‘Not enough resources’: US faces ‘vaccine cliff’ against monkeypox

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Federal officials this week announced the arrival of hundreds of thousands of additional doses of the monkeypox vaccine, heralding it as a major 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 vaccines won’t arrive until October at the earliest.

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

As the number of cases in the United States doubles each week, some health experts warn that a vaccine shortage 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 voiced privately.

“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, said in a podcast Friday, 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. Hard-hit communities such as New York and D.C. have decided to give only one dose for now, against the advice of regulators, prompting federal officials to make larger distributions. Some experts also encourage people to get the ACAM2000 vaccine, which is approved for the smallpox virus and not for monkeypox.

“There aren’t enough similarities” to implement a strategy of relying solely on ginneos, said a federal official working on monkeypox, who spoke 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 men, have contracted bisexual monkeypox. spreads through skin-to-skin contact, causing fever, swollen glands, severe pain, and sores. 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 reintroduces to rodents and other small mammals. Disc transmission in Central and West Africa.

U.S. officials said they have now secured 1.1 million Jynneos vaccines, including 786,000 doses that were 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 said. Secretary Xavier Becerra 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, there are currently insufficient vaccine doses to meet demand, and most jurisdictions are increasing or exceeding their allocations and in some cases are still unable to meet demand,” concluded the Kaiser Family Foundation, a nonpartisan health care think tank. , in analysis on Friday.

If the outbreak spreads to other populations in the coming weeks and millions more Americans are encouraged to seek vaccines, the shortages are likely to worsen. 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 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. According to Trevor Bedford, a computational biologist at the Fred Hutchinson Cancer Center, the population 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 material for 11 million potential doses of Jyneos.

“We don’t know what’s going to happen next, and we have to be prepared for it 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 stop 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 the first dose of Ginneos as much as possible and forgo the second dose in hopes of expanding the vaccine as much as possible.

“DC Health has decided as an immediate priority to provide the first doses of the vaccine to at-risk residents,” the city’s health department said in a statement this week. “This is very important because the first vaccination will help us contain the virus.”

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

“While the FDA understands the desire to obtain as large a dose as possible, the agency is recommending that the product be withdrawn 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 so far many vaccine appointments have been disproportionately “disrupted.” good people.

Some experts called for US officials instead Encourage Americans to vaccinate with ACAM2000, which is approved against smallpox, a related virus, and which the United States has previously stockpiled in case of potential outbreaks. That vaccine relies on injecting 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. A vaccine is available when needed, but public health officials are wary of relying on it.

“Nobody’s crazy about it. You don’t have to be crazy about it. But you have to give people a choice,” said Ezekiel Emanuel, a bioethicist who has advised the Biden administration on the coronavirus and attended a White House briefing on the monkeypox 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 deals,” he said. “This is a serious problem.”

The next shipment of 500,000 Jynneos vaccines from Denmark-based Bavarian Nordic is not expected until later this year. Amid tough global demand in October, said two officials of the administration who did not want to be named because they are not authorized to speak publicly.

“US ordered 50,000 additional doses in June,” an email from a Bavarian Nordic representative said in response to a specific company’s commitment to meet another company’s commitment.

HHS spokeswoman Sarah Lowenheim said officials shipped the doses announced this week and are working to expedite future shipments.

“We will take every opportunity to expedite the process of securing as many doses as possible ahead of schedule,” Loewenheim said.

Peter Hotes, dean of Baylor College of Medicine’s National School of Tropical Medicine, said he was open to the idea of ​​a temporary fix to the idea of ​​”dose splitting,” saying people could 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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