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Will there be enough monkeypox vaccine?

As the United States begins a monkeypox vaccination campaign, concern is growing among some experts that demand may soon far outstrip available supply.

Jynneos, the only vaccine developed for monkeypox, is made by a small Danish company, Bavarian Nordic. The company is expected to ship about 2 million doses to the United States by the end of the year, but may produce fewer than 5 million more for the rest of the world.

The manufacturing plant that could do more has been closed for an extension planned since last August. The facility isn’t expected to reopen until late this summer at the earliest, and additional vaccine made there may not be available for at least six months after that.

Because testing has been patchy, the extent of the monkeypox outbreak, and thus the need for vaccines, is uncertain, said Angela Rasmussen, a research scientist at the University of Saskatchewan’s Organization for Vaccines and Infectious Diseases. in Canada.

But the current supply is “certainly not enough to vaccinate everyone who is going to be at risk,” he said.

Roughly 60 countries are dealing with cases of monkeypox, and all but the United States will have to share available doses, enough for fewer than 2.5 million people, through early 2023.

Bavarian Nordic has “a very small inventory of finished products” already distributed, said Paul Chaplin, the 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 else at high risk, an approach that can rapidly increase the number of doses required around the world.

“We still have a window of opportunity to contain the virus,” said Zain Rizvi, who studies access to medicines 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 may take permanent root in several countries, leading to outbreaks for years to come.

The global count has risen to about 5,500 cases and at least another 5,000 are under investigation. Cases in Europe have tripled in the past two weeks, according to the World Health Organization. The United States has identified 400 cases of monkeypox, but the true number is believed to be much higher, and the number of people at risk is much higher than that.

The outbreak has been largely concentrated among men who have sex with men. It is estimated that six million men who have sex with men live in the United States alone.

The US stockpile contains about 56,000 doses to 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 manufactured for the United States, but must be inspected and approved by the Food and Drug Administration before they can be released, a process that typically takes three months or more, according to Chaplin.

The agency is speeding up its review, but a spokeswoman declined to say how long it might take.

In addition, the United States had previously purchased a “bulk” vaccine that could be “finished” to produce up to 15 million doses, which would require five months, according to Chaplin.

the administration has ordered 2.5 million doses of that stock, of which the first 500,000 are expected to be delivered by the end of the year.

Bavarian Nordic is talking to other manufacturers who could produce more doses, but that too usually takes at least four to six months, Chaplin said.

The situation will potentially leave the United States with about 2 million doses by the end of the year, but it may hamper the response in other countries, particularly African countries where the virus has been endemic for decades, experts said.

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 monkeypox.

There is an alternative: ACAM2000, a version of the vaccine used to eradicate smallpox decades ago, which is also likely to be effective against monkeypox. But that vaccine has severe side effects, including heart problems, and can be fatal in people with certain conditions.

“I want to underscore the absurdity of relying on a single manufacturer to be the global provider of a vaccine that is needed to curb outbreaks,” Rizvi said. “It is so stupid that we are in this situation again.”

Rizvi and others have called for government-owned manufacturing facilities to be commandeered during outbreaks to quickly produce vaccines. Plans for such a facility are being considered, according to a senior administration official with knowledge of the discussions.

The limited supply of Jynneos in the United States over the next few weeks may mean that people in big cities will be able to get the shots, while people in small rural counties will have to make do with ACAM2000, or nothing at all, said Elizabeth Finley, director of communications of the National Coalition of Directors of STD.

“We would like to see everyone who needs the vaccine get vaccinated, regardless of what community they are in,” he said.

The World Health Organization has ordered 100,000 doses of Jynneos. The Biden administration is considering the request and awaiting more details on where and how those doses would be used, according to a senior administration official with knowledge of the negotiations.

“The United States has the greatest power in the world, frankly, right now, to shape the course of the epidemic,” Rizvi said. “We need global cooperation to make sure doses get to where they are needed most.”

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