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Background <p>Mpox is a re-emerging zoonotic infection caused by an <i>Orthopoxvirus</i> 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.</p> Objective <p>This study assessed the safety and effectiveness of mpox and historical smallpox vaccines, administered during pregnancy and childhood.</p> Methods <p>We 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.</p> Results <p>We 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.</p> Conclusions <p>Vaccinia-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.</p>

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Maternal and Pediatric Use of Vaccines for Mpox: A Living Systematic Review and Meta-analysis of Safety and Effectiveness

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年3月6日

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  • Agustín Ciapponi,
  • Jamile Ballivian,
  • Mabel Berrueta,
  • Juan M. Sambade,
  • Noelia Castellana,
  • Ariel Bardach,
  • Martin Brizuela,
  • Julieta Caravario,
  • Daniel Comande,
  • Esteban Couto,
  • Agustina Mazzoni,
  • Edward Parker,
  • Florencia Salva,
  • Katharina Stegelmann,
  • Xu Xiong,
  • Andy Stergachis,
  • Flor M. Munoz,
  • Pierre Buekens

摘要

Background

Mpox 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.

Objective

This study assessed the safety and effectiveness of mpox and historical smallpox vaccines, administered during pregnancy and childhood.

Methods

We 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.

Results

We 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.

Conclusions

Vaccinia-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.