Mpox shows smallpox risk, says vaccine maker Bavarian Nordic


A healthcare worker prepares a dose of the JYNNEOS Monkeypox vaccine at a pop-up vaccination clinic in Los Angeles, California, August 9, 2022.

Patrick T. Fallon | AFP | Getty Images

The maker of the mpox vaccine is looking for ways to dramatically increase its production capacity to prepare for a potential smallpox threat.

Bavarian Nordic CEO Paul Chaplin said the rapid spread of mpox last year was a wake-up call for the company, based in Denmark.

“If it wasn’t mpox but smallpox, we’re completely on the wrong scale,” Chaplin told CNBC in an interview.

“We’re looking at ways to radically change the way we manufacture to increase our scale,” he said.

Mpox belongs to the same virus family as smallpox. Bavarian Nordic’s Jynneos vaccine is approved by the Food and Drug Administration to protect against both pathogens.

Formerly known as monkeypox, the World Health Organization changed the name to mpox last year to reduce stigma.

Bavarian Nordic plans to simplify its production process so that it can easily partner with other manufacturers and increase its production capacity to hundreds of millions of doses in an emergency.

The company’s current production capacity is several tens of millions of doses.

Smallpox was eradicated from the world in 1980 after a successful global vaccination campaign. Although the risk of the virus returning is low, some governments do not want to take any risks.

“There are concerns, either through re-engineering, or accidental outbreaks due to lockdown, or other terrorist activities, that it could be reintroduced,” Chaplin said of smallpox.

Smallpox was one of the deadliest diseases known to mankind. It had a mortality rate of up to 30% depending on the strain, according to the WHO.

Following the mpox outbreak, the European Union Health Emergency Preparedness and Response Authority and at least two European national governments expressed interest in stockpiling the Jynneos vaccine for use against smallpox, a said Chaplin.

“Last year it was all about mpox. And now it’s a mix of mpox, but also more strategic storage, including smallpox indication,” Chaplin said of the order talks. future.

“The discussions have undeniably intensified and increased,” he said.

The United States has long had a stockpile of more than 100 million doses of an older smallpox vaccine, called ACAM2000.

Bavarian Nordic will complete delivery of an order of 5 million doses of Jynneos for the US government in the first half of this year. This contract was signed during the mpox epidemic.

Mpox as warning

Once confined mainly to Africa, mpox, originally known as monkeypox, suddenly and rapidly spread around the world last summer, catching public health authorities and Nordic Bavarians by surprise. .

Unlike smallpox, mpox is rarely fatal, but the virus can be fatal for people with severely weakened immune systems. And the skin lesions associated with the disease can cause excruciating pain.

Bavarian Nordic only had several thousand finished doses of Jynneos when the UK reported the first known case of the outbreak to the WHO last May.

“We sold the entire stock to the UK government, thinking this was, as usual, an isolated case,” Chaplin said.

Sporadic cases of mpox had occurred in countries outside Africa by travelers in the past. In 2003, there was a small outbreak in the United States from imported animals.

But when other countries in Europe started reporting cases of the virus last year, it became clear something unusual was going on, Chaplin said.

“The phone started ringing and we realized we were in a situation we hadn’t seen before,” Chaplin said.

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The virus has since exploded to more than 87,000 cases, with 120 deaths, in 110 countries, according to WHO data.

The global outbreak is the largest in the observed history of the virus. The United States has had the worst outbreak with more than 30% of reported cases worldwide.

At that time, “we had no intention of making Jynneos,” Chaplin said. “We are making other vaccines and our order book was full, but we had to make the decision on the spot, we have to change all our manufacturing plants and only make Jynneos.”

Bavarian Nordic distributed more than 4 million doses of Jynneos to more than 70 countries from May to December last year, Chaplin said.

More production capacity needed

Since last year, Mpox has mainly spread through sexual contact among gay and bisexual men.

But the rate of new cases of the virus has dropped dramatically as vaccine distribution intensified and communities at risk had better information about precautions to take.

Bavarian Nordic estimates that potential demand for the mpox vaccine could reach tens of millions of doses.

The company’s current annual production capacity is between 15 and 20 million doses, Chaplin said.

