First meeting of the International Health Regulations Emergency Committee reports on mpox surge

The Director-General of the World Health Organization (WHO), having concurred with the advice offered by the International Health Regulations (2005) (IHR or Regulations) Emergency Committee regarding the upsurge of mpox 2024 during its first meeting, held on 14 August 2024, has determined, on the same date, that the ongoing upsurge of mpox in the Democratic Republic of the Congo (DRC) and in a growing number of countries in Africa constitutes a public health emergency of international concern (PHEIC) under the provisions of the Regulations. The communication of the Director-General regarding the determination of the above-mentioned PHEIC on 14 August 2024 is available here.

The Director-General is hereby transmitting the report of the first meeting of the IHR Emergency Committee regarding the upsurge of mpox 2024.

Noting that the Director-General will be communicating to States Parties a 12-month extension of the current standing recommendations for mpox, the temporary recommendations, issued by the Director-General in relation to the PHEIC associated with the ongoing upsurge of mpox are presented in the last section of this statement and reflect the advice offered by the Committee.

The Director-General is taking the opportunity to express his most sincere gratitude to the Chair, Vice-Chair, and Members of the IHR Emergency Committee, as well as to its Advisors. 

Proceedings of the meeting

Sixteen (16) Members of, and two Advisors to, the Emergency Committee were convened by teleconference, via Zoom, on Wednesday, 14 August 2024, from 12:00 to 17:00 CEST. Fifteen (15) of the 16 Committee Members and the two Advisors to the Committee participated in the meeting.

The Director-General of the World Health Organization (WHO) joined in person and welcomed the participants. The opening remarks by the Director-General are available here.

The Representative of the Office of Legal Counsel briefed the Members and Advisers on their roles and responsibilities and identified the mandate of the Emergency Committee under the relevant articles of the IHR. The Ethics Officer from the Department of Compliance, Risk Management, and Ethics provided the Members and Advisors with an overview of the WHO Declaration of Interests process. The Members and Advisors were made aware of their individual responsibility to disclose to WHO, in a timely manner, any interests of a personal, professional, financial, intellectual or commercial nature that may give rise to a perceived or actual conflict of interest. They were additionally reminded of their duty to maintain the confidentiality of the meeting discussions and the work of the Committee. Each Member and Advisor was surveyed, with no conflicts of interest identified.

The Representative of the Office of Legal Counsel then facilitated the election of officers of the Committee, in accordance with the rules of procedures and working methods of the Emergency Committee. Professor Dimie Ogoina was elected as Chair of the Committee, Professor Inger Damon as Vice-Chair, and Professor Lucille Helen Blumberg as Rapporteur, all by acclamation.

The meeting was handed over to the Chair who introduced the objectives of the meeting, which were to provide views to the Director-General on whether the event constitutes a public health emergency of international concern (PHEIC), and if so, to provide views on the potential proposed temporary recommendations.

Session open to representatives of States Parties invited to present their views

The WHO Secretariat presented an overview of the global epidemiological situation of mpox, highlighting that, during the first six months of 2024, the 1854 confirmed cases of mpox reported by States Parties in the WHO African Region account for 36% (1854/5199) of the cases observed worldwide. Of these confirmed cases in the WHO African region in 2024, 95% (1754/1854) were reported in the Democratic Republic of the Congo (DRC), that is experiencing an upsurge of cases of mpox, with more than 15,000 clinically compatible cases and over 500 deaths reported, already exceeding the number of cases observed in the DRC in 2023.

The upsurge of mpox cases in the DRC is being driven by outbreaks associated with two sub-clades of clade I monkeypox virus (MPXV) – clade Ia and clade Ib. Clade I mpox was classically described in studies conducted by WHO in the 1980's to have a mortality rate of approximately 10%, with most deaths occurring in children.

MPXV clade Ia is endemic in the DRC, the disease primarily affects children, data available for 2024 show an aggregated case fatality rate of 3.6%, and the spread is likely sustained through multiple modes of transmission including person-to-person transmission following zoonotic introduction in a community.

