Testing bottlenecks and vaccine rollout problems have let the monkeypox virus spread unchecked, echoing the mistakes of the U.S. COVID response
Waits in long lines. A shortage of testing. People scrambling to refresh websites for vaccine appointments. But this time, it’s not COVID—it’s monkeypox.
The number of confirmed monkeypox cases in the U.S. had reached 1,053 as of July 13, according to the Centers for Disease Control and Prevention. Some experts say that number is likely a serious underestimate, however.
“The scale of testing is very low—lower than would allow us to really make inferences about the dynamics of the epidemic, besides the idea that it’s an expanding epidemic,” says Keletso Makofane, a social network epidemiologist at Harvard University’s FXB Center for Health and Human Rights. For example, New York City had until recently only been testing 10 people per day at its public health laboratory, the city’s only testing site. That is “absurd,” given the number of people there who are at risk of monkeypox and the amount of travel in and out of the city, Makofane says. “It’s a gross underinvestment in the response right now.”
Monkeypox is a viral disease related to smallpox. It causes blisterlike lesions and flulike symptoms and spreads through close skin-to-skin contact (and possibly through respiratory droplets at close range or contaminated objects such as clothing). It was first documented in a human in 1970 and was previously only endemic to countries in Central and West Africa. In May 2022 new cases were reported in Europe, and the first U.S. case was reported on May 12. Most known monkeypox cases in the current outbreaks outside of Africa have been among men who have sex with men, or MSM (although the virus is not limited to that community).
In describing the U.S. response to monkeypox, “the main adjective that comes to mind is sluggish,” says Monica Gandhi, a professor of medicine at the University of California, San Francisco, School of Medicine. She published a June 24 essay in the Atlantic arguing that the country was underreacting to monkeypox. At that time the “fire was already being lit,” she says: the U.K. and Canada had already started vaccinating people. “I was actually surprised that we are this far behind.”
Monkeypox testing in the U.S., like testing for COVID, was initially limited to a small number of government-run labs. Until recently, testing for orthopoxviruses (a group of poxviruses that includes monkeypox, as well as smallpox and other pathogens) was available at fewer than 70 laboratories that were part of the CDC’s Laboratory Response Network. On June 22 the Department of Health and Human Services announced that five commercial labs would soon begin offering the tests, and on July 6 the CDC announced that the company Labcorp would become the first to start testing—effectively doubling the country’s existing capacity. On July 11 Mayo Clinic Laboratories also began offering testing, bringing the capacity up to 30,000 tests per week, according to Kristen Nordlund, a CDC spokesperson. “Having an orthopoxvirus test within public health labs nationwide helped enable the United State to quickly and accurately test for monkeypox cases,” Nordlund wrote in an e-mail to Scientific American. “We anticipate additional commercial laboratories will come online in the coming days, and monkeypox testing capacity will continue to increase throughout the month of July.”
But such moves may be coming too late to tamp down community spread of the virus. The situation has distinct echoes of the early days of SARS-CoV-2, the virus that causes COVID. “They should have known from COVID that, even from this crisis, there was a very early warning that this can happen,” Makofane says. “By not ramping up testing immediately, we’ve missed a really critical window of opportunity to bring the outbreak under control or at least to warn people.”
Activists in the gay community say they have been extremely frustrated by the slow response. “We lost weeks and weeks because we weren’t routinely screening for people with monkeypox,” says James Krellenstein, co-founder and managing director for strategy and policy at PrEP4All, an organization working to increase access to HIV medication. “I view this from a pandemic preparedness perspective as our first real trial run since SARS-CoV-2, and we’re flunking.”
Vaccination is another bottleneck. Fortunately, unlike when COVID first appeared, vaccines for monkeypox already exist. The U.S. has stockpiled millions of doses of ACAM2000, an older smallpox vaccine that also works against monkeypox, but it can cause nasty side effects and shouldn’t be used by people who are immunocompromised or pregnant, for example. The country also has a newer vaccine called JYNNEOS, made by the Danish company Bavarian Nordic, but doses are in short supply.
When the first shots were made available in New York City, appointments ran out within minutes. Glitches in the New York City Department of Health and Mental Hygiene’s Web site caused confusion, as people desperately refreshed the site only to find the promised appointments were already taken.
In a June 28 letter to top Biden administration officials, Krellenstein and a colleague allege that the U.S. had more than a million doses of the JYNNEOS vaccine in a stockpile in Denmark that couldn’t be used because the Food and Drug Administration had not completed its inspection of the facility that makes them. Although the European Medicines Agency previously inspected and approved the facility, the FDA does not recognize EMA authorizations of vaccines. The U.S. agency has since completed its own expedited inspection, but Krellenstein says it has led to costly delays.*
“I’m a gay man who’s obviously impacted by this personally,” he says. “It’s incredibly disturbing that, right now, my friends and, in some cases, loved ones are being turned away from being vaccinated—all while over a million doses of the JYNNEOS monkeypox vaccine, that their tax dollars paid for, are sitting unused in a freezer in Denmark.”
Scientific American reached out to HHS for comment but had not heard back at the time of publication. An FDA spokesperson replied but did not wish to comment on the record about monkeypox vaccines or testing. On July 7 HHS announced it would make an additional 144,000 JYNNEOS doses available to states and other jurisdictions, in addition to the 56,000 doses distributed previously.
Gandhi, who runs an HIV clinic at Zuckerberg San Francisco General Hospital and Trauma Center that serves a large number of gay men, says this population is highly motivated in terms of sexual health—which makes the vaccination problems even more frustrating. “The gay male community, who are either living with HIV or at risk for HIV, is a highly mobilized population with a lot of advocacy and a lot of community work,” Gandhi says. “If we had the supply right now, there would be community organizations and HIV clinics just chomping at the bit to help.”
As for monkeypox treatment, there is an existing antiviral drug called TPOXX (tecovirimat) that is FDA-approved for smallpox. But doctors must file an investigational new drug application to obtain it for their monkeypox patients, “causing days of delay,” Krellenstein says. The biggest priority right now, he says, is getting vaccines into arms in an equitable way. And that will require resources from the federal government.
Some health experts say the chaotic vaccine rollout has also exposed gaps in the country’s ability to respond to a bioterrorism event. “If there was some kind of threat that had to do with this particular set of illnesses—orthopoxviruses—we would have failed to respond to it quickly,” Makofane says. “That, to me, should be alarming to people—even [those] who are not paying attention to public health but are paying attention to security.”
GATHERING BETTER DATA
In order to address the outbreak in places where monkeypox is spreading, researchers need a better idea of how it is spreading—particularly among MSM.
Makofane and his colleagues are launching a study of the prevalence of monkeypox-like symptoms in New York City. The Rapid Epidemiologic Study of Prevalence, Networks, and Demographics of Monkeypox Infection (RESPOND-MI) study, which is currently in the fundraising stage, aims to determine the places where gay, bisexual or other MSM have had group sex in the city and to establish a network of men who have sex with each other. The researchers hope to use this information to determine clusters of infection and help target vaccination efforts. Makofane and his team are developing an app that aims to communicate with the community “in a way that reflects culture, humor, the language that people use, normalizes the way that gay and bi men live,” he says. He adds that the goal of the project is to avoid having it feel like outsiders are coming in and collecting information.