The US faces a ‘vaccine cliff’ against monkeypox

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

Despite the latest shipment, two-dose vials of the Jynneos vaccine are enough to cover about a third of the estimated 1.6 million gay and bisexual men who officials consider to be at highest risk and are urging them to get the shot.

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As cases in the United States double each week, some health experts warn that a shortage of vaccines could threaten the country’s ability to contain the expanding epidemic and prevent the virus from taking root forever — a concern that some federal officials have privately expressed.

“When you look at the math of what the requirements are … we’re going to have a hard time sledding here,” J.J. Stephen Morrison, director of the Center for Global Health Policy at the Center for Strategic and International Studies, on Friday’s podcast. He added that 3.2 million doses would be needed to fully cover the high-risk group of HIV-positive men and others targeted by the Centers for Disease Control and Prevention to receive vaccines.

“We won’t have 2 million doses until the end of the year,” Morrison said.

The shortage 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 develop strategies. Those in hard-hit communities such as New York and Washington have decided to give only one dose for now, against the advice of regulators, prompting federal officials to make larger distributions. Some experts also advocate giving people the option to get the ACAM2000 vaccine, which is approved for the specific smallpox virus, rather than for smallpox.

“There aren’t enough similarities” to implement a strategy of relying solely on Ginneos, said a federal official working on monkeypox, speaking on condition of anonymity because he was not authorized to comment, warning of a possible “vaccine cliff.” in the coming weeks.

About 5,200 people in the United States, mostly gay and bisexual men, have been diagnosed with monkeypox, a skin-to-skin infection that causes fever, swollen glands, severe pain and lesions. Most experts believe that hundreds or thousands of cases may go undetected.

“We expect cases to increase over the next few days or weeks as testing becomes more widely available,” a CDC spokeswoman said Friday.

Although the virus has not yet been linked to a single confirmed U.S. death, public health leaders worry that it will be difficult to eradicate, especially if it recirculates into rodents and other small mammals, as has been the case in the Midwest and West. Africa.

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

But the total population that federal officials use to calculate vaccine distribution includes people with monkeypox, as well as men who have had multiple sexual partners in the past two weeks in areas where monkeypox is known. According to the CDC, at least 1.6 million people and possibly more.

Demand is also coming from people seeking vaccines who may not fall into these categories but are concerned about the potential effects.

“Overall, vaccine doses are currently insufficient to meet demand, and most jurisdictions are increasing or exceeding their allocations and in some cases are still falling short of meeting demand,” concluded the Kaiser Family Foundation, a nonpartisan health research center. . In Friday’s analysis.

In the coming weeks, the shortage will be exacerbated if the outbreak spreads to other populations and millions of Americans are encouraged to seek vaccines. The first two cases were confirmed last week in children and this week in a pregnant woman. Previous outbreaks abroad have spread to children, women and other vulnerable groups.

“If we’re going to go to mass vaccination, it’s going to require a lot of vaccine,” Morrison told CSIS.

Experts have warned that limited testing has made it difficult to get a true picture of how the virus is spreading in an attempt to accurately predict the course of monkeypox. Trevor Bedford, a computational biologist at the Fred Hutchinson Cancer Center, said the number is doubling every 7.6 days in the United States.

In an effort to curb local outbreaks, many states and local health officials have requested as many Jynneos vaccines as possible, with the hardest-hit states like California and New York asking the federal government for more doses than officials have said.

Biden administration officials said they are working to secure more vaccines, noting that they have received raw materials for 11 million potential doses of Jyneos.

“We don’t know what’s going to happen next, and we have to be prepared to spread to more of the population,” Dawn O’Connell, the assistant secretary overseeing the Strategic Preparedness and Response Administration, said Thursday. But officials said it could take months to find a manufacturing partner to turn that raw material into a vaccine.

In addition to vaccines, the administration is proposing a multi-pronged strategy, including making testing and treatment more accessible and educating high-risk communities about how to protect themselves, officials say, to help contain the outbreak.

White House Press Secretary Chris Meagher said: “We will continue to look for ways to quickly get more vaccines to people across the country, but this is only one part of our strategy.”

During the limited time, public health leaders in New York and D.C. said they would focus on giving as many first doses of Jynneos as possible and forgo second doses in hopes of expanding the vaccine as much as possible.

“DC Health has determined as the most immediate priority to provide the first doses of the vaccine to high-risk residents,” the city’s health department said in a statement this week. “This is very important because getting vaccinated first helps us contain the virus.”

Federal officials on Friday reiterated that a two-dose strategy is necessary to provide adequate protection.

“While we understand that the FDA wants to avoid as many doses as possible, the agency is recommending that the product be removed from the label,” the spokesperson said.

Amanda Jezek, senior vice president of public policy and government affairs at the Infectious Diseases Society of America, said local public health clinics are also working to target “underserved populations” because many vaccine appointments have been disproportionately “disrupted.” good people.

Some experts have urged US officials to instead vaccinate Americans with ACAM2000 against smallpox, a related virus and that the United States has already stockpiled in case of a potential outbreak. This vaccine relies on injecting a live, weakened virus into people, which carries additional risks. It is also administered through a series of rapid punctures that may draw blood and cause scarring.

“Nobody’s crazy about it. You shouldn’t be crazy about it. But you have to give people a choice,” said Ezekiel Emanuel, a bioethicist who advised the Biden administration on the coronavirus and attended a White House briefing on the monkey disease this week.

Emanuel blamed health officials for not ordering more doses of Ginneos before the outbreak, especially as other countries moved to buy the vaccines. “I don’t know who made these contracts,” he said. – This is a serious issue.

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

“The 50,000 additional doses ordered by the US in June,” an email from a Bavarian Nordic representative declined to comment on the time it took to meet a specific company’s commitment to meet another company’s commitment.

Peter Hotes, dean of Baylor College of Medicine’s National School of Tropical Medicine, said he is open to the idea of ​​a temporary fix to the idea of ​​”dose splitting,” so that people can take one dose and one dose of Ginneos. ACAM2000.

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

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