Data discrepancies and substandard reporting of interim data of Sputnik V phase 3 trial

Enrico M Bucci¹, Johannes Berkhof², André Gillibert³, Gowri Gopalakrishna², Raffaele A Calogero⁴, Lex M Bouter⁵, Konstantin Andreev⁶, Florian Naudet⁷, Vasiliy Vlassov⁸

Affiliations

¹ Sbarro Institute, Temple University Department of Biology, Philadelphia, 19122 PA, USA. Electronic address: enrico.bucci@temple.edu.
² Department of Epidemiology and Data Science, Amsterdam University Medical Centers, Amsterdam, Netherlands.
³ Department of Biostatistics, CHU Rouen, Rouen, France.
⁴ Department of Molecular Biotechnology and Health Sciences, University of Turin, Turin, Italy.
⁵ Department of Epidemiology and Data Science, Amsterdam University Medical Centers, Amsterdam, Netherlands; Department of Philosophy, Faculty of Humanities, Vrije Universiteit Amsterdam.
⁶ Department of Molecular Biosciences, Howard Hughes Medical Institute, Northwestern University, Evanston, IL, USA.
⁷ Centre Hospitalier Universitaire de Rennes, Université de Rennes, Rennes, France.
⁸ Higher School of Economics University, Moscow, Russia.

PMID: 33991475
PMCID: PMC9751705
DOI: 10.1016/S0140-6736(21)00899-0

Comment

Data discrepancies and substandard reporting of interim data of Sputnik V phase 3 trial

Enrico M Bucci et al. Lancet. 2021.

. 2021 May 22;397(10288):1881-1883.

doi: 10.1016/S0140-6736(21)00899-0. Epub 2021 May 12.

Authors

Enrico M Bucci¹, Johannes Berkhof², André Gillibert³, Gowri Gopalakrishna², Raffaele A Calogero⁴, Lex M Bouter⁵, Konstantin Andreev⁶, Florian Naudet⁷, Vasiliy Vlassov⁸

Affiliations

¹ Sbarro Institute, Temple University Department of Biology, Philadelphia, 19122 PA, USA. Electronic address: enrico.bucci@temple.edu.
² Department of Epidemiology and Data Science, Amsterdam University Medical Centers, Amsterdam, Netherlands.
³ Department of Biostatistics, CHU Rouen, Rouen, France.
⁴ Department of Molecular Biotechnology and Health Sciences, University of Turin, Turin, Italy.
⁵ Department of Epidemiology and Data Science, Amsterdam University Medical Centers, Amsterdam, Netherlands; Department of Philosophy, Faculty of Humanities, Vrije Universiteit Amsterdam.
⁶ Department of Molecular Biosciences, Howard Hughes Medical Institute, Northwestern University, Evanston, IL, USA.
⁷ Centre Hospitalier Universitaire de Rennes, Université de Rennes, Rennes, France.
⁸ Higher School of Economics University, Moscow, Russia.

PMID: 33991475
PMCID: PMC9751705
DOI: 10.1016/S0140-6736(21)00899-0

No abstract available

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Conflict of interest statement

EMB is the owner of Resis Srl. All other authors declare no competing interests. Code to test the homogeneity of vaccine efficacy across age groups is available on the Open Science Framework, https://osf.io/sudxe/

Comment on

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.
Logunov DY, Dolzhikova IV, Zubkova OV, Tukhvatullin AI, Shcheblyakov DV, Dzharullaeva AS, Grousova DM, Erokhova AS, Kovyrshina AV, Botikov AG, Izhaeva FM, Popova O, Ozharovskaya TA, Esmagambetov IB, Favorskaya IA, Zrelkin DI, Voronina DV, Shcherbinin DN, Semikhin AS, Simakova YV, Tokarskaya EA, Lubenets NL, Egorova DA, Shmarov MM, Nikitenko NA, Morozova LF, Smolyarchuk EA, Kryukov EV, Babira VF, Borisevich SV, Naroditsky BS, Gintsburg AL. Logunov DY, et al. Lancet. 2020 Sep 26;396(10255):887-897. doi: 10.1016/S0140-6736(20)31866-3. Epub 2020 Sep 4. Lancet. 2020. PMID: 32896291 Free PMC article. Clinical Trial.
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.
Logunov DY, Dolzhikova IV, Shcheblyakov DV, Tukhvatulin AI, Zubkova OV, Dzharullaeva AS, Kovyrshina AV, Lubenets NL, Grousova DM, Erokhova AS, Botikov AG, Izhaeva FM, Popova O, Ozharovskaya TA, Esmagambetov IB, Favorskaya IA, Zrelkin DI, Voronina DV, Shcherbinin DN, Semikhin AS, Simakova YV, Tokarskaya EA, Egorova DA, Shmarov MM, Nikitenko NA, Gushchin VA, Smolyarchuk EA, Zyryanov SK, Borisevich SV, Naroditsky BS, Gintsburg AL; Gam-COVID-Vac Vaccine Trial Group. Logunov DY, et al. Lancet. 2021 Feb 20;397(10275):671-681. doi: 10.1016/S0140-6736(21)00234-8. Epub 2021 Feb 2. Lancet. 2021. PMID: 33545094 Free PMC article. Clinical Trial.

References

1. Logunov DY, Dolzhikova IV, Shcheblyakov DV, 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;397:671–681. - PMC - PubMed
1. Logunov DY, Dolzhikova IV, Zubkova OV, et al. Safety and immunogenicity of an rAd26 and rAd5 vector-based heterologous prime-boost COVID-19 vaccine in two formulations: two open, non-randomized phase 1/2 studies from Russia. Lancet. 2020;396:887–897. - PMC - PubMed
1. Vlassov V, Rebrova O, Aksenov V. Commentary on the publication of preliminary results of the Sputnik-V vaccine phase 3 trial. Feb 5, 2021. http://osdm.org/english/2021/02/06/a-commentary-on-the-publication-of-pr...
1. Bucci E, Andreev K, Björkman A, et al. Safety and efficacy of the Russian COVID-19 vaccine: more information needed. Lancet. 2020;396:e53. - PMC - PubMed
1. 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:e54–e55. - PMC - PubMed

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Data discrepancies and substandard reporting of interim data of Sputnik V phase 3 trial

Affiliations

Data discrepancies and substandard reporting of interim data of Sputnik V phase 3 trial

Authors

Affiliations

Conflict of interest statement

Comment on

References

Publication types

MeSH terms

LinkOut - more resources

Full Text Sources

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