWARDS phase 3 clinical trials evaluating the novel weekly insulin icodec in people with diabetes.
ADVANCED SEARCH
Log in
Top
BMC Medicine
Published in: BMC Medicine 1/2022

Open Access 01-12-2022 | Triage | Research article

Vaccine effectiveness against referral to hospital after SARS-CoV-2 infection in St. Petersburg, Russia, during the Delta variant surge: a test-negative case-control study

Authors: Anton Barchuk, Mikhail Cherkashin, Anna Bulina, Natalia Berezina, Tatyana Rakova, Darya Kuplevatskaya, Oksana Stanevich, Dmitriy Skougarevskiy, Artemiy Okhotin

Published in: BMC Medicine | Issue 1/2022

Login to get access

Abstract

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.
Appendix
Available only for authorised users
Literature
1.
Logunov DY, Dolzhikova IV, Zubkova OV, Tukhvatullin AI, Shcheblyakov DV, Dzharullaeva AS, Grousova DM, Erokhova AS, Kovyrshina AV, Botikov AG, et al. Safety and immunogenicity of an rAd26 and rAd5 vector-based heterologous prime-boost COVID-19 vaccine in two formulations: two open, non-randomised phase 1/2 studies from Russia. Lancet. 2020; 396(10255):887–97.CrossRef
2.
Logunov DY, Dolzhikova IV, Shcheblyakov DV, Tukhvatulin AI, Zubkova OV, Dzharullaeva AS, Kovyrshina AV, Lubenets NL, Grousova DM, Erokhova AS, et al. Safety and efficacy of an rAd26 and rAd5 vector-based heterologous prime-boost covid-19 vaccine: an interim analysis of a randomised controlled phase 3 trial in Russia. Lancet. 2021; 397(10275):671–81.CrossRef
3.
Voysey M, Clemens SAC, Madhi SA, Weckx LY, Folegatti PM, Aley PK, Angus B, Baillie VL, Barnabas SL, Bhorat QE, et al.Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK. Lancet. 2021; 397(10269):99–111.CrossRef
4.
Polack FP, Thomas SJ, Kitchin N, Absalon J, Gurtman A, Lockhart S, Perez JL, Marc GP, Moreira ED, Zerbini C, et al. Safety and efficacy of the BNT162b2 mRNA Covid-19 vaccine. N Engl J Med. 2020; 383:2603–15.CrossRef
5.
6.
Bucci E, Andreev K, Björkman A, Calogero RA, Carafoli E, Carninci P, Castagnoli P, Cossarizza A, Mussini C, Guerin P, et al. Safety and efficacy of the Russian COVID-19 vaccine: more information needed. Lancet. 2020; 396(10256):53.CrossRef
7.
Bucci EM, Berkhof J, Gillibert A, Gopalakrishna G, Calogero RA, Bouter LM, Andreev K, Naudet F, Vlassov V. Data discrepancies and substandard reporting of interim data of Sputnik V phase 3 trial. Lancet. 2021; 397(10288):1881–83.CrossRef
8.
Logunov DY, Dolzhikova IV, Tukhvatullin AI, Shcheblyakov DV. Safety and efficacy of the Russian COVID-19 vaccine: more information needed – Authors’ reply. Lancet. 2020; 396(10256):54–55.CrossRef
9.
Logunov DY, Dolzhikova IV, Shcheblyakov DV. Data discrepancies and substandard reporting of interim data of Sputnik V phase 3 trial – Authors’ reply. Lancet. 2021; 397(10288):1883–84.CrossRef
10.
11.
Pagotto V, Ferloni A, Mercedes Soriano M, et al. Active monitoring of early safety of Sputnik V vaccine in Buenos Aires, Argentina. Monitoreo activo de la seguridad temprana de la vacunación con Sputnik V en Buenos Aires, Argentina. Medicina (B Aires). 2021;81(3):408–14.
12.
