The WHO highlights the importance of standardized safety monitoring protocols for mpox vaccines, particularly in low-income settings where challenges in accessing diagnostics may limit the ability to apply restrictions for people living with HIV.
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| WHO reassures the safety of mpox vaccines for high-risk groups, emphasizing the need for continued monitoring and research. Image Courtesy: Africa CDC |
Geneva, Switzerland – October 5, 2024:
The World Health Organization (WHO) has reaffirmed the safety of the available mpox vaccines for use in high-risk groups, including pregnant women and children. In a recent statement from its Global Advisory Committee on Vaccine Safety (GACVS), the WHO emphasized the importance of continued safety monitoring and the need for further research to address specific concerns.
The resurgence of mpox cases in the African region, coupled with the emergence of a new variant, has prompted renewed global concern. The WHO has declared a Public Health Emergency of International Concern (PHEIC) in response to the outbreak.
The GACVS reviewed the safety data of three mpox vaccines: MVA-BN, LC16m8, and ACAM2000. While the vaccines have shown favorable safety profiles in adults, the committee emphasized the need for close monitoring to detect any potential safety signals, especially in high-risk groups.
One of the key recommendations is the importance of proper training for healthcare workers administering these vaccines, particularly the LC16m8 vaccine which requires intradermal injection. This will help minimize immunization errors and reduce adverse events.
The WHO also highlighted the need for standardized safety monitoring protocols, such as the 'WHO Protocol: Cohort Event Monitoring (CEM) for Active Safety Surveillance of Mpox Vaccines.' This will help countries capture potential safety signals early on, especially in groups with limited data.
While the vaccines are generally safe, the WHO encourages continued monitoring and research to address specific concerns, such as the use of LC16m8 in immunocompromised individuals and pregnant women. The committee also noted challenges in applying restrictions for people living with HIV due to limited access to diagnostics and testing in certain regions.
The WHO called upon public health authorities, researchers, regulatory agencies, and other stakeholders to conduct comprehensive vaccine safety surveillance and studies to identify any rare or unknown adverse events. The 'WHO Protocol: Cohort Event Monitoring' will provide a framework for countries to implement these measures.
Overall, the WHO's statement reaffirms the safety of the available mpox vaccines while emphasizing the need for continued vigilance and research to ensure their optimal use in all target populations.