Vascular thrombosis after single dose Ad26.COV2.S vaccine in healthcare workers in South Africa: open label, single arm, phase 3B study (Sisonke study).

ABSTRACT:

Objective

To assess the rates of vascular thrombotic adverse events in the first 35 days after one dose of the Ad26.COV2.S vaccine (Janssen/Johnson & Johnson) in healthcare workers in South Africa and to compare these rates with those observed in the general population.

Design

Open label, single arm, phase 3B study.

Setting

Sisonke study, South Africa, 17 February to 15 June 2021.

Participants

The Sisonke cohort of 477 234 healthcare workers, aged ≥18 years, who received one dose of the Ad26.COV2.S vaccine.

Main outcome measures

Observed rates of venous arterial thromboembolism and vaccine induced immune thrombocytopenia and thrombosis in individuals who were vaccinated, compared with expected rates, based on age and sex specific background rates from th

SUBMITTER: Jacobson BF 

PROVIDER: S-EPMC10083528 | biostudies-literature | 2023

REPOSITORIES: biostudies-literature