Danish vaccine manufacturer Bavarian Nordic said it can provide 10 million doses of its mpox vaccine by 2025.
The announcement follows the WHO declaring mpox a ‘global public health emergency’ due to the outbreak in the Democratic Republic of Congo.
“We have additional manufacturing capacity of two million doses for 2024 and (a total of) 10 million doses by 2025,” Rolf Sass Sorensen, vice-president of Bavarian Nordic, told AFP.
“Danish drugmaker Bavarian Nordic is prepared to produce up to 10 million doses of its Mpox vaccine by 2025 after the WHO declared a surge in the virus in Africa a global health emergency. The company, which has 500,000 doses in stock, awaits orders before beginning production. Shares rose 8% after the announcement, following a 12% jump the previous day,” Mario Nawfal wrote.
AFP reports:
Shares in Bavarian Nordic, whose vaccine against mpox has been licensed since 2019, rose nearly eight percent on the Copenhagen Stock Exchange on Thursday, following the WHO announcement. This followed a 12 percent climb on Wednesday.
On Tuesday, the Africa Centres for Disease Control and Prevention, the African Union’s health agency, announced that over 200,000 doses of the vaccine were to be deployed in Africa, following an agreement with the European Union (EU) and Bavarian Nordic.
A total of 38,465 cases of the disease, formerly known as monkeypox, have been reported in 16 African countries since January 2022, with 1,456 deaths.
There has been a 160 percent increase in cases this year compared to the previous year, according to data published last week by the health agency.
Bavarian Nordic mainly supplies it’s mpox vaccine — called Jynneos in the United States and Imvanex in the European Union — to governments and international organisations, but began marketing it on the US market in April.
“Bavarian Nordic said Friday that it had submitted data to the Europe Union’s drug regulator to extend the use of its mpox vaccine for teenagers,” CNBC reports.
Per CNBC:
CEO Paul Chaplin told CNBC that the expanded approval for 12 to 17 year-olds would be crucial in tackling the outbreak of the latest strain of the virus, clade 1b, which particularly afflicts teenagers and young children.
It comes after the World Health Organization on Wednesday declared an escalating mpox outbreak in Africa as a public health emergency, with the first case of the new strain outside of the continent confirmed in Sweden on Thursday.
“The latest data that we’ve submitted is really, really important because hopefully it will extend the use of our vaccine down to adolescents,” Chaplin told “Squawk Box Europe.”
“More than 70% of the cases in Africa currently are in people younger than 18, so it’s going to be critical that our vaccine can be used in this younger age group,” he said.
Bavarian Nordic’s JYNNEOS vaccine, also known as IMVANEX, is currently only approved for use in adults aged 18 and over. It is also the only mpox vaccine approved by the Food and Drug Administration and the European Medicines Agency.
Before anyone, especially children, receive the JYNNEOS mpox vaccine, it’s imperative to read the package insert made available by the FDA.
“Bavarian Nordic’s JYNNEOS live-attenuated MPOX vaccine resulted in elevated troponin levels in up to 18.4% of trial participants, with 1.3% experiencing cardiac adverse events. Among those previously vaccinated for smallpox, 2.1% reported cardiac adverse events,” McCullough Foundation wrote.
“These findings indicate an unacceptable safety signal for cardiac damage. The widespread deployment of JYNNEOS for the current MPOX Clade Ib outbreak, particularly in populations at risk for myocarditis (such as young males), poses significant safety concerns,” the post added.
The insert also cites myocarditis and pericarditis.
From the FDA:
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