The first diagnosed case of monkeypox in the US, on May 18, did not seem like a major cause for alarm. Unlike the virus that causes COVID-19, monkeypox was not novel, not airborne, and rarely fatal. In fact, the US government already possessed a robust arsenal of tools that could be used to combat it.
In 2003 the US government began developing a detailed response plan for smallpox, a far more lethal virus that belongs to the same family as monkeypox. The plan, which over two decades grew to fill 333 pages, offered a playbook for how to mount an effective response to such pathogens.
The US government had also spent close to $2 billion to develop a new smallpox vaccine called Jynneos, which is manufactured by the Danish biotech company Bavarian Nordic. The Strategic National Stockpile contains 20 million doses of the Jynneos vaccine, which is much safer than earlier smallpox vaccines, but, according to The New York Times, its shelf life is only three years, and the majority expired over the past decade. (A freeze-dried version that would last longer is still in the works.)
Millions more doses sat in liquid form in plastic bags at Bavarian Nordic’s manufacturing plant in Denmark. These had been purchased by the US long before the first domestic cases of monkeypox were identified.
Viewed from one angle, Jynneos looked like an infectious disease success story: a vaccine at the ready, for when it counted most. “But for the United States government, we wouldn’t have the Jynneos vaccine,” said Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota. “We are the reason why the world has a vaccine.”
But as cases of monkeypox ticked upward around the country, spreading primarily via skin-to-skin contact among men who have sex with men, six long weeks passed without significant action to deploy vaccines widely. Vulnerable Americans found themselves hunting for elusive shots and scrambling to add their names to digital sign-up sheets that filled up within minutes of being posted.
Said a former federal health official who worked on the US smallpox response plan, “I can’t see where any part of it was activated.”
The liquid vaccine at the Bavarian Nordic plant couldn’t be distributed until it was placed into vials—a process known as “fill-finish.” And that couldn’t happen until the FDA inspected the new facility where the work would be done. Two inspectors finally arrived on July 1, six weeks after monkeypox made its first appearance on American shores. By then there had been 506 documented cases of monkeypox in the US. Today the CDC’s total number of confirmed cases stands at 11,177—higher than in any other country in the world—and federal officials are contending with a shortfall of more than 2.5 million needed vaccine doses.
In early August, Peter Marks, the FDA’s director of the Center for Biologics Evaluation and Research, participated in a call with community doctors and health care workers concerned about the lagging federal response. Marks surprised those on the call by suggesting that the FDA wasn’t to blame for the delay in inspecting the fill-finish plant in Denmark, because the agency had been waiting for an invitation from Bavarian Nordic to do so. He later added that the FDA had asked the company to apply for an inspection early on, when there were roughly 100 domestic cases.
It’s true that the agency typically does not inspect overseas facilities without an invitation. Still, according to an FDA employee familiar with the agency’s vaccine inspections, more could have been done sooner. “They could have gotten out there fairly quickly,” the employee said. “It seemed like there wasn’t a sense of urgency.”
A senior FDA official, speaking on background, told Vanity Fair that the agency mobilized “as quickly as we could. Nobody was sitting on this.” The agency viewed the supply in Denmark as a backup to the unexpired doses in the US stockpile. When the distribution of those doses—a combined responsibility of several federal agencies—failed to contain the outbreak, “it became clearer that we needed to move more quickly.”
A Bavarian Nordic spokesman said, “In May, when the first case of monkeypox arrived in the UK, Bavarian Nordic and the FDA started working together to expedite the inspection.” He added that “the inspection was originally anticipated in August, but was moved up in partnership with the FDA.”
To critics, the six-week delay in inspecting the Danish plant is just one in a cascade of unforced errors by the federal government that has allowed the US monkeypox outbreak to spiral out of control. It has revealed a public health infrastructure in a state of deep burnout from the ongoing COVID-19 response. And it has raised the prospect that continued spread could lead the monkeypox virus to become endemic in the United States, as it has been in Africa for decades.
“States and cities like New York need federal direction, which has been lacking from the beginning,” Brad Hoylman, a New York state senator and longtime advocate for the LGBTQ community, told Vanity Fair. He cited the federal government’s “foot-dragging in getting vaccines to the US, the fact that the FDA hadn’t inspected the plant, [and] the inability for Washington to move” treatments into wider circulation. “Patients shouldn’t have to be part of a Hunger Games contest to get a vaccine,” he added.
On August 2, President Joe Biden finally appointed a White House monkeypox response team helmed by Robert J. Fenton, a Federal Emergency Management Agency (FEMA) regional administrator and veteran of disaster management. And on August 4, Department of Health and Human Services Secretary Xavier Becerra declared monkeypox a public health emergency—more than a week after the World Health Organization had designated monkeypox a public health emergency of international concern, and days after New York, Illinois, and California had declared emergencies.
Many public health experts view the federal government’s announcements as welcome but long overdue. “They are getting a lot of heat, and I think it’s deserved heat, after what we’ve been through with COVID,” said Rick Bright, the former director of the Biomedical Advanced Research and Development Authority (BARDA). “[The federal response] has been much slower and more hesitant than it should have been—too much ‘wait and see.’”