Rearte A, Castelli JM, Rearte R, Fuentes N, Pennini V, Pesce M, Barbeira PB, Iummato LE, Laurora M, Bartolomeu ML, et al. Effectiveness of rAd26-rAd5, ChAdOx1 nCoV-19, and BBIBP-CorV vaccines for risk of infection with SARS-CoV-2 and death due to COVID-19 in people older than 60 years in argentina: a test-negative, case-control, and retrospective longitudinal study. Lancet. 2022; 399(10331):1254–64.CrossRef
13.
Vokó Z, Kiss Z, Surján G, Surján O, Barcza Z, Pályi B, Formanek-Balku E, Molnár GA, Herczeg R, Gyenesei A, et al. Nationwide effectiveness of five SARS-CoV-2 vaccines in Hungary—the HUN-VE study. Clin Microbiol Infect. 2022; 28(3):398–404.CrossRef
14.
González S, Olszevicki S, Salazar M, Calabria A, Regairaz L, Marín L, Campos P, Varela T, Martínez VVG, Ceriani L, et al. Effectiveness of the first component of Gam-COVID-Vac (Sputnik V) on reduction of SARS-CoV-2 confirmed infections, hospitalisations and mortality in patients aged 60-79: a retrospective cohort study in argentina. EClinicalMedicine. 2021; 40:101126.CrossRef
15.
Horváth KJ, Ferenci T, Ferenczi A, Túri G, Röst G, Oroszi B. Real-time monitoring of the effectiveness of six COVID-19 vaccines in Hungary in 2021 using the screening method. medRxiv. 2022.
16.
Barchuk A, Bulina A, Cherkashin M, Berezina N, Rakova T, Kuplevatskaya D, Stanevich O, Skougarevskiy D, Okhotin A. COVID-19 vaccines effectiveness against symptomatic SARS-CoV-2 delta variant infection: a population-based case-control study in St. Petersburg, Russia. medRxiv. 2022.
17.
18.
Lopez Bernal J, Andrews N, Gower C, et al. Effectiveness of the Pfizer-BioNTech and Oxford-AstraZeneca vaccines on covid-19 related symptoms, hospital admissions, and mortality in older adults in England: test negative case-control study. BMJ. 2021;373:n1088. https://​doi.​org/​10.​1136/​bmj.​n1088. Published 2021 May 13.
19.
Hitchings MD, Ranzani OT, Torres MSS, de Oliveira SB, Almiron M, Said R, Borg R, Schulz WL, de Oliveira RD, da Silva PV, et al.Effectiveness of CoronaVac among healthcare workers in the setting of high SARS-CoV-2 gamma variant transmission in Manaus, Brazil: a test-negative case-control study. Lancet Reg Health — Am. 2021.
20.
Sheikh A, McMenamin J, Taylor B, Robertson C. SARS-CoV-2 Delta VOC in Scotland: demographics, risk of hospital admission, and vaccine effectiveness. Lancet. 2021; 397(10293):2461–62.CrossRef
21.
Karlinsky A, Kobak D. Tracking excess mortality across countries during the COVID-19 pandemic with the World Mortality Dataset. eLife. 2021; 10:69336.CrossRef
22.
Arce JS, Warren SS, Meriggi NF, Scacco A, McMurry N, Voors M, Syunyaev G, Malik AA, Aboutajdine S, Armand A, et al.Covid-19 vaccine acceptance and hesitancy in low and middle income countries, and implications for messaging. Nat Med. 2021.
23.
Barchuk A, Skougarevskiy D, Kouprianov A, Shirokov D, Dudkina O, Tursun-zade R, Sergeeva M, Tychkova V, Komissarov A, Zheltukhina A, et al. Covid-19 pandemic in saint petersburg, russia: combining surveillance and population-based serological study data in may, 2020–april, 2021. PLoS ONE. 2022; 17(6):0266945.CrossRef
24.
25.
Vandenbroucke JP, Pearce N. Test-negative designs: differences and commonalities with other case–control studies with “other patient” controls. Epidemiology. 2019; 30(6):838–44.CrossRef
26.
