Stronger monkeypox response needed in both the global North and Africa

Protestors at AIDS 2022 demanding increased access to monkeypox vaccines and treatment. Photo by Liz Highleyman
Protestors at AIDS 2022 demanding increased access to monkeypox vaccines and treatment. Photo by Liz Highleyman

Some of the world’s leading monkeypox experts and public health officials discussed the global response to the growing outbreak at the 24th International AIDS Conference (AIDS 2022) this week in Montreal. But advocates said the world is not doing enough to address the crisis, which is primarily affecting gay and bisexual men.

At a media roundtable on Sunday, Dr Meg Doherty of the World Health Organization (WHO) gave an update on the outbreak. According to its latest situation report, dated 2 August, WHO has received reports of 23,351 laboratory confirmed monkeypox cases worldwide, resulting in eight deaths. The United States is now reporting the most cases (exceeding 6000), followed by Spain, Germany and the United Kingdom (more than 2600).

“The epidemiology is becoming more clear as time goes on,” Doherty said.

Glossary

Food and Drug Administration (FDA)

Regulatory agency that evaluates and approves medicines and medical devices for safety and efficacy in the United States. The FDA regulates over-the-counter and prescription drugs, including generic drugs. The European Medicines Agency performs a similar role in the European Union.

traditional risk factors

Risk factors for a disease which are well established from studies in the general population. For example, traditional risk factors for heart disease include older age, smoking, high blood pressure, cholesterol and diabetes. ‘Traditional’ risk factors may be contrasted with novel or HIV-related risk factors.

low income countries

The World Bank classifies countries according to their income: low, lower-middle, upper-middle and high. While the majority of the approximately 30 countries that are ranked as low income are in sub-Saharan Africa, many African countries including Kenya, Nigeria, South Africa and Zambia are in the middle-income brackets. 

boosting agent

Booster drugs are used to ‘boost’ the effects of protease inhibitors and some other antiretrovirals. Adding a small dose of a booster drug to an antiretroviral makes the liver break down the primary drug more slowly, which means that it stays in the body for longer times or at higher levels. Without the boosting agent, the prescribed dose of the primary drug would be ineffective.

shedding

Viral shedding refers to the expulsion and release of virus progeny (offspring such as competent particles, virions, etc.) following replication. In HIV this process occurs in the semen, the vaginal secretions and other bodily fluids, making those fluids more infectious.

Three months into the outbreak, cases remain overwhelmingly concentrated among men who have sex with men, even as testing for other groups has increased. According to WHO, 99% are among men, most of whom identify as gay or bisexual and report sex as their most likely transmission route. Of cases with a known age, 25 were children up to age 4.

Dr Marina Klein of McGill University in Montreal described the local monkeypox response, which has exceeded that of many other countries. The city appears to have an ample supply of the vaccine and is providing shots for all men who have sex with men and sex workers. The same vaccine product has the brand name Imvanex in Canada, Jynneos in the United States and Imvanex in Europe. The city offered vaccines to conference attendees, many of whom are gay and bisexual men who will not have that opportunity when they get home.

Reporters asked numerous questions at the roundtable, but Klein acknowledged that many of them don’t yet have answers. We don’t know the exact mechanisms of transmission, whether the respiratory route is important or whether people can transmit the virus before they develop symptoms. What’s more, there is little clinical trial data showing how well the vaccine works after one or two doses and whether treatment with tecovirimat (TPOXX) reduces symptoms or lessens virus shedding, which has implications for the isolation period.

That uncertainty is reflected in differing vaccine protocols. The US Food and Drug Administration (FDA) maintains that Jynneos is a two-dose vaccine and people need both doses. Many cities and countries are administering one dose initially, to partially protect as many people as possible right away, but there is confusion about how much protection the first dose offers and when people will need to get the second.

