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Big step as WHO prequalifies the first vaccine against mpox

Big step as WHO prequalifies the first vaccine against mpox


A major milestone has been achieved as World Health Organization (WHO) adds the MVA-BN vaccine to its prequalification list, marking it as the first-ever vaccine against monkeypox (mpox) to achieve this status.

It has only been one month since both the WHO and the Africa CDC declared the outbreak a public health emergency.

And it's easy to understand why.

As of September 8, 2024, WHO estimates that there have been 25,237 mpox cases and 723 deaths across 14 African countries.

With these figures expected to rise, it is important to implement strategies that would curb the spread of the virus.

One way to do this is through vaccination.

This first prequalification of a vaccine against mpox is an important step in our fight against the disease, both in the context of the current outbreaks in Africa, and in future.

 

WHO Director-General Dr Tedros Adhanom Ghebreyesus

The WHO has moved fast to expedite availability and accessibility of mpox vaccines through triggering emergency use listing (EUL), allowing lower-income nations that are yet to achieve national regulatory approval to have access to the jab.


RELATED: WHO invites Mpox vaccine manufacturers to apply for emergency use listing


The decision to approve MVA-BN for listing was based upon data provided by the manufacturer, Bavarian Nordic A/S, assessment by the European Medicines Agency, and the authority of record for the vaccine.

After review by the WHO Strategic Advisory Group of Experts (SAGE) concerned with immunization, the team recommended that the vaccine may be used in an outbreak situation where the benefits of vaccination outweigh the risks.

Use of the MVA-BN vaccine

It is recommended that individuals aged 18 and above receive the MVA-BN vaccine, which demonstrates 82% effectiveness when given as two doses, spaced four weeks apart. However, in the context of supply shortages during outbreaks, the WHO advises administering a single dose, which still offers 76% effectiveness.

The WHO also emphasizes that while post-exposure vaccination is beneficial, it is less effective than vaccination administered prior to exposure.

The vaccine can be stored for up to eight weeks at 2–8 °C after initial cold storage. With priority given to those classified under high risk of exposure.

Additionally, according to WHO, in situations where the benefits outweigh the risk, those under 18, pregnant, and immunocompromised persons can also receive “off-label” vaccination with the drug.

However, it has emphasized the need to collect as much data as possible related to the safety and effectiveness of the vaccine.

About the Monkeypox virus

Monkeypox is a disease caused by the Mpox virus, a genus of the Orthopoxvirus and having two distinct subtypes referred as genetic clades I and II.

Clade I is endemic in Central Africa, while II in West Africa.

Notably, the ongoing global outbreak is due to the clade II subtype.

Typical symptoms of the disease include mucosal lesions, rash, muscle aches, headache and fever.

Transmission occurs through physical contact with infected humans or animals, as well as contact with infected surfaces.


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APR Team

African Pharmaceutical Review team dedicated to providing the latest news, insights and developments from the pharma, biotech and medtech industries.