WASHINGTON – The Biden administration on Thursday declared the growing monkeypox outbreak a national health emergency, a rare designation signaling that the virus now represents a significant risk to Americans and setting in motion new measures aimed at containing the threat.
The declaration by Xavier Becerra, President Joe Biden’s health secretary, marks just the fifth such national emergency since 2001, and comes as the country remains in a state of emergency over the coronavirus pandemic. The World Health Organization declared a global health emergency over the monkeypox outbreak late last month.
Becerra’s announcement, at an afternoon news briefing where he was joined by other top health officials, gives federal agencies power to quickly direct money toward developing and evaluating vaccines and drugs, to gain access to emergency funding and to hire additional workers to help manage the outbreak, which began in May.
“We’re prepared to take our response to the next level in addressing this virus,” Becerra said, adding that “we urge every American to take monkeypox seriously, and to take responsibility to help us tackle this virus.”
Biden has faced intense pressure from public health experts and activists to move more aggressively to combat monkeypox, which has infected more than 6,600 people in the United States. Lawrence O. Gostin, a health law expert at Georgetown University, called Thursday’s declaration “a pivotal turning point in the monkeypox response, after a lackluster start.”
Supplies of the monkeypox vaccine, called Jynneos, have been severely constrained, and the administration has been criticized for moving too slowly to expand the number of doses. Less than a decade ago, the United States had 20 million Jynneos doses; by May, the vast majority of them had expired.
In echoes of the early coronavirus response, tests have been difficult to obtain, surveillance has been spotty and it has been challenging to get an accurate count of cases. The administration has also been faulted for not doing enough to educate people in the LGBTQ community, who are at high risk, before gay pride celebrations in June.
“We have 5% of the world’s population and 25% of the world’s cases,” said Dr. Carlos del Rio, an infectious disease physician at Emory University in Atlanta. “That, to me, honestly, is a failure. We were caught sleeping at the wheel.”
To address the vaccine shortage, Dr. Robert Califf, the Food and Drug Administration commissioner, who joined Becerra on Thursday, said his agency was exploring a strategy that would expand the number of available Jynneos doses by administering the shots differently – into layers of the skin, rather than the fat underneath. If it works, one-fifth of the current dose could be used to protect against the virus.
Califf said the agency was optimistic about the idea and expected to make a final decision “within the next few days,” adding, “It’s important to note that overall safety and efficacy profile will not be sacrificed for this approach.”
Under current regulations, doctors have to navigate byzantine rules to request tecovirimat, the drug recommended for treating the disease, for their patients. The declaration does not change those rules, and federal officials have said they believe the regulations are necessary to ensure that the drug is safe and effective in patients.
Monkeypox, a virus similar to smallpox but with symptoms that are less severe, has in the past primarily been found in parts of Central and West Africa. But in the current outbreak, the United States has the world’s largest number of monkeypox cases, and the virus is spreading fast. Less than a month ago, there were about 700 cases; now there are nearly 10 times that many.
More than 99% of people infected with monkeypox in this country are men who have sex with men, which has posed a delicate task for public health officials communicating with the public about the threat. They do not want to stigmatize gay people, as happened in the early days of the HIV/AIDS epidemic, but neither do they want to downplay their particular risk.
This week, Biden named a veteran emergency response official, Robert Fenton, and an infectious disease specialist, Dr. Demetre Daskalakis, to coordinate the response from the White House – a sign that the administration was stepping up its attention to the outbreak. Daskalakis, who is gay, has built deep credibility in the LGBTQ community over his career. Both he and Fenton were on Thursday’s call.
Monkeypox is transmitted mostly during close physical contact. The infection is rarely fatal – no deaths have been reported in the United States – but it can be very painful. The number of cases is expected to rise as the virus continues to spread and as surveillance and testing improve, Dr. Rochelle Walensky, the director of the Centers for Disease Control and Prevention, said Thursday.
