What does it mean to declare monkeypox a PHEIC?

Abstract

Monkeypox has been declared a public health emergency of international concern, but what does it mean for the response? Talha Burki reports. On July 23, 2022, WHO Director-General Tedros Adhanom Ghebreyesus declared monkeypox a public health emergency of international concern (PHEIC). “We have an outbreak that has spread around the world rapidly, through new modes of transmission about which we understand too little”, stated Tedros. Between Jan 1 and Aug 4, there were over 26 000 confirmed cases of monkeypox in more than 80 countries, nearly all of which are not endemic for the disease. 12 people have died. In the first 4 days of August, eight nations from Asia, Europe, and South America detected their first monkeypox infections. On July 29, Brazil became the first country outside of Africa to report a fatal case of monkeypox. Deaths were subsequently reported from Spain and India. Tedros stressed that monkeypox represents a moderate risk in every region of the world except for Europe, where the risk is high. “Although I am declaring a public health emergency of international concern, for the moment this is an outbreak that is concentrated among men who have sex with men [MSM], especially those with multiple sexual partners. That means that this is an outbreak that can be stopped with the right strategies in the right groups.” 97% of the 17 422 cases of monkeypox for which there are data on sexual orientation have been in MSM. Viral DNA has been detected in seminal fluid, although it remains unclear as to whether this translates to an infection risk. “Monkeypox is turning into another sexually transmitted disease; that is not entirely unexpected, from what we know about the virus, but it is still a new development in terms of the history of the disease”, David Evans, a virologist in the Department of Medical Microbiology and Immunology at the University of Alberta (Edmonton, AB, Canada), told The Lancet Infectious Diseases. Notably, MSM do not seem to be driving new infections in the endemic regions of west and central Africa. Around 17 000 case reports from around the world include information on sex. They indicate that 99% of infections in the ongoing monkeypox outbreak are in males. Lack of testing capacity means that data from the endemic countries of Africa are scarce, but the available figures show that women comprise more than a third of infections. Researchers at the Pasteur Institute have calculated that in a completely susceptible population, the monkeypox virus would have a basic reproduction number (R0) of 1·46–2·67. However, many people older than 50 years are likely to have cross-protection conferred by the now-discontinued smallpox vaccination campaigns. In a population with 10–25% immunity, the R0 for monkeypox is likely to be somewhere in the region of 1·1–2·4. WHO has previously declared six PHEICs, two of which are continuing: polio (2014) and COVID-19 (2020). On each occasion, the declaration was backed by the advice of the WHO Emergency Committee. But this time the committee voted 9-6 against recommending a PHEIC. Tedros declared one nonetheless, on the basis that monkeypox satisfied the criteria for a PHEIC under the International Health Regulations. These stipulate that an outbreak should be an extraordinary event, which could present a public health danger to countries around the world, and requires an internationally coordinated response. Lawrence Gostin is the O’Neill Chair in Global Health Law at Georgetown Law (Washington DC, USA). He welcomed the WHO declaration. “If monkeypox does not qualify as a PHEIC, I am not sure what would”, said Gostin. “This is a virus that until this year had not been seen outside of the endemic parts of Africa, aside from a few isolated travel-associated cases. Now it is everywhere; the situation clearly warrants raising the global alert level to PHEIC”. Still, aside from allowing WHO to issue formal, non-binding recommendations, a PHEIC designation is not associated with any substantial powers. It does not open any funding streams, for example, or mandate any serious action. “The impact of the PHEIC is largely symbolic”, Gostin told The Lancet Infectious Diseases. “It encourages governments to take monkeypox seriously, and makes it easier for WHO and others to fundraise. People are more likely to pay attention to a situation that has been officially designated as an emergency”. Opponents of the declaration have pointed out that cases of monkeypox are concentrated in a dozen countries in Europe and the Americas, and show no sign of exponential increase. The vast majority of people recover without requiring hospitalisation, and death remains an extremely rare occurrence. There has been speculation that a PHEIC declaration could stigmatise MSM communities, as well as spark demand for the monkeypox vaccine among people who are at very low risk of infection, which could further reduce the already constricted supplies. Clare Wenham is Associate Professor of Global Health Policy at the London School of Economics and Political Science (London, UK). She pointed out that WHO has been in a tricky position. “There is a huge amount of pandemic fatigue and at the same time we have this escalating public health crisis. It was really important for WHO to do something and, perhaps as importantly, to be seen to do something”, said Wenham. Whether a PHEIC designation alters the course of a disease outbreak is a moot point. “There is very little evidence on the effects of PHEICs”, said Wenham. “It would be good to see a study which systematically tracked policy developments either side of the declaration of a PHEIC to determine the kind of impact it has”. On Aug 5, the USA declared a public health emergency for monkeypox. At the time, the country had registered over 6600 cases of the disease. In the days preceding the declaration, New York state, Illinois, and California, which together accounted for roughly half the American cases of monkeypox, had all declared emergencies. New York City and San Francisco have taken similar measures. The mayor of New York City and the health commissioner issued a joint statement asserting that the “outbreak must be met with urgency, action, and resources, both nationally and globally, and this declaration of a public health emergency reflects the seriousness of the moment”. They went on to suggest that 150 000 city residents could be at risk of contracting monkeypox. A national public health emergency declaration in the USA releases funding and opens a path for the Secretary of Health and Human Services to take action to address the crisis. Gostin recommends strengthening the International Health Regulations so that declaring a PHEIC is associated with comparable powers. “We have to find an appropriate approach to communicate with the affected communities without increasing stigma”, said Evans. “We should be working closely with community leaders and arranging vaccination campaigns at sites where MSM congregate”. He has not been impressed by the response so far. “This is a relatively poorly spread orthopoxvirus in a narrowly defined community, for which we have stockpiles of vaccine and drugs; yet we have struggled to get enough vaccines into people's arms and break transmission”, said Evans. “It makes you wonder how we would fare in the event of an accidental or deliberate release of smallpox.” Gostin worries that monkeypox could end up either becoming an endemic disease that predominantly affects MSM or spills over into the general population, causing widespread infection. He urged countries that have detected the disease to act quickly. “The window for containing monkeypox is closing”, he said. For the WHO PHEIC declaration see https://www.who.int/director-general/speeches/detail/who-director-general-s-statement-on-the-press-conference-following-IHR-emergency-committee-regarding-the-multi--country-outbreak-of-monkeypox--23-july-2022For the analysis by Pasteur Institute see https://www.pasteur.fr/en/research-journal/news/monkeypox-epidemic-potential-will-continue-increasing-diminishing-herd-immunity-against-viruses For the WHO PHEIC declaration see https://www.who.int/director-general/speeches/detail/who-director-general-s-statement-on-the-press-conference-following-IHR-emergency-committee-regarding-the-multi--country-outbreak-of-monkeypox--23-july-2022 For the analysis by Pasteur Institute see https://www.pasteur.fr/en/research-journal/news/monkeypox-epidemic-potential-will-continue-increasing-diminishing-herd-immunity-against-viruses