lancet-header

Preprints with The Lancet is part of SSRN´s First Look, a place where journals identify content of interest prior to publication. Authors have opted in at submission to The Lancet family of journals to post their preprints on Preprints with The Lancet. The usual SSRN checks and a Lancet-specific check for appropriateness and transparency have been applied. Preprints available here are not Lancet publications or necessarily under review with a Lancet journal. These preprints are early stage research papers that have not been peer-reviewed. The findings should not be used for clinical or public health decision making and should not be presented to a lay audience without highlighting that they are preliminary and have not been peer-reviewed. For more information on this collaboration, see the comments published in The Lancet about the trial period, and our decision to make this a permanent offering, or visit The Lancet´s FAQ page, and for any feedback please contact preprints@lancet.com.

Adverse Events Following the BNT162b2 mRNA COVID-19 Vaccine (Pfizer-BioNtech) in Aotearoa New Zealand

19 Pages Posted: 3 Feb 2023

See all articles by Muireann Walton

Muireann Walton

Government of New Zealand - Ministry of Health

Vadim Pletzer

Government of New Zealand - Ministry of Health

Thomas Teunissen

Government of New Zealand - Ministry of Health

Thomas Lumley

University of Auckland - Faculty of Science

Timothy Hanlon

Government of New Zealand - Ministry of Health

More...

Abstract

Background:  In February 2021, New Zealand began its largest ever immunisation programme with the BNT162b2 mRNA COVID-19 vaccine. We aimed to understand the association between 12 adverse events of special interest (AESIs) and a primary dose of BNT162b2 in the New Zealand population, aged ≥ 5 years, from 19 February 2021 through 10 February 2022.

Methods: Using national electronic health records, the observed rates of AESIs within a risk period (0-21 days) following vaccination were compared to the expected rates based on background data (2014 - 2019). The incidence rate ratio (IRR) for each AESI was estimated with 95% confidence intervals (CI) and adjusted by age. The risk difference was calculated to estimate the excess number of events per 100,000 persons vaccinated.

Findings: As of 10 February 2022, 4,277,163 first and 4,114,364 second doses of BNT162b2 were administered to the eligible New Zealand population, aged ≥ 5 years. The observed rates of most AESIs post-vaccination were not statistically different than the expected rates. The IRR (95% CI) of myo/pericarditis following the first dose was 2.6 (2.2– 2.9) with a risk difference (95% CI) of 1.6 (1.1– 2.1) per 100,000 persons vaccinated and was 4.1 (3.7– 4.5) with a risk difference of 3.2 (2.6– 3.9) per 100,000 persons vaccinated following the second dose. The highest IRR was 25.8 (95% CI 15.6– 37.9) in the 5-19 years age group, following the second dose of the vaccine, with an estimated 5 additional myo/pericarditis cases per 100,000 persons vaccinated. An increased incidence of acute kidney injury (AKI) was observed following the first (1.6 (1.5– 1.6)) and second (1.7 (1.6– 1.7)) dose of BNT162b2.

Interpretation: Although rare, a statistically significant association between BNT162b2 vaccination and myo/pericarditis and AKI was observed. While the association between BNT162b2 and myo/pericarditis has been confirmed internationally, further research is required to understand the association of AKI. BNT162b2 was not found to be associated with most of the AESIs investigated, providing reassurances around the safety of the vaccine.

Funding: The work reported in this publication was undertaken during the COVID-19 Vaccine and Immunisation programme within the Ministry of Health New Zealand. Funding for this programme was provided by the New Zealand government. This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.

Declaration of Interest: The authors have no conflicts of interest to disclose.

Ethics Approval: The study did not require informed consent of individual participants as we used a deidentified dataset and received an exemption from New Zealand’s Health and Disability Ethics Committee (HDEC) of New Zealand (Reference #:2022 OOS 11950).

Keywords: COVID-19, mRNA Vaccines, BNT162b2, Adverse events, Pharmacoepidemiology

Suggested Citation

Walton, Muireann and Pletzer, Vadim and Teunissen, Thomas and Lumley, Thomas and Hanlon, Timothy, Adverse Events Following the BNT162b2 mRNA COVID-19 Vaccine (Pfizer-BioNtech) in Aotearoa New Zealand. Available at SSRN: https://ssrn.com/abstract=4329970 or http://dx.doi.org/10.2139/ssrn.4329970

Muireann Walton

Government of New Zealand - Ministry of Health ( email )

Vadim Pletzer

Government of New Zealand - Ministry of Health ( email )

Thomas Teunissen

Government of New Zealand - Ministry of Health ( email )

Thomas Lumley

University of Auckland - Faculty of Science ( email )

Timothy Hanlon (Contact Author)

Government of New Zealand - Ministry of Health ( email )

Click here to go to TheLancet.com

Paper statistics

Abstract Views
22,689
Downloads
3,898
PlumX Metrics