Bavarian Nordic aims for 'essential' EU authorization of mpox vaccine for adolescents following WHO's health emergency declaration

• Bavarian Nordic, a Danish biotech company, announced on Friday that it had submitted data to the European Union's drug regulator to expand the use of its mpox vaccine to teenagers.
• Paul Chaplin, CEO, stated on CNBC that the approval for 12 to 17 year-olds is vital in combating the current outbreak, which disproportionately affects teenagers and young children.
• The WHO declared an escalating mpox outbreak in Africa as a public health emergency on Wednesday.

The Danish biotech company submitted data to the EU's drug regulator to expand the use of its mpox vaccine for teenagers.

Paul Chaplin, CEO of CNBC, stated that the approval of the vaccine for 12 to 17 year-olds is crucial in controlling the spread of the latest strain of the virus, clade 1b, which disproportionately affects teenagers and young children.

The World Health Organization declared an escalating mpox outbreak in Africa as a public health emergency on Wednesday, and the first case of the new strain outside of the continent was confirmed in Sweden on Thursday.

""Squawk Box Europe" reported that "The latest data we submitted is crucial because it may allow our vaccine to be used among adolescents," according to Chaplin."

It is crucial that our vaccine is effective for people under 18 years old, as more than 70% of cases in Africa currently affect this age group.

The JYNNEOS vaccine, also known as IMVANEX, is the only mpox vaccine approved for use in adults aged 18 and over. It has been approved by both the Food and Drug Administration and the European Medicines Agency.

If the EMA approves the vaccine for teenagers, the company will use it as a stepping stone to secure approval for teens in Africa. Additionally, the company is currently evaluating the vaccine's effectiveness in children aged two and above, with results expected next year.

On Thursday, Bavarian Nordic's share price increased by 17% following the WHO's emergency declaration, and by an additional 17.5% in Copenhagen, Denmark, by midday Friday.

Although Chaplin stated that the company had substantial vaccine stockpiles and was prepared to ship it to countries in need, he pointed out that Africa's bottlenecks have hindered its distribution so far.

The vaccine is currently approved only in the Democratic Republic of Congo and Nigeria, where the outbreak is occurring. Chaplin stated that the company is still collaborating with authorities in neighboring countries to facilitate access to the vaccine.

The DRC and Nigeria have now approved the vaccine, allowing governments to purchase it and Bavarian Nordic to donate doses and ship them, with the hope of starting to vaccinate people soon.

The current mpox outbreak has resulted in over 15,000 cases and 537 deaths, according to the WHO. This follows a previous outbreak of another mpox strain in 2022, which was also classified as a public health emergency.

On Friday, the European Centre for Disease Prevention issued a warning about the high risk of infection for individuals traveling to affected countries, while the WHO advised against border closures at this time.

Although Chaplin stated that authorities are now better equipped to handle the outbreak, with vaccines readily available, particularly in affluent countries, which hoarded supplies during the previous outbreak, he emphasized the need for greater international cooperation to ensure that vaccines reach those who need them the most.

"While Bavarian Nordic is part of the solution, we are not the only solution here. The international community must collaborate with us to distribute the vaccine and control the outbreak."