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Thrombotic events following the BNT162b2 mRNA COVID-19 vaccine (Pfizer-BioNTech) in Aotearoa New Zealand: A self-controlled case series study.
Walton, Muireann; Tomkies, Robert; Teunissen, Thomas; Lumley, Thomas; Hanlon, Timothy.
  • Walton M; Ministry of Health New Zealand, Wellington, New Zealand; Te Whatu Ora, Health New Zealand, New Zealand. Electronic address: muireann.walton@tewhatuora.govt.nz.
  • Tomkies R; Ministry of Health New Zealand, Wellington, New Zealand.
  • Teunissen T; Ministry of Health New Zealand, Wellington, New Zealand.
  • Lumley T; Chair in Biostatistics, Faculty of Science, Statistics, University of Auckland, New Zealand. Electronic address: t.lumley@auckland.ac.nz.
  • Hanlon T; Ministry of Health New Zealand, Wellington, New Zealand; Te Whatu Ora, Health New Zealand, New Zealand. Electronic address: tim.hanlon@tewhatuora.govt.nz.
Thromb Res ; 222: 102-108, 2023 02.
Article Dans Anglais | MEDLINE | ID: covidwho-2326956
ABSTRACT

BACKGROUND:

An association between thrombotic events and SARS-CoV-2 infection and the adenovirus-based COVID-19 vaccines has been established, leading to concern over the risk of thrombosis after BNT162b2 COVID-19 vaccination.

OBJECTIVES:

To evaluate the risk of arterial thrombosis, cerebral venous thrombosis (CVT), splanchnic thrombosis, and venous thromboembolism (VTE) following BNT162b2 vaccination in New Zealand.

METHODS:

This was a self-controlled case series using national hospitalisation and immunisation records to calculate incidence rate ratios (IRR). The study population included individuals aged ≥12 years, unvaccinated, or vaccinated with BNT162b2, who were hospitalised with one of the thrombotic events of interest from 19 February 2021 through 19 February 2022. The risk period was 0-21 days after receiving a primary or booster dose of BNT162b2.

RESULTS:

6039 individuals were hospitalised with one of the thrombotic events examined, including 5127 with VTE, 605 with arterial thrombosis, 272 with splanchnic thrombosis, and 35 with CVT. The proportion of individuals vaccinated with at least one dose of BNT162b2 ranged from 82.7 % to 91.4 %. Compared with the control unexposed period, the IRR (95 % CI) of VTE, arterial thrombosis, splanchnic thrombosis, and CVT were 0.87 (0.76-1.00), 0.73 (0.56-0.95), 0.71 (0.43-1.16), and 0.87 (0.31-2.50) in the 21 days after BNT162b2 vaccination, respectively. There was no statistically significant increased risk of thrombosis following BNT162b2 in different ethnic groups in New Zealand.

CONCLUSION:

The BNT162b2 vaccine was not found to be associated with thrombosis in the general population or different ethnic groups in New Zealand, providing reassurance for the safety of the BNT162b2 vaccine.
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Texte intégral: Disponible Collection: Bases de données internationales Base de données: MEDLINE Sujet Principal: Thrombose / Thrombose intracrânienne / Thromboembolisme veineux / Vaccins contre la COVID-19 / COVID-19 Type d'étude: Études expérimentales / Étude observationnelle / Étude pronostique / Essai contrôlé randomisé Les sujets: Vaccins Limites du sujet: Humains Pays comme sujet: Océanie langue: Anglais Revue: Thromb Res Année: 2023 Type de document: Article

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Texte intégral: Disponible Collection: Bases de données internationales Base de données: MEDLINE Sujet Principal: Thrombose / Thrombose intracrânienne / Thromboembolisme veineux / Vaccins contre la COVID-19 / COVID-19 Type d'étude: Études expérimentales / Étude observationnelle / Étude pronostique / Essai contrôlé randomisé Les sujets: Vaccins Limites du sujet: Humains Pays comme sujet: Océanie langue: Anglais Revue: Thromb Res Année: 2023 Type de document: Article