WHO Approves First Mpox Vaccine: What This Means for Bavarian Nordic and Biotech Investors

The World Health Organization (WHO) has granted approval for the first-ever mpox vaccine from Bavarian Nordic (COPENHAGEN: BVNRY), marking a significant advancement in combating this disease, particularly in severely affected regions of Africa. This momentous prequalification milestone is designed to facilitate access for developing countries, which often lack the resources to conduct detailed assessments of vaccine safety and effectiveness. WHO Director-General Dr. Tedros Adhanom Ghebreyesus expressed the importance of this achievement, stating, "This first prequalification of a vaccine against mpox is an important step in our fight against the disease, both in the context of the current outbreaks in Africa, and in the future."

The mpox virus has been actively spreading from the Democratic Republic of Congo (DRC), where the outbreak first surfaced earlier this year. As the situation evolves, neighboring nations are also feeling the ripple effects. The recent approval enables these nations to obtain the Bavarian Nordic vaccine, also marketed as Jynneos in the U.S., which was initially introduced as a safeguard against smallpox. Some doses are already being allocated to the DRC, with a vaccination initiative slated to commence in early October.

Though vaccination is a vital part of the strategy, experts remind us that it is not a panacea. Dimie Ogoina, chair of the WHO's mpox emergency committee, highlighted the necessity of complementary public health measures, such as rigorous testing and contact tracing. Communicating this to the public is essential, especially with lingering uncertainties regarding the vaccine's duration of protection against mpox.

Bavarian Nordic has announced its capability to produce a staggering 13 million doses of the vaccine by the end of 2025. While primarily indicated for adults aged 18 and older, the vaccine may also be utilized "off-label" for younger populations, including infants, children, and those who are pregnant or immunocompromised, given that the advantages of vaccination are deemed to outweigh any potential risks in outbreak settings. It's noteworthy that during the initial vaccination phase in the DRC, children will not be included in the rollout plan.

In addition to Bavarian Nordic's efforts, attention is also focused on a second vaccine produced by Japan's K M Biologics, which is currently under WHO review and may be suitable for pediatric use. However, this option is not yet available outside Japan and requires special administration techniques.