Update: Hours after this report was published, the FDA granted certification to the Danish medical facility, freeing up more than 1 million vaccine doses to be sent to the United States.
As monkeypox case numbers climb nationwide, the Biden administration says that it remains opposed to efforts that would bypass the bureaucratic red tape keeping more than 1 million doses of vaccine stuck on another continent.
But with fears mounting that the previously rare disease now is on the verge of becoming endemic in the United States, patients, physicians and public health experts say that refusal to learn from the mistakes of the coronavirus pandemic is unacceptable—particularly when a safe and effective vaccine is already in reach.
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“It's just déjà vu all over again,” said Lawrence Gostin, director of the O’Neill Institute for National and Global Health Law at Georgetown Law Center. “When you have a fast-moving, out-of-control spread of monkeypox in the United States, when the White House goes the extra mile and purchases a million doses, and then to not have them available to respond in a smart, effective way, it’s intolerable.”
“There literally is no excuse.”
Since the first domestic monkeypox case was identified in May, there have been more than 1,000 confirmed cases in the United States, although a lack of access to testing and broad clinical unfamiliarity with the illness means that the true case count is likely far greater, according to epidemiologists. At the outbreak’s onset, government officials downplayed the risk that monkeypox posed to Americans, pointing to a vast supply of more than 100 million doses of preventative vaccines for both monkeypox and its more dangerous relative, smallpox, held in national vaccine stockpiles.
The monkeypox virus—which likely originates in rodents, despite its name—has historically been almost entirely restricted to children in Central and West Africa, in part because it is spread primarily through close physical contact. But the most recent outbreak has already been found in more than 10,000 people worldwide, primarily in men who have sex with men. The illness caused by the monkeypox virus is not dissimilar from chickenpox, although they are not related, as monkeypox symptoms include fever, headaches and soreness, as well as the fluid-filled lesions that give the disease its name. All of the people who have tested positive for the illness in the latest outbreak have recovered, according to public health authorities, but the long-term side effects of the illness are not well understood.
“We have access to vaccines and even treatments here in the U.S., and so the risk we believe is substantially lower,” Dr. Raj Panjabi, the senior director for global health security and biodefense at the White House’s National Security Council, told NPR in May. The National Strategic Stockpile, the nation’s emergency repository for medical supplied, possesses roughly 100 million doses of ACAM2000, a second-generation vaccine, and the United States owns more than 1 million doses of Jynneos, a two-dose vaccine approved in 2019 that has fewer side effects than ACAM2000.
But as the scale of the current monkeypox outbreak came to be understood, public health officials came to realize an enormous hitch in plans for swift disbursement of a vaccine: nearly all of the Jynneos doses owned by the United States have not been cleared to enter the United States by the Food and Drug Administration.
In 2020, one year after Jynneos was approved for use by the FDA, the vaccine’s Danish manufacturer, Bavarian Nordic, began moving each step of its vaccine manufacturing in-house after having used a contractor to fill doses of Jynneos offsite. This resulted in roughly 1.1 million doses of the vaccine being filled at a Bavarian Nordic facility near Copenhagen—a facility which, unlike its predecessor, was not yet inspected by the FDA. While the U.S. still possessed 300,000 doses of Jynneos that had been filled at the FDA-inspected contractor facility, the 1.1 million remaining doses remain stuck in limbo until the new facility is inspected.
“An inspection is one of the final steps of a long process,” a Bavarian Nordic spokesperson told The Daily Beast. “Moving production from one facility to a new facility is a major manufacturing change that needs to be very well supported with data including sterility, specifications, and analytical methods and to establish reliable supply chains so that manufacturing is as consistent as possible.”
That would be a reasonable excuse for the delay, health experts and public officials said, if the new Bavarian Nordic facility had not already passed muster with European regulators more than a year ago—and if the FDA had not delayed its own inspections process until a public health crisis.
“The FDA has their heads in the ground!” said Michael Donnelly, a data scientist and a prominent critic of the public health response to monkeypox. “Thousands of GBTQ Americans are denied these vital vaccines every day while they sit in a warehouse in Denmark. It’s not a question of if this process will cause a delay—the delay is already here.”
The delay is explained partly by the same thing that has made the current monkeypox outbreak so surprising: its previous rarity outside of a few communities in Central and West Africa.
“The FDA hadn’t gotten around to inspecting the new factory and whose fault that is, I don’t know. But until this started in May, monkeypox was at the bottom of everybody's list,” said Dr. David Freedman, a professor emeritus of infectious diseases at the University of Alabama and an expert in tropical diseases. “Nobody anticipated that so many doses would be needed, and it just kind of dropped down there.”
Bavarian Nordic, Freedman said, also had no incentive to expedite the FDA inspection, “because at that time, nobody wanted to buy their vaccine.”
