The World Health Organization (WHO) has recently initiated the process for Emergency Use Listing (EUL) of two vaccines against mpox (formerly known as monkeypox), a significant step aimed at improving vaccine access in lower-income countries. This decision comes amid alarming trends in the spread of the disease, particularly in the Democratic Republic of the Congo (DRC), where over 14,000 cases and 511 deaths have been reported in 2024 alone. The WHO Director-General, Tedros Adhanom Ghebreyesus, emphasized that the EUL will facilitate vaccine procurement by partners like Gavi and UNICEF, enabling a more rapid response to the outbreak.
The Current Situation of Mpox
Mpox is a viral disease endemic to Central and West Africa, transmitted through physical contact with infected individuals, animals, or contaminated materials. The current outbreak in the DRC is attributed to a new strain, clade 1b, which is associated with more severe disease than the clade responsible for the global outbreak in 2022. In recent months, approximately 50 confirmed cases have also emerged in neighboring countries, including Burundi, Kenya, Rwanda, and Uganda, marking a concerning expansion of the outbreak.
The WHO’s EUL process is designed to expedite the availability of unlicensed medical products during public health emergencies. By granting EUL, the WHO aims to ensure that vaccines are safe, effective, and suitable for target populations, particularly in regions lacking national regulatory approval for these vaccines.
Vaccine Safety and Efficacy
Currently, two vaccines are available for mpox: Jynneos and ACAM2000. Jynneos was licensed for monkeypox in the U.S. in 2019, while ACAM2000 has been made available under an Expanded Access Investigational New Drug protocol during the ongoing outbreak. Both vaccines were initially developed for smallpox, and while they have shown efficacy against mpox, concerns regarding their safety profiles have been raised. Reports indicate that these vaccines may cause serious side effects, including myocarditis and pericarditis, particularly in younger populations, as neither vaccine is approved for children under 18.
Myocarditis, an inflammation of the heart muscle, and pericarditis, an inflammation of the lining around the heart, have been associated with the use of these vaccines, particularly ACAM2000, which is a live-virus vaccine known to have a higher risk of such adverse events compared to Jynneos, a non-replicating vaccine. Dr. Meryl Nass, a biological warfare expert, has pointed out that while mpox has generally presented as a mild illness in the U.S., it has been more deadly in Africa, particularly among children under 15, who account for a significant proportion of cases and deaths.
The efficacy of these vaccines has also been questioned, as it is based on immunogenicity studies rather than direct evidence of protection against disease. Despite these concerns, vaccination remains a key strategy in controlling mpox outbreaks, with studies showing that Jynneos can reduce the risk of mpox illness, although no vaccine is 100% effective.
Vaccine Profit Potential
Manufacturer: Bavarian Nordic. Market Launch: Bavarian Nordic has recently launched Jynneos commercially in the U.S. after previously relying on government stockpiling and distribution. The commercial rollout allows access through pharmacies and physician offices, expanding its availability beyond public health channels. Market Size: Approximately 2 million individuals in the U.S. are eligible for Jynneos under CDC recommendations, with a significant portion still unvaccinated. Revenue: In 2023, Jynneos sales nearly tripled to over DKK 5 billion (approximately $720 million), driven by contracts with various governments, including the U.S.[6]
Manufacturer: Emergent BioSolutions. Market Considerations: ACAM2000 is another vaccine used for mpox, but specific details about its current market performance and revenue were not available. Historically, ACAM2000 has been used in government stockpiling efforts, which may continue to influence its earning potential. Vaccine Characteristics and Usage: ACAM2000 is a second-generation vaccine derived from Dryvax®, used primarily for smallpox prevention but also considered for mpox due to the similarity between the viruses. It is a live vaccinia virus vaccine with a high rate of adverse events, making it less favorable for use compared to JYNNEOS, especially for immuno-compromised individuals.[7][8]
WHO’s Response and Future Directions
In light of the current outbreak, the WHO has developed a $15 million response plan aimed at enhancing surveillance, preparedness, and response activities. This includes an initial release of $1 million from the WHO Contingency Fund for Emergencies to support these efforts. Furthermore, an Emergency Committee under the International Health Regulations has been convened to assess whether the outbreak constitutes a public health emergency of international concern.
The situation in the DRC and its neighboring countries underscores the critical need for a coordinated global response to address the mpox outbreak effectively. The WHO’s actions, including the EUL process and financial support, aim to enhance vaccine access and ultimately control the spread of this viral disease.
Conclusion
As the WHO moves forward with its emergency response to the mpox outbreak, the focus remains on ensuring that vaccines are accessible to those most in need while addressing safety and efficacy concerns. The collaboration between international health organizations, governments, and local communities will be pivotal in managing this public health challenge effectively.
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[1] https://www.who.int/news/item/09-08-2024-who-invites-mpox-vaccine-manufacturers-to-submit-dossiers-for-emergency-evaluations
[2] https://punchng.com/who-invites-mpox-vaccine-manufacturers-to-submit-dossiers-for-emergency-evaluation/
[3] https://iris.who.int/bitstream/handle/10665/356120/WHO-MPX-Immunization-2022.1-eng.pdf
[4] https://news.un.org/en/story/2024/08/1152931
[5] https://www.cdc.gov/poxvirus/mpox/interim-considerations/overview.html
[6] https://www.fiercepharma.com/pharma/bavarian-nordic-begins-commercial-launch-mpox-vaccine-jynneos-us
[7] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10120163/
[8] https://www.cdc.gov/poxvirus/mpox/interim-considerations/overview.html