Vaccine efficacy against hospital discharge after SARS-CoV-2 infection in St. Petersburg, Russia, during the Delta variant outbreak: a test-negative case-control study | BMC Medicine

  • 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 a heterologous prime-boost COVID-19 vaccine based on rAd26 and rAd5 vectors in two formulations: two open-label, non-randomized phase 1/2 studies performed in Russia. Lancet. 2020; 396(10255):887–97.

    CAS Google Scholar Article

  • 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 a heterologous covid-19 prime-boost vaccine based on rAd26 and rAd5 vectors: an interim analysis of a phase 3 randomized controlled trial in Russia. Lancet. 2021; 397(10275):671–81.

    CAS Google Scholar Article

  • 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 ChAdOx1 nCoV-19 (AZD1222) vaccine against SARS-CoV -2: an interim analysis of four randomized controlled trials in Brazil, South Africa and the United Kingdom. Lancet. 2021; 397(10269):99–111.

    CAS Google Scholar Article

  • 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.

    CAS Google Scholar Article

  • Baraniuk C. Covid-19: What do we know about Sputnik V and other Russian vaccines? BMJ. 2021;372:n743. https://doi.org/10.1136/bmj.n743.

    PubMed Google Scholar article

  • 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.

    Google Scholar article

  • Bucci EM, Berkhof J, Gillibert A, Gopalakrishna G, Calogero RA, Bouter LM, Andreev K, Naudet F, Vlassov V. Data gaps and substandard reports of interim data from the Sputnik V phase 3 trial. Lancet. 2021; 397(10288):1881–83.

    CAS Google Scholar Article

  • Logunov DY, Dolzhikova IV, Tukhvatullin AI, Shcheblyakov DV. Safety and efficacy of Russia’s COVID-19 vaccine: more information needed – Authors’ response. Lancet. 2020; 396(10256):54–55.

    Google Scholar article

  • Logunov DY, Dolzhikova IV, Shcheblyakov DV. Data Discrepancies and Substandard Interim Data Reporting from the Sputnik V Phase 3 Trial – Authors’ Response. Lancet. 2021; 397(10288):1883–84.

    CAS Google Scholar Article

  • Montalti M, Soldà G, Di Valerio Z, et al. ROCCA observational study: first results on the safety of the Sputnik V (Gam-COVID-Vac) vaccine in the Republic of San Marino using active surveillance. ECClinical Medicine. 2021;38:101027. https://doi.org/10.1016/j.eclinm.2021.101027. Posted July 8, 2021.

  • Pagotto V, Ferloni A, Mercedes Soriano M, et al. Active monitoring of the early safety of the Sputnik V vaccine in Buenos Aires, Argentina. Monitoreo activo de la seguridad early de la vacunación con Sputnik V in Buenos Aires, Argentina. Medicine (B Aires). 2021;81(3):408–14.

  • Rearte A, Castelli JM, Rearte R, Fuentes N, Pennini V, Pesce M, Barbeira PB, Iummato LE, Laura M, Bartolomeu ML, et al. Efficacy of rAd26-rAd5, ChAdOx1 nCoV-19 and BBIBP-CorV vaccines for the risk of SARS-CoV-2 infection and death from COVID-19 in people aged over 60 in Argentina: a case -test-negative control, and retrospective longitudinal study. Lancet. 2022; 399(10331):1254–64.

    CAS Google Scholar Article

  • Vokó Z, Kiss Z, Surján G, Surján O, Barcza Z, Pályi B, Formanek-Balku E, Molnár GA, Herczeg R, Gyenesei A, et al. National efficacy of five SARS-CoV-2 vaccines in Hungary – the HUN-VE study. Clin Microbiol Infect. 2022; 28(3):398–404.

    Google Scholar article

  • González S, Olszevicki S, Salazar M, Calabria A, Regairaz L, Marín L, Campos P, Varela T, Martínez VVG, Ceriani L, et al. Efficacy of the first component of Gam-COVID-Vac (Sputnik V) on reducing confirmed SARS-CoV-2 infections, hospitalizations and mortality in patients aged 60-79 years: a retrospective cohort study in Argentina. ECClinical Medicine. 2021; 40:101126.

    Google Scholar article

  • 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.

  • Barchuk A, Bulina A, Cherkashin M, Berezina N, Rakova T, Kuplevatskaya D, Stanevich O, Skougarevskiy D, Okhotin A. Effectiveness of COVID-19 vaccines against symptomatic SARS-CoV-2 delta-variant infection: a case -Population-based witness study in St. Petersburg, Russia. medRxiv. 2022.