“They weren’t ordering any more—they had a contract for these couple of million doses, and the U.S. was being resupplied with the older vaccine,” Freedman said. “So I think that's what happened here.”
That inspection snafu has slowed the number of doses available to Americans at high risk for infection down to a trickle, and has turned obtaining a dose into a grim combination of The Hunger Games and a radio call-in competition for concert tickets. In New York City, the current epicenter of the U.S. outbreak, the announcement that 1,700 doses of the vaccine would be made available by the city’s health department on Tuesday turned into a free-for-all as the appointment website crashed within seconds of going live. For nearly two hours, thousands of would-be patients hit “Refresh” on the site hoping to obtain a shot, with nearly all of them closing their browsers without an appointment.
The solution, public health authorities and elected officials are increasingly saying, is for the FDA to waive the inspection requirement and accept the European Medicines Agency’s inspections as reciprocation to its own. The FDA already accepts reciprocity for various medical products, and is set to decide by this Friday if they will extend that reciprocity to vaccines.
“It isn’t as though the idea of vaccine reciprocity is ludicrous. The FDA has already been contemplating it,” said Erik Bottcher, a member of the New York City Council who represents Manhattan’s Greenwich Village, Chelsea and Hell’s Kitchen, all of which have large LGBTQ populations. “We should absolutely use the European Medicines Agency’s determination that the Bavarian Nordic facility is in compliance.”
The White House has downplayed the delay in FDA inspection, with Panjabi telling reporters at a New York press conference last week that the agency had actually expedited inspections by “several months to make sure we have those vaccines here as quickly as possible.”
A White House spokesperson told The Daily Beast that the inspection of the Danish facility, which began on July 1, is ongoing, and punted the question of bypassing the inspection requirement to the agency.
“Inspection of Denmark is not delayed,” said White House Assistant Press Secretary Kevin Munoz. “As you know, it’s an independent regulatory agency so we do not have an opportunity to have a role.”
The FDA, along with the Department of Health and Human Services and the Centers for Disease Control and Prevention, did not respond to requests for comment on bypassing the inspection requirements. But no epidemiology expert who spoke with The Daily Beast doubted that European regulators are more than competent at determining the safety of a manufacturing facility.
“I suspect that the European Union’s regulatory arm is capable of undertaking effective inspections,” said Dr. Timothy Brewer, a professor of epidemiology at UCLA's Fielding School of Public Health and of Medicine. “I would not have any personal concerns with using an EU-inspected vaccine.”
With the coronavirus pandemic in its third year, public health experts told The Daily Beast that there is no excuse for any hurdles in the nation’s response to monkeypox, whether they be the result of federal red tape or local incompetence.
“The White House doesn’t get to just sit back and watch a comedy of errors at the city and state level, because it's not a city and state problem—it’s a national problem,” said Gostin. “This is an infectious disease. By definition, it will cross state borders and it needs a unified, rigorous, well-resourced federal response.”
In late June, the White House did outline its plan for addressing the outbreak, with announced distribution of nearly 300,000 doses of the vaccine “over the coming weeks,” as well as the purchase of 2.5 million additional new doses—although those will not be available until next year.
More immediately, the White House is partnering with GLAAD in hosting a monkeypox briefing aimed at social media influencers aimed at informing their followers about vaccine eligibility and at-risk behavior. The briefing, first reported by Politico on Wednesday, was met with scorn by many of the very influencers who would normally take part in it, many of whom pointed out that wider access to the vaccine would do more to prevent monkeypox’s spread than posts on TikTok.
“whatever brave influencer says yes to this opportunity… good luck,” tweeted Tyler Oakley, perhaps the most famous gay influencer working. “everyone already hates it & you & everything you’ve ever done.”
In addition to the cringe factor, Gostin said, the risk of farming out vaccine information to influencers is that it looks like the administration is treating those at high risk—many of whom are already well informed about monkeypox, and are simply waiting for their shots—like children.
“Using influencers is, in some ways, talking down to them, whereas you need to have community-based organizations and people who are at risk themselves getting support,” Gostin said. “What we learned from the AIDS epidemic is that working closely with affected communities and finding out what they need for support is clearly the best way to go.”
The risks of the delayed vaccine rollout grow every day. With tens of thousands of monkeypox cases worldwide likely going unconfirmed, a number floated grimly by one administration source, the United States is quickly approaching a day when containment is no longer feasible, and the illness becomes a fixture of American life.
“We are very much at risk of monkeypox becoming entrenched in the U.S.,” said Bottcher. “And unlike many purely sexually transmitted infections, there are still many questions and unknowns about other forms of monkeypox transmission outside of sexual contact.”
That day, Freedman said, may already be here.
“I don’t think, whatever we do, that monkeypox is now going to go away,” Freedman said. “I think the best we can hope for is to control this outbreak. Of course, any delay in getting people vaccinated is going to prevent us from being able to minimize or prevent the further growth of the disease.”
