Outbreak Alerts
Editor: Alyson Browett, MPH

Contributors: Noelle Huhn, MSPH, Christina Potter, MSPH, Eric Toner, MD, and Rachel Vahey, MHS

NOTICE This will be the final regular publication of this report. Future updates on the global monkeypox outbreak will be included in the Center’s Health Security Headlines news digest that is published 3 times per week. To subscribe to Health Security Headlines, please visit https://www.centerforhealthsecurity.org/news/newsletters/hsh/

Additional Monkeypox Resources

EPI UPDATE As of September 13, 58,285 total confirmed cases and 480 probable cases, including 22 deaths, have been reported to the WHO from 102 Member States across all 6 WHO regions. The US reports the most cases of any country globally, with 22,630 confirmed cases. The next 5 countries include Spain (6,947), Brazil (6,033), France (3,785), the UK (3,552), and Germany (3,547). Three other countries—Peru, Canada, and the Netherlands—have reported more than 1,000 cases. According to a September 14 global trends report from the WHO, the number of weekly reported new cases globally decreased by 3.2% in week 36 (September 5-11) (n=4,863 cases) compared to week 35 (August 29-September 4) (n=5,026 cases). The majority of cases over the past 4 weeks were notified from the Americas (74.9%) and European (24.1%) regions.

As of September 6, US states reporting the highest number of cases are California (4,300), New York (3,679), Florida (2,282), Texas (2,017) and Georgia (1,607). As of September 7, 94,385 total specimens have been tested in the US with a cumulative test positivity rate of 29.7%, despite submitted specimens falling far short of current test capacity. The majority of cases continue to be among men, with Black/African American and Hispanic/Latino individuals accounting for 66% of reported cases during the week of September 3.

GLOBAL VACCINE & TREATMENT ACCESS As many nations move on from the COVID-19 pandemic, it is becoming clear that at least one of the mistakes made during that global emergency is being repeated in the current global monkeypox emergency. As they did during COVID-19, high-income countries have bought the majority of vaccines and therapeutics available to prevent and treat monkeypox, leaving little to no supply for low- to middle-income countries (LMICs). With more than 100 countries and territories reporting monkeypox cases, a majority have no vaccines or treatments. Even in West and Central African nations, where cases of monkeypox have regularly occurred over the past 5 decades, vaccines and treatments remain nonexistent. Experts are calling on high-income nations to share their supplies and on the WHO to do more to facilitate equitable access, because even if vaccine doses and treatments became available, most countries could not afford to pay for them. Additionally, many LMICs lack the funding available to conduct comprehensive diagnostic testing and surveillance for monkeypox, making it difficult to gain a full understanding of who has the disease and where they are located. Funding for epidemiological research is also limited, including research regarding potential animal reservoirs. Public health experts warn that the lethargic and uneven response to monkeypox ignores the potential future threat of the virus to human health.

US SITUATION The average number of new daily confirmed monkeypox cases appears to have largely slowed down globally and in the US, although the future trajectory of the outbreak remains unclear. While the US CDC predicts the outbreak will continue to slowly grow over the next few weeks, eventually reaching a point where occasional imported cases, episodic clusters, or short chains of transmission might occur, many public health experts are warning that a decline in cases should not breed complacency. Public health officials, healthcare providers, and communities most at-risk—especially gay, bisexual, and other men who have sex with men (GBMSM)—must remain vigilant by maintaining risk awareness communications about the disease, recognizing symptoms and getting tested as needed, seeking vaccination as eligible, and temporarily changing behaviors in line with personal risk assessments, such as reducing one-time sexual encounters. So far in the US, monkeypox is spreading primarily in social networks of GBMSM, although cases have been reported outside of those networks, including among college students and at least one healthcare worker who was exposed on the job

Today, the US Senate Committee on Health, Labor & Pensions heard testimony from US health leaders—including CDC Director Dr. Rochelle Walensky, NIAID Director Dr. Anthony Fauci, FDA Commissioner Dr. Robert Califf, and HHS Assistant Secretary for Preparedness and Response (ASPR) Dawn O’Connell—regarding the federal response to the outbreak and their agencies' needs. The Biden administration recently included US$4.5 billion for monkeypox in an emergency spending request, mostly to cover the costs of vaccinations, testing, and treatment. Some US Senators are hoping to include monkeypox funding in a continuing resolution to keep the government running into the next fiscal year or an FDA user-fee bill, both of which must be passed by the end of the month. However, other Senators say there should be enough previously appropriated public health funding, including for COVID-19, that can be used for the monkeypox response.  

