WHO has declared a new global public health emergency over the Monkeypox outbreak which has now spread to more than 16,000 people in over 75 countries and territories – in what some public health experts described as a “bold decision” by Director General Dr Tedros Adhanom Ghebreyesus, overriding a divided group of expert advisors.

The WHO Director General announced his decision after a two-day meeting by a 15-member International Health Emergency committee failed to come up with a consensus recommendation.

Speaking at an extraordinary WHO press conference convened on Saturday, Dr Tedros said that took the decision in line with his authority to do so, deciding that the outbreak meets the criteria for a “public health emergency of international concern” (PHEIC) under the the terms of WHO’s binding International Health Regulations.

“There are now more than 16,000 reported cases from 75 countries and territories, and five deaths,” said Tedros. “Information provided by countries…. in this case shows that this virus has spread rapidly to many countries that have not seen it before,” he added.  “We have an outbreak that has spread around the world rapidly, through new modes of transmission, about which we understand too little, and which meets the criteria in the International Health Regulations.”

He said he took that decision despite the fact that the Expert Committee was 6-9 against declaring a PHEIC at this time – which he described as “very close” for a group that typically decides by consensus.

He said that he took the decision despite the fact that currently, WHO’s determination is that the global risk of Monkeypox to public health remains “moderate” except for in the European region, where risks are “high.”

Acted as a tie-breaker

“Under the International Health Regulations, I am required to consider five elements in deciding whether an outbreak constitutes a public health emergency of international concern,” he added, citing those as country reports, the Emergency Committee’s views, other scientific evidence, and WHO’s own assessment of the risks of international spread.

“I had then to act as a tie breaker,” Tedros said of the split Emergency Committee’s views.

“There was no consensus by them.  We believe that it’s time to declare a PHEIC, considering their advice and considering how it has spread since the last meeting of the Emergency Committee in late June, at a time when the infection was only being seen in 37 countries.

“We believe this will mobilize the world to act together, it needs coordination, solidarity, especially [for] the use of vaccines and treatments,” said Tedros.

Access to vaccines and treatments uneven – with many unknowns

Currently vaccines and anti-viral treatments are only available in about half of the countries that are seeing cases, said WHO’s Tim Nguyen, who described the current state of play. In the other half, WHO officials have inadequate information about countries’ access to treatments and vaccines, which are being prioritized to at-risk groups.

“We know that from the countries that are having reporting cases at the moment, roughly half of them have already secured access …. For those other half we don’t know,” Nguyen said. “At the same time WHO continues to discuss with member states holding larger stockpiles about sharing and donating vaccines to those that have don’t have access at the moment.”

Nguyen said that there are three “third generation” smallpox vaccines that have been recommended by WHO for use against monkeypox, totaling over 116 million doses, and scattered among various national stockpiles. They include about 100 million doses of the ACAM2000® vaccine, about 16.4 million doses of the MVA-BN, vaccine, most of which are held by the USA, and an unreported quantity of the LC16, vaccine produced by Japan’s KM Biologics and held in Japan’s national stockpile.

However, Nguyen admitted that there are “uncertainties” around the effectiveness of the three vaccines “because they haven’t been used in this context and at this scale before.”

The US Centers for Disease Control, for instance, is rolling out the MVA-BN vaccine produced by Bavarian Nordic and marketed in the United States under the trade name JYNNEOS^TM to the broader at-risk population, while reserving the ACAM2000, which can create severe complications, only for researchers and military personnel. On Friday, the European Medicines Agency also has moved recently to approve the same Bavarian Nordic vaccine for use against monkeypox.  The vaccine is marketed in Europe under the trade name Imvanex.

Big concern is sustained person-to-person transmission

Meanwhile, the “big concern” with this outbreak is that sustained person-to-person transmission is now occurring in so many parts of the world, added Rosamund Lewis, Monkeypox technical lead.

She noted that traditionally, monkeypox outbreaks that were first observed among human communities in the 1970s, were small and self-contained. They typically occured in West and Central Africa as a result of contact with infected animals or food – and those infected might go on to infect other family members with onward transmission of two or three chains, before it died out.

However, more recently, the “chains of transmission have become longer – possibly 6 possibly 9 sequential chains” she added.  And more recently, the virus also began infecting some foreign travelers and groups of people who had frequent, close, intimate contact, particularly men who have sex with men.