“It was contained in that at-risk population, it didn’t spread,” the CEO said of last year’s outbreak. “If that’s how it manifests again, I think we can handle it.”

While mpox is primarily spread through close physical contact, smallpox infects people primarily through respiratory droplets, which means the virus has a greater potential for large-scale spread.

And Bavarian Nordic’s annual production capacity for Jynneos would not be enough to deal with a large-scale smallpox outbreak, Chaplin said.

“We will need many, many more doses. We need to think about how best we are prepared,” the CEO said.

Bavarian Nordic’s current production capacity is limited by the fact that the weakened virus used in the vaccine is produced from chicken cells taken from special chicken eggs.

Bavarian Nordic has developed a permanent line of avian cells that will simplify production and make it easier to switch to other manufacturers in an emergency, Chaplin said.

The company plans to introduce the new cell line within the next 18 months, he said.

Smallpox risks

Although smallpox was eradicated more than 40 years ago, there are still two known stocks of the virus.

The US Centers for Disease Control and Prevention and the Russian State Center for Virology and Biotechnology Research each have smallpox samples available for research. These are the only two laboratories in the world approved to hold the virus.

The World Health Assembly, a United Nations entity, has repeatedly passed resolutions calling for the eventual destruction of remaining smallpox samples.

In 2011, the United States rebuffed this effort, arguing that the samples should be kept for now, developing countermeasures in case someone deliberately reintroduces smallpox, or if the virus escapes from an undisclosed stockpile somewhere in the world.

The United States has 360 samples stored by the CDC in Atlanta. And Russia has 120 samples stored at its research center in a small town called Koltsovo in Siberia, according to a 2021 WHO report.

They are used to research the development of diagnostics, antivirals and vaccines.

In 2019, a gas cylinder exploded in the Russian factory and caused a fire. No biological material was stored in the room where the explosion occurred, according to a statement from the Russian authorities at the time.

The Soviet Union had a biological weapons program until the early 1990s, which included stockpiling tens of tons of smallpox, according to congressional testimony of Ken Alibek, the former deputy director of this program, who had defected to the United States

And in 2018, scientists in Canada builds a smallpox virus in the laboratory, raising fears that the same method could be used to synthesize smallpox.

Chaplon said: “Russia is known to have weaponized smallpox and grown in large quantities, so there are concerns that it may have fallen into the hands of other people.”

“If you can redesign a related virus like smallpox, you can design smallpox, which is the smallpox virus that infects humans,” Chaplin said.

Declining population immunity

Smallpox vaccines have not been routinely given to the general population for decades. As a result, many people around the world are unprotected against the virus.

“Herd immunity in the human population since that time has not been what it was at the time of smallpox eradication,” said Dr Rosamund Lewis, head of the WHO smallpox secretariat. said last summer.

Most people under 40 are unprotected because they were born after smallpox vaccination was stopped, Lewis said.

The United States, the WHO and other countries maintain stocks of smallpox vaccines for emergencies, but many of these vaccines use older technology.

The overwhelming majority of US smallpox vaccine stock is ACAM2000. Although effective in protecting against smallpox, ACAM2000 can cause serious side effects in pregnant women, people with skin conditions such as eczema, and those with weakened immune systems.

This is because ACAM2000 uses a mild virus strain related to smallpox that can still spread in the human body of the vaccinated patient and to other unvaccinated people. The vaccine cannot cause smallpox.

But the virus from the vaccine can spread to a pregnant woman’s fetus and cause stillbirth. It can also grow out of control and cause dangerous infections in people with weakened immune systems and those with skin problems.

People who receive ACAM2000 can also transmit the virus contained in the vaccine for several weeks to other unvaccinated people. This could lead to serious side effects if anyone in the vaccinated person’s household belongs to one of the risk groups.

The Jynneos vaccine uses a weakened virus strain that cannot spread and does not cause the side effects associated with ACAM2000.

Jynneos was originally developed with support from the National Institutes of Health for people who cannot take photos like ACAM2000.

Jynneos is given in two doses taken four weeks apart.

One dose of the Jynneos vaccine is estimated to be 80% effective in preventing disease caused by mpox, according to scientific studies.

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