Move announced to expedite vaccine availability as deadlier variant of virus spreads in Africa
The World Health Organisation has invited manufacturers of Mpox vaccines to submit dossiers for emergency evaluation, a critical step in addressing the growing outbreak of the disease raging across the African continent.
The WHO issued a call for expressions of interest for Emergency Use Listing (EUL) on 8 August as the global health body ramped up efforts to combat the spread of a new, deadlier strain of the virus named clade 1b.
WHO director-general Tedros Ghebreyesus said the organisation had triggered the EUL process in response to the troubling expansion of Mpox beyond the Democratic Republic of the Congo, where the strain first emerged in September last year.
“Clade 1b has been confirmed in Kenya, Rwanda and Uganda, while the clade in Burundi is still being analysed,” Ghebreyesus told a media briefing on 7 August.
On 14 August, Ghebreyesus declared Mpox a public health emergency of international concern on the advice of an emergency expert meeting held that day. Africa’s leading health body, the African Centres for Disease Control and Prevention, had already declared a continental public emergency on 13 August.
Emergency authorisation
The WHO uses the EUL procedure as an emergency authorisation process to quickly make available unlicensed medical products like vaccines that are needed in public health emergency situations. This procedure is only temporary and the WHO weighs the risks of unlicensed medical products against the benefits of making them available.
The WHO has asked manufacturers to submit data demonstrating that their vaccines meet safety and efficacy standards, paving the way for quicker distribution in regions most affected by the outbreak.
“There are two vaccines for Mpox that have been approved by WHO-listed national regulatory authorities, and which are recommended by WHO’s Strategic Advisory Group of Experts on Immunization, or SAGE,” Ghebreyesus said on 7 August. “The granting of an EUL will not only facilitate vaccine access in vulnerable countries but also enable global health partners…to procure and distribute vaccines more efficiently.”
Vaccines for Africa
Mpox, caused by the monkeypox virus of the genus Orthopoxvirus, poses a significant public health risk due to its mode of transmission. The virus spreads through direct contact with an infected person, contaminated materials, or animals, making rapid vaccine deployment an important part of controlling outbreaks, experts have said.
This week, the Africa CDC announced that it had established a 25-member incident management team based in the DRC to work with other affected and at-risk countries to manage the Mpox outbreak.
The body has also signed a partnership agreement with the European Commission’s Health Emergency Preparedness and Response Authority and Bavarian Nordic for more than 215,000 doses of JYNNEOS, an Mpox vaccine widely used in the global north during the 2022-23 outbreak of clade 2b Mpox. JYNNEOS is the only Mpox vaccine that has been approved by both European and United States drug authorities, Africa CDC says.
This is far fewer than the 10 million vaccine doses that Africa estimates it needs, Africa CDC director-general Jean Kaseya said this week. However, he told journalists on 13 August that there was a plan to secure millions more doses by the end of the year. “We will leave no Africans behind,” he said.