“No one is saying anything about efficacy and no one is saying anything about time to protection,” said Simon Collins of HIV i-Base. “You have people who are stopping their behavior and are doing everything they can to get a shot in their arm, but most people are not being given any information at all… That could contribute to a worse epidemic because people will go out thinking they're protected.”

One area where we do have more answers is symptoms, thanks to the efforts of frontline clinicians and patients who have shared their stories. Professor Chloe Orkin of Queen Mary University of London and a large team of collaborators recently published an analysis of more than 500 monkeypox cases, revealing new symptoms not previously reported in countries where the virus is endemic.

“Advocates are loathe to see a repeat of the COVID-19 situation, where lower-risk people in high-income countries have better access than many high-risk people in low-income countries.”

Among those with a known HIV status in this case series, 41% were HIV positive, most of them on effective antiretroviral therapy. Reassuringly, there were no differences in outcomes overall between HIV-positive and HIV-negative people, Orkin said. However, she noted, people with HIV have a weaker response to the first dose of the Jynneos vaccine, suggesting they should be prioritised for second doses.

At both the media briefing and a conference symposium, Orkin asked the WHO and the US Centers for Disease Control and Prevention (CDC) to update their monkeypox case definitions to reflect new symptoms that are being reported for the first time, including anal lesions and single sores that may resemble common sexually transmitted infections.

Addressing the Monday symposium virtually, Dr Dimie Ogoina of Niger Delta University in Nigeria described the shifting outbreak in countries where monkeypox is endemic. As NPR recently reported, Ogoina was among the first to observe that during a 2017 outbreak in Nigeria, monkeypox cases shifted to young urban men without traditional risk factors, suggesting the virus was spreading through sexual contact.

Since cases started appearing in Europe and North America, there’s been increased monkeypox awareness and surveillance in Nigeria, Ogoina said, but "we must ensure there is equity in the distribution of vaccines and therapeutics.”

Demanding access

Public health officials, clinicians and advocates alike all agree that the global monkeypox vaccine supply is not keeping up with demand, especially as high-income countries vie for the limited number of doses. Although countries in west and central Africa have faced monkeypox for decades, they have virtually no access to vaccines and treatment.

As Dr Demetre Daskalakis, the director of the CDC’s Division of HIV Prevention and newly appointed deputy co-ordinator of the US monkeypox response, prepared to speak at the symposium, dozens of activists stormed the stage. The protesters – including veteran AIDS activists – demanded increased access to vaccines and treatment both in the US and worldwide.

Although the US already owns the lion’s share of the global vaccine supply, advocates are particularly frustrated that some 800,000 finished doses sat unused for weeks at a factory in Denmark awaiting a delayed FDA inspection. The US and some other countries stockpile smallpox vaccines and therapeutics (which also work for monkeypox) to be prepared for bioterrorism, but activists insist they should be used in this health crisis facing gay men.

“We need to act now,” said James Krellenstein of PrEP4All, which has spearheaded monkeypox advocacy. “We’re in a worsening outbreak that could have easily been prevented.”

The activists’ list of demands includes “decisive leadership” from WHO and the United Nations on global monkeypox vaccine and treatment access, including efforts to scale up production. Currently, only a single facility in Denmark can produce the vaccine, with a production capacity of less than 50 million doses per year. They called for “immediate transfer of intellectual property, know-how and technology” to manufacturers around the world that can make vaccines, treatments and diagnostics.

The activists also demanded that the US, Canada, the European Union and other higher-income countries make good on their commitment to be a “vaccine arsenal for the world.” Advocates are loathe to see a repeat of the situation with COVID-19 vaccines, where lower-risk people in some high-income countries may be on their second booster while many high-risk people in low-income countries have not been vaccinated at all.

The protesters demanded that the global monkeypox response prioritises vulnerable populations and communities and called for funding and support for people who need to isolate. But, they emphasised, increased funding for the monkeypox response must not jeopardise responses to HIV, tuberculosis, hepatitis C and sexually transmitted infections.