The World Health Organization (WHO) announced this Friday the 13th that it prequalified the vaccine against Mpox produced by pharmaceutical company Bavarian Nordic. This is the first immunizer against the disease that joins the entity’s list of pre-qualified inputs.
In practice, the dose, from now on, can be distributed to low-income countries facing Mpox outbreaks through entities such as the United Nations Children’s Fund (Unicef) and the World Alliance for Vaccines and Immunization ( Gavi, its acronym in English).
“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,” assessed the OMS in note.
For the entity’s general director, 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 current outbreaks recorded in Africa and considering future scenarios related to the disease. .
“We now need to urgently intensify acquisition, donations and distribution, to ensure equitable access to doses where they are most needed, along with other public health tools, in order to prevent infections, interrupt 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 or over in a two-dose schedule, with an interval of four weeks between doses. After prior cold storage, the dose can be kept at temperatures ranging from 2 to 8 degrees Celsius (°C) for up to eight weeks.
Use off label
The entity emphasizes that, although the vaccine is not currently licensed for use in children under 18 years of age, the so-called use off label It is permitted in children and adolescents and also in pregnant women and immunosuppressed people. “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 the application of a single dose in outbreak situations combined with a limited supply of the vaccine. The entity highlights, however, the need to collect data on the safety and effectiveness 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 Mpoxwhile the two-dose regimen achieves an estimated efficacy of 82%. Vaccination after exposure to the virus is less effective than pre-exposure vaccination.”
Security
Also 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.
“Due to epidemiological change and the emergence of new variants of the virus, it remains important to collect as much data as possible on the safety and effectiveness of the vaccine in different contexts”, he added.
Scenario
WHO data indicate 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 were recorded, in addition to 723 deaths from the disease, arising from different outbreaks, caused by variants different, in 14 African countries.