  • Evans SJW, Jewell NP. Vaccine efficacy studies in the field. N Engl J Med Editorial. 2021. https://doi.org/10.1056/NEJMe2110605. http://arxiv.org/abs/https://doi.org/10.1056/NEJMe2110605.

  • Lopez Bernal J, Andrews N, Gower C, et al. Efficacy of Pfizer-BioNTech and Oxford-AstraZeneca vaccines on covid-19-related symptoms, hospitalizations and mortality in older adults in England: a test-negative case-control study. BMJ. 2021;373:n1088. https://doi.org/10.1136/bmj.n1088. Posted May 13, 2021.

  • 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. -2 transmission of the gamma variant in Manaus, Brazil: a test-negative case-control study. Lancet Reg Health – Am. 2021.

  • Sheikh A, McMenamin J, Taylor B, Robertson C. SARS-CoV-2 Delta VOC in Scotland: demographics, risk of hospitalization and vaccine effectiveness. Lancet. 2021; 397(10293):2461–62.

    CAS Google Scholar Article

  • Karlinsky A, Kobak D. Tracking excess mortality in countries during the COVID-19 pandemic with the World Mortality Dataset. eLife. 2021; 10:69336.

    Google Scholar article

  • 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. NatMed. 2021.

  • 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 st petersburg, russia: combination of surveillance data and population-based serological studies in May 2020-April 2021. PLoS ONE. 2022; 17(6):0266945.

    Google Scholar article

  • Fontanka Ru. V Smolnom rasskazali, kakaya iz treh vaktsin zaschitila peterburzhtsev ot koronavirusa lutshe vsego. 2021. https://www.fontanka.ru/2021/08/02/70057487/. Accessed April 21, 2022.

  • Vandenbroucke JP, Pearce N. Negative test patterns: differences and similarities with other case-control studies with “other patient” controls. Epidemiology. 2019; 30(6):838–44.

    Google Scholar article

  • Bloemenkamp KW, Rosendaal FR, Büller HR, Helmerhorst FM, Colly LP, Vandenbroucke JP. The risk of venous thrombosis associated with the use of current low-dose oral contraceptives is not explained by diagnostic suspicion and referral bias. Arch Med Intern. 1999; 159(1):65–70.

    CAS Google Scholar Article

  • Forsyth BW, Horwitz RI, Acampora D, Shapiro ED, Viscoli CM, Feinstein AR, Henner R, Holabird NB, Jones BA, Karabelas AD, et al. New epidemiological evidence confirming that bias does not explain the association of aspirin and Reye’s syndrome. JAMA. 1989; 261(17):2517–24.

    CAS Google Scholar Article

  • 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 Diag. 2020; 1(1):27–36.

    Google Scholar article

  • Williams B. The National Early Warning Score 2 (NEWS2) in patients with hypercapnic respiratory failure. Clin Med. 2019; 19(1):94.

    Google Scholar article

  • WHO. COVID-19 Vaccine Efficacy Evaluation: Interim Guidance, March 17, 2021. Technical Papers. Geneva: World Health Organization; 2021.

  • Althouse AD. Post-hoc power: non-enabling, just deceptive. J Surg Res. 2021; 259:3–6.

    Google Scholar article

  • Franquet T, Jeong YJ, Lam HYS, Wong HYF, Chang YC, Chung MJ, Lee KS. Imaging results in coronavirus infections: SARS-CoV, MERS-CoV and SARS-CoV-2. Br J Radiol. 2020; 93(1112):20200515. https://doi.org/10.1259/bjr.20200515.

    Google Scholar article

  • Desmet J, Biebaû C, De Wever W, Cockmartin L, Viktor V, Coolen J, Verschakelen J, Dubbeldam A. Performance of low-dose chest CT as a triage tool for patients with suspected COVID-19. J Belg Soc Radiol. 2021; 105(1):1–8. https://doi.org/10.5334/jbsr.2319.

    Google Scholar article

  • Rubin GD, Ryerson CJ, Haramati LB, Sverzellati N, Kanne JP, Raoof S, Schluger NW, Volpi A, Yim JJ, Martin IBK, Anderson DJ, Kong C, Altes T, Bush A, Desai SR, Goldin O, Goo JM , Humbert M, Inoue Y, Kauczor HU, 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 care 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.

    Google Scholar article

  • Sara H. Byrd