WHO grants first Mpox vaccine approval for prequalification

The World Health Organisation (WHO) has announced the approval of the MVA-BN vaccine as the first vaccine against mpox to be added to its prequalification list.

The prequalification approval was announced on WHO website on Friday, noting that it is expected to reduce transmission and help contain the outbreak.

The global health organisation noted that its assessment for prequalification is based on information submitted by the manufacturer, Bavarian Nordic A/S, and reviewed by the European Medicines Agency, the regulatory agency of record for the vaccine.

The approval comes as the mpox outbreak continues to spread, with over 120 countries reporting more than 103,000 cases since 2022. In Africa, there have been 25,237 suspected and confirmed cases and 723 deaths in 14 countries in 2024, according to WHO.

“This first prequalification of a vaccine against mpox is an important step in our fight against the disease, both in the context of the current outbreaks in Africa, and in future,” said WHO Director-General, Tedros Ghebreyesus.

Mr Ghebreyesus called for “urgent” scale-up of procurement, donations and rollout to get the vaccine where it is needed most, along with other response measures.

More on MVA-BN vaccine

According to WHO, the MVA-BN vaccine can be administered to people over 18 years old as a two-dose injection given four weeks apart.

WHO said available data shows it is effective in protecting against mpox, with an estimated 76 per cent effectiveness after a single dose and 82 per cent after two doses.

WHO has also recommended using the vaccine in infants, children, and adolescents, as well as in pregnant and immunocompromised people, in outbreak settings where the benefits outweigh the risks.

The statement reads in part: “The WHO Strategic Advisory Group of Experts (SAGE) on Immunisation reviewed all available evidence and recommended the use of MVA-BN vaccine in the context of a mpox outbreak for persons at high risk of exposure.

“While MVA-BN is currently not licensed for persons under 18 years of age, this vaccine may be used “off-label” in infants, children and adolescents, and in pregnant and immunocompromised people.

“This means vaccine use is recommended in outbreak settings where the benefits of vaccination outweigh the potential risks.”

Africa receives Jynneos vaccine

Nigeria recently received a donation of 10,000 doses of Jynneos, an anti-mpox vaccine, from the United States government.

On 5 September, Africa CDC also announced the arrival of the first shipment of 99,100 doses of the Jynneos mpox vaccine to the Democratic Republic of Congo (DRC).

Jynneous is approved by the US government’s Food and Drug Administration (FDA) for the prevention of smallpox and mpox for 18-year-olds and older who are at risk.

It is also recommended by the Centre for Disease Control and Prevention (CDC) and the Advisory Committee on Immunisation Practices (ACIP).

Since the start of 2024, the Democratic Republic of Congo (DRC) has been driving the surge in mpox cases in Africa with nearly 22,000 cases and 716 deaths recorded, according to the Africa CDC.

READ ALSO: Man dies after taking herbal concoction

Nigeria, according to the Nigeria Centre for Disease Control and Prevention (NCDC), has confirmed 67 cases out of more than 1,000 suspected cases reported across 23 states and the Federal Capital Territory (FCT).

NCDC’s Director General, Jide Idris, gave the latest statistics on 11 September.

Meanwhile, other countries of concern in Africa include Burundi, Kenya, Rwanda, Uganda, Ghana and Liberia.