MPXV clade Ib is a new strain of MPXV that emerged in the DRC is transmitting between people, presumed via sexual contact, which has been spreading in the eastern part of the country. Although first characterized in 2024, estimates suggest it emerged around September 2023. The outbreak associated with clade Ib in the DRC primarily affects adults and is spreading rapidly, sustained largely, but not exclusively, through transmission linked to sexual contact and amplified in networks associated with commercial sex and sex workers.

Since July 2024, cases of mpox due to MPXV clade Ib, epidemiologically and phylogenetically linked to the outbreak in the eastern provinces of DRC, have been detected in four countries, neighbouring the DRC, which had not reported cases of mpox before: Burundi, Kenya, Rwanda and Uganda.

Additionally, in 2024, cases of mpox linked to MPXV clade Ia have been reported in the Central African Republic and the Republic of Congo, and cases linked to MPXV clade II have been reported in Cameroon, Côte d'Ivoire, Liberia, Nigeria and South Africa.

The clinical presentation of mpox associated with MPXV clade Ia has historically been characterized by more severe disease than that associated with MPXV clade II. Clade IIb viruses circulated during the multi-country outbreak that constituted a PHEIC from July 2022 to May 2023. There is, as yet, insufficient information available to fully characterize mpox severity due to clade Ib as data are emerging and, so far, few deaths were recorded, precluding age-stratified analyses.

The secretariat outlined challenges in understanding the true extent of infection, epidemiologic trends and morbidity and mortality, thus cautioning overinterpretation of available data to calculate crude CFRs by different clades/outbreaks.

The assessed risk presented by the WHO Secretariat – grouping geographical areas as a result of the assessment of population groups affected, predominant modes of transmission, and MPXV clades involved –, was: "high" for eastern DRC and neighbouring countries; "high" for areas of the DRC where mpox is known to be endemic; "moderate" for Nigeria and countries of West, Central and East Africa where mpox is endemic; and "moderate" for other countries in Africa and around the world.

The WHO Secretariat additionally provided an overview of the actions already taken to support readiness and response interventions in States Parties experiencing the upsurge of cases of mpox and facing such risk. These include, inter alia: the release of USD 1.45 million from the WHO Contingency Fund for Emergencies; initiating the process for including Emergency Use Listing two mpox vaccines; coordinating with partners and stakeholders, including to facilitate equitable access to vaccines, therapeutics, and diagnostics; the development of a regional response plan, costed at an initial USD 15 million, and more.

Representatives of Burundi, the Democratic Republic of the Congo, Kenya, Rwanda, South Africa and Uganda updated the Committee on the mpox epidemiological situation in their countries and the current response efforts, needs and challenges. Although most reported few cases of MPXV clade Ib related mpox, Burundi reported one hundred confirmed cases of mpox associated with clade Ib since July 2024, identified in multiple districts and 28% of cases were amongst children less than five years of age.

Members of, and Advisors to, the Committee then engaged in questions and answers with the presenters. The questions and discussions focused around the issues and challenges enumerated below:

