Monkeypox vaccine distribution process failing as cases rise

Monkeypox cases in the U.S. as of August 17. Numbers range from 1 to 10 cases (white), to over 500 (dark blue).

When will the federal government stop misrepresenting the availability of monkeypox vaccines and acknowledge it has mishandled the monkeypox health emergency? With 12,689 total confirmed monkeypox cases in the U.S. as of August 16 — a third of the global cases — frustration with the ever-widening outbreak is building among those at highest risk as well as those who are merely scared by the lack of data and education on the disease. 

Back on May 22, President Biden said monkeypox is a virus “that everybody should be concerned about.”

Biden told reporters, “[The CDC] haven’t told me the level of exposure yet, but it is something that everybody should be concerned about,” and then said “we’re working on it hard to figure out what we do and what vaccine may be available.”

That is when the government should have ordered more vaccine — that very day. It took five more weeks for the Centers for Disease Control and Prevention (CDC) to activate its Emergency Operations Center. It was two more weeks after that until the U.S. sent inspectors to the plant in Denmark that makes the vaccine so that the orders could begin to be filled. 

Another month later, on August 2,  Biden appointed a White House monkeypox team, including FEMA’s Robert Fenton as the White House National Monkeypox Response Coordinator and Dr. Demetre Daskalakis as White House National Monkeypox Response Deputy Coordinator. Fenton previously coordinated testing and vaccines for COVID-19 for the Biden administration. Daskalakis, who is openly gay, has a long history in New York of working with gay, bisexual and men who have sex with men on sexual health issues, including HIV/AIDS.

Biden said Fenton and Daskalakis would “lead the administration’s strategy and operations to combat the current monkeypox outbreak, including equitably increasing the availability of tests, vaccinations and treatments.”

But by the time those appointments were made, the U.S. had gone from a handful of cases in May to leading the world with thousands of cases, doubling every couple weeks. That White House team, which should be speaking out to impacted communities and healthcare professionals, has been invisible — unavailable for interviews or even comments. 

Since those appointments, the caseload has doubled. What exactly is that team doing?

Rick Bright, the former director of the Biomedical Advanced Research and Development Authority (BARDA), told Vanity Fair that the federal government is “getting a lot of heat, and I think it’s deserved heat, after what we’ve been through with COVID.” 

Bright said, “[The federal response] has been much slower and more hesitant than it should have been—too much ‘wait and see.’”

That lack of action has angered gay activists who see echoes of the government’s lax response to the HIV/AIDS epidemic. If monkeypox hadn’t targeted men who have sex with men, would the response have been swifter and more focused on containment?

It’s not an unreasonable presumption. While the virus is not a sexually transmitted infection, a new study in the New England Journal of Medicine estimated 95% of monkeypox infections were being acquired through sex, particularly sex between men.

The New England Journal of Medicine report also highlights how painful and long-lasting the illness is, citing the most common reason for hospitalizations are “severe anorectal pain; soft-tissue superinfection; pharyngitis limiting oral intake and infection-control purposes. No deaths were reported.”

There has also been a significant amount of gaslighting from the government which said from the outset that there was plenty of vaccine available when that was never the case. The 20 million doses stockpiled by the Obama administration had dwindled to just over 2,000 unexpired doses by May 2022. It would not be until July 1, after some scathing exposes of the expired vaccines, that the administration finally sent inspectors to the Bavarian Nordic plant in Denmark that is the world’s sole purveyor of the JYNNEOS monkeypox vaccine. 

Bavarian Nordic is completely funded by the U.S. — $2 billion in financial support. In exchange, the U.S. has expected vaccines. But on August 17, Rolf Sass Sorensen, a vice president at Bavarian Nordic, told Bloomberg news that it was no longer sure the company could provide the vaccine as promised, due to a myriad of factors.

Sorensen said, “Demand keeps rising and it’s no longer certain that we can continue to meet the demand we’re facing even with the upgrade of our existing manufacturing site in Denmark.”   

Bavarian claims it can currently produce 30 million doses per year. Bloomberg reports that the company says “a possible tech transfer for JYNNEOS to a U.S. producer could take about three months if the process is sped up, compared with about nine months under normal circumstances.”

That’s a long time without vaccines; other nations are reporting shortfalls similar to that in the U.S.

Yet despite these incontrovertible facts, the U.S. government keeps reiterating that “there are hundreds of thousands of monkeypox vaccines available.” In New York, the epicenter of the current outbreak with more than 2,600 cases, CBS News reports that “As of Monday [August 15], we’re told there are 442,000 doses for local health departments.” 

There are 1.7 million people eligible for the vaccine now in the U.S., under the very limited scope of eligibility — four times the available doses. That eligibility criteria does not include vaccinating healthcare workers, children (an eighth child was diagnosed August 16), unhoused people or sex workers. The number of doses cited is deceptive, as it suggests a larger number of vials of vaccine than are actually available. That 442,000 doses is the extrapolation after the individual vials are divided into five separate doses to be used via the FDA’s new delivery system of intradermal injection, as opposed to the one originally intended, subcutaneous injection. 

On August 15, the New York Times reported a plethora of problems with vaccine distribution, including misdelivered and spoiled vaccines. The story also revealed that the CDC’s VTrckS system that delivers billions of vaccines annually and is able to link with state databases to track vaccinations and doses is not distributing the JYNNEOS vaccine. 

Instead, the vaccine is being sent out of the National Strategic Stockpile through an arm of the Department of Health and Human Services (HHS). Compounding the wait times for vaccine allotment is that unlike CDC’s VTrckS system, which runs smoothly with little external effort, HHS was not equipped to manage orders for vaccines, arrange deliveries from the stockpile, track shipments or link to the individual state systems.

Orders for JYNNEOS had to be submitted by email rather than through an automated system. In addition, healthcare officials had no way of tracking shipments. 

Add to this that Paul Chaplin, the CEO of Bavarian Nordic, has expressed “some reservations” about the FDA’s decision to administer the vaccine intradermally.  Chaplin voiced his concerns in an August 9 letter to FDA Commissioner Robert Califf and HHS Secretary Xavier Becerra. 

Chaplin said that “due to the very limited safety data available,” concomitant with more side-effects from this type of vaccination, “This may have a negative impact on vaccine uptake and coverage.” 

But on August 17, in a sweeping story on the timeline of the health emergency, the Washington Post reported Chaplin “accused the Biden administration of breaching its contracts with his company by planning to use the doses in an unapproved manner.” 

Sources told the Post that “Chaplin threatened to cancel all future vaccine orders from the United States, throwing into doubt the administration’s entire monkeypox strategy.”

This is where we are. Gay and bisexual men are suffering with weeks-long illness and the potential to stop it lies in a small factory outside Copenhagen with a CEO concerned that what lies ahead may not be a contained outbreak, but a failed vaccine delivery system that may harm the very people it’s meant to help.

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