This should enable greater and more timely access to this vital product for communities in urgent need, in order to reduce transmission and help contain the outbreak.

WHO gave the green light for prequalification basing itself on the information presented by the manufacturer Bavarian Nordic A/S and on the tests applied by the European Medicines Agency, the recognized regulatory body for this vaccine.

According to specialists, MVA-BN can be administered to people over 18 years of age into two doses inoculated four weeks apart.

The vaccine, which has been stored in refrigerators, can be kept at temperatures between two and eight degrees Celsius for up to eight weeks.

The WHO Strategic Advisory Group of Experts on Immunization reviewed all available evidence and recommended the use of MVA-BN in the context of the mpox outbreak for people at high risk of exposure.

Although it is not currently authorized for children under 18 years of age, it can be used off-label in infants, children and adolescents, as well as in pregnant women and immunosuppressed people, meaning that its use is recommended in outbreak contexts where the benefits of vaccination outweigh the potential risks.

The health agency also recommends the administration of a single dose in outbreak situations where there are limitations in the supply of vaccines, and emphasizes the need to collect more data on the safety and effectiveness of the product in these circumstances.

Available data show that the estimated effectiveness of a single dose of MVA-BN, administered before exposure, in terms of protection against mpox, is 76 percent, while in the case of the two-dose regimen it reaches 82 percent.

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