Bloemenkamp KW, Rosendaal FR, Büller HR, Helmerhorst FM, Colly LP, Vandenbroucke JP. Risk of venous thrombosis with use of current low-dose oral contraceptives is not explained by diagnostic suspicion and referral bias. Arch Intern Med. 1999; 159(1):65–70.CrossRef
27.
Forsyth BW, Horwitz RI, Acampora D, Shapiro ED, Viscoli CM, Feinstein AR, Henner R, Holabird NB, Jones BA, Karabelas AD, et al. New epidemiologic evidence confirming that bias does not explain the aspirin/reye’s syndrome association. JAMA. 1989; 261(17):2517–24.CrossRef
28.
Morozov SP, Chernina VY, Blokhin AI, Gombolevskiy VA. Chest computed tomography for outcome prediction in laboratory-confirmed COVID-19: a retrospective analysis of 38,051 cases. Digit Diagn. 2020; 1(1):27–36.CrossRef
29.
Williams B. The National Early Warning Score 2 (NEWS2) in patients with hypercapnic respiratory failure. Clin Med. 2019; 19(1):94.CrossRef
30.
WHO. Evaluation of COVID-19 vaccine effectiveness: interim guidance, 17 March 2021. Technical documents. Geneva: World Health Organization; 2021. 
31.
Althouse AD. Post hoc power: not empowering, just misleading. J Surg Res. 2021; 259:3–6.CrossRef
32.
33.
34.
Rubin GD, Ryerson CJ, Haramati LB, Sverzellati N, Kanne JP, Raoof S, Schluger NW, Volpi A, Yim J-J, Martin IBK, Anderson DJ, Kong C, Altes T, Bush A, Desai SR, Goldin O, Goo JM, Humbert M, Inoue Y, Kauczor H-U, Luo F, Mazzone PJ, Prokop M, Remy-Jardin M, Richeldi L, Schaefer-Prokop CM, Tomiyama N, Wells AU, Leung AN. The role of chest imaging in patient management during the COVID-19 pandemic: a multinational consensus statement from the Fleischner Society. Radiology. 2020;296(1):172–80 https://​doi.​org/​10.​1148/​radiol.​2020201365.CrossRef
Metadata
Title
Vaccine effectiveness against referral to hospital after SARS-CoV-2 infection in St. Petersburg, Russia, during the Delta variant surge: a test-negative case-control study
Authors
Anton Barchuk
Mikhail Cherkashin
Anna Bulina
Natalia Berezina
Tatyana Rakova
Darya Kuplevatskaya
Oksana Stanevich
Dmitriy Skougarevskiy
Artemiy Okhotin
Publication date
01-12-2022
Publisher
BioMed Central
Published in
BMC Medicine / Issue 1/2022
Electronic ISSN: 1741-7015
DOI
https://doi.org/10.1186/s12916-022-02509-8

Other articles of this Issue 1/2022

BMC Medicine 1/2022 Go to the issue

Research article

Predictive value of circulating NMR metabolic biomarkers for type 2 diabetes risk in the UK Biobank study

Research article

Systematic review and meta-analysis of the diagnostic accuracy of prostate-specific antigen (PSA) for the detection of prostate cancer in symptomatic patients

Research article

Frequency of adding salt at the table and risk of incident cardiovascular disease and all-cause mortality: a prospective cohort study

Research article

Human serum from SARS-CoV-2-vaccinated and COVID-19 patients shows reduced binding to the RBD of SARS-CoV-2 Omicron variant

Research article

Overlap of high-risk individuals predicted by family history, and genetic and non-genetic breast cancer risk prediction models: implications for risk stratification

Research article

Distinct implications of body mass index in different subgroups of nonobese patients with heart failure with preserved ejection fraction: a latent class analysis of data from the TOPCAT trial