COVID-19 vaccination and birth outcomes of 186,990 women vaccinated before pregnancy: an England-wide cohort study
Year: 2024
Type: article
Study design: Observational Study
Abstract: Background: COVID-19 vaccination in pregnancy is recommended by the World Health Organisation as effective and safe. However, there remains a lack of robust evidence to inform vaccination choices for women of childbearing potential in relation to their future pregnancies. Here we investigated the association between starting a course of COVID-19 vaccination before pregnancy and birth outcomes. Methods: We analysed England-wide linked electronic health records for all pregnancies reaching at least 24 weeks gestation between 25th May 2021 and 28th October 2022. We estimated incidence rates and hazard ratios for birth and pregnancy outcomes by pre-pregnancy COVID-19 vaccination status. Findings: Based on 186,990 women, compared to starting a pregnancy unvaccinated, receiving COVID-19 vaccination within 12 months before pregnancy was associated with lower risks of very and extremely preterm birth and small-for-gestational age in term babies for any vaccine type (adjusted hazard ratio and 95% confidence interval: 0.74 [0.63, 0.88] and 0.94 [0.88, 1.00], respectively), and lower stillbirth risk in those receiving an mRNA vaccine (0.72 [0.52, 1.00]). Incidence of venous thromboembolism during pregnancy was higher amongst women receiving a viral-vector, but not an mRNA vaccine (1.54 [1.10, 2.16] and 1.02 [0.70, 1.50], respectively). Results were generally consistent for different dose regimens and across sensitivity analyses. Interpretation: We found evidence that pregnancies starting within 12 months from a first COVID-19 vaccination, compared to those in unvaccinated women, experienced fewer adverse birth outcomes, overall or in selected subgroups of the general population, accounting for potential confounders. An mRNA vaccine should be preferred to a viral-vector vaccine, to minimise safety issues, but where the latter is the only choice, it is still to be preferred to starting a pregnancy unvaccinated. The venous thromboembolism risk of the viral-vector vaccine was substantially lower compared to that attributable to SARS-CoV-2 infection in pregnancy or to commonly used medications such as hormone replacement therapy and oral contraceptives in the non-pregnant population. Funding: UK National Institute for Health and Care Research (NIHR), UKRIMedical Research Council, UK Research and Innovation, The Alan Turing Institute, Health Data Research UK, the Department of Health and Social Care.
Language: English
Subfield: Obstetrics and Gynecology
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $4,000
Funders: Alan Turing Institute, Government of the United Kingdom, UK Research and Innovation, National Institute for Health and Care Research, British Heart Foundation, Department of Health and Social Care, University College London, Vetenskapsrådet, Forskningsrådet om Hälsa, Arbetsliv och Välfärd, Medical Research Council, Engineering and Physical Sciences Research Council, NIHR Cambridge Biomedical Research Centre
Awards: Accelerator Award, G139696651, G2123105393, Novel risk factors for cardiovascular disease during pregnancy in whole populations of the UK, G2328232902, Large-scale integrative genomic studies of high-dimensional traits in cardiovascular diseases (renewal), G2465463101, Mental and cognitive health in relation to functional ability and somatic health in the elderly. The influence of age, sex, birth cohort, genetic, psychological, social and neurobiological factors, G2493601830, G2537968379, G2558559306, G370598735, UKRI Centre for Doctoral Training in AI-enabled healthcare systems, G4753630297, G4782868754, Characterisation, determinants, mechanisms and consequences of the long-term effects of COVID-19: providing the evidence base for health care services, G5323192444, G5421189793, G5509661070, Understanding Mechanisms of Thrombosis and Thrombocytopenia in COVID-19 and with SARS-CoV-2 Vaccines, G6526062327, G6641991021, G6781659469, BHF Data Science Centre, G8415457339
OpenAlex ID: W4401529471
