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 deemed most at risk by officials and who are urged to get vaccinated.
And with cases in the US doubling every week or so, some health experts warn that vaccine dose shortfalls could threaten the nation’s ability to contain the growing outbreak and prevent the virus from becoming permanently entrenched — a concern that some federal officials privately acknowledge.
“When you mathematically look at the requirements … we’re having some tough skids here,” J. Stephen Morrison, director of the Center for Global Health Policy at the Center for Strategic and International Studies, said in a podcast on Friday. Adding that 3.2 million doses are needed to cover the at-risk population of men with HIV and others targeted for vaccinations by the Centers for Disease Control and Prevention.
“We won’t have, until the end of the year, two million doses,” Morrison said.
The shortage of Genus, the only FDA-approved vaccine to protect against monkeypox, has prompted health officials at every level of government to devise strategies. Those in hard-hit communities like New York City and Columbia City have chosen to give only one dose for now, against the advice of regulators, with federal officials pushing for larger allocations. Some experts also advocate encouraging people to take an unwanted vaccine, ACAM2000, which is approved for the related smallpox virus but not for monkeypox.
A federal official working on the monkeypox response, who spoke on the condition of anonymity because they were not authorized to comment, said “there aren’t enough footage” to follow the Genos-only strategy. In the coming weeks.
Approximately 5,200 people in the United States, mostly gay and bisexual men, have been diagnosed with monkeypox, which can be fatal. It spreads through skin-to-skin contact and causes fever, swollen glands, severe pain, and lesions. Most experts believe that hundreds or thousands of cases are likely to remain undetected.
“We expect cases to continue to rise in the next several days or weeks as testing becomes more widely available,” a CDC spokesperson said Friday.
While the virus has not yet been linked to a single confirmed American 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 has helped. Transmission in Central and West Africa.
US officials said they have now secured 1.1 million doses of the Jynneos vaccine, including 786,000 doses finally approved by regulators after being delayed in Denmark by more than a month, which will be “in the hands of people who need them over a period of time,” the health and services minister said. Humanitarian Xavier Becerra on Thursday Federal regulators reiterated Friday that the vaccine should be given to most people in two doses, meaning US officials have enough doses to cover about 550,000 people.
But the total population that federal officials used to calculate vaccine allocations — which includes people who were exposed to someone with monkeypox, as well as men who had multiple sexual partners in the past two weeks in areas known to have monkeypox — is now at least 1.6 million and possibly higher, according to to the Centers for Disease Control and Prevention.
The demand is also driven by people seeking vaccination who may not fall into these categories but are concerned about potential exposures.
The Kaiser Family Foundation, a nonpartisan healthcare think tank, concluded that “Overall, there are not enough vaccine doses to meet demand at present, and most jurisdictions are exceeding or exceeding their allocations, and in some cases, still unable to meet Demand” in Friday’s analysis.
If the outbreak spreads to other populations in the coming weeks, and millions of Americans are encouraged to seek a vaccine, that shortage will be even more pronounced. The first two cases were confirmed in children last week and a pregnant woman this week. Previous outbreaks abroad have spread to children, women and other vulnerable groups.
“If we drift to mass vaccination, it’s going to require massive amounts” of doses, CSIS’s Morrison said.
Experts have struggled to accurately predict the course of the monkeypox outbreak, warning that limited testing has complicated efforts to get a true picture of the virus’ spread. Cases double every 7.6 days in the United States, said Trevor Bedford, a computational biologist at the Fred Hutchinson Cancer Center.
In an effort to curb local outbreaks, many state and local health officials have demanded as many doses of the Jynneos vaccine as possible, with hard-hit states like California and New York repeatedly asking the federal government for more doses than officials say are available.
Biden administration officials said they are working to secure more doses, noting that they also obtained raw materials for a potential 11 million doses from Jynneos.
“We don’t know what’s going to happen next, and we have to be prepared to spread to a larger population,” Dawn O’Connell, the assistant secretary who oversees the Department of Strategic Preparedness and Response, said Thursday. But officials said it could take months to find a manufacturing partner to turn those raw materials into vaccine doses.
In addition to vaccination, the administration is promoting a multi-pronged strategy, including making tests and treatments available and informing high-risk communities how to protect themselves, which officials insist can help contain the outbreak.
“We will continue to look for ways to quickly get more vaccines to populations across the country — but that’s just one part of our strategy,” White House spokesman Chris Major said in a statement.
Meanwhile, public health leaders in New York City and Metropolitan City said they will focus on giving as many first doses of Jynneos as possible and forgo a second dose for now, hoping to expand limited vaccine supplies as much as possible.
“DC Health has determined that the most urgent priority is 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 vaccinating more people with the first injection will help us contain the virus.”
Federal officials emphasized Friday that the two-dose strategy is necessary to provide adequate protection.
“While the FDA understands the desire to get as many doses as possible, the agency advises against straying from product labels,” an FDA spokesperson said.
Amanda Gizek, senior vice president of public policy and government relations at the Infectious Diseases Society of America, said local public health clinics are also working to target “disadvantaged individuals,” since many previous vaccination appointments have been “cut off” disproportionately for wealthy people.
Some experts called US officials instead Encourage Americans to get the ACAM2000 vaccine, which has been approved for smallpox, a related virus that the United States has previously stockpiled in case of a potential outbreak. This vaccine It is based on injecting people with live virus, if weakened, which carries additional risks. It is also given in a series of rapid punctures that can draw blood and lead to scarring. The vaccine is available as needed, although public health officials have been 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 Emmanuel, a bioethicist who advised the Biden administration on the coronavirus and attended a White House briefing this week on monkeypox.
Emmanuel criticized health officials for not ordering more Jynneos doses earlier in the outbreak, especially since other countries have moved to buy doses. “I don’t know who was negotiating these deals,” he said. “It’s a serious problem.”
The next shipment of 500,000 doses of Jynneos from Bavaria Nordic, the Denmark-based manufacturer, is not expected until the end October in the midst of great global demand, Two administration officials said they spoke on condition of anonymity because they were not authorized to speak publicly.
“An additional 500,000 doses ordered by the United States are expected to be delivered in June this year,” a spokesman for Northern Bavaria wrote in an email, declining to answer specific questions about timing or the company’s commitments to other countries.
HHS spokeswoman Sarah Lowenheim said officials have accelerated the doses announced this week and are working to speed up future shipments as well.
“We will take every opportunity to speed up the track to secure more doses ahead of schedule, as much as possible,” Lovenheim said.
Peter Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine, said he’s open to the idea of ”dose-sharing” as a temporary solution, suggesting people can get one dose of Genos and one dose of ACAM2000.
“We don’t have a lot of windows to fix that,” Hotez said. “Once it gets into the rodent population, it becomes a staple here, as it is in Central and West Africa.”