As the United States embarks on a vaccination campaign against monkeypox, some experts are growing concerned that demand may soon far exceed available supply.
Jynneos, the only vaccine developed for monkey pox, is made by a small Danish company, Bavarian Nordic. The company is expected to ship about two million doses to the United States by the end of the year, but could produce less than five million more for the rest of the world.
The factory that could make more has been closed since August for a planned expansion. The facility is not expected to reopen until late this summer at the earliest, and additional vaccines produced there may not become available until six months later.
Because testing has been patchy, the magnitude of the monkeypox outbreak, and thus the need for vaccines, is uncertain, said Angela Rasmussen, a research scientist with the Vaccine and Infectious Disease Organization at the University of Saskatchewan in Canada.
But the current supply “is certainly not enough to vaccinate everyone at risk,” she said.
About 60 countries are struggling with monkeypox cases, and all but the United States will have to share available doses until early 2023 — enough for fewer than 2.5 million people.
Bavarian Nordic has already distributed “a very small stock of finished products,” said Paul Chaplin, its chief executive. The company has been able to fulfill all the orders it has received so far, he said.
But already several countries are vaccinating close contacts of patients and anyone at high risk – an approach that could rapidly increase the number of doses needed worldwide.
“We still have a chance to contain the virus,” said Zain Rizvi, who studies drug access at the advocacy group Public Citizen. “But that means everyone who needs access to the vaccine needs it now.”
If the number of cases continues to rise unchecked, he warned, monkeypox could become permanently entrenched in several countries, leading to outbreaks for years to come.
The global number has risen to about 5,500 cases and at least 5,000 are still under investigation. The number of cases in Europe has tripled in the past two weeks, according to the World Health Organization. The United States has identified 400 cases of monkeypox, but the actual number is believed to be much higher — and the number of patients at risk is orders of magnitude greater than that.
The outbreak is largely concentrated among men who have sex with men. An estimated six million men live in the United States alone who have sex with men.
The US stockpile contains about 56,000 doses that will be distributed immediately, and federal officials expect to receive another 300,000 doses in the coming weeks.
An additional 1.1 million doses have been produced for the United States, but the Food and Drug Administration must inspect and sign them off before they can be released — a process that Mr Chaplin says typically takes three months or more.
The agency is expediting the assessment, but a spokeswoman declined to say how long it could take.
In addition, the United States had previously purchased “bulk” vaccine that could be “ready” to produce up to 15 million doses, which Mr Chaplin said would take five months.
The administration has ordered 2.5 million doses from that stock, with the first 500,000 expected to be delivered by the end of the year.
Bavarian Nordic is talking to other manufacturers who can produce more doses, but that too generally takes at least four to six months, Mr Chaplin said.
The situation may leave the United States with about two million doses by the end of the year, but could hinder response in other countries, especially African countries where the virus has been endemic for decades, experts noted.
The United States helped Bavarian Nordic develop Jynneos, a safer alternative to older smallpox vaccines, primarily to prevent smallpox in the event of a bioterrorist attack. Instead, Jynneos has become a crucial tool in the race to contain monkey pox.
There is an alternative: ACAM2000, a version of the vaccine that was used decades ago to eradicate smallpox, and that will likely be effective against monkeypox as well. But that vaccine has serious side effects, including heart problems, and can be fatal in people with certain conditions.
What you need to know about the Monkeypox virus?
What is monkey pox? Monkeypox is a virus endemic to parts of Central and West Africa. It is similar to smallpox, but less serious. It was discovered in 1958, after outbreaks occurred in monkeys kept for research, according to the Centers for Disease Control and Prevention.
“I want to underline the absurdity of relying on a single manufacturer to be the global supplier of a vaccine needed to contain outbreaks,” said Mr Rizvi. “It’s so stupid that we’re in this situation again.”
Mr Rizvi and others have called for government-owned manufacturing facilities that can be requisitioned during outbreaks to quickly produce vaccines. Plans for such a facility are under consideration, according to a senior executive who is aware of the discussions.
The limited supply of Jynneos in the United States in the coming weeks could mean people in major cities can get the shots, while those in small rural counties will have to make do with ACAM2000 — or nothing, said Elizabeth Finley, communications director for the National Coalition. of STD directors.
“We’d like to see everyone who needs the vaccine get the vaccine, no matter what community they’re in,” she said.
The World Health Organization has requested 100,000 doses of Jynneos. The Biden administration is considering the request and awaiting more details about where and how those doses would be used, according to a senior government official with knowledge of the negotiations.
“The US frankly has the most power in the world right now to shape the course of the epidemic,” said Mr Rizvi. “We need global collaboration to ensure that the doses get where they are needed most.”
