ArticleVaccine2021
Guidance for design and analysis of observational studies of fetal and newborn outcomes following COVID-19 vaccination during pregnancy.
Article in Vaccine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
23 citing papers in PubMed, 2 syntheses or guidelines pooled it, 36 citations in OpenAlex.
- Pooled it
- Pooled it
- Association Between COVID-19 Vaccination During Pregnancy and Safety Among Infants.Journal of the Pediatric Infectious Diseases Society · 2026Article
- Article
- COVID-19 vaccination around the time of conception and risk of placenta-mediated adverse pregnancy outcomes.Acta obstetricia et gynecologica Scandinavica · 2025Article
- Perinatal outcomes of symptomatic chikungunya, dengue and Zika infection during pregnancy in Brazil: a registry-based cohort study.Nature communications · 2025Article
- COVID-19 vaccination and birth outcomes of 186,990 women vaccinated before pregnancy: an England-wide cohort study.The Lancet regional health. Europe · 2024Article
- Nonadjuvanted Bivalent Respiratory Syncytial Virus Vaccination and Perinatal Outcomes.JAMA network open · 2024Observational
- Article
- COVID-19 Vaccine Safety Surveillance in Early Pregnancy in the United States: Design Factors Affecting the Association Between Vaccine and Spontaneous Abortion.American journal of epidemiology · 2023Article
- COVID-19 Booster Vaccination in Early Pregnancy and Surveillance for Spontaneous Abortion.JAMA network open · 2023Observational
- COVID-19 vaccination and changes in the menstrual cycle among vaccinated persons.Fertility and sterility · 2023Article
- Maternal mRNA covid-19 vaccination during pregnancy and delta or omicron infection or hospital admission in infants: test negative design study.BMJ (Clinical research ed.) · 2023Article
- Pregnancy, fetal, and neonatal outcomes after a first booster dose of covid-19 vaccine during pregnancy in Ontario, Canada: population based, retrospective cohort study.BMJ medicine · 2023Article
- Pregnancy outcomes after SARS-CoV-2 infection in periods dominated by delta and omicron variants in Scotland: a population-based cohort study.The Lancet. Respiratory medicine · 2022Article
- COVID-19 vaccination effectiveness rates by week and sources of bias: a retrospective cohort study.BMJ open · 2022Article
- Risk of preterm birth, small for gestational age at birth, and stillbirth after covid-19 vaccination during pregnancy: population based retrospective cohort study.BMJ (Clinical research ed.) · 2022Article
- Point: Uncertainty about estimating the risks of COVID-19 during pregnancy.Paediatric and perinatal epidemiology · 2022Article
- Receipt of COVID-19 Vaccine During Pregnancy and Preterm or Small-for-Gestational-Age at Birth - Eight Integrated Health Care Organizations, United States, December 15, 2020-July 22, 2021.MMWR. Morbidity and mortality weekly report · 2022Article
- The Use of the Target Trial Approach in Perinatal Pharmacoepidemiology: A Scoping Review Protocol.Frontiers in pharmacology · 2022Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 7 institutions in 2 countries.
Funding
Abstract
COVID-19 vaccines are now being deployed as essential tools in the public health response to the global SARS-CoV-2 pandemic. Pregnant individuals are a unique subgroup of the population with distinctive considerations regarding risk and benefit that extend beyond themselves to their fetus/newborn. As a complement to traditional pharmacovigilance and clinical studies, evidence to comprehensively assess COVID-19 vaccine safety in pregnancy will need to be generated through observational epidemiologic studies in large populations. However, there are several unique methodological challenges that face observational assessments of vaccination during pregnancy, some of which may be more pronounced for COVID-19 studies. In this contribution, we discuss the most critical study design, data collection, and analytical issues likely to arise. We offer brief guidance to optimize the quality of such studies to ensure their maximum value for informing public health decision-making.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.