• The observed complex and dynamic evolution of the multiple outbreaks driving the upsurge of mpox, and related international spread, of mpox in the DRC and neighbouring countries. Elements underpinning such observation, and representing reasons for concern, including:
  • Scientific uncertainties and evidence gaps (e.g., role of ecological changes in the spread of mpox, modes of disease transmission, transmission dynamics, risk factors, disease severity and case fatality rate associated with the different MPXV clades, outcome of pregnancy in women infected with different MPXV clades);
  • Adequacy of capacities, recognizing capacities gained during COVID-19, and heterogeneity thereof, across States Parties for surveillance, diagnostic capacities, surveillance modalities at borders, access to clinical care, integration of HIV/STI services in prevention and treatment, and risk communication and community engagement, vaccination delivery, and other capacities to support prevention, readiness and response activities;
  • Lack of full understanding of the geographical spread and detailed epidemiology of the dynamic mpox outbreaks, including of molecular epidemiology, to optimize targeted prevention and control measures, including risk communication and community engagement with local partners to enable appropriate support and behavior modifications, as well as the targeted use of mpox vaccines in at risk groups;
  • Availability and access to laboratory tests that can be used in challenging environments, and where necessary, methods to distinguish between circulating MPXV clades; and
  • An incomplete mapping of mpox-related research and development efforts underway, noting several initiatives underway, including a WHO and Africa Centers for Disease Control and Prevention (Africa CDC) consultation to be held in August 2024;
• The unpredictability and lack of financial resources at both, national and international levels to scale up and sustain interventions to prevent and control the spread of mpox, despite the development of costed global, regional and national response plans;
• The needs-based access to mpox vaccines, given the current limited available globally; the currently limited production of the vaccine, conditional to orders placed to the manufacturer; and the extensive time to develop legal agreements in relation to donation of mpox vaccines, as opposed to direct procurement. With respect to access to vaccines, the WHO Secretariat informed the Committee of its ongoing work with numerous partners through the Interim coordination mechanism for medical countermeasures (i-MCM-Net), including Gavi and the United Nations Children's Fund on the coordination of the donation and allocation process in an equitable, needs-based manner;
• The access to the antiviral drug tecovirimat, considering that both, the minimum amount for orders to be placed with the manufacturer and the price of the product represent key challenges for many States Parties. While evidence is being gathered on its use for the treatment of cases of mpox, it can be accessed under protocol for Monitored Emergency Use of Unregistered and Experimental Interventions (MEURI); as well as optimized and safe clinical care; and
• The need for information on the implementation, by States Parties, of the standing recommendation for mpox issued on 21 August 2023.

Deliberative session

Following the session open to invited States Parties, the Committee reconvened in a closed session to examine the questions in relation to whether the event constitutes a PHEIC or not, and if so, to consider the temporary recommendations drafted by the WHO Secretariat in accordance with IHR provisions.

The Chair reminded the Committee Members of their mandate and recalled that a PHEIC is defined in the IHR as an "extraordinary event, which constitutes a public health risk to other States through the international spread of disease, and potentially requires a coordinated international response".

The Committee was unanimous in expressing the views that the ongoing upsurge of mpox meets the criteria of a PHEIC and that the Director-General be advised accordingly.

The considerations underpinning the unanimous views of the Committee further elaborated upon issues and challenges addressed during the question and answers session.

The Committee considered the event as "extraordinary" because of (a) the increase in mpox clade I disease occurrence in the DRC and the emergence of the new MPXV clade Ib, the human-to-human transmission context in which it is occurring, its rapid spread in some settings, and available evidence suggesting that MPXV clade I is associated with a more severe clinical presentation with respect to MPXV clade II; (b) the diverse, complex, dynamic, and rapidly evolving epidemiology observed across States Parties in the WHO African Region in terms of: overall rapid increase of the number of cases reported in some settings, differences in population age-groups affected, routes and modes sustaining transmissions in different contexts; and (c) the severity of the clinical presentation in children and immunocompromised individuals, including people living with uncontrolled HIV infection or advanced HIV disease, as well as the long-term consequences of MPXV infection.

Additionally, the Committee strongly underscored that its level of concern is further heightened by (a) uncertainties and gaps in knowledge and evidence related to (i) multiple epidemiological aspects, including drivers of transmission, morbidity and mortality associated with infections with different MPXV sub-clades; (ii) the incompleteness and uncertainties of available epidemiological data and considered by the Committee, due to the limitations of current surveillance (e.g., sub-optimal levels of case detection and case reporting), the availability and performance of laboratory diagnostics, and ongoing conflicts and humanitarian challenges in certain areas of the DRC experiencing the upsurge of mpox, that, ultimately, hamper the implementation of control measures; (iii) the impact of control measures, including the targeted use of vaccines and their overall effectiveness; and (b) the risk of occurrence of additional mutations of MPXV clade I and clade II, and their subsequent emergence and spread in the context of limited capacity to implement control measures.

