The World Health Organization (WHO) has on Friday approved an mpox vaccine for the first time, to help restrain the rapidly growing outbreak in Africa.
The UN organization prequalified the MVA-BN vaccine, manufactured by the Danish pharmaceutical company Bavarian Nordic, to accelerate access for millions of people and reduce virus transmission.
First Mpox Vaccine
According to the WHO, the approval will facilitate “timely and increased access” to the vaccine in communities with urgent need, to help contain the outbreak in Africa and beyond.
In the light of this, WHO Director-General, Tedros Adhanom Ghebreyesus, said: “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.”
The approval of the vaccine means that donors and partners, such as UNICEF, can buy doses and donate them to Africa. However, the vaccine supplies are limited because there is only one manufacturer.
With regards to this, WHO Director-General noted: “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.”
Vaccine Access
People aged 18 years or above can get the MVA-BN vaccine in a 2-dose injection, 4 weeks apart, with an estimated 82% effectiveness. However, infants, children and adolescents, as well as pregnant women can get the MVA-BN vaccine “off-label.” The WHO recommended the vaccine “in outbreak settings where the benefits of vaccination outweigh the potential risks.”
Moreover, the organization recommended a single-dose injection in supply-constrained outbreak situations, with 76% effectiveness. It also emphasized the need to collect more data on safety and effectiveness.
Public Health Emergency
On August 14, the WHO declared mpox virus a global public health emergency of international concern, after it spread in more than a dozen African countries, killing hundreds of people. The current mpox outbreak started in the Democratic Republic of Congo (DRC) and has spread to neighboring countries, including Burundi, Kenya, Rwanda and Uganda. Other countries reported mpox cases, including Sweden, Philippines and Morocco.
According to the WHO, more than 120 countries have confirmed over 103,000 mpox cases since the start of the outbreak in 2022. In 2024, outbreaks in 14 African countries have led to 25,237 suspected and confirmed cases and 723 deaths, as of September 8.
Vaccine Assessments
After approving the MVA-BN vaccine, also known as JYNNEOS in the US, the WHO said it is considering LC-16, manufactured by the Japanese KM Biologics, and ACAM2000, by Emergent BioSolutions.
On this matter, the WHO Director for Regulation and Prequalification, Rogerio Gaspar, said: “We are progressing with prequalification and emergency use listing procedures with manufacturers of two other mpox vaccines: LC-16 and ACAM2000. We have also received 6 expressions of interest for mpox diagnostic products for emergency use listing so far.”
Mpox Vaccination Campaign
The US, European countries and Japan pledged to donate 3.6 million doses of the two approved mpox vaccines, reported Reuters. Congo, the epicenter of the current outbreak, will start mpox vaccination campaign on October 2, after receiving the first batches of the vaccine.
Congo on Tuesday received 50,000 of mpox vaccines donated by the US. The head of Congo’s mpox response, Cris Kacita, told Reuters that his country has so far received a total of 265,000 doses from the US and the European Union (EU), adding that France and Belgium promised to send vaccines.
Additionally, Japan has pledged 3.5 million doses that can be given to children, who are the most vulnerable to the mpox virus. The mpox virus spreads via close contact with infected people. It causes flu-like symptoms, including fever, chills and body aches. In more serious cases, it causes lesions on the body.
The WHO Assistant Director-General for Access to Medicines and Health Products, Yukiko Nakatani, said that the WHO approval of the MVA-BN vaccine “will help accelerate ongoing procurement of the mpox vaccines by governments and international agencies such as Gavi and UNICEF to help communities on the frontlines of the ongoing emergency in Africa and beyond.”
