WHO Permits Partners to Purchase Mpox Vaccines Ahead of Approval

London: In a proactive move, the World Health Organization (WHO) has granted permission for its partners, such as Gavi and UNICEF, to start purchasing mpox vaccines before their formal approval by the United Nations health agency. This decision aims to accelerate the distribution of vaccines to Africa, where a significant outbreak of the virus is currently unfolding.
Traditionally, organizations like Gavi, which assist lower-income countries in acquiring vaccines, are only authorized to purchase vaccines post-approval by the WHO. However, the urgency of the situation has led to a temporary relaxation of these rules, allowing discussions to proceed even before the expected emergency license, which is anticipated in a few weeks.
Two vaccines, developed by Denmark's Bavarian Nordic and Japan's KM Biologics, have already received approval from regulators in countries like the United States and Japan. These vaccines have been widely used for mpox since 2022, with approximately 1.2 million people in the United States having received the Bavarian Nordic vaccine.
The WHO is expected to grant an emergency license for these vaccines in September, enabling broader distribution. This follows the WHO's declaration of mpox as a public health emergency of international concern, prompted by the rapid spread of a new virus variant in the Democratic Republic of Congo and other regions.
In response to the escalating situation, the WHO had earlier requested vaccine manufacturers to submit the necessary information to expedite the approval process. However, concerns have been raised by Bavarian Nordic, one of the vaccine manufacturers, regarding the need for immediate orders from organizations like Gavi and the WHO to ensure sufficient production of vaccines this year. Without these orders, lower-income countries risk missing out or becoming reliant on donations from wealthier nations, as seen during the COVID-19 pandemic.
The Africa Centres for Disease Control and Prevention announced that the first shipments of donated mpox vaccines are expected to arrive in Africa next week. The WHO’s swift action underscores the critical need for rapid response to emerging global health threats, particularly in vulnerable regions.