Concerns over the outbreak rose this week after the County of Los Angeles (California) confirmed the first US death due to monkeypox. The person had a severely weakened immune system, leading officials to urge people with compromised immune systems to quickly seek care if they suspect monkeypox infection. Research published September 9 in the CDC’s Morbidity and Mortality Weekly Report (MMWR) suggests a significant proportion of people diagnosed with monkeypox also have HIV infection (38%) or were diagnosed with a sexually transmitted infection (STI) in the preceding year (41%). Additionally, people living with HIV infection are more likely to be hospitalized for monkeypox infection than those without HIV infection. The report’s authors said the data underline the importance of leveraging existing systems for delivering HIV and STI care and prevention and prioritizing persons with HIV infection and STIs for vaccination. Therefore, people screened for monkeypox should be evaluated for HIV and other STIs, and eligible persons be offered HIV preexposure prophylaxis. The CDC currently recommends that people with HIV get pre- or postexposure vaccination for monkeypox when indicated, such as when a sexual partner is diagnosed with monkeypox, but the agency is considering broadening that recommendation to include many men with HIV or those recently diagnosed with other STIs.

Overall demand for monkeypox vaccination has declined since mid-August, although the proportion of people receiving their second dose of vaccine is increasing. Federal health officials last month launched a pilot program to vaccinate participants at large events, but supply outpaced demand at those events. Now, they are starting another pilot to bring vaccines to smaller, more local events and venues in an effort to close gaps in racial, ethnic, and geographical access. As of September 6, 35 jurisdictions reported administering 461,049 vaccine doses. About 50% of those doses have gone to White men, 13% to Black/African American people, 24% to Hispanic/Latino individuals, and 9% to people in the Asian American and Pacific Islander community. However, monkeypox is disproportionately affecting Black/African American and Hispanic/Latino individuals, with 38% of monkeypox cases occurring among Black/African American people, who make up only 12% of the US population, and 28% of cases diagnosed among Hispanic/Latino people, who make up about 19% of the US population. Additionally, many gay men in the South are reporting difficulty accessing the vaccine, raising concerns that local governments are not responding with urgency to the disease because it primarily affects marginalized communities.

CLINICAL TRIALS The US National Institutes of Health (NIH) recently began enrollment for clinical trials evaluating dose-sparing regimens of the Jynneos monkeypox vaccine and the antiviral tecovirimat, or TPOXX, for treatment of the disease. The vaccine trial will enroll more than 200 people aged 18 to 50 nationwide deemed to be at high risk of monkeypox or smallpox and will test 3 different dosing regimensthe standard dose delivered subcutaneously, one-fifth of the standard dose delivered intradermally, and one-tenth of the standard dose delivered intradermally. Investigators will assess whether the immune responses induced in participants receiving the vaccine intradermally are at least as good as those induced by the licensed subcutaneous regimen, as well as evaluate the different regimens’ safety and tolerability. Bavarian Nordic, the maker of the vaccine, recently posted a preprint study to medRxiv showing that single and 2-dose Jynneos vaccinations administered subcutaneously induced durable neutralizing antibody responses in healthy volunteers. 

The trial evaluating tecovirimat will aim to enroll more than 500 people with severe monkeypox infection or those at risk of severe disease, including people with HIV infection, pregnant women, and children. Some patients will receive the antiviral while others will receive a placebo, so investigators can evaluate whether the drug shortens healing time, impacts pain scores, prevents progression to severe disease, or quickens clearance of monkeypox virus from various samples, as well as its safety, tolerability, and other data. Tecovirimat is currently approved to treat smallpox and is available to treat monkeypox under an investigational new drug (IND) protocol. A report published in CDC’s MMWR suggests that the antiviral is well-tolerated among monkeypox patients, supporting continued access to the drug for that purpose. 

DISEASE SEVERITY The clinical presentation of people with monkeypox in the current global outbreak varies from previous outbreaks, including significantly lower death rates, causing experts to reevaluate their knowledge about severe monkeypox. At least 10 countries have reported monkeypox deaths in the current global outbreak. Some of those deaths were among people who were severely immunocompromised or had other severe illnesses, and at least 2 people who died developed encephalitis but had no other known risk factors. Several viral infections can cause encephalitis, so while the condition is rare, it is not unexpected. A report in the CDC’s MMWR describes 2 cases of encephalomyelitis associated with acute monkeypox infection among healthy men presumed to be immunocompetent and who had no known monkeypox exposure or recent travel. Additionally, a study published in eClinicalMedicine suggests that a small percentage of monkeypox patients may experience severe neurological complications such as encephalitis and seizures and nonspecific neurological conditions such as confusion, headache, and myalgia. The researchers called for more additional surveillance to evaluate psychiatric issues, including depression and anxiety, which appear to be more common.

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