The World Health Organization (WHO) has named the MVA-BN vaccine as the first vaccine against mpox to be added to its prequalification list.
The prequalification approval of monkey pox vaccine will likely make it easier for more people in communities that need this product immediately to get it quickly. This will help stop the spread of the disease and keep the outbreak under control. A/S, the company that makes the vaccine, sent information to WHO for prequalification, and the European Medicines Agency, which is in charge of regulating this vaccine, looked it over.
“This first prequalification of a vaccine against mpox is an important step in our fight against the disease, considering the present scenario and in the future,” said Dr. Tedros Adhanom Ghebreyesus, Director-General of the WHO. “”We need to buy more, donate more, and roll out more vaccines right away to make sure everyone has equal access to them where they are needed most. Vaccines and other public health tools can help stop infections, stop transmission, and save lives.”
A 2-dose shot of the MVA-BN of monkey pox vaccine with a 4 weeks gap can be given to people over the age of 18. The vaccine can be kept at 2–8°C for up to 8 weeks after being kept in the fridge.
“The WHO prequalification of the MVA-BN vaccine will help speed up the ongoing procurement of mpox vaccines by governments and international organizations such as Gavi and Unicef to help communities in Africa and beyond who are on the front lines of the ongoing emergency,” said Dr. Yukiko Nakatani, WHO Assistant Director-General for Access to Medicines and Health Products. “The decision may also help national regulatory bodies speed up approvals, which will eventually make it easier for people to get quality-assured mpox vaccines.”
The WHO Strategic Advisory Group of Experts (SAGE) on Immunization looked at all the data and said that people who are very likely to get mpox should get the MVA-BN vaccine during an outbreak. Even though MVA-BN isn’t approved for people younger than 18, this vaccine can be used “off-label” on babies, kids, teens, pregnant women, and people with weak immune systems. This means that people should get vaccinated during outbreaks when the benefits are greater than the risks.
WHO also suggests using a single dose of monkey pox vaccine during outbreaks where supplies are limited. WHO stresses the need to gather more information about the safety and usefulness of vaccines in these situations.
Based on the information we have access to, the single-dose MVA-BN vaccine given before contact protects against mpox about 76% of the time, while the two-dose schedule protects against mpox about 82% of the time. Getting vaccinated after exposure doesn’t work as well as getting vaccinated before exposure.
It has been shown over and over again in clinical tests and in real life during the ongoing global outbreak since 2022 that the vaccine is safe and works well. As the spread of disease changes and new virus strains appear, it is still important to gather as much information as possible about the safety and usefulness of vaccines in various settings.
Since August 7, 2024, when the WHO Director-General put mpox vaccines on the list of emergency uses, WHO has done reviews of the MVA-BN vaccine’s suitability for both products and programs.
“The results of the assessments are especially important now that there is a public health emergency of international concern (PHEIC) because of the spread of mpox in Africa,” said Dr. Rogerio Gaspar, Director for Regulation and Prequalification at the WHO. “We are moving forward with the prequalification and emergency use listing processes with the makers of LC-16 and ACAM2000, two other mpox vaccines.” Also, six people have shown interest in the MPox diagnostic tools for emergency use listing.
The current mpox outbreak in the Democratic Republic of the Congo and other places was named a PHEIC on August 14, 2024, by the WHO Director-General.
As of now, more than 103 000 cases of mpox have been reported in over 120 countries since the global outbreak began in 2022. Based on information from September 8, 2024, there were 25,237 suspected and proven cases and 723 deaths in 14 African countries during 2024. We hope the monkey pox vaccine brings in a new ray of hope for all.
