WHO invites mpox vaccine manufacturers to submit dossiers for emergency evaluation

The World Health Organisation has invited manufacturers of mpox vaccines to submit an expression of interest for Emergency Use Listing.

The WHO disclosed this in a statement on Friday.

The WHO Director-General, Tedros Ghebreyesus, announced on Wednesday that he had triggered the process for EUL of mpox vaccines given worrying trends in the disease’s spread.

There is a serious and growing outbreak in the Democratic Republic of the Congo that has now expanded outside the country. A new viral strain, which first emerged in September 2023, has for the first time been detected outside DRC.

Since the beginning of this year, the DRC has been experiencing a severe outbreak of mpox with more than 14,000 reported cases and 511 deaths.

Outbreaks of mpox have been reported in DRC for decades, and the number of cases reported each year has been increasing steadily.

However, the number of cases reported in the first six months of this year matches the number reported last year and the virus has spread to previously unaffected provinces.

WHO disclosed that in the past month, about 50 confirmed and more suspected cases have been reported in four countries neighbouring the DRC that have not been reported before – Burundi, Kenya, Rwanda, and Uganda.

The EUL procedure is an emergency use authorisation process, specifically developed to expedite the availability of unlicensed medical products like vaccines that are needed in public health emergencies.

This is a time-limited recommendation, based on a risk-benefit approach.

WHO is requesting manufacturers to submit data to ensure that the vaccines are safe, effective, of assured quality, and suitable for the target populations.

Granting of an EUL will accelerate vaccine access, particularly for those lower-income countries that have not yet issued their national regulatory approval. The EUL also enables partners including Gavi and UNICEF to procure vaccines for distribution.

Mpox is a viral illness caused by the monkeypox virus, a species of the genus Orthopoxvirus. Mpox can be transmitted to humans through physical contact with someone infectious, with contaminated materials, or with infected animals.

There are currently two vaccines in use against the disease, both of which have been recommended for use by the WHO Strategic Advisory Group of Experts on Immunisation, or SAGE.

The Director General of the Africa Centre for Disease Control, Dr Jean Kaseya on Thursday said the African continent is poised to declare a Public Health Emergency of Continental Security as mpox continues to spread across many countries.

Kaseya stated, “Public health officials have warned that without urgent action, the situation could worsen, putting even more lives at risk.

“As the continent braces for the official declaration of the PHECS, there is a growing sense of urgency to contain the outbreak. The declaration is expected to facilitate the rapid deployment of medical supplies, enhance the sharing of critical information, and improve the overall resilience of public health systems across Africa.

“The global community is closely monitoring these developments, recognising that Africa’s response to the Mpox outbreak will have far-reaching implications for public health security both on the continent and worldwide,” he said.

Also, the UN body noted that an Emergency Committee under the International Health Regulations would be convened to discuss whether the current mpox outbreak in the DRC represents a public health emergency of international concern.