U.S. faces 'vaccine cliff' on monkeypox

U.S. faces ‘vaccine cliff’ on monkeypox

Federal officials this week touted the arrival of hundreds of thousands of additional monkeypox vaccine doses, heralding it as a milestone in the nation’s fight against the outbreak. What they left out: The United States is entering a critical three-month period where cases may continue to multiply, but no more vaccines are scheduled to arrive until October at the earliest.

Even with the latest shipments, there are only enough vials of the two-dose Jynneos vaccine to cover about a third of the estimated 1.6 million gay and bisexual men who officials consider at highest risk and who are being urged to get the shots.

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And with cases in the United States doubling every week or so, some health experts warn a shortfall of vaccines could threaten the nation’s ability to contain the expanding outbreak and prevent the virus from becoming permanently entrenched – a concern that some federal officials privately concede.

“When you look mathematically at what the requirements are . . . we’re facing some tough sledding here,” J. Stephen Morrison, director of the Global Health Policy Center at the Center for Strategic and International Studies, said on a podcast Friday, adding that 3.2 million doses would be needed to fully cover the at-risk population of HIV-positive men and others targeted to receive vaccines by the Centers for Disease Control and Prevention.

“We’re not going to have, until year’s end, 2 million doses,” Morrison said.

The shortfall of Jynneos, the only vaccine approved by the Food and Drug Administration to protect against monkeypox, has health officials at every level of government scrambling to come up with strategies. Those in hard-hit communities like New York City and Washington D.C. have opted to give out only one dose for now, against regulators’ advice, while pushing federal officials for larger allotments. Some experts also are advocating that people be given the choice of taking a less desirable vaccine, ACAM2000, which was approved for the related virus of smallpox but not for monkeypox.

“There are not enough shots” to pursue a strategy of relying solely on Jynneos, said a federal official working on the monkeypox response, who spoke on the condition of anonymity because they were not authorized to comment, warning of a possible “vaccine cliff” in coming weeks.

Nearly 5,200 people in the United States, mostly gay and bisexual men, have been diagnosed with monkeypox, which can spread through skin-to-skin contact, and causes fever, swollen glands, severe pain and lesions. Most experts believe that hundreds or thousands of cases likely remain undetected.

“We would expect cases to continue to go up in the next several days or weeks as testing has becoming more widely available,” a CDC spokesperson said Friday.

While the virus has yet to be linked to a single confirmed U.S. death, public health leaders continue to worry that it will become difficult to eradicate, especially if it spills back into rodents and other small mammals, which have helped drive transmission in Central and Western Africa.

U.S. officials said that they have now secured 1.1 million Jynneos vaccines, including 786,000 doses finally cleared by regulators after being delayed in Denmark for more than a month, and which will “be in the hands of people who need them over the course of the next several weeks,” Health and Human Services Secretary Xavier Becerra said Thursday. Federal regulators reiterated Friday that the vaccine should be given to most people as a two-dose regimen, meaning that U.S. officials have enough shots to cover about 550,000 people.

But the total population that federal officials have used to calculate vaccine allocations – which includes people who have been exposed to someone with monkeypox, as well as men who have had multiple sexual partners within the past two weeks in areas of known monkeypox spread – is at least 1.6 million individuals and possibly higher, according to CDC.

Demand is also being driven by people seeking vaccines who may not fall into those categories but who are worried about possible exposures.

“Overall, there are not enough vaccine doses to meet demand right now and most jurisdictions are maxing out or exceeding their allocation and, in some cases, still unable to meet demand,” the Kaiser Family Foundation, a nonpartisan health care think tank, concluded in an analysis Friday.

Should the outbreak spill over into other populations in coming weeks, and millions more Americans be encouraged to seek out vaccines, that shortfall would be even more pronounced. The first two cases were confirmed in children last week and in a pregnant woman this week. Prior outbreaks overseas have spread to children, women and other vulnerable groups.

“If we’re drifting into mass vaccination, that’s going to require huge volumes” of vaccine, said Morrison of CSIS.

Experts have struggled to accurately predict the course of the monkeypox outbreak, cautioning that limited testing had complicated efforts to get a true picture of the virus’s spread. Cases have been doubling about every 7.6 days in the United States, said Trevor Bedford, a computational biologist at the Fred Hutchinson Cancer Center.

Seeking to curb local outbreaks, many state and local health officials have demanded as many Jynneos vaccines as possible, with the hardest hit states like California and New York repeatedly asking the federal government for more doses than officials say are available.

Biden administration officials have said they are working to secure more vaccines, noting they have also acquired raw materials for 11 million potential Jynneos doses.

“We don’t know what comes next and we need to be prepared for the spread into the larger population,” Dawn O’Connell, the assistant secretary who oversees the Administration for Strategic Preparedness and Response, said Thursday. But officials have said that it may take months to find a manufacturing partner to turn those raw materials into vaccines.

In addition to vaccines, the administration also touts a multipronged strategy, including making testing and treatments accessible and informing high-risk communities how to protect themselves, that officials insist can help contain the outbreak.

“We will continue to look at ways to quickly get more vaccines out to populations across the country – but that’s just one part of our strategy,” White House spokesperson Chris Meagher said in a statement.

In the meantime, public health leaders in New York City and D.C. have said they will focus on giving out as many first doses of Jynneos as possible and forgo a second dose for now, in hopes of stretching limited vaccine supply as far as they can.

“DC Health has decided that the most urgent priority is providing the first doses of vaccine to high-risk residents,” the city health department said in a statement this week. “This is extremely important because getting more individuals vaccinated with their first shot will help us to contain the virus.”

Federal officials on Friday reiterated that a two-dose strategy is necessary for sufficient protection.

“While the FDA understands the desire to get out as many doses as possible, the agency advises against departing from the product labeling,” a spokesperson said.

Amanda Jezek, senior vice president of public policy and government relations at the Infectious Diseases Society of America, said that local public health clinics are also working to target “underserved individuals,” since many of the earlier vaccine appointments were “snapped up” by disproportionately well-off people.

Some experts have called on U.S. officials to instead encourage Americans to get vaccinated with ACAM2000, which was approved for smallpox, a related virus, and that the United States had previously stockpiled in case of a potential outbreak. That vaccine relies on injecting people with a live, if weakened virus, which carries additional risks. It also is administered in a series of rapid punctures that can draw blood and lead to scarring.

“No one’s crazy about it. You shouldn’t be crazy about it. But you should give people the choice,” said Ezekiel Emanuel, a bioethicist who has advised the Biden administration on coronavirus and attended a White House briefing this week on monkeypox.

Emanuel faulted health officials for not ordering more doses of Jynneos earlier in the outbreak, especially as other countries have moved to buy up vaccines. “I don’t know who was negotiating these deals,” he said. “It’s a serious problem.”

The next shipment of 500,000 Jynneos vaccines from Bavarian Nordic, the Denmark-based manufacturer, is not expected until the end of October amid heavy global demand, said two administration officials who spoke on the condition of anonymity because they were not authorized to speak publicly.

“The 500,000 additional doses that the U.S. ordered in June is anticipated to be delivered this year,” a Bavarian Nordic spokesperson wrote in an email, declining to respond to specific questions about timing or the company’s commitments to other countries.

Peter Hotez, dean for the National School of Tropical Medicine at the Baylor College of Medicine, said he was open to the idea of “dose sharing” as a temporary fix, suggesting that people could get one dose of Jynneos and one dose of ACAM2000.

“We don’t have much of a window to fix this,” Hotez said. “Once it gets into the rodent population, it becomes a fixture here, like it’s been in Central and West Africa.”

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