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?”
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