The World Health Organization said in a statement on Friday that its 'prequalification approval' of the Mpox vaccine is expected to "facilitate timely and increased access to this vital product in communities with urgent need, to reduce transmission and help contain the outbreak."

The WHO Strategic Advisory Group of Experts (SAGE) on Immunization based its prequalification approval after analyzing the Danish vaccine maker's data and a review submitted by the regulatory board of European Medicines Agency. 

MVA-BN vaccine is currently approved only for adults aged above 18. According to the health experts, two doses of injection taken in a gap of 4 weeks can best protect against the mpox infection.

But, in case of shortage of the vaccine, a single dose should be administered. Previous data shows that a single dose of the vaccine can give 76 percent of protection against mpox compared to 82 percent provided by a double dose.

Mpox vaccines manufactured by Bavarian Nordic are sold under brand names like Jynneos, Imvamune and Imvanex.

Terming as 'off-label,' and by citing situations where "benefits outweigh potential risks," the health advisory has given permission to administer the vaccine on children under 18 and people at higher risk of exposure including infants and pregnant women.  

"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," WHO Director-General Dr Tedros Adhanom Ghebreyesus, said.

"We now need urgent scale up in procurement, donations and rollout to ensure equitable access to vaccines where they are needed most, alongside other public health tools, to prevent infections, stop transmission and save lives."

The current approval is expected to increase "access to quality assured mpox vaccine products," WHO Assistant Director-General for Access to Medicines and Health Products, Dr Yukiko Nakatani said.

WHO said it is currently analyzing prequalification approval of two other mpox vaccines LC-16 and ACAM2000.

LC-16 of KM Biologics in Japan already has a domestic approval. ACAM2000 is a small pox vaccine, manufactured by Emergent Biosolutions which received FDA approval for protecting against Mpox recently.

On 14 August 2024, WHO declared the mpox outbreak as a Public Health Emergency of International Concern (PHEIC) and to control the outbreak, on 31 Aug, UNICEF issued an emergency tender to obtain mpox vaccines for the countries, worst -hit by the viral disease.

Democratic Republic of Congo received its first doses of mpox vaccines manufactured by Bavarian Nordic on 5 Sep. The mpox vaccines were donated to Congo by European Union.

Mpox, a viral illness caused by the monkey pox virus- a species of the genus Orthopoxvirus- was first reported in monkeys kept in a research lab in Denmark in 1958. In 1970, Democratic Republic of the Congo, reported the first human case of mpox in a nine-month-old boy. The viral disease started spreading to different parts of the world in 2022.

According to a WHO report, between January 2022 and August 2024, more than 120 countries have reported cases of Mpox with one lakh laboratory confirmed cases and more than 220 deaths.