Serologic Response and Safety after a Third Dose of the COVID-19 BNT162b2 Vaccine in Patients with Inflammatory Bowel Diseases

on behalf of the REsponses to COVid-19 vaccinE IsRaeli IBD group [RECOVERI]

doi:10.3390/vaccines11071263

Serologic Response and Safety after a Third Dose of the COVID-19 BNT162b2 Vaccine in Patients with Inflammatory Bowel Diseases

on behalf of the REsponses to COVid-19 vaccinE IsRaeli IBD group [RECOVERI]

Research output: Contribution to journal › Article › peer-review

1 Scopus citations

Abstract

Vaccines are pivotal for control of the coronavirus disease (COVID-19) pandemic. Patients with inflammatory bowel diseases (IBDs) treated with antitumor necrosis factor (TNF)-α have lower serologic response after two COVID-19 vaccine doses. Data regarding a third vaccine dose are scarce. An Israeli multicenter prospective observational study recruited 319 subjects: 220 with IBD (79 treated with anti-TNFα) and 99 healthy control (HC) participants. All patients received two mRNA-BNT162b2 vaccines (Pfizer/BioNTech), 80% of whom received a third vaccine dose. Evaluation included disease activity, anti-spike (S) and nucleocapsid (N) antibody levels, anti-TNFα drug levels, and adverse events (AEs). All participants showed significant serologic response one month after receiving a third dose. However, three months later, the anti-S levels decreased significantly in patients treated with anti-TNFα compared with the non-anti-TNFα and HC groups. A correlation between serologic response to the third vaccine dose and anti-TNF drug levels was not found. No significant AE or IBD exacerbation was observed. Importantly, lower serologic response after the third vaccine dose predicted infection. A third dose of BNT162b2 is effective and safe in patients with IBD. Lower serologic response predicted infection, even in seropositive subjects. Lower serologic responses and their rapid decline suggest a fourth vaccine dose in this patient population.

Original language	English
Article number	1263
Journal	Vaccines
Volume	11
Issue number	7
DOIs	https://doi.org/10.3390/vaccines11071263
State	Published - 20 Jul 2023
Externally published	Yes

Bibliographical note

Publisher Copyright:
© 2023 by the authors.

Funding

We would like to thank study participants for their effort and time. The Israeli IBD Society and Israeli GI association are thanked for their support, and Naim Abu-Freha is thanked for specific efforts to promote the study. This study was partially supported by a generous grant from the Leona M. and Harry B. Helmsley Charitable Trust. The Crohn’s and Colitis Foundation of Israel, the European Federation of Crohn’s and Colitis Associations, and the AMICI group are thanked for partially funding this study and supporting recruitment efforts. We thank Kawsar Kaboub and Hanan Abu Taha from the Mucosal Immunology Laboratory at the Felsenstein Medical Research Center for their scientific contribution. This study was performed in collaboration with the Israeli Ministry of Health. This research was funded by the Leona M. and Harry B. Helmsley Charitable Trust, grant number G-2101-04950 (I.D). The Crohn’s and Colitis Foundation of Israel and the European Federation of Crohn’s and Colitis Associations partially supported the study. I.D.: consultation/advisory board: Abbvie, Athos, Arena, Cambridge Healthcare, Celltrion, Celgene/BMS, DSM, Ferring, Food Industries Organization, Iterative Scopes, Integra Holdings, Janssen, MSD, Neopharm, Pfizer, Rafa laboratories, Roche/Genentech, Sangamo, Sublimity, Takeda, and Wildbio; speaking/teaching: Abbvie, Altman, Celltrion, Celgene/BMS, Ferring, Falk Pharma, Janssen, MSD, Neopharm, Nestle, Pfizer, Rafa laboratories, Roche/Genentech, Sandoz, and Takeda. A.B.G.S.; grant support from Takeda and Janssen; consultancy and lecture fees from Takeda, Janssen, Abbvie, Pfizer, Neopharm, and BMS. E.Z. has received research support and consulting fees from Janssen, Abbvie, Takeda, Neopharm, Celgene, and Pfizer. All other authors declare they have no conflicts of interest.

