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. 2024 Feb 6;331(5):396-407.
doi: 10.1001/jama.2023.26945.

Neonatal Outcomes After COVID-19 Vaccination in Pregnancy

Mikael Norman  1   2 , Maria C Magnus  3 , Jonas Söderling  4 , Petur B Juliusson  5   6   7 , Lars Navér  1   2 , Anne K Örtqvist  4   8 , Siri Håberg  3   9 , Olof Stephansson  4   10
Affiliations

Neonatal Outcomes After COVID-19 Vaccination in Pregnancy

Mikael Norman et al. JAMA. .

Abstract

Importance: Better knowledge about neonatal adverse events after COVID-19 vaccination during pregnancy could help address concerns about vaccine safety.

Objective: To evaluate the risks of neonatal adverse events after exposure to COVID-19 vaccination during pregnancy.

Design, setting, and participants: Population-based cohort study including all infants in Sweden and Norway born from June 2021 to January 2023. Unique personal identity numbers were used to link individual information from different national registers.

Exposure: Administration of any mRNA vaccine against COVID-19 during pregnancy, irrespective of previous vaccination, number of doses during pregnancy, or vaccine manufacturer.

Main outcomes and measures: Outcomes were neonatal conditions with bleeding/thrombosis or inflammation/infection; disorders of the central nervous system; circulatory, respiratory, or gastrointestinal problems; and neonatal mortality. Statistical methods included logistic regression adjusted for characteristics of the pregnant individuals, with additional restricted and stratified analyses.

Results: Of 196 470 newborn infants included (51.3% male, 93.8% born at term, 62.5% born in Sweden), 94 303 (48.0%) were exposed to COVID-19 vaccination during pregnancy. Exposed infants exhibited no increased odds of adverse neonatal outcomes, and they exhibited lower odds for neonatal nontraumatic intracranial hemorrhage (event rate, 1.7 vs 3.2/1000; adjusted odds ratio [aOR], 0.78 [95% CI, 0.61-0.99]), hypoxic-ischemic encephalopathy (1.8 vs 2.7/1000; aOR, 0.73 [95% CI, 0.55-0.96]), and neonatal mortality (0.9 vs 1.8/1000; aOR, 0.68 [95% CI, 0.50-0.91]). Subgroup analyses found a similar association between vaccination during pregnancy and lower neonatal mortality; subgroups were restricted to infants delivered by individuals unvaccinated before pregnancy, individuals vaccinated before pregnancy, individuals vaccinated after a general recommendation of vaccination during pregnancy was issued, and individuals without COVID-19 infection during pregnancy. Analyses restricted to term infants, singleton births, or infants without birth defects yielded similar results. Stratifying the analysis by vaccine manufacturer did not attenuate the association between vaccination and low neonatal mortality.

Conclusions and relevance: In this large population-based study, vaccination of pregnant individuals with mRNA COVID-19 vaccines was not associated with increased risks of neonatal adverse events in their infants.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Magnus reported receiving grants from Research Council of Norway, NordForsk, and European Research Council during the conduct of the study. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. Cohort Development in a Study of COVID-19 Vaccination During Pregnancy
Figure 2.
Figure 2.. Time to Death in Liveborn Infants Exposed or Unexposed to mRNA COVID-19 Vaccine in Pregnancy in Sweden and Norway
See this image and copyright information in PMC

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References

    1. Rahmati M, Yon DK, Lee SW, et al. . Effects of COVID-19 vaccination during pregnancy on SARS-CoV-2 infection and maternal and neonatal outcomes: a systematic review and meta-analysis. Rev Med Virol. 2023;33(3):e2434. doi:10.1002/rmv.2434 - DOI - PubMed
    1. Carlsen EO, Magnus MC, Oakley L, et al. . Association of COVID-19 vaccination during pregnancy with incidence of SARS-CoV-2 infection in infants. JAMA Intern Med. 2022;182(8):825-831. doi:10.1001/jamainternmed.2022.2442 - DOI - PMC - PubMed
    1. European Medicines Agency . Safety of COVID-19 vaccines. Accessed July 25, 2023. https://www.ema.europa.eu/en/human-regulatory/overview/public-health-thr...
    1. UK National Health Service . COVID-19 vaccines side effects and safety. Accessed July 25, 2023. https://www.nhs.uk/conditions/covid-19/covid-19-vaccination/covid-19-vac...
    1. Norman M, Navér L, Söderling J, et al. . Association of maternal SARS-CoV-2 infection in pregnancy with neonatal outcomes. JAMA. 2021;325(20):2076-2086. doi:10.1001/jama.2021.5775 - DOI - PMC - PubMed

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