Attachments
Executive Summary
The overarching goal of the global response for monkeypox, on 23 July 2022 declared a public health emergency of international concern, is to stop human-to-human transmission and to minimize zoonotic transmission of monkeypox virus where it occurs. Judicious use of vaccines can support this response. This interim guidance provides WHO recommendations on use of vaccines for monkeypox. It should be noted that there is significant uncertainty about the efficacy and effectiveness of vaccination in the context and characteristics of the current monkeypox outbreak. This guidance is for all countries, those with confirmed human-to-human transmission and to support preparedness and readiness in countries with no current or ongoing monkeypox outbreak in the human population. It will be updated as information becomes available.
General
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Monkeypox is an infectious disease caused by the monkeypox virus (MPXV). This double-stranded DNA virus is a member of the Orthopoxvirus genus in the Poxviridae family, related to the virus which caused smallpox (eradicated in 1980).
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Control of monkeypox outbreaks primarily relies on public health measures including surveillance, contact-tracing, isolation and care of patients. While smallpox vaccines are expected to provide some protection against monkeypox, efficacy data are limited.
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Most interim vaccination recommendations provided here concern off-label use.
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On 23 July 2022, WHO declared the global monkeypox outbreak as a public health emergency of international concern (PHEIC).
Summary of interim recommendations
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Based on currently assessed risks and benefits and regardless of vaccine supply, mass vaccination is not required nor recommended for monkeypox at this time.
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Human-to-human spread of monkeypox can be controlled by public health measures including surveillance, early case-finding, diagnosis and care, isolation and contact-tracing, and self-monitoring by contacts.
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In managing the response, vaccination should be considered an additional measure to complement primary public health interventions.
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All decisions around immunization with smallpox or monkeypox vaccines should be by shared clinical decision-making, based on a joint assessment of risks and benefits, between a health care provider and prospective vaccinee, on a case-by-case basis. At an individual level, vaccination should not replace other protective measures.
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Post-exposure preventive vaccination (PEPV): For close contacts of cases (for definition, see Recommendation 3 – Post-exposure preventive vaccination (PEPV)), PEPV with an appropriate second- or third-generation vaccine is recommended prior to onset of any symptoms, ideally within four days of first exposure (and up to 14 days in the absence of symptoms), to prevent onset of disease or mitigate disease severity.
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Primary preventive (pre-exposure) vaccination (PPV): PPV is recommended for individuals at high-risk of exposure including: individuals but not limited to those who self-identify as gay or bisexual or other men who have sex with men (MSM) or other individuals with multiple sexual partners; and health workers at high risk of exposure, laboratory personnel working with orthopoxviruses, clinical laboratory personnel performing diagnostic testing for monkeypox, outbreak response team members (as designated by national public health authorities).
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Vaccination programmes should be accompanied by:
- a strong information campaign to inform vaccinees that it takes approximately 2 weeks from finalizing a complete series of vaccination (1 or 2 doses depending on product) for immunity to develop and that the level of protection conferred by vaccination is currently unknown; and
- robust pharmacovigilance.
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All efforts should be made to administer vaccines for monkeypox within a framework of collaborative research, including randomized controlled trials (RCT). Where observational study designs are considered, they should be carefully planned to minimize bias and include standardized data collection tools for clinical and outcome data.
Vaccines
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Some countries have maintained strategic supplies of smallpox vaccines procured for the Smallpox Eradication Programme (SEP) which concluded in 1980. These first-generation vaccines held in national reserves since that time are not recommended for monkeypox at this time, as they do not meet current safety and manufacturing standards.
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Many years of research have led to development of new and safer (second- and in particular third-generation) vaccines for smallpox, some of which may be useful for monkeypox. Two vaccines (MVA-BN and LC16) have been approved in several jurisdictions for prevention of monkeypox.
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The supply of the newer, especially third-generation, vaccines is limited at this time and approaches for enhancing vaccine access are under discussion.
Changes from earlier version
This is an updated version of the guidance published on 24 June 2022. The revision contains minor updates as outlined in the table of revisions at the end of this document, primarily to emphasize the groups at risk of monkeypox for consideration for preventive vaccination, and to update terminology used in the guidance.