Funders	Funder number
Crohn’s and Colitis Foundation of Israel
European Federation of Crohn’s and Colitis Associations
Bristol-Myers Squibb
Leona M. and Harry B. Helmsley Charitable Trust	G-2101-04950

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

SDG 3 Good Health and Well-being

Keywords

BNT162b2 vaccine
COVID-19
anti-TNFα
inflammatory bowel diseases

Access to Document

10.3390/vaccines11071263

Cite this

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title = "Serologic Response and Safety after a Third Dose of the COVID-19 BNT162b2 Vaccine in Patients with Inflammatory Bowel Diseases",

abstract = "Vaccines are pivotal for control of the coronavirus disease (COVID-19) pandemic. Patients with inflammatory bowel diseases (IBDs) treated with antitumor necrosis factor (TNF)-α have lower serologic response after two COVID-19 vaccine doses. Data regarding a third vaccine dose are scarce. An Israeli multicenter prospective observational study recruited 319 subjects: 220 with IBD (79 treated with anti-TNFα) and 99 healthy control (HC) participants. All patients received two mRNA-BNT162b2 vaccines (Pfizer/BioNTech), 80\% of whom received a third vaccine dose. Evaluation included disease activity, anti-spike (S) and nucleocapsid (N) antibody levels, anti-TNFα drug levels, and adverse events (AEs). All participants showed significant serologic response one month after receiving a third dose. However, three months later, the anti-S levels decreased significantly in patients treated with anti-TNFα compared with the non-anti-TNFα and HC groups. A correlation between serologic response to the third vaccine dose and anti-TNF drug levels was not found. No significant AE or IBD exacerbation was observed. Importantly, lower serologic response after the third vaccine dose predicted infection. A third dose of BNT162b2 is effective and safe in patients with IBD. Lower serologic response predicted infection, even in seropositive subjects. Lower serologic responses and their rapid decline suggest a fourth vaccine dose in this patient population.",

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AU - Ollech, Jacob E.

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AU - Pauker, Maor H.

AU - Friedenberg, Adi

AU - Levy-Barda, Adva

AU - Broitman, Yelena

AU - Ben Zvi, Haim

AU - Perets, Tsachi Tsadok

AU - Eliakim, Rami

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AB - Vaccines are pivotal for control of the coronavirus disease (COVID-19) pandemic. Patients with inflammatory bowel diseases (IBDs) treated with antitumor necrosis factor (TNF)-α have lower serologic response after two COVID-19 vaccine doses. Data regarding a third vaccine dose are scarce. An Israeli multicenter prospective observational study recruited 319 subjects: 220 with IBD (79 treated with anti-TNFα) and 99 healthy control (HC) participants. All patients received two mRNA-BNT162b2 vaccines (Pfizer/BioNTech), 80% of whom received a third vaccine dose. Evaluation included disease activity, anti-spike (S) and nucleocapsid (N) antibody levels, anti-TNFα drug levels, and adverse events (AEs). All participants showed significant serologic response one month after receiving a third dose. However, three months later, the anti-S levels decreased significantly in patients treated with anti-TNFα compared with the non-anti-TNFα and HC groups. A correlation between serologic response to the third vaccine dose and anti-TNF drug levels was not found. No significant AE or IBD exacerbation was observed. Importantly, lower serologic response after the third vaccine dose predicted infection. A third dose of BNT162b2 is effective and safe in patients with IBD. Lower serologic response predicted infection, even in seropositive subjects. Lower serologic responses and their rapid decline suggest a fourth vaccine dose in this patient population.

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Serologic Response and Safety after a Third Dose of the COVID-19 BNT162b2 Vaccine in Patients with Inflammatory Bowel Diseases

Abstract

Bibliographical note

Funding

UN SDGs

Keywords

Access to Document

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Cite this