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https://www.wsj.com/articles/smallpox-vaccine-enters-wider-production-amid-monkeypox-outbreak-11653329895

◆ WSJ NEWS EXCLUSIVEHEALTH

Smallpox Vaccine Enters Wider Production

Amid Monkeypox Outbreak
Bavarian Nordic has fielded requests from dozens of countries seeking the
shot, CEO Paul Chaplin says

By Denise Roland Follow

Updated May 23, 2022 7:41 pm ET

Danish vaccine maker Bavarian Nordic A/S is making more of a smallpox vaccine
typically stockpiled in case of biological warfare, as governments seek doses that also
offer protection against monkeypox amid an unusual outbreak around the world.

Monkeypox, a viral illness that is only rarely detected outside of Africa, has been
reported in recent weeks in at least 17 countries including the U.S., U.K., Spain, Portugal
and Australia, according to nonprofit data platform Global.health. In the U.S., a case was
confirmed in Massachusetts and at least five more are suspected—one each in Florida,
New York and Washington and two in Utah, state officials and the Centers for Disease
Control and Prevention said Monday.

There is no vaccine directed specifically against monkeypox. But smallpox vaccines like
Bavarian Nordic’s shot, known as Jynneos in the U.S., have been shown in studies to be
at least 85% at preventing monkeypox, which is closely related to smallpox but much less
severe.

Paul Chaplin, chief executive officer of Bavarian Nordic, said the company had received
calls from dozens of countries inquiring about doses of the vaccine. He said stocks are
currently limited but that the company will make more doses in the coming weeks and
months.

“We feel confident based on discussions that we’ll be able to meet the demand in a
relatively short period of time,” he said.

Jynneos, which is known as Imvanex in Europe and Imvamune in Canada, was developed
as a safer alternative to older smallpox vaccines. The Food and Drug Administration
approved Jynneos for smallpox and monkeypox in 2019.

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Smallpox vaccination uses a live version of a related virus, called vaccinia. Older
smallpox vaccines used a form of the vaccinia that could replicate, creating the risk of
infection from the vaccine itself. Those vaccines are particularly risky for people with
weakened immune systems such as older people or people with HIV. Bavarian Nordic’s
shot uses a non-replicating version of the vaccinia virus that doesn’t pose that risk.

Jynneos is also easier to administer. It is given by a standard injection, whereas older

vaccines require an unusual technique that involves puncturing the skin several times.

The U.S. and Canada are the only two countries that have built up meaningful stockpiles
of Jynneos, Mr. Chaplin said. President Biden said Sunday that the public should be
concerned about the recent spate of cases of monkeypox around the world. His national
security adviser Jake Sullivan, said the U. S.—which has reported a confirmed case in
Massachusetts and a suspected case in Florida—has vaccines available to protect
against monkeypox, if needed.

Mass vaccination is unlikely to be required because monkeypox isn’t easily passed from
one person to another. But it can be spread from person to person through close contact.
The CDC has said the U.S. has access to enough doses of smallpox vaccine—in a stockpile
that includes older vaccines too—to inoculate the entire population against smallpox in
the event of a biological attack.

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Only the Jynneos shot is also authorized for monkeypox. The U.S., which has purchased
doses mainly for use in its strategic defense stockpile, has access to 1.4 million doses
from an order placed in 2020, according to Mr. Chaplin. Due to the sporadic nature of
orders, Bavarian Nordic doesn’t typically produce the shot continuously but rather
makes doses to order at a plant north of Copenhagen.

Mr. Chaplin said immediate demand from governments around the world could be met
with stocks that Bavarian Nordic has in storage, which he expects to send out over
coming days. Those doses, he said, were surplus stock from earlier production runs. He
didn’t specify how many doses were already available.

The current outbreak is unusual because it is rare for large numbers of cases to occur
outside the Western and Central African regions where monkeypox is endemic. When
cases do occur elsewhere, they are usually in a person who has traveled from the
affected region.

Cases have mostly, but not exclusively, been identified among men who have sex with
men, according to the World Health Organization, leading experts to believe that the
virus has somehow taken hold among a close-knit community. It isn’t sexually
transmitted but does require close contact to spread.

“My feeling is this is an outbreak that’s happened because, presumably, there was a
travel-associated case and then it got into a sexual network and it’s a sexual network
where there’s the possibility for a lot of close contact,” said Jake Dunning, senior
researcher in emerging and high consequence infections at the Epidemic Diseases
Research Group at the University of Oxford.

In Madrid, which has so far reported 34 confirmed cases, authorities are investigating
possible links between a recent Gay Pride event in the Canary Islands that attracted
some 80,000 attendees and cases at a sauna in the Spanish capital, according to the
city’s senior health official Enrique Ruiz Escudero.

If demand continues, Bavarian plans to extend a production run that is already under
way for a recent order from the Canadian government that predated the monkeypox
outbreak. The plant has the capacity to make up to 30 million doses of the shot a year,

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although the company would need to scale back production of other vaccines to do so, he
said. Bavarian Nordic also makes vaccines for rabies, tick-borne encephalitis and Ebola.

Governments haven’t disclosed how they will use smallpox vaccination to curb the
monkeypox outbreak. Infectious-disease experts say the strategy would most likely
involve offering the shot to people at highest risk of catching the disease, such as close
contacts of confirmed cases and healthcare workers who are treating monkeypox
patients. That approach has been used by the U.K. government in previous, smaller,
monkeypox outbreaks, according to Dr. Dunning.

Smallpox vaccination can prevent the onset of monkeypox if given within four days of
exposure, according to the CDC. Given within 14 days of exposure, it may still reduce
symptoms of the disease.

—Jon Kamp contributed to this article.

Write to Denise Roland at Denise.Roland@wsj.com

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