In 1980 the World Health Organization made a triumphant announcement: Smallpox had been eradicated worldwide. The terrifying and deadly virus, which killed an estimated 300 million people in the 20th century, had been vanquished.
This monumental public health achievement brought routine smallpox vaccinations to an end. And that, in turn, opened the door to monkeypox, a less lethal relative of the virus. Believed to have originated in rodents on the African continent, monkeypox first appeared in humans in 1970 in the Democratic Republic of Congo.
In October 2001, at a dinner at Oceanaire in Washington, DC, the late legendary disease detective D.A. Henderson, who helped lead the global campaign to eradicate smallpox, treated his tablemates to a grim prediction. Given Africa’s massive population of people under 40 who’d never been vaccinated against smallpox, “monkeypox is going to become a big problem in the next 20 years,” Henderson said, according to Osterholm, who attended the dinner.
In 2003 the US government began to prepare in earnest for a possible resurgence of smallpox. On the eve of Operation Iraqi Freedom, the fear that Saddam Hussein might have weaponized the virus led to the development of medical countermeasures and a push to vaccinate US health care workers. With that preparation came a plentiful stockpile of vaccines.
Then, in 2017, an astute physician in southern Nigeria, Dr. Dimie Ogoina, treated an 11-year-old boy who had unusual lesions all over his body and diagnosed a rare malady: monkeypox. Experts believe it was the start of the outbreak that is now sweeping the world.
Almost three years into the COVID-19 pandemic, one might expect the US to respond to infectious disease outbreaks with well-oiled efficiency. But the opposite seems to be true. Federal funding, state and local staffing, and even federal oversight have all been depleted by the grueling SARS-CoV-2 marathon. “Public health systems are really fragile right now,” said Osterholm. “We’ve lost so many employees. We have so much backlogged work that needs to be done.”
There is a sense, as well, that federal agencies simply failed to see what was coming. One week after the first US case was diagnosed, in a Boston resident who’d recently returned from Canada, the Department of Health & Human Services (HHS) made a fateful miscalculation, giving Bavarian Nordic permission to deliver 215,000 doses of US-owned vaccine to European countries instead of requiring that they be delivered to the US. As one former senior HHS official said of Secretary Becerra: “That guy is on life support. What the hell is he doing?”
“There is clearly a role for White House leadership in a situation like this, but where is HHS?” asked Bruce Gellin, chief of global public health strategy for the Rockefeller Foundation’s Pandemic Prevention Institute. “Does the White House run a war? The Defense Department runs a war. At what point does it get shifted back to be managed by the public health agencies?”
According to an HHS spokesperson, “Aggressively responding to the monkeypox outbreak is a critical priority for HHS. Within days of the first U.S. case, we activated a multi-pronged response.” The spokesperson told Vanity Fair that the federal government expects to make 6.9 million doses of the vaccine available by the middle of next year, and said that Secretary Becerra is “actively engaged in the monkeypox response, meeting routinely with Administration officials, state and city health officials, and others to mobilize a nationwide response.”
Also surprising was Biden’s decision to put a FEMA regional administrator in charge of the White House monkeypox response, said several former federal officials. Though Fenton is a FEMA superstar with ample experience responding to tornadoes and hurricanes, it would have been more logical for the top person to come from within the HHS family of agencies, though a division director from the Centers for Disease Control and Prevention (CDC) was assigned as Fenton’s deputy. The choice “reflects the fact that CDC can’t operate its way out of a paper bag,” said the former HHS official. (The CDC did not respond to several emails seeking comment.)
Things are not much better at the FDA. Since 2019, 11 of the 14 inspectors in Team Biologics, the elite unit that inspects vaccine-manufacturing plants, have left amid plunging morale, Vanity Fair has learned. (One of the two inspectors who reviewed the Bavarian Nordic plant hailed from the unit, according to FDA records.) The team’s managers frequently override inspectors’ on-site judgments, and many new hires are far less experienced than those they’ve replaced, according to one current FDA employee and one person who used to work there.
An FDA spokesperson acknowledged that Team Biologics, like other divisions, “has seen attrition over the last few years.” The agency is nonetheless “proud” that “inspections and investigations” of vaccine manufacturers have continued throughout the pandemic, said the spokesperson, adding that “as the complexity of inspections increases, so too does the level of review that a supervisor may provide to best support the investigator.”
The brittleness of the nation’s public health apparatus has turned the monkeypox response into an avoidable scramble. Facing an estimated three months to get liquid vaccines into vials, transport them into the US, and distribute them to state health departments, federal health officials have been forced to improvise on the fly.
On August 9, they greenlighted a new method of injection—between layers of skin—that uses one fifth of the standard amount of vaccine per dose. On Monday, the HHS secretary announced that the switch, from subcutaneous to intradermal injection, will allow the government to significantly increase the number of doses it’s allocating to states right away. And last week Bavarian Nordic announced that it was testing expired doses at the request of the US government to determine if some might still be usable.
Those are positive steps, but they may have come too late. Scientists at the Yale University and Brown University schools of public health recently found that it might have been possible to quell the outbreak by vaccinating as few as 329,000 high-risk men in the outbreak’s early days.
“It’s tragic,” said the former senior HHS official. “You had the president saying in May that it was a real concern. You’d think that someone would keep their eye on the ball to take the simplest of preparatory action.”
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