Since the United States has launched a vaccination campaign against monkeypox, there is growing concern among some experts that demand may soon exceed available supply.
Jynneos, the only vaccine made for monkeypox, was developed by Bavarian Nordic, a small Danish company. The company is expected to send about two million doses to the United States by the end of the year, but could produce less than five million doses for the rest of the world.
The production facility that could do more has been shut down for planned expansion since last August. The facility is not expected to reopen very soon later this summer, and additional vaccines made there may not be available for at least six months after that.
Angela Rasmussen, a research scientist at the Institute for Vaccines and Infectious Diseases at the University of Saskatchewan in Canada, said because the tests were complex, the chances of a monkeypox outbreak and therefore the need for a vaccine were uncertain.
But the current supply is “certainly not enough to vaccinate everyone who is going to be at risk,” he said.
Approximately 60 countries have jumped on the bandwagon with monkeypox, and everyone except the United States will have to share the available dose – enough for less than 2.5 million people – by early 2023.
The Bavarian Nordic has “a very small inventory of finished products” already distributed, said Paul Chaplin, chief executive. He said the company has been able to meet all the orders it has received so far.
But, in the meantime, several countries are vaccinating patients and close acquaintances of someone else at high risk – a method that could rapidly increase the number of doses needed worldwide.
“We still have a window of opportunity to contain the virus,” said Joyn Rizvi, who is studying access to medicine at Advocacy Group Public Citizen. “But that means everyone needs access to the vaccine now.”
If the number of cases continues to rise without control, he warned, monkeypox could enter several countries permanently, leading to an outbreak over the next few years.
The number worldwide has risen to about 5,500 cases, and at least 5,000 more are 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 monkeypox cases, but the actual number is thought to be much higher – and the number of people at risk is even higher.
The prevalence is mainly concentrated in men who have sex with men. An estimated six million men who have sex with men live in the United States alone.
U.S. stocks contain about 56,000 doses that will be delivered immediately, and federal officials expect to receive another 300,000 doses in the next few weeks.
An additional 1.1 million doses have been created for the United States, but the Food and Drug Administration must inspect them and sign off before release – a process that usually takes three months or more. According to Chaplin.
The agency is speeding up its review, but a spokesman declined to say how long it could take.
In addition, the United States previously purchased “bulk” vaccines that could “finish” up to 15 million doses, which would take five months, according to Mr. Chaplin.
The administration has ordered 2.5 million doses from that stock, the first 500,000 of which are expected to be delivered by the end of the year.
The Bavarian Nordic is talking to other manufacturers who can produce more doses, but it also usually takes at least four to six months, Mr Chaplin said.
The situation is likely to drop nearly two million doses from the United States by the end of the year, but could disrupt the response in other countries, especially in African countries where the virus has been epidemic for decades, experts noted.
The United States helped the Bavarian Nordic to create Genius, a safe alternative to the old smallpox vaccine, primarily to prevent smallpox in the event of a bio-terrorist attack. Instead, Genius has become an important tool in the race to contain monkeys.
There is an alternative: ACAM2000, a version of the vaccine used to eradicate smallpox decades ago, which may also be effective against monkeypox. But that vaccine has serious side effects, including heart problems, and can be fatal for people with certain conditions.
What to know about monkeypox virus
What is a monkeypox? Monkeypox is a virus endemic to parts of Central and West Africa. It is similar to smallpox, but less severe. According to the Center for Disease Control and Prevention, it was discovered in 1958 after an outbreak in monkeys kept for research.
“I would like to underscore the irrationality of relying on a single manufacturer as a global supplier for a vaccine that is needed to prevent outbreaks,” Mr 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 can be commanded during outbreaks to quickly create vaccines. Plans for such a facility are under consideration, according to a senior official in the administration with knowledge of the negotiations.
The limited supply of Genius in the U.S. over the next few weeks could mean that people in big cities will be able to get shots while in small rural counties they won’t have to do ACAM2000 – or anything, says Elizabeth Finlay, communications director of the National Coalition of STD Directors.
“We want to see people who need the vaccine get the vaccine, no matter what community they belong to.”
The World Health Organization has asked for 100,000 doses of Genius. The Biden administration is considering the request and is waiting for more details on where and how these doses will be used, according to a senior administration official with knowledge of the negotiations.
“The United States has the most power in the world to shape the course of the epidemic, obviously, right now,” Rizvi said. “We need global cooperation to ensure that doses reach where they are most needed.”