“Regulators have already approved two vaccines developed by Denmark’s Bavarian Nordic and Japan’s KM Biologics.”
WHO Eases Rules to Expedite Mpox Vaccine Distribution Amid Escalating Outbreak in Africa
The World Health Organization (WHO) announced on Friday that it would allow partners, including Gavi and UNICEF, to begin purchasing mpox vaccines before they receive official approval from the UN health agency. This decision aims to accelerate the delivery of vaccines to Africa as the continent grapples with a rapidly worsening outbreak of the virus.
Traditionally, organizations like Gavi, which aids lower-income countries in acquiring vaccines, can only initiate the purchase of vaccines once they have been formally approved by the WHO. However, in this instance, the WHO has decided to relax these rules to speed up the process. The WHO’s approval is expected within a few weeks, but discussions and preparations can now begin immediately to ensure that vaccines reach the affected regions as quickly as possible.
Two vaccines, developed by Denmark’s Bavarian Nordic and Japan’s KM Biologics, have already received regulatory approval in several countries, including the United States and Japan. These vaccines have been widely used in combating mpox since 2022. In the United States alone, approximately 1.2 million people have been vaccinated with the Bavarian Nordic vaccine. The WHO is anticipated to grant an emergency license for these vaccines by mid-September, further facilitating their distribution.
Mpox, a viral infection that spreads through close contact, is generally mild but can be fatal in certain cases. The WHO recently declared mpox a Public Health Emergency of International Concern (PHEIC) following a significant outbreak of a new variant of the virus in the Democratic Republic of Congo, which has since spread to other regions.
In response to the escalating crisis, the WHO has urged vaccine manufacturers to expedite the submission of information necessary for the approval process. This accelerated timeline is designed to ensure that an emergency license can be granted by mid-September, allowing for more immediate and widespread distribution of the vaccines.
However, concerns have been raised about the availability of vaccines, particularly for lower-income countries. This week, Bavarian Nordic, one of the vaccine manufacturers, emphasized the urgent need for immediate orders from organizations such as Gavi and the WHO to produce additional doses this year. The company’s warning has sparked fears that lower-income countries may face difficulties securing sufficient vaccine supplies or may be forced to rely on uncertain donations from wealthier nations—a scenario reminiscent of the challenges faced during the COVID-19 pandemic.
The Africa Centres for Disease Control and Prevention (Africa CDC) has reported that donated mpox vaccines are expected to arrive in Africa next week. The agency has identified a need for 10 million doses to effectively combat the outbreak on the continent. The timely arrival and distribution of these vaccines are crucial to controlling the spread of the virus.
A spokesperson for Bavarian Nordic acknowledged the WHO’s decision as a positive development but refrained from commenting on specific negotiations. “We will update the market in due time if and when orders materialize,” the spokesperson stated, underscoring the importance of securing firm commitments from purchasing organizations.
Gavi, which is heavily involved in facilitating vaccine access for lower-income countries, has made it clear that its top priority is to distribute donated doses to the countries in need and integrate them into national vaccination programs. A spokesperson for Gavi highlighted the urgency of the situation, stating, “Since a public health emergency of international concern was announced last week, we have intensified our efforts, with near-daily contact with manufacturers: we are ready to go as soon as we get a clear picture on demand.”
As of now, KM Biologics, another key vaccine manufacturer, has not responded to requests for comment on their role in the current crisis or their plans for increasing production.
In the meantime, UNICEF has launched an urgent appeal for $16.5 million to bolster its mpox response in East and Southern Africa. The UN agency’s regional director for Eastern and Southern Africa, Etleva Kadilli, emphasized the vulnerability of children and communities in the region, where confirmed cases of mpox have been reported in countries including Burundi, Rwanda, Uganda, Kenya, and South Africa.
Burundi, in particular, is facing a severe outbreak, with over 500 confirmed cases spread across 25 of the country’s 49 districts, according to the Africa CDC. UNICEF’s appeal is aimed at scaling up efforts to protect children and other vulnerable populations from the expanding threat of mpox in the region.
The WHO’s decision to allow the early procurement of vaccines and the coordinated efforts of international organizations like Gavi, UNICEF, and Africa CDC are crucial steps in addressing the growing mpox crisis in Africa. However, the success of these efforts will depend on the timely delivery and equitable distribution of vaccines to those most in need.