As the number of monkeypox cases rises nationally, the Biden administration says it remains opposed to efforts to break through the bureaucratic red tape that keeps more than 1 million doses of vaccine stranded on another continent.
But with growing fear that the formerly rare disease is now on the brink endemic to the United StatesPatients, doctors and public health experts say it is unacceptable to refuse to learn from the mistakes of the coronavirus pandemic — especially when a safe and effective vaccine is available.
“It’s just about déjà vu again,” said Lawrence Gostin, director of the O’Neill Institute for National and Global Health Law at the Georgetown Law Center. “When you have a rapid, uncontrolled spread of monkeypox in the United States, when the White House goes the extra mile and buys a million doses of the drug, and then doesn’t have them available to respond intelligently. , effective by the way, it’s intolerable.”
“There are really no excuses.”
Since first case of monkeypox in the country was identified in May, there have been more than 1,000 confirmed cases in the United States, although the lack of access to testing and clinical familiarity with the disease mean that the true number of cases the likelihood is much greater, according to epidemiologists. At the time of the outbreak, government officials downplayed the risk that monkeypox posed to Americans, pointing to a massive supply of more than 100 million doses of vaccine for both smallpox and smallpox. monkey season and its more dangerous smallpox, kept in the national vaccine stockpile.
The monkeypox virus – which likely originated in rodents, despite its name – has historically been almost entirely restricted to children in Central and West Africa, in part because it spreads primarily through close physical contact. But the most recent outbreak has been detected in more than 10,000 people worldwide, mostly in men who have sex with men. The disease caused by monkeypox virus is not different from chickenpox, although they are not related, as monkeypox symptoms include fever, headache, and aches, as well as lesions filled with the fluid that gives the name of the disease. All people who test positive for this disease in the latest outbreak recovered, according to public health authorities, but the long-term side effects of the disease are not well understood.
Raj Panjabi, senior director for global health security and biosecurity at the White House National Security Council, told NPR in May. The National Strategic Reserve, the nation’s emergency stockpile of medical supplies, possesses approximately 100 million doses of ACAM2000, a second-generation vaccine, and the United States possesses more than 1 million doses of Jynneos, a The two-dose vaccine approved in 2019 has fewer side effects than ACAM2000.
But as the scale of the current monkeypox outbreak became fully understood, public health officials recognized a major obstacle to plans to rapidly disburse a vaccine: nearly all U.S.-owned doses of Jynneos have not been cleared for import into the United States by the Food and Drug Administration.
In 2020, a year after Jynneos was approved for use by the FDA, the Danish vaccine manufacturer, Bavarian Nordic, began moving the vaccine production step-by-step in-house after using a contractor to supply it. peripheral doses of Jynneos. This resulted in about 1.1 million doses of the vaccine being filled at a Nordic facility in Bavaria near Copenhagen — a facility that, unlike its predecessor, has not been inspected by the FDA. While the US still has 300,000 doses of Jynneos filled at the FDA-inspected contractor facility, the remaining 1.1 million doses remain stuck until the new facility is inspected.
“Checking is one of the last steps of a long process,” a spokesman for Bavaria Nordic told The Daily Beast. “Moving production from one facility to the new is a major change in manufacturing that needs to be very well supported in terms of data including sterility, specifications and analytical methods, and chain setup. reliable supplier so that the production process is as consistent as possible.”
That would be a valid reason for the delay, said health experts and state officials, if the new Bavarian Nordic facility had not been approved with European regulators for more than a year. years ago — and if the FDA doesn’t delay its own review until the public health crisis.
“FDA has their head!” Michael Donnelly, a data scientist and prominent critic of the public health response to monkeypox. “Thousands of GBTQ Americans are denied this vital vaccine every day as they sit in warehouses in Denmark. It’s not a matter of whether the process causes a delay – the delay is already here. “
This delay is partly explained by the same thing that made monkeypox outbreaks so surprising: its previous rarity outside of a few communities in Central and West Africa.
“The FDA didn’t go check the new plant and whose fault it was, I don’t know. But until this starts in May, monkeypox remains at the bottom of everyone’s list,” said Dr. David Freedman, professor emeritus of infectious diseases at the University of Alabama and an expert on tropical diseases said. “Nobody predicted that so many doses would be needed, and it was just that.”
Mr. Freedman said Bavarian Nordic also had no incentive to expedite the FDA review, “because at the time, nobody wanted to buy their vaccine.”
“They’re not ordering anymore — they’ve got contracts for several million of these doses, and the United States is being supplied with the older vaccine,” Freedman said. “So I think that’s what happened here.”
