The World Health Organization (WHO) announced this Friday (13) that it has prequalified the vaccine against mpox produced by the pharmaceutical company Bavarian Nordic. This is the first immunizer against the disease to be included in the entity’s list of prequalified inputs.
In practice, the dose can now be distributed to low-income countries facing outbreaks of mpox through entities such as the United Nations Children’s Fund (UNICEF) and the Global Alliance for Vaccines and Immunization (Gavi).
“Approval of prequalification should facilitate expanded and timely access to an essential input in communities with urgent needs, to reduce transmission and help contain outbreaks,” WHO said in a statement.
For the entity’s director-general, Tedros Adhanom Ghebreyesus, the first pre-qualification of a vaccine against mpox represents an important step in the fight against the disease, both from the point of view of the current outbreaks registered in Africa and considering future scenarios related to the disease.
“We now need to urgently scale up procurement, donations and distribution to ensure equitable access to doses where they are needed most, alongside other public health tools, to prevent infections, stop transmission and save lives,” he added.
Indication and vaccination schedule
According to the WHO, the vaccine produced by Bavarian Nordic can be administered to people aged 18 and over in a two-dose schedule, with a four-week interval between doses. After prior cold storage, the dose can be kept at a temperature ranging from 2 to 8 degrees Celsius (°C) for up to eight weeks.
Off-label use
The entity emphasizes that, although the vaccine is not currently licensed for use in minors under 18 years of age, the so-called use off label It is permitted in children and adolescents, as well as in pregnant women and immunosuppressed individuals. “This means that the use of the vaccine is recommended in outbreak situations where the benefits outweigh the potential risks.”
Single dose
The WHO also recommends applying a single dose in outbreak situations combined with limited supply of the vaccine. The entity highlights, however, the need to collect data on the safety and efficacy of the vaccine in this type of circumstance.
“Available data show that a single dose of the vaccine administered prior to exposure has an estimated efficacy of 76% in protecting against mpox, while the two-dose regimen achieves an estimated efficacy of 82%. Vaccination after exposure to the virus is less effective than pre-exposure vaccination.”
Security
According to the organization, the Bavarian Nordic vaccine has a good safety and performance profile, demonstrated in clinical studies and also in the midst of the first global emergency due to mpox, declared in 2022.
“Given the changing epidemiology and the emergence of new variants of the virus, it remains important to collect as much data as possible on the safety and efficacy of the vaccine in different contexts,” he added.
Scenario
WHO data indicates that, to date, 120 countries have confirmed more than 103,000 cases of mpox since 2022. This year alone, 25,237 suspected and confirmed cases have been recorded, in addition to 723 deaths from the disease, resulting from different outbreaks, caused by different variants, in 14 African countries.
