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What went wrong with the rollout of the monkeypox vaccine?

Limited testing, a delayed FDA inspection and technical issues with online appointments have likely helped the virus take hold in the U.S.
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A series of crucial mistakes in the rollout of the monkeypox vaccine has significantly inhibited America’s ability to distribute doses and prevent the troubling and in some cases extremely painful disease from becoming endemic.

In the meantime, the virus has deepened its hold on the country, with confirmed cases rising tenfold in the last month, to a total of more than 1,000 as of Thursday, though that’s almost certainly an undercount. Vaccine seekers have become fearful and frustrated as they watch friends and loved ones get sick or they themselves develop uncomfortable lesions.

“I actually struggled with sleep the past couple of nights,” said Philip Cheng, a urologist from New Jersey who spent three weeks looking for a dose in New York City before finally booking an appointment. “The number of cases in New York has reached a level where a lot of people now know someone who has it.”

In a pattern familiar from the Covid pandemic, the missteps started with limited testing capacity. The U.S. also didn’t order more monkeypox vaccine doses to add to its stockpile until June, even though the virus started spreading in May. In addition, regulators did not finish inspecting a key Denmark facility manufacturing monkeypox vaccines until Saturday, leaving 1.1 million ready-to-distribute doses still waiting to be shipped to the U.S.

Even when tens of thousands of doses were finally sent to states this month, the allocations quickly fell out of step with the geographic distribution of cases. A confusing patchwork of vaccine appointment systems was then marred by technical issues.

“We’re dealing with extremely limited supply of vaccine, certainly in comparison to demand or risk,” New York City Health Commissioner Ashwin Vasan told NBC News. 

Vasan offered a public apology on Wednesday for the city’s glitchy rollout. 

“We own it. You know, those mistakes shouldn’t happen and so we’re working to correct those and do better,” he said at a news conference. 

How do vaccine appointments and eligibility differ state to state?

In most cities and states, monkeypox vaccines are being offered to people with known or presumed exposure to the virus, including men who have sex with men and transgender, gender nonconforming or nonbinary residents with multiple sexual partners. 

But specific eligibility criteria vary from place to place. Washington, D.C.’s criteria includes sex workers and staff at establishments where sexual activity occurs, such as bathhouses and saunas. Los Angeles expanded its eligibility on Tuesday to patients at sexual health clinics with a recent diagnosis of rectal gonorrhea or early syphilis and certain "high-risk individuals" in the L.A. County jail. San Francisco is also vaccinating laboratory workers and clinicians with a high risk of exposure to monkeypox at work.

A healthcare worker administers a vaccine to Ed Stupi for the prevention of monkeypox at the Pride Center on July 12, 2022, in Wilton Manors, Fla.
A healthcare worker administers a vaccine to Ed Stupi for the prevention of monkeypox at the Pride Center on July 12, 2022, in Wilton Manors, Fla.Joe Raedle / Getty Images

Vaccination appointments across the country are limited and tend to fill up quickly, often within minutes.

People can call to make appointments in Boston, Dallas, North Carolina, San Francisco, Sacramento and San Diego. Los Angeles’ public health department is contacting people directly if they meet the county’s eligibility criteria. Colorado is using an interest form, but appointments are no longer available. And Steamworks bathhouses in Chicago and Berkeley, California, are offering doses on select days on a first-come, first-served basis.  

Broward County, Florida, New York City and Washington, D.C., are offering appointments through online scheduling tools. Both New York City and Washington were temporarily out of doses as of Thursday, but New York City is releasing more appointments on Friday evening. New York state is also offering text alerts to notify residents when more doses become available.

Research suggests that if given within four days of exposure, the Jynneos vaccine might prevent monkeypox, and if given within 14 days might at least mitigate symptoms. When given as a preventive, it is meant as a two-dose vaccine given four weeks apart, which research suggests can reduce the risk of infection by about 85%. 

It’s possible that a single dose might suffice, however, so some politicians have asked the federal government to adjust its vaccine strategy accordingly, given the short supply and mounting demand. 

The Department of Health and Human Services initially sent out 56,000 doses to cities and states, then on Monday began distributing an additional 144,000 doses, at least 132,000 of which have gone out.

“It’s slow, but we’re getting there,” said Anil Mangla, the state epidemiologist for Washington, D.C. “The bottleneck for us right now is the number of doses coming into the district. If that was increased, we’d be fine.”

More than 1 million doses held up in Denmark

Going into the current outbreak, Vasan said, the U.S. had a stockpile of 36,000 available Jynneos doses meant to be used in case of a smallpox bioterrorism event; Jynneos is FDA-approved for both smallpox and monkeypox. The supply was intended to fill a gap, since an older smallpox vaccine, ACAM2000, can’t be given to immunocompromised people, whereas Jynneos can.

But when monkeypox started spreading, the U.S. wasn’t ready to roll out Jynneos doses on a national scale, Vasan said.

“We’ve had to ramp that system up, bring that system to life for epidemic response, which is a totally different thing and a totally different scale of activity,” he said. “That’s why you’re seeing things take more time than all of us would hope.”