“Two things are happening at once that I think can account for the rise in cases that we’re seeing: One is more widely available testing, and two, potentially more infections that are actually happening,” Walensky said, adding that “it’s hard to disentangle those right now.”
The emergency declaration that Becerra issued Thursday falls under a specific section of federal law that allows the health secretary to declare an emergency that generally lasts for 90 days, but may be extended. But it does not grant the FDA authority to give emergency authorization to vaccines, tests and treatments; that requires a separate declaration.
“It should help galvanize more testing and more health care provider awareness, especially in places outside the big cities where the level of attention to this has been far less,” said Tom Inglesby, director of the Johns Hopkins Center for Health Security at the Bloomberg School of Public Health, who has helped the Biden administration with its coronavirus response.
Anne Rimoin, an epidemiologist at UCLA and a member of the WHO’s advisory panel on monkeypox, said the declaration would send “a strong message that this is important, that it must be dealt with now.”
Rimoin is one of the scientific advisers who urged the WHO to categorize monkeypox as a “public health emergency of international concern,” a designation the organization has used only seven times since 2007. With panelists divided on the matter, Dr. Tedros Adhanom Ghebreyesus, the WHO’s director general, overruled the advisers to declare monkeypox a global emergency – a status currently held by only two other diseases, COVID-19 and polio.
In the United States, demands for stronger action against monkeypox have intensified recently and several states – California, Illinois and New York – have declared their own health emergencies. Recently, Rep. Adam Schiff, D-Calif., called on the Biden administration to step up the manufacturing and distribution of vaccines, and develop a long-term strategy for combating the virus.
Sen. Patty Murray, D-Wash., chair of the Senate health committee, pushed the Department of Health and Human Services to provide a detailed account of the steps it is taking the contain the outbreak.
Gay rights activists, who have been sharply critical of the administration, have been demanding an emergency declaration for weeks. “This is all too late,” said James Krellenstein, a founder of PrEP4All, an advocacy group that works to expand treatment for people with HIV. “I don’t really understand why they didn’t do this weeks ago.”
The FDA’s plan to consider fractional doses of Jynneos took some federal scientists by surprise.
There is some data to suggest that injecting one-fifth of a regular dose of Jynneos between skin layers would be just as effective as the approach being used now, administering a full dose under the skin. The skin is rich in immune cells that mediate the response to vaccines, so this approach is sometimes used, especially with vaccines in short supply, although it requires more skill.
Researchers at the National Institutes of Health had planned to test the strategy for Jynneos in a clinical trial that was set to begin in a few weeks, with results expected later in the fall.
“That was our plan, so we’ll have to see how it fits into the new landscape, which has changed,” said Dr. Emily Erbelding, who directs the NIH’s division of microbiology and infectious diseases. “We thought that there was a desire to get a more robust data set, but if it’s a race against time, then this is a different situation.”
“Things are moving fast,” she added.
Declaring an emergency gives the CDC more access to information from health care providers and from states.
During the outbreak, federal health officials have regularly shared information on testing capacity or on the number of vaccines shipped to states. But the CDC’s data on the number of cases lags that of local public health departments, and the number of people vaccinated, or their demographic information, is mostly unavailable.
“We are again really challenged by the fact that we at the agency have no authority to receive those data,” Walensky said recently at an event hosted by The Washington Post.
The agency is working to broaden its access to state data, but in the meantime, the information is spotty and unreliable. Local health departments are underfunded, understaffed and exhausted after more than two years of grappling with the COVID-19 pandemic.
“A declaration of this monkeypox outbreak as a public health emergency is important, but more important is to step up the level of federal, state and local coordination, fill our gaps in vaccine supply and get money appropriated from Congress to address this crisis,” said Gregg Gonsalves, an epidemiologist at the Yale School of Public Health and an adviser to the WHO on monkeypox.
“Otherwise,” he said, “we’re talking about a new endemic virus sinking its roots into this country.”
This article originally appeared in The New York Times.
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