“In a way, using influencers is talking to them, while you need community-based organizations and people at risk to get support themselves.“
– Lawrence Gostin, director of the O’Neill Institute for National and Global Health Law at the Georgetown Law Center
That rapid testing has slowed the number of doses available to high-risk Americans to a trickle, and has turned getting a single dose into a grim combination of The Hunger Games and a radio call contest for concert tickets. In New York City, The current epicenter of the outbreak in the USannounced that 1,700 doses of the vaccine will be provided by the city’s health department on Tuesday turned into free for all as the appointment website crashed within seconds live broadcast. In nearly two hours, thousands of patients will hit “Refresh” on the website in the hope of getting an injection, with nearly all of them closing their browsers without an appointment.
Public health authorities and elected officials increasingly argue that the solution is for the FDA to waive the testing requirement and accept the European Medicines Agency tests as its own response. The FDA has accepted reciprocity for various medical products and will decide this Friday if it extends that reciprocity to vaccines.
“It is not that the idea of vaccine reciprocity is ludicrous. The FDA has contemplated that,” 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 decision that the Bavarian Nordic facility is compliant.”
White House downplays FDA inspection delays, with Panjabi told reporters during a press conference in New York last week that the agency was actually running an inspection “several months to make sure we have those vaccines here as quickly as possible.”
A White House spokesman told The Daily Beast that inspections of the facility in Denmark, which began July 1, were ongoing, and questioned the agency’s disregard for inspection requirements. this.
“The Danish inspection should not be delayed,” White House Press Assistant Kevin Munoz said. “As you know, it’s an independent regulator so we don’t have the 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 a request for comment about the omission of testing requests. But none of the epidemiologists who spoke to The Daily Beast doubted that European regulators are overqualified in determining how safe a manufacturing facility is.
“I doubt that the European Union’s regulator is capable of carrying out effective inspections,” said Dr Timothy Brewer, professor of epidemiology at UCLA’s Fielding School of Medicine and Health. “I wouldn’t have any personal concerns about the use of EU-tested vaccines.”
With the coronavirus pandemic in its third year, public health experts told The Daily Beast there’s no reason for any hurdles in the nation’s response to monkeypox, whether it’s is the result of federal red tape or local incompetence.
“The White House can’t sit back and watch a comedy about flaws at the city and state level, because it’s not a city and state problem — it’s a nation issue,” Gostin said. . “This is an infectious disease. By definition, it will cross state borders, and it needs a unified, coherent, well-resourced federal response.”
At the end of June, the White House did outline its plan to tackle the outbreak, with the distribution of nearly 300,000 doses of the vaccine announced “in the coming weeks”, as well as the purchase of 2.5 million new doses – although these will not be available until next year.
Immediately, the White House is partnering with GLAAD to hold a monkeypox press conference aimed at social media influencers to inform their followers of eligibility. vaccines and risky behavior. The briefing, first reported by Politico on Wednesday, was met with scorn from many of the influencers who normally participate in it, many of whom point to widespread outreach. More with a vaccine will help prevent the spread of monkeypox than TikTok posts.
“Any brave influencer who says yes to this opportunity… good luck,” tweeted Tyler Oakley, perhaps the most famous gay influencer working at the time. “Everybody hated it and you and everything you’ve ever done.”
Beyond the confusing factor, says Gostin, the risk of giving vaccine information to influencers is that it appears the administration is treating people at high risk — many of whom have been informed. Fully informed about monkeypox and simply waiting for the vaccine. -like children.
“Using influencers in a way is to talk to them, whereas you need to have community-based organizations and at-risk people get support,” says Gostin. “What we’ve learned from the AIDS pandemic is that working closely with affected communities and figuring out what they need to get support is clearly the best way to go.”
The risk of delayed vaccine deployment increases every day. With tens of thousands of potentially unconfirmed cases of monkeypox worldwide, a number given by an administration source, the United States is fast approaching a day where containment is not possible. viable and the disease became a fixture in American life.
“We have a lot of risk that monkeypox is entrenched in the US,” said Bottcher. “And unlike many purely sexually transmitted infections, there are still many questions and unknowns about other forms of monkeypox transmission besides sex.”
That day, Freedman said, could have been here.
“I don’t think, no matter what we do, monkeypox is going to go away now,” Freedman said. “I think the best we can hope for is to get this outbreak under control. Of course, any delay in vaccinating everyone will make it impossible for us to minimize or prevent further development of this disease.”
