Journal Article Epublish 1 citation
PubMed: 38538736 DOI: 10.1038/s41598-024-57880-8
Lack of association between COVID-19 vaccines and miscarriage onset using a case-crossover design.
Sci Rep 14(1):7275
Authors: Irati Gastesi Orbegozo, Lucía Cea-Soriano, Ana Llorente, Consuelo Huerta-Álvarez
Affiliations
- Biomedical Research Foundation Hospital 12 de Octubre, Instituto de Investigación 12 de Octubre (imas12), Madrid, Spain.
- Department of Public Health and Maternal Child Health, Faculty of Medicine, Complutense University of Madrid, Pza. Ramón y Cajal, s/n. Ciudad Universitaria, 28040, Madrid, Spain.
- BIFAP, Division of Pharmacoepidemiology and Pharmacovigilance, Spanish Agency for Medicines and Medical Devices (AEMPS), Madrid, Spain.
- Department of Public Health and Maternal Child Health, Faculty of Medicine, Complutense University of Madrid, Pza. Ramón y Cajal, s/n. Ciudad Universitaria, 28040, Madrid, Spain.
Abstract
Pregnant women might have an increased risk of SARS-COV-2 infection. Although evidence towards the efficacy and safety of COVID-19 is growing still there is room for improvement on the knowledge towards pregnancy adverse events, such as miscarriage. We explored the association of COVID-19 vaccine with the risk of miscarriages using the Real-World. We identified a cohort of vaccinated pregnancies using the BIFAP database which contains systematically recorded data on care patients in Spain (N = 4054). We then restricted it to those women who had a miscarriage using a validated algorithm (N = 607). Among them, we performed a case-crossover design to evaluate the effect of intermittent exposures on the risk of miscarriage. Adjusted Odds Ratio with their confidence intervals were calculated using two analytical approaches: conditional logistic regression and Generalized Linear Mixed-Effects Models. A total of 225 (37.1%) were aged 35-39 years. The most common comorbidities were asthma, migraine, gastritis, and hypothyroidism. A total of 14.7% received only one dose of COVID-19 and 85.3% two doses, respectively. A total of 36.8% of women with one dose and 27.6% with two doses received the vaccine 7 days prior to the miscarriage. Corresponding adjusted estimates for the risk of miscarriage using the conditional logistic regression where as follows: 1.65 (95% CI 0.85-3.23) when using as the sum of 3 control moments among women with one dose, 1.02 (95% CI 0.72-1.46) among women with two doses and 1.03 (95% CI 0.72, 1.46) using the whole study population. Very similar results were obtained when conducting the Generalized Linear Mixed-Effects Models. There was no overall increased risk of miscarriage onset associated with COVID-19 vaccine although contradictory results were found according to the number of doses. Further studies are required with larger sample sizes to assess this association.
MeSH
Pregnancy, Vaccines, Covid-19 Vaccines, Abortion, Spontaneous, Covid-19, Natural Science Disciplines