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LONDON — Danish biotech company Bavarian Nordic said Friday that it had submitted data to the European Union’s drug regulator to increase the usage of its mpox vaccine for teenagers.
CEO Paul Chaplin told CNBC that the expanded approval for 12 to 17 year-olds could be crucial in tackling the outbreak of the newest 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 a public health emergency, with the primary case of the brand new strain outside of the continent confirmed in Sweden on Thursday.
“The most recent data that we have submitted is basically, really essential because hopefully it should extend the usage of our vaccine right down to adolescents,” Chaplin told “Squawk Box Europe.”
“Greater than 70% of the cases in Africa currently are in people younger than 18, so it will be critical that our vaccine may be utilized in this younger age group,” he said.
Bavarian Nordic’s Jynneos vaccine, also often known as Imvanex, is currently only approved to be used in adults aged 18 and over. It’s also the one mpox vaccine approved by the Food and Drug Administration and the European Medicines Agency.
Should the EMA approve the vaccine to be used for teenagers, the corporate said it might pave the way in which for approval amongst teens in Africa. The firm can also be currently studying the vaccine’s efficacy in children aged two and over, with results due next 12 months.
The WHO’s emergency declaration saw Bavarian Nordic’s share price rally 17% on Thursday, alongside other healthcare stocks, amid perceptions of heightened demand for the vaccine. It was up an extra 17.5% by midday Friday in Copenhagen, Denmark.
Chaplin said the corporate had significant stockpiles of the vaccine and that it was “able to ship” to countries in need. Nevertheless, he cited bottlenecks in Africa which have to date prevented its distribution.
The vaccine is currently only approved within the Democratic Republic of Congo — the epicentre of the outbreak — in addition to Nigeria. Chaplin said the corporate was continuing to work with authorities in neighbouring affecting countries to enable access to the vaccine.
“There’s now an approval within the DRC also in Nigeria, so it opens the door now, each for governments to purchase the vaccine, but in addition for Bavarian Nordic, as now we have, to donate doses and get those doses shipped, and hopefully we are able to start vaccinating people very, very soon,” he said.
To this point this 12 months, greater than 15,000 cases and not less than 537 deaths have been reported from the outbreak, according to the WHO. It follows a previous outbreak of one other mpox strain in 2022, which was also declared a public health emergency.
The European Centre for Disease Prevention warned on Friday of the high risk of infection for people traveling to affected countries, however the WHO said that it didn’t recommend border closures at this stage.
Chaplin said authorities were now in a greater position to take care of the outbreak, with doses of the vaccine already available, particularly in wealthy countries, which created stockpiles throughout the last outbreak. But he urged greater international cooperation to make sure doses reach those most in need.
“Bavarian Nordic is an element of the answer, but we usually are not the only solution here,” he said. “The international community needs to come back along with Bavarian Nordic and really discover a way of distributing this vaccine and containing the outbreak.”