The Committee considered that the event "constitutes a public health risk to other States through the international spread of disease" because of (a) the documented recent spread of MPXV clade Ib from eastern DRC to Burundi, Kenya, Rwanda and Uganda; (b) the limited capacity to control transmission in endemic situations and in areas of upsurge through enhanced surveillance enabling the implementation of targeted response interventions that are ultimately subordinated to (i) the unavailability of sustainable funding, and (ii) the limited ability to access vaccines, therapeutics, and diagnostics; and (c) the challenges in implementing concerted surveillance and response interventions in contiguous areas of bordering States Parties, in particular where borders are porous.

The Committee considered that the event "requires a coordinated international response". The Committee noted that (a) mpox is endemic in parts of Africa, with surges increasingly reported, and also resulting in a multi-country outbreak determined to constitute a PHEIC in 2022-2023; and (b) the event is occurring in the context of standing recommendations issued by the Director-General in August 2023 under IHR provisions and following the termination of the afore mentioned PHEIC; the presence of the "WHO Strategic framework for enhancing prevention and control of mpox- 2024-2027"; and the activation for mpox of the i-MCM-Net. In that light and noting the declaration of the event as a Public Health Emergency of Continental Security by the Africa CDC on 13 August 2024, the Committee considered that international cooperation requires enhanced and coordination, in particular with respect to (a) the facilitation of equitable access to vaccines, therapeutics, and diagnostics; and (b) the mobilization of financial resources.

The Committee subsequently considered the draft of the temporary recommendations proposed by the WHO Secretariat, briefly presented during the meeting. The Committee indicated that it would be giving further consideration to the proposed temporary recommendations while finalizing the report of the meeting.

The Committee noted that, in his opening remarks, the Director-General communicated the 12-month extension of the current standing recommendations for mpox, which were set to expire on 20 August 2024. The Committee also noted that, should the Director-General determine that the upsurge of mpox constitutes a PHEIC, it would be the first time, since the entry into force of the Regulations, that temporary and standing recommendations to States Parties related to the same public health risk would coexist.

Therefore, the Committee underscored that any temporary recommendation that may be issued by the Director-General should be very specific and targeted, and hence, not duplicate the standing recommendations.

Notwithstanding that both, temporary and standing recommendations constitute non-binding advice to States Parties, the Committee advised that mechanisms to monitor the uptake, implementation and impact of such recommendations should be embedded in the set of temporary recommendations to States Parties that the Director-General may issue in relation to the event considered.

Conclusions

The Committee reiterated its concern regarding the evolution of the multi-faceted upsurge of mpox, including the many uncertainties surrounding it and the capacities in place to control the spread of mpox in States Parties experiencing the outbreaks, or in States Parties that may have to do so as a result of further international spread.

The Committee recognized the critical role of coordinated international cooperation in supporting States Parties' efforts to control the spread of mpox in the WHO African Region – including in facilitating access to and use of vaccines, therapeutics, and diagnostics; mobilizing financial resources for States Parties experiencing the upsurge of disease; and synergic initiatives by WHO and partners, including Africa CDC.

Nevertheless, the Committee indicated that the development of strategic approaches for States Parties to become more self-reliant in controlling the spread of mpox are warranted. To that effect, the Committee considers that the determination by the Director-General that the upsurge of mpox constitutes a PHEIC would stimulate States Parties facing the outbreaks to more effectively commit and employ domestic resources. 

Temporary recommendations issued by the Director-General of the World Health Organization (WHO) to States Parties in relation to the public health emergency of international concern associated with the upsurge of mpox 

These temporary recommendations are issued to States Parties experiencing the upsurge of mpox, including, but not limited to, the Democratic Republic of the Congo and Burundi, Kenya, Rwanda, and Uganda.

