Will monkeypox vaccine suffice?

As the United States launches its monkeypox vaccination campaign, fears are growing among some experts that demand may soon far outstrip available supply.

Jynneos, the only vaccine developed against monkeypox, 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 may produce less than five million more for the rest of the world.

A manufacturing plant that could produce more was close for a planned expansion from last August. The facility is not expected to open until the end of this summer, and additional vaccine produced there may not arrive until six months after that.

Because testing has been patchy, the extent of the monkeypox outbreak, and thus the need for vaccines, is unclear, said Angela Rasmussen, a research fellow at the Vaccine and Infectious Diseases Organization at the University of Saskatchewan in Canada.

But current supplies are “definitely not enough to vaccinate everyone who would be at risk,” she said.

Approximately 60 countries are battling cases of monkeypox, and all but the United States will have to share available doses of less than 2.5 million people by early 2023.

According to chief executive Paul Chaplin, Bavarian Nordic has “a very small stock of finished goods”. According to him, the company has been able to fulfill all the orders it has received so far.

But several countries are already 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 window of opportunity to contain the virus,” said Zayn Rizvi, who studies drug access at the advocacy group Public Citizen. “But it means that everyone who needs access to a vaccine needs it now.”

He warned that if the number of cases continues to rise unchecked, monkeypox could become permanently established in several countries, leading to outbreaks for years to come.

The total number of cases has increased to around 5,500, and at least another 5,000 are under investigation. The number of cases in Europe has tripled in the past two weeks, according to the World Health Organization. There are 400 cases of monkeypox identified in the United States, but the real number is thought to be much higher, and the number of people at risk orders of magnitude higher.

The outbreak was mostly concentrated among men who have sex with men. There are an estimated six million men who have sex with men in the United States alone.

The US stockpile contains about 56,000 doses. which will be sent out immediatelyand federal officials expect to receive another 300,000 doses in the next few weeks.

Another 1.1 million doses have been made for the United States, but the Food and Drug Administration must inspect and sign them off before they can be released — a process that typically takes three months or longer, according to Mr. on K. Chaplin.

The agency is expediting the 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 Mr. D. Chaplin said.

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

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

Experts say the situation could leave about two million doses in the United States by the end of the year, but that could make it difficult to respond elsewhere, especially in African countries where the virus has been endemic for decades.

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 variant of the vaccine used decades ago to eradicate smallpox, 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 medical conditions.

“I want to emphasize the absurdity of relying on one single manufacturer as the global supplier of the vaccine needed to contain outbreaks,” he said. Rizvi said. “It’s so stupid that we’re in this situation again.”

mr. Rizvi and others called on government manufacturing facilities, which could be confiscated during outbreaks, to quickly produce vaccines. Plans for such a facility are under consideration, according to a senior administration official familiar with the discussions.

Jynneos’ limited offer in the United States over the next few weeks could mean people in big cities can get vaccinated while those in smaller, rural areas have to make do with ACAM2000 — or nothing, Elizabeth Finley said. director of communications for the National Coalition of STD Directors.

“We would like everyone who needs a vaccine to get a vaccine, 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 will be used, according to a senior administration official familiar with the talks.

“Honestly, right now, the US has the most power in the world to influence the course of the epidemic,” he said. Rizvi said. “We need global collaboration to make sure doses get to where they’re needed most.”