Will there be enough monkeypox vaccine?

As the United States launches a monkeypox vaccination campaign, some experts fear demand will soon far exceed available supply.

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

The manufacturing plant that could do more has been closed for a planned expansion since last August. The facility is not expected to reopen until late summer at the earliest, and additional vaccines being manufactured there may not be available for at least six months after that.

Because testing has been spotty, the extent of the monkeypox outbreak, and therefore the need for vaccines, is uncertain, said Angela Rasmussen, a researcher at the Vaccine and Infectious Disease Organization at the University of Saskatchewan in Canada. .

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

About 60 countries are grappling with cases of monkeypox, and all but the United States will have to share available doses – enough for less than 2.5 million people – until early 2023.

Bavarian Nordic has “a very small inventory of finished goods” already distributed, said Paul Chaplin, the managing director. The company has been able to fulfill all of 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 could 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 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 take a permanent hold in several countries, leading to epidemics for years to come.

The global tally has risen to around 5,500 cases, with at least 5,000 more 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 thought to be much higher – and the number of people at risk orders of magnitude larger than that.

The epidemic has largely been concentrated among men who have sex with men. An estimated six million men who have sex with men live in the United States alone.

The US stockpile contains about 56,000 doses that will be distributed immediately, and federal officials expect to receive an additional 300,000 doses in the coming weeks.

An additional 1.1 million doses have been made for the United States, but the Food and Drug Administration must inspect and approve them before they can be released – a process that typically takes three months or more, according to Mr Chaplin .

The agency is accelerating its review, but a spokeswoman declined to say how long that might take.

Additionally, the United States had previously purchased “bulk” vaccine that could be “finished” to produce up to 15 million doses, which would take five months, Chaplin said.

The administration has ordered 2.5 million doses from this stockpile, with the first 500,000 expected to be delivered by the end of the year.

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

The situation will potentially leave the United States with about two million doses by the end of the year, but could hamper the response in other countries, especially African countries where the virus has been endemic for decades, have said. noted the experts.

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 this vaccine has serious 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 supplier of a vaccine needed to curb outbreaks,” Rizvi said. “It’s so stupid that we’re back in this situation.”

Mr. Rizvi and others have called for government-owned manufacturing facilities that could be commandeered during outbreaks to quickly produce vaccines. Plans for such a facility are under consideration, according to a senior administration official familiar with the discussions.

The limited supply of Jynneos in the United States over the next few weeks could mean that people in big cities will be able to get vaccinated, while those in smaller rural counties will have to settle for ACAM2000 – or nothing, said Elizabeth Finley, director of communications for the National Coalition of STD Directors.

“We would like everyone who needs the vaccine to have it, no matter what community they are in,” she said.

The World Health Organization has requested 100,000 doses of Jynneos. The Biden administration is reviewing 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 most power in the world, frankly, right now to shape the course of the outbreak,” Rizvi said. “We need global cooperation to make sure the doses get to where they’re needed most.”

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