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Reactogenicity After Heterologous and Homologous COVID-19 Prime-Boost Vaccination Regimens: Descriptive Interim Results of a Comparative Observational Cohort Study

27 Pages Posted: 25 Oct 2021

See all articles by Lisette Warkentin

Lisette Warkentin

Friedrich-Alexander-Universität Erlangen-Nürnberg - Institute of General Practice

Nikoletta Lippert

Friedrich-Alexander-Universität Erlangen-Nürnberg

Thomas Kühlein

Friedrich-Alexander-Universität Erlangen-Nürnberg

Philipp Steiniger

Friedrich-Alexander-Universität Erlangen-Nürnberg

Klaus Überla

Friedrich-Alexander-Universität Erlangen-Nürnberg

Isabelle Kaiser

Friedrich-Alexander-Universität Erlangen-Nürnberg

Christine Gall

Friedrich-Alexander-Universität Erlangen-Nürnberg

Maria Sebastião

Friedrich-Alexander-Universität Erlangen-Nürnberg

Susann Hueber

Friedrich-Alexander-Universität Erlangen-Nürnberg

More...

Abstract

Background: Due to safety signals after vaccination with COVID-19 vector vaccines, several states recommended to complete the primary immunization series in individuals having received one dose of ChAdOx1 (AstraZeneca) with an mRNA vaccine. However, data on safety and reactogenicity of this heterologous regimen are still scarce. The aim of this study was therefore to compare the reactogenicity and the frequency of medical consultations after boost vaccination in a heterologous regimen with ChAdOx1 and mRNA-vaccines (BNT162b2, BioNTech/Pfizer or mRNA-1273, Moderna) to homologous regimens with ChAdOx1 or mRNA-vaccines, respectively.

Methods: In an observational cohort study reactogenicity and safety were assessed 14 to 19 days (short-term) and 40 to 56 days (long-term) after the boost vaccination using web-based surveys. In the short-term survey solicited and unsolicited reactions were assessed. The long-term survey focussed on health problems leading to medical consultation after the vaccination, including those that were not suspected to be vaccine-related.

Findings: In total, 9146 participants completed at least one of the surveys (ChAdOx1/ChAdOx1: n = 552, ChAdOx1/mRNA: n = 2382, mRNA/mRNA: n = 6212). In the short-term survey, 86 % with ChAdOx1/mRNA regimen reported at least one reaction, in the ChAdOx1/ChAdOx1 and mRNA/mRNA cohorts 58 % and 76 %, respectively (age and sex adjusted p < 0·0001). In the long-term survey, comparable proportions of individuals reported medical consultation (ChAdOx1/ChAdOx1 vs. ChAdOx1/mRNA vs. mRNA/mRNA: 15 % vs. 18 % vs. 16 %, age and sex adjusted p = 0·398). Female gender was associated with a higher reactogenicity and more medical consultations. Younger age was associated with a higher reactogenicity, whereas elderly people reported more medical consultations.

Interpretation: Although the short-term reactogenicity with the heterologous regimen was higher than with the homologous regimes, other factors such as higher efficacy and limited resources during the pandemic may prevail in recommending specific regimens.

Funding: Bavarian Ministry of Science and Art.

Declaration of Interest: LW, NL own(ed) stocks of BioNTech, the investments were made before being involved in the project. The other authors declare not to have any conflict of interests.

Ethical Approval: The Ethics Committee of the Friedrich Alexander University approved the study (47_21 B, 01.03.2021 and 161_21 B, 12.05.2021). All participants consented to participate.

Keywords: COVID-19, Vaccination, heterologous prime-boost regimen, homologous prime-boost regimen, ChAdOx1, BNT162b2, mRNA-1273, reactogenicity, observational study

Suggested Citation

Warkentin, Lisette and Lippert, Nikoletta and Kühlein, Thomas and Steiniger, Philipp and Überla, Klaus and Kaiser, Isabelle and Gall, Christine and Sebastião, Maria and Hueber, Susann, Reactogenicity After Heterologous and Homologous COVID-19 Prime-Boost Vaccination Regimens: Descriptive Interim Results of a Comparative Observational Cohort Study. Available at SSRN: https://ssrn.com/abstract=3949414 or http://dx.doi.org/10.2139/ssrn.3949414

Lisette Warkentin (Contact Author)

Friedrich-Alexander-Universität Erlangen-Nürnberg - Institute of General Practice ( email )

Germany

Nikoletta Lippert

Friedrich-Alexander-Universität Erlangen-Nürnberg ( email )

Lange Gasse 20
Lange Gasse 20,
Nürnberg, 90403
Germany

Thomas Kühlein

Friedrich-Alexander-Universität Erlangen-Nürnberg ( email )

Lange Gasse 20
Lange Gasse 20,
Nürnberg, 90403
Germany

Philipp Steiniger

Friedrich-Alexander-Universität Erlangen-Nürnberg ( email )

Lange Gasse 20
Lange Gasse 20,
Nürnberg, 90403
Germany

Klaus Überla

Friedrich-Alexander-Universität Erlangen-Nürnberg ( email )

Lange Gasse 20
Lange Gasse 20,
Nürnberg, 90403
Germany

Isabelle Kaiser

Friedrich-Alexander-Universität Erlangen-Nürnberg ( email )

Lange Gasse 20
Lange Gasse 20,
Nürnberg, 90403
Germany

Christine Gall

Friedrich-Alexander-Universität Erlangen-Nürnberg ( email )

Lange Gasse 20
Lange Gasse 20,
Nürnberg, 90403
Germany

Maria Sebastião

Friedrich-Alexander-Universität Erlangen-Nürnberg ( email )

Lange Gasse 20
Lange Gasse 20,
Nürnberg, 90403
Germany

Susann Hueber

Friedrich-Alexander-Universität Erlangen-Nürnberg ( email )

Lange Gasse 20
Lange Gasse 20,
Nürnberg, 90403
Germany

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