Infectious disease experts and public health advocates are warning that the Biden administration has been too slow to respond to the monkeypox outbreak and that the U.S. is at risk of losing control of the disease. 

The response to monkeypox is mirroring the worst parts of the early days of the coronavirus pandemic, they say, with severely limited testing and a sluggish rollout of vaccines leading to a virus that’s spreading undetected.

“Where we have lagged is streamlining testing, making vaccines available, streamlining access to the best therapeutics. All three areas have been bureaucratic and slow, and that means we haven’t contained this outbreak,” said David Harvey, executive director of the National Coalition of STD Directors (NCSD).

Unlike COVID-19, monkeypox is not a novel virus, and the strategies to reduce the spread are well known. Biden administration officials said they are confident in their approach.

“We as a global community have known about it for decades. We know how it spreads. We have tests that help identify people who are infected. We have vaccines that are highly effective against it,” White House coronavirus response coordinator Ashish Jha said during a recent briefing.

According to the Centers for Disease Control and Prevention (CDC), there are 460 cases in 30 states, Puerto Rico and D.C., though experts say that number is almost certainly an undercount, as many people who may be infected don’t yet have access to widespread testing.

The administration is ramping up its response by expanding testing capacity and broadening access to vaccinations, though critics say the efforts may be coming too late.

“We’ve been sort of screaming for a month about how bad the diagnostic situation is for monkeypox. And that really was a clear error, preventable, and it’s very clear that this administration has not learned lessons from early COVID,” said James Krellenstein, co-founder of the HIV treatment advocacy group Prep4All. 

Jon Andrus, an adjunct professor of global health at George Washington University’s Milken Institute School of Public Health, said the U.S. is lucky that monkeypox is not as contagious as COVID-19, or as deadly, because the public health system is underfunded and overly fractured.

“I think we’ll continue to repeat these mistakes because that’s been our track record. That’s been our track record. We’ve had, what, more than five or six waves of COVID, and we seem every time to be a little bit caught off guard,” Andrus said. “Stopping transmission requires that we’re all reading from the same page. We all have the same road map.”

The administration expanded testing to commercial labs in late June, so providers will soon be able to order tests directly from the labs where they have established relationships and can jump through fewer hoops.

But it took more than a month for that move to happen, which increased testing capacity from about 8,000 tests a week to 10,000 across the entire system. 

Demand is also not evenly spread across the public health laboratory networks; it is concentrated in urban areas such as New York City, leading to backlogs and frustrated patients who wait days for test results.  

Biden administration health officials this week touted efforts to expand testing.

“I strongly encourage all health care providers to have a high clinical suspicion for monkeypox among their patients,” CDC Director Rochelle Walensky said during a call with reporters. “Patients presenting with a suspicious rash should be tested.”

Testing for monkeypox is a relatively simple process that involves swabbing a skin lesion. Unlike with COVID-19, the CDC already had a previously developed test, but patients were limited to a narrow set of specific criteria in order to qualify for testing. 

“We already had testing available. We already had vaccines available. We should have really been much more aggressive with testing … and I think this speaks to some of the bureaucracy of both FDA [Food and Drug Administration] and CDC,” said Celine Gounder, an infectious disease specialist and editor-at-large for public health at Kaiser Health News.

“Getting the commercial labs on board they could have done sooner. Getting academic medical centers to do testing, hospital labs to develop their own PCR tests. I mean, that’s not a very difficult thing to do,” Gounder said.

The White House is also working to scale up its vaccination program and announced a plan to immediately send out tens of thousands of doses of Jynneos, the only FDA-approved vaccine specifically for monkeypox. 

More than a million doses will be made available throughout the year. The CDC is also broadening the eligibility criteria so individuals with confirmed monkeypox exposures and presumed exposures can be vaccinated, rather than only those who have a confirmed case.

But activists and experts say the administration moved too slowly and that the updated vaccination strategy is not nearly sufficient.

“We believe this outbreak is already out of control. So, we have not contained it. Vaccines are not going to contain it at this point. Because we don’t have enough. Getting them into arms is an expensive and intense process,” said NCSD’s Harvey.

New York City and Washington, D.C., began offering the vaccines to men who have sex with other men or may have been exposed to the virus. But both cities ran through their supplies less than a day after launching their local immunization initiatives. D.C. Health had to shut access about 10 minutes after making shots available. 

There are about 56,000 Jynneos doses in the Strategic National Stockpile that will be allocated immediately, officials said, and the administration plans to allocate 296,000 doses over the coming weeks.

The U.S. has tens of millions of doses of the smallpox vaccine ACAM2000, but that shot has more dangerous and severe side effects.

According to a spokesman for Jynneos’s Denmark-based manufacturer Bavarian Nordic, 300,000 doses have already been delivered or will be arriving over the next few days.

An additional 1.1 million filled doses are still being inspected by the FDA, which should finish in the next couple weeks.  

The government also owns bulk materials totaling as many as 15 million doses, but they are still frozen, and the administration has not told the company how it wants those doses filled. 

“American taxpayers spent money buying and manufacturing these doses precisely so they can be used rapidly in the event of an outbreak,” said Krellenstein of Prep4All. 

“Here we have an outbreak, and my friends are literally being turned away from being vaccinated because the Biden administration can’t figure out how to get a million doses out of a freezer in Denmark into the United States,” Krellenstein added.