They are intended to be implemented by those States Parties in addition to the current standing recommendations for mpox, which will be extended until 20 August 2025 and are presented at the end of this document for easy reference. 

In the context of the global efforts to prevent and control the spread of mpox disease outlined in the WHO Strategic framework for enhancing prevention and control of mpox- 2024-2027, the aforementioned standing recommendations apply to all States Parties. 

All current WHO interim technical guidance can be accessed on this page of the WHO website. WHO evidence-based guidance has been and will continue to be updated in line with the evolving situation, updated scientific evidence, and WHO risk assessment to support States Parties in the implementation of the WHO Strategic Framework for enhancing mpox prevention and control. 

• Promote and implement infection prevention and control measures and basic water and sanitation services in health care facilities, household settings, congregate settings (e.g. prisons, internally displaced persons and refugee camps, schools, etc.), and cross border transit areas;

International traffic

• Establish or strengthen cross-border collaboration arrangements for surveillance and management of suspect cases of mpox, the provision of information to travellers and conveyance operators, without resorting to general travel and trade restrictions unnecessarily impacting local, regional or national economies;

Vaccination

• Prepare for the introduction of mpox vaccine for emergency response through convening of national immunization technical advisory groups, briefing of national regulatory authorities, preparing national policy mechanisms to apply for vaccines through available mechanisms;
• Initiate plans to advance mpox vaccination activities in the context of outbreak response in areas with incident cases (i.e. with disease onset in the previous 2-4 weeks), targeting people at high risk of infection (e.g., contacts of cases, including sexual contacts, children, and health and health care workers). This entails the agile adaptation of immunization strategies and plans to concerned areas; the availability of vaccines and supplies; the proactive community engagement, to generate and sustain demand for and trust in vaccination; and the collection of data during vaccination according to implementable research protocols;

Risk communication and community engagement

• Strengthen risk communication and community engagement systems with affected communities and local workforces for outbreak prevention, response and vaccination strategies, including through training, mapping high risk and vulnerable populations, social listening and community feedback, managing misinformation. This entails, inter alia, communicating effectively the uncertainties regarding the natural history of mpox, updated information about mpox including information from ongoing clinical trials, about the efficacy of vaccines against mpox, and the uncertainties regarding duration of protection following vaccination;
• Address stigma and discrimination of any kind via meaningful community engagement, particularly in health services and during risk communication activities;

Governance and financing

• Galvanize and scale up national funding and explore external opportunities for targeted funding of prevention, readiness and response activities;
• Integrate mpox prevention and response measures in existing programmes aimed at prevention, control and treatment of other endemic diseases – especially HIV, as well as STIs, malaria, tuberculosis, and COVID-19, as well as non-communicable diseases –, striving, to the extent possible, not to negatively impact their delivery;

Addressing research gaps

• Invest in addressing knowledge gaps and in generating evidence, during and after outbreaks, regarding the dynamics of transmission of mpox, risk factors, the social and behavioural drivers of transmission, the natural history of disease, through trials for novel therapeutics and vaccines against mpox, the effectiveness of public health interventions, with a One Health approach;

Reporting on the implementation of temporary recommendations

• Report quarterly to WHO on the status of, and challenges related to the implementation of these temporary recommendations, using a standardized tool and channels that will be made available WHO.

Standing recommendations for mpox issued by the Director-General of the World Health Organization (WHO) in accordance with the International Health Regulations (2005) (IHR)

A. States Parties are recommended to develop and implement national mpox plans that build on WHO strategic and technical guidance, outlining critical actions to sustain control of mpox and achieve elimination of human-to-human transmission in all contexts through coordinated and integrated policies, programmes and services. Actions are recommended to:

1. Incorporate lessons learned from evaluation of the response (such as through intra- or after-action reviews) into related plans and policies in order to sustain, adapt, and promote key elements of the response and inform public health policies and programmes.
2. Aim to eliminate human-to-human transmission of mpox by anticipating, detecting, preparing for and responding to mpox outbreaks and taking action to reduce zoonotic transmission, as appropriate.
3. Build and retain capacity in resource-limited settings, and among marginalized groups, where mpox transmission continues to occur, to improve understanding of modes of transmission, quantify resource needs, and detect and respond to outbreaks and community transmission.

