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The first vaccine against mpox has got the World Health Organization’s approval with the MVA-BN vaccine being added to its prequalification list.
Prequalification paves the way for quick access and adoption of the vaccine, especially in countries and communities dealing with an outbreak. The WHO’s assessment was based on information submitted by the manufacturer, Bavarian Nordic and review by the European Medicines Agency, the regulatory agency of record for this vaccine, the UN health agency said.
The development comes in the week India reported its first confirmed mpox case. Last month, India’s Serum Institute said it was working on a vaccine against mpox. The escalating mpox outbreak in the Democratic Republic of Congo and other countries was declared a Public Health Emergency of International Concern by the WHO, last month.
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The MVA-BN vaccine can be administered in people over 18-years of age as a 2-dose injection given 4 weeks apart. After prior cold storage, the vaccine can be kept at 2–8°C for up to 8 weeks. The WHO also recommends single-dose use in supply-constrained outbreak situations and emphasizes the need for more data on vaccine safety and effectiveness in these circumstances.
More vaccines in line
Dr Rogerio Gaspar, WHO Director for Regulation and Prequalification, 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.”
Over 120 countries have confirmed more than 103,000 cases of mpox since the onset of the global outbreak in 2022. In 2024 alone, there were 25,237 suspected and confirmed cases and 723 deaths from different outbreaks in 14 countries of the African Region (based on data from 8 September 2024).
Allocation mechanism
The WHO has also established an access and allocation mechanism (AAM) for mpox medical countermeasures including vaccines, treatments and diagnostic tests. “The COVID-19 pandemic illustrated the need for international coordination to promote equitable access to these tools so they can be used most effectively where they are most needed. We urge countries with supplies of vaccines and other products to come forward with donations, to prevent infections, stop transmission and save lives,” the WHO DG added.
Over 3.6 million doses of vaccines have been pledged for the mpox response. This includes 620 000 doses of the MVA-BN vaccine pledged to affected countries by the European Commission, Austria, Belgium, Croatia, Cyprus, France, Germany, Luxembourg, Malta, Poland, Spain, and the US, as well as vaccine manufacturer Bavarian Nordic. Japan has pledged 3 million doses of the LC16 vaccine, the largest number of doses pledged so far.
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