United States – On Friday, the World Health Organization noted that organizations like Gavi and UNICEF could purchase the mpox vaccines before the final approval from a U.N. health agency to bring vaccines to Africa faster as the region grapples with a rising spread of the virus, as reported by Reuters.
Relaxation of Vaccine Procurement Rules
For most of the time in the past, organizations such as Gavi, through which developing countries can afford vaccines, can only begin procuring shots upon clearance by the WHO. However, this has been relaxed in this instance in order to kickstart discussions, as the WHO approval is expected in a couple of weeks.
Two of the vaccines produced by Denmark’s Bavarian Nordic (BAVA. CO) and KM Biologics of Japan have been approved by most of the regulators across the globe including the USA and Japan, and have been used extensively for mpox since 2022. Around 1.2 million people in the United States have received Bavarian Nordic’s vaccine. The WHO is anticipated to approve the license for the shots in the coming September.
Mpox, a viral disease that is most often transmitted sexually or through contact with contaminated surfaces but can be fatal, was labeled a public health emergency of international concern by the WHO last week in response to a new subvariant of the virus emerging rapidly in the Democratic Republic of Congo and other countries.
Earlier this month, the WHO called on vaccine producers to provide data to give the organization a head start on fast-track approval and to issue an emergency use authorization by mid-September.
Urgent Need for Vaccine Orders
But this week, one of the vaccine makers, Bavarian Nordic, said it required orders right now from the likes of Gavi and WHO to manufacture more needles this year, causing concerns that LMICs may not get them at all or will have to rely on unpredictable donations from HICs, as was the case with COVID shots.
According to Africa Centres for Disease Control and Prevention, some of the donated mpox vaccines are expected to be received in Africa next week. The agency has said 10 Million doses are required.
Manufacturer Responses
While Bavarian Nordic welcomed the news from WHO as a plus, it declined to talk about specifics on negotiations, saying, “We will communicate with the marketplace in due course depending on the actualization of orders,” a spokesperson revealed.
A spokesperson for Gavi added that getting donated vaccines to countries and then into immunization programs was the aim.
“When it comes to procuring vaccines directly, 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,” the spokesperson said, as reported by Reuters.
Representatives from KM Biologics were unavailable to comment on the story at the time of publication.