SynthesisDrug safety2026
Maternal and Pediatric Use of Vaccines for Mpox: A Living Systematic Review and Meta-analysis of Safety and Effectiveness.
Synthesis in Drug safety, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.
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
3 citing papers in PubMed.
- Article
- Comment on "Maternal and Pediatric Use of Vaccines for Mpox: A Living Systematic Review and Meta-analysis of Safety and Effectiveness".Drug safety · 2026Article
- Mpox (Monkeypox) in Pregnancy Updates.Health science reports · 2026Article
Corrections and comments
- Commented on by
Authors and funding
18 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundMpox is a re-emerging zoonotic infection caused by an Orthopoxvirus closely related to smallpox. The 2022-23 global outbreak prompted rapid use of vaccinia-based vaccines, historically developed for smallpox and those of the latest generation used for mpox prevention. Assessing their safety and effectiveness in pregnant persons and children is critical to guide policies protecting populations at an elevated risk of severe illness.
objectiveThis study assessed the safety and effectiveness of mpox and historical smallpox vaccines, administered during pregnancy and childhood.
methodsWe conducted a living systematic review and meta-analysis (PROSPERO CRD42024591322/CRD42024586205) following Cochrane, World Health Organization, and Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) standards. We searched biweekly across major databases, trial registries, preprints, and gray literature (inception to September 2025) for studies evaluating the safety and effectiveness of vaccinia-based smallpox vaccines, including historical (first- and second-generation) and modern (third-generation) vaccines, in maternal and pediatric populations. Reviewers independently conducted study selection, data extraction, and risk-of-bias assessment. Meta-analyses employed random-effects models, and results are presented through an interactive dashboard and a living platform.
resultsWe included 27 clinical studies (1949-2025), involving 1,406,771 children/adolescents (eight studies) and 11,482 pregnant persons (19 studies). Most maternal data came from first-generation vaccines (Lister, Finnish, Dryvax, APSV). These vaccines were not associated with an increased risk of spontaneous abortion (risk ratio [RR] 1.02, 95% confidence interval [CI] 0.70-1.48), stillbirth (RR 1.02, 95% CI 0.70-1.48), or preterm birth (RR 1.08, 95% CI 0.78-1.50), but were linked to a higher risk of congenital anomalies (RR 1.25, 95% CI 1.01-1.54). Fifty-two fetal vaccinia cases were reported globally up to 1978, with none since. Evidence on second- (ACAM2000) and third-generation (MVA-BN) non-replicating vaccines remains limited. In children, serious adverse events were rare, and MVA-BN caused only mild self-limiting reactions. No study assessed vaccine effectiveness in pregnant persons, while limited pediatric data suggested possible protection after post-exposure prophylaxis.
conclusionsVaccinia-based vaccines appear generally safe in pregnancy and children. However, evidence on the safety and effectiveness of third-generation mpox vaccines is still scarce. High-quality prospective studies and strengthened pharmacovigilance are urgently needed to inform policy and clinical decision making.
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