Clinical Scorecard: Vaccination Against Mpox in Pregnant Individuals and Children: An Ongoing Systematic Review and Meta-analysis of Safety and Efficacy

At a Glance

Key Highlights

• First-generation vaccinia vaccines showed a slight increase in congenital anomalies; second- and third-generation vaccines show no increased adverse pregnancy outcomes.
• Serious adverse events in children are rare, generally mild, and self-limiting.
• Limited safety data exist for third-generation mpox vaccines in pregnancy and pediatric populations, necessitating ongoing high-quality studies and pharmacovigilance.

Guideline-Based Recommendations

Diagnosis

• Identify mpox infection primarily through clinical presentation and laboratory confirmation, especially in high-risk groups including pregnant persons and children.

Management

• Use vaccinia-based vaccines, primarily third-generation non- or minimally replicating formulations (e.g., MVA-BN, LC16m8), for prevention and outbreak control.
• Prioritize vaccination in high-risk populations such as pregnant persons and children despite limited trial data, guided by emerging evidence.

Monitoring & Follow-up

• Implement strengthened pharmacovigilance systems to monitor vaccine safety in pregnant and pediatric populations.
• Conduct ongoing systematic reviews and living meta-analyses to integrate emerging safety and efficacy data.

Risks

• Recognize potential increased risk of congenital anomalies with first-generation vaccines.
• Acknowledge limited data on third-generation vaccine safety in pregnancy and children; monitor for rare adverse events.

Patient & Prescribing Data

Pregnant persons, neonates, infants, children, and adolescents receiving vaccinia-based vaccines for mpox prevention.

Vaccinia-based vaccines have a favorable safety profile in these populations, with second- and third-generation vaccines preferred due to lower risk of adverse pregnancy outcomes and mild, rare adverse events in children.

Clinical Best Practices

• Exclude pregnant persons and children from vaccine trials only when necessary; prioritize their inclusion to generate direct safety and efficacy data.
• Use third-generation vaccinia vaccines preferentially for pregnant and pediatric populations due to better safety profiles.
• Maintain adaptive vaccination policies informed by living systematic reviews and real-world observational data.
• Enhance pharmacovigilance and reporting systems to detect and evaluate adverse events in vulnerable populations.
• Educate healthcare providers on the evolving evidence base and risk-benefit considerations for vaccinia-based mpox vaccination in pregnancy and childhood.

References

• WHO Mpox Outbreak Information
• Safe in Pregnancy/Safe in Children Public Platform
• PROSPERO Registration CRD42024586205
• PROSPERO Registration CRD42024591322