It remains unclear if the more sustained transmission is also a result of mutations in the endemic clades of the virus – or the decline in immunity from smallpox vaccination  – which ceased on a mass scale in the 1970s.

Tedros’ ‘bold decision’ welcomed – but could it already be too late?

Tedros’ decision to declare a PHEIC, despite the hung jury of his expert committee, was welcomed as a “bold decision” by leading global health experts like Lawrence Gostin of Georgetown University, who earlier had said the outbreak was “spinning out of control.”

. @WHO declares #monkeypox a global emergency. @DrTedros exhibited bold leadership. It’s the first time a DG has declared a PHEIC despite the EC failing to make a rec. @WHO has learned a key lesson. Act quickly, act decisively. The window for containing monkeypox is closing

— Lawrence Gostin (@LawrenceGostin) July 23, 2022

Over the past week, not only Gostin but a long list of other prominent global health experts were expressing rising concerns that it might be too late to contain the outbreak.

“Now that WHO has declared monkeypox a global emergency it’s vital to publish a global action plan with ample funding,” Gostin added, shortly after the WHO announcement was made. “There’s no time to lose.”

At the same time, emergency declarations cannot be taken too frequently, if WHO wants to mobilize action effectively when they are declared, stressed Stephen Morse, an epidemiologist at Columbia University.

“There are many concerns that have to be balanced with the decision to declare a PHEIC,” he told Health Policy Watch. “Doing it too often can be desensitizing, and we just had the COVID-19 (SARS-CoV-2) PHEIC.

Stigmatization and different transmission patterns in Europe and Africa also pose challenges

“There are also political and social concerns (in this case, stigmatization),” he added, referring to the fact that most of the cases seen outside of central and west Africa are occurring among men who have sex with men. At the same time,  Morse added, “Certainly the monkeypox epidemic is international and requires a coordinated response and resources.  Don’t forget Nigeria, which has had an ongoing epidemic of West African clade human monkeypox since 2017 and the current epidemic may be “spillover” from that epidemic.  They should get assistance in dealing with human monkeypox.

“There is another issue, he added.  “Historically, human monkeypox is not self-sustaining in the human population.  Classically, it might transmit person to person for a few cycles (a few links in a chain of transmission) but then usually dies out. This has been going on for several months now, and on an unprecedented scale.

“So we don’t know if cases would essentially drop or if, as has sometimes been suggested, that the virus is now more human-adapted.  Either way, for a variety of reasons it’s important to contain and stop the outbreak as quickly as possible.  Unlike the beginning of the SARS-CoV-2/COVID-19 pandemic (which is manyfold more transmissible than monkeypox), we have tools – vaccine and an antiviral – if we can produce and effectively deploy them.”

Question remains if PHEIC will mobilize sufficient action to halt transmission trends

Speaking at the briefing, Lewis said she was still personally unsure if the world would be able to control the outbreak at this stage – although she expressed hopes that it might be possible.

“We don’t have a crystal ball,” she said, ” So we don’t know for sure if we’re going to be able to support countries enough and communities enough to stop this outbreak.  We think it is still possible precisely because it remains primarily in one group – who are very active in health-seeking behaviour.

“So we are very much appealing communities and community leaders who have many years of experience in managing HIV/AIDs or sexually transmitted infections to work with more mainstream… public health officials and agencies…..if we all pull together, this is how we will get to the end  of this outbreak.”

She noted that in the African regions where the disease is endemic, about 30% of the cases seen have been in women and children – reflecting the broader risks communities around the world face.

While 98% of the cases seen abroad have been in communities of men who have sex with men, as the virus becomes more deeply embedded elsewhere, it will also spread much more broadly in communities, including women and children, she and other WHO experts have warned.

Further transmission will also lead to the disease becoming embedded itself in animal populations – which will then continue to transmit the disease back to humans.

“If we don’t assist the affected community, there is the risk it will become broader,” said Dr Mike Ryan, WHO executive director of Health Emergencies, “So this is about enlightened self interest.

For more about communities at risk and preventive measures see below:

https://youtu.be/Zjy0wR1pQgw

Image Credits: WHO .