Vaccine Safety Shaping the Fight against mpox

On June 9th, the World Health Organization (WHO) called for enhanced prevention and response efforts for mpox, which was deemed a public health emergency last August.  The WHO Director-General stated that more than 37,000 confirmed mpox cases have been reported from 25 countries, including 125 deaths, since the beginning of 2024. The Democratic Republic of Congo (DRC) accounts for 60% of confirmed cases and 40% of deaths, and the country reports between 2,000 and 3,000 suspected cases each week.

In late 2023, a new mpox strain called clade Ib was identified in eastern DRC. As vaccines for mpox were sent to help fight the rapidly growing outbreak, the need to monitor their safety was crucial. Three vaccines (MVA-BN, LC16m8 and ACAM2000) that were used to eradicate smallpox can also be used to protect against mpox. They were offered for use in the DRC and other African countries, but no vaccines like this had ever been used in Africa before. In response, the Coalition for Epidemic Preparedness Innovations (CEPI) requested The Task Force for Global Health’s Brighton Collaboration to take action. 

With funding from CEPI, Brighton’s Safety Platform for Emergency vACcines (SPEAC) project worked to develop and distribute a set of user-friendly tools to facilitate vaccine safety assessments, monitoring and decision-making. 

“The mpox response demonstrates Brighton’s ability to turn evidence into action and ensures that vaccine safety remains a core component of global outbreak preparedness and response,” said Dr. Robert Chen, Scientific Director at Brighton.

A 3-week-old girl suffering from mpox in the emergency room at Kavumu Hospital in South Kivu, Democratic Republic of the Congo. Photo credit: WHO / Guerchom Ndebo.

About mpox

Mpox (formerly known as monkeypox) is a painful disease that can cause rashes, fever, headaches, muscle aches, and in severe cases, severe skin lesions and disseminated disease complicated by pneumonia or encephalitis, as well as secondary bacterial infections and sepsis. Historically, the virus was transmitted sporadically from animals and could cause small outbreaks through limited household and community transmission, but clade Ib is also passed through human-to-human transmission by close and intimate contact. This most recent strain has compounded the effects of endemic disease and outbreaks caused by other strains in Africa (clades Ia and clade II), making the outbreak more pervasive and difficult to counteract. 

Equipping Partners with Tools and Guidance 

Working in partnership with Africa CDC, Brighton Collaboration contributed many resources for countries responding to the outbreak.  

To provide up-to-date information regarding the vaccines, Brighton Collaboration  reviewed the most recent literature about mpox vaccine safety and effectiveness. 

A list of potential side effects for mpox vaccines was created with consideration for groups like children, pregnant women and people living with HIV. This “adverse event of special interest list” was shared with CEPI, Africa CDC, the DRC Ministry of Health and other organizations. It was also incorporated into a template protocol for active vaccine safety surveillance. This and other tools and resources were published online for the global public health community. In cases of unusual or severe reactions, such as eye complications, new case definitions had to be created, so Brighton organized working groups to complete these. 

Summaries about each vaccine were also prepared using standard formats. Those drafts were then sent for vaccine manufacturers to review and eventually publish. The same information was also shared with CEPI to help guide their response. An online, regularly updated analysis about safety and effectiveness is also available. It addresses all populations, but puts an emphasis on special populations, like pregnant women. 

Raising community awareness to protect against mpox. Photo Credit: WHO Congo.

Working with Africa CDC, these tools and protocols have been deployed to countries in Africa that are experiencing an mpox outbreak and planning to deploy vaccines. According to the WHO, more than one million doses of mpox vaccines have been delivered to 10 countries so far, with more planned in the months ahead. 

Advancing a Coordinated and Evidence-Based Response

Since its inception in 2000, the Brighton Collaboration has developed more than 60 standardized case definitions and guidelines for recording and reporting adverse events following immunizations. 

“Now when we study vaccine safety outcomes, they are as meaningful as possible,” said Dr. Chen.

Dr. Chen attending World Vaccine Congress Event. Photo Credit: Brighton Collaboration.

Brighton’s mpox work highlights the program’s contribution to the Task Force’s broader mission of delivering rapid, coordinated, and science-informed support during public health emergencies. These tools are supporting vaccine safety surveillance in challenging settings, and lessons from this response will continue to inform future work.

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