Bavarian Nordic seeks crucial EU approval for Mpox vaccine for teens

Danish biotech company Bavarian Nordic announced on Friday that it has submitted data to the European Medicines Agency (EMA) seeking to extend the use of its Mpox vaccine to include teenagers aged 12 to 17.

This move comes in response to a recent World Health Organization (WHO) declaration of a public health emergency due to a new strain of the virus.

EMA approval for Mpox vaccine use in teens

Paul Chaplin, CEO of Bavarian Nordic, stated that the approval for the vaccine, branded as JYNNEOS and also known as IMVANEX, is critical for addressing the current outbreak of Mpox, specifically the clade 1b strain.

This new strain has been notably affecting teenagers and young children, as evidenced by a recent surge in cases. The company’s application to the EMA aims to address this concern by extending vaccine eligibility to younger populations.

“The latest data we’ve submitted is crucial as it aims to extend our vaccine’s use to adolescents,” Chaplin told CNBC’s "Squawk Box Europe."

He highlighted that over 70% of Mpox cases in Africa involve individuals under 18, underscoring the need for broader vaccine coverage in this age group.

EMA review pending

Currently, Bavarian Nordic’s vaccine is approved for use in adults aged 18 and over, and it is the only Mpox vaccine authorized by both the FDA and EMA.

The company’s request for extended approval would allow the vaccine to be administered to teenagers, which Chaplin believes is essential for controlling the outbreak.

Approval from the EMA would also potentially facilitate the vaccine’s use in Africa, where the outbreak has been most severe.

In addition to seeking approval for teens, Bavarian Nordic is studying the vaccine’s efficacy in children aged two and older, with results expected next year.

This research aims to further extend the vaccine’s use and provide additional protection against the virus.

Stock market reaction

Following the WHO’s declaration of a public health emergency on Wednesday, Bavarian Nordic’s share price saw a significant increase.

The company’s stock rose by 17% on Thursday and another 17.5% by midday Friday in Copenhagen, reflecting a surge in investor interest amid heightened demand for the vaccine.

Chaplin reported that the company has substantial stockpiles of the vaccine and is prepared to distribute it to countries in need. However, he noted that logistical challenges have hindered distribution in Africa.

The vaccine is currently approved for use in the Democratic Republic of Congo (DRC) and Nigeria, and Bavarian Nordic is working with authorities in neighboring countries to facilitate access.

WHO advises against border closures

The ongoing Mpox outbreak has resulted in more than 15,000 reported cases and at least 537 deaths this year, according to the WHO.

The outbreak follows a previous Mpox strain that was declared a public health emergency in 2022.

The European Centre for Disease Prevention has warned of a high risk of infection for travelers to affected regions, but the WHO has not recommended border closures at this time.

Chaplin emphasized that while Bavarian Nordic is a key player in addressing the outbreak, broader international cooperation is necessary.

He stressed the need for coordinated efforts to ensure the vaccine reaches those most in need and to effectively contain the outbreak.

“Bavarian Nordic is part of the solution, but we are not the sole solution,” Chaplin said. “The international community needs to collaborate with us to distribute the vaccine and manage this outbreak.”