B. States Parties are recommended to, as a critical basis for actions outlined in A in support of the elimination goal, establish and sustain laboratory-based surveillance and diagnostic capacities to enhance outbreak detection and risk assessment. Actions are recommended to:

4. Include mpox as a notifiable disease in the national epidemiological surveillance system.

5. Strengthen diagnostic capacity at all levels of the health care system for laboratory and point of care diagnostic confirmation of cases.

6. Ensure timely reporting of cases to WHO, as per WHO guidance and Case Reporting Form, in particular reporting of confirmed cases with a relevant recent history of international travel.

7. Collaborate with other countries so that genomic sequencing is available in, or accessible to, all countries. Share genetic sequence data and metadata through public databases.

8. Notify WHO about significant mpox-related events through IHR channels.

C. States Parties are recommended to enhance community protection through building capacity for risk communication and community engagement, adapting public health and social measures to local contexts and continuing to strive for equity and build trust with communities through the following actions, particularly for those most at risk. Actions are recommended to:

9. Communicate risk, build awareness, engage with affected communities and at-risk groups through health authorities and civil society.

10. Implement interventions to prevent stigma and discrimination against any individuals or groups that may be affected by mpox.

D. States Parties are recommended to initiate, continue, support, and collaborate on research to generate evidence for mpox prevention and control, with a view to support elimination of human-to-human transmission of mpox. Actions are recommended to:

11. Contribute to addressing the global research agenda to generate and promptly disseminate evidence for key scientific, social, clinical, and public health aspects of mpox transmission, prevention and control.

12. Conduct clinical trials of medical countermeasures, including diagnostics, vaccines and therapeutics, in different populations, in addition to monitoring of their safety, effectiveness and duration of protection.

13. States Parties in West, Central and East Africa should make additional efforts to elucidate mpox-related risk, vulnerability and impact, including consideration of zoonotic, sexual, and other modes of transmission in different demographic groups.

E. States Parties are recommended to apply the following measures related to international travel. Actions are recommended to:

14. Encourage authorities, health care providers and community groups to provide travelers with relevant information to protect themselves and others before, during and after travel to events or gatherings where mpox may present a risk.

15. Advise individuals suspected or known to have mpox, or who may be a contact of a case, to adhere to measures to avoid exposing others, including in relation to international travel.

16. Refrain from implementing travel-related health measures specific for mpox, such as entry or exit screening, or requirements for testing or vaccination.

F. States Parties are encouraged to continue providing guidance and coordinating resources for delivery of optimally integrated clinical care for mpox, including access to specific treatment and supportive measures to protect health workers and caregivers as appropriate. States Parties are encouraged to take actions to:

17. Ensure provision of optimal clinical care with infection prevention and control measures in place for suspected and confirmed mpox in all clinical settings. Ensure training of health care providers accordingly and provide personal protective equipment.

18. Integrate mpox detection, prevention, care and research within HIV and sexually transmitted disease prevention and control programmes, and other health services as appropriate.

G. States Parties are encouraged to work towards ensuring equitable access to safe, effective and quality-assured countermeasures for mpox, including through resource mobilization mechanisms. States Parties are encouraged to take action to:

19. Strengthen provision of and access to diagnostics, genomic sequencing, vaccines, and therapeutics for the most affected communities, including in resource-constrained settings where mpox occurs regularly, and including for men who have sex with men and groups at risk of heterosexual transmission, with special attention to those most marginalized within those groups.

20. Make mpox vaccines available for primary prevention (pre-exposure) and post-exposure vaccination for persons and communities at risk of mpox, taking into account recommendations of the WHO Strategic Advisory Group of Experts on Immunization (SAGE).