CDC cites monkeypox vaccine supply snag
As the monkeypox outbreak grows in the United States, demand for the vaccine is outstripping the nation’s supply, Dr. Rochelle Walensky, director of the Centers for Disease Control and Prevention, said at a news briefing Friday.
“We don’t yet have all the vaccine that we would like in this moment,” she said.
When the supply crunch will ease is unknown. The federal government made another 131,000 doses available to states and jurisdictions Friday. But the scope of the outbreak remains unclear, in part because diagnostic testing has been slow and limited.
Nearly 1,500 cases have been identified in the United States, primarily in men who have sex with men, and the figure was likely to rise in the coming weeks, Walensky said. Globally, more than 11,000 cases have been identified in 65 countries, she added.
The Department of Health and Human Services ordered an additional 2.5 million doses of the vaccine, known as Jynneos, on Friday, but those doses are not scheduled to arrive until next year.
A previously ordered 2.5 million doses should begin arriving late this year, officials said.
“It’s like saying we have a tanker of water coming next week when the fire is happening today,” said Gregg Gonsalves, a public health researcher at the Yale School of Public Health.
Public health experts have criticized the U.S. response to the outbreak as slow and inefficient, beset by some of the same problems that plagued the early months of the COVID-19 pandemic.
Initially, for instance, monkeypox testing was extremely limited, and each diagnosis had to be confirmed by the CDC, creating delays that might have allowed the virus to spread unseen and unchecked.
“Now we’re in a situation where it’s going to be exceedingly difficult, with limited supplies of the vaccine and still some problems with testing, to get this under control,” Gonsalves said.
The CDC has teamed up with five commercial testing companies to expand the nation’s testing capacity, which now stands at 70,000 samples per week, up from 6,000 at the beginning of the outbreak.
“We have the capacity for testing that we need and have made it easier to access,” Walenksy said.
But health officials should be doing more active surveillance for the disease, Gonsalves said, getting out into the community and proactively offering testing in venues that serve men who have sex with men, as well as in congregate settings, such as homeless shelters, in which the virus might spread.
The monkeypox test involves swabbing one of the lesions that typically accompany the disease, making it difficult to expand testing to people who do not have symptoms, Walensky said, adding, “You do need to have a lesion in order to get a test.”
Jynneos, the only vaccine approved by the Food and Drug Administration specifically for monkeypox, is given in two doses, 28 days apart. It is made by Bavarian Nordic, a small company in Denmark, and its global supply has been exceedingly limited.
The United States has purchased a total of nearly 7 million doses but has received just 372,000, Dawn O’Connell, assistant secretary for preparedness and response at the Department of Health and Human Services, said Friday. So far, 156,000 doses have been distributed nationally, she said.
State health officials can request an alternative vaccine known as ACAM2000, which was developed to prevent smallpox and should also provide protection against monkeypox, experts say. But that vaccine is associated with serious side effects, and the federal government has only provided it to “a few states in relatively modest quantities,” O’Connell said.
The FDA recently finished inspecting Bavarian Nordic’s manufacturing facility in Denmark and is deciding whether to approve an additional 780,000 doses made there.
“We’re diligently working to finish up our evaluation of the required information, anticipating the hopeful release of these doses before the end of July,” said Dr. Peter Marks, a top vaccine regulator at the FDA.
The United States is not considering shifting to a one-dose strategy to stretch the existing supply, he added. “We’re confident that we’ll have a supply of vaccine in order to be able to vaccinate with the second dose at the appropriate 28-day interval or close to it,” he said.
States and jurisdictions that are seeing high or increasing cases of monkeypox, and populations that are considered to be at high risk, will receive priority in the allocation of new vaccine doses, officials said.
“We are working around the clock to increase supply and make sure we’re reaching those most at risk,” O’Connell said.