But avoidable mistakes also slowed down the distribution of vaccines, according to some politicians and activists. 

“The federal government should have ordered far more of this vaccine to stockpile,” said California state Sen. Scott Wiener. “It’s not surprising that we’re having a monkeypox problem. People have predicted this. This should not be shocking. And so now, the U.S. is having to scramble to order more.”

The U.S. ordered 1.4 million Jynneos doses in 2020. Then in response to the current outbreak, it ordered another 500,000 doses in June for delivery this year, followed by 2.5 million in July for delivery in 2022 through early 2023. 

Bavarian Nordic, which makes Jynneos, is prepared to ship 1.1. million doses to the U.S. But the Food and Drug Administration needed to inspect the company’s manufacturing facility before those doses could be released. That inspection was originally planned for later this year but the FDA moved it up in response to the monkeypox outbreak, said Rolf Sass Sørensen, vice president of investor relations and communications at Bavarian Nordic. The FDA finished inspecting the facility on Saturday, he said.

Even so, the agency hasn’t signed off on the doses yet, so none have been shipped, Sørensen said.

“It’s really up to the FDA,” he said. “We have had plenty of bought vaccine in storage.”

Michael Felberbaum, FDA’s associate commissioner for media affairs, wrote Wednesday on Twitter that the agency hopes to approve the release of doses from the facility by the end of July.

The agency told NBC News that it did not expect a delay in vaccine availability due to this issue. But some activists have criticized what they see as a lack of urgency on the FDA’s part.

“The epidemiological consequences of not having a robust vaccine supply a couple of weeks ago are pretty severe,” said James Krellenstein, co-founder of PrEP4All, an HIV advocacy group. “Gay men are going to be paying for this with their health.”

Krellenstein urged the U.S. government in a letter in June to accept the European Medicines Agency’s signoff on the Bavarian Nordic facility. But the FDA told NBC News that it “takes the quality of vaccine manufacturing very seriously” and determined that it needs to conduct its own inspections of foreign facilities. 

Vaccines may not be going to communities with the greatest need 

Even the doses available in the U.S. have not been distributed as strategically as possible. At first, the CDC allocated them to states based on the numbers of men who have sex with men and residents who are HIV positive. That made sense when states were only seeing a few cases each, Mangla said, but it may have amounted to an unrefined system that failed to prioritize areas with the most cases.

“As the numbers started increasing, many states — and we were one of them — complained to CDC,” Mangla said. “So the CDC changed their formula.”

The CDC’s current distribution plan now accounts for how many monkeypox cases each state is recording, a more precise way to target scarce doses.

In a Monday letter, New York Mayor Eric Adams asked President Joe Biden to allocate more doses to the city and to extend the time period between first and second doses to allow more shots to go into arms. Adams expressed frustration at not knowing how many doses the city would receive in the future.

“The current piecemeal approach to relaying allocation amounts, by phase, makes it incredibly challenging to plan and communicate in a thoughtful, evidence- and equity-driven way,” he wrote.

Multiple high-capacity commercial labs have come online to offer testing over the past week, which should improve surveillance and allocate resources. But a lack of good demographic data about people getting tested for monkeypox has undermined the ability to target vaccination efforts where they will have the greatest impact.

A senior adviser to the CDC who spoke on background because they are not a federal employee said some local health departments are doing a poor job of collecting and relaying this data. 

“We’re asking jurisdictions for this data every day,” the adviser said. 

Mary Foote, a senior medical coordinator at the New York City Department of Health and Mental Hygiene, said on a call with reporters on Thursday that “a lot of health departments in these high-impact areas are overwhelmed.”

“We’re all suffering from staffing shortages to really be able to clean the data and report out on it,” she added.

Technical issues hindered online appointments in New York City

Then there are the many glitches and challenges that come with booking online appointments.

Cheng, the urologist who lives in Hoboken, finally got his monkeypox vaccine in New York on Wednesday, since New Jersey is still only vaccinating people with known exposure to monkeypox. But on Tuesday when he tried to reserve a slot, the city’s scheduling tool kept crashing or freezing. Cheng reloaded the website on his lunch break and between patients, eventually nabbing an appointment in Harlem. But that meant he would need to take a bus to the subway after work. And his partner wasn’t so lucky.

“My partner never got to a point where he could see an appointment slot,” Cheng said. 

New York’s health department said the site delivered error messages due to overwhelming traffic. Other technical glitches allowed some people to make appointments prematurely last week and prevented others from scheduling vaccinations.

“We apologize for the frustration caused and are working to build stable appointment infrastructure as we roll out more appointments,” the department told NBC News.

Jeff, a New Yorker who asked that his last name not be used to avoid stigma, said he felt like he’d won the lottery when he secured an appointment in Harlem last week. But he ended up waiting in line for nearly an hour and a half: “I figured I’d go into the building and be in and out in 15 minutes, but when I arrived, there was a very long line of men waiting outside.”