WHO Authorizes First Monkeypox Vaccine to Combat Africa’s Current Outbreak

LI-96 Monkeypox Thailand

The last time I reported on monkeypox, news had just broken that Thailand’s public health officials confirmed a case of the more virulent strain that is part of an outbreak in Central Africa. Sweden has also recently announced that it had the first case of the same virus strain detected outside of Africa.

As a reminder, this particular variety of monkeypox (which the press is desperately trying to rebrand as ‘mpox’ with little success outside of the “journalists”) is easier to catch via skin contact and causes more serious illness than the version of monkeypox that I reported on during 2022 global outbreak.

The strain of concern here is Clade 1b. The World Health Organization (WHO) declared a global health emergency to gather supplies for a massive vaccination campaign targeting this pathogen.

Now, the organization has so quickly authorized the first vaccine against monkeypox that it surprised the head of the manufacturing firm.

The World Health Organization has given its authorization to a first vaccine to protect against mpox, a decision announced in such haste on Friday that it caught even the head of the company that makes the vaccine by surprise.The vaccine, made by the Danish company Bavarian Nordic, has been approved by the regulatory authorities in Europe as well as the United States and other high-income countries since a global mpox outbreak in 2022. But low- and middle-income countries rely on the W.H.O., through a process called prequalification, to determine which drugs, vaccines and health technologies are safe and efficient uses of limited health funding, and the organization had declined to act until now.The W.H.O. had come under increasing criticism for declaring a global public health emergency for mpox last month without giving a vaccine that prequalification stamp of approval, or a more provisional form of approval called emergency use authorization. Bavarian Nordic first submitted its safety and effectiveness data on the vaccine, called Jynneos, to the W.H.O. in 2023.The W.H.O. had defended its slow pace of review, saying that it needed to subject the vaccine to careful study because it, and two others that have been used to protect against mpox, were originally designed as smallpox immunizations, and because delivering it in low-resource settings such as Central Africa would involve factors different from those relating to its use in high-income countries.

The approval, known as prequalification, means U.N. agencies can now buy the vaccines and help coordinate donations. It is reported that 3.6 million doses of vaccines are now on their way to Central Africa, 50,000 from this country have already arrived in the Congo, and vaccinations are due to start on Oct. 2 with the first tranches of donations.

Prior to this approval, multiple vaccines developed for smallpox were being made available globally as medical countermeasures for monkeypox. In the United States, the modified vaccinia Ankara-Bavarian Nordic (MVA-BN, sold as Jynneos) and ACAM2000 are the only vaccines approved for preventing both smallpox and mpox.

Given the nature of the disease, WHO officials stress other counter-measures will need to be put in place.

Other factors, including the roughly $100 price tag for the vaccine, competing disease outbreaks, and sluggish processes in badly-hit countries like Congo have also played a role.”The evidence we have now is… it is important we take advantage of it (the vaccine) to protect our population,” Dimie Ogoina, chair of the WHO’s mpox emergency committee, had said before the approval.He however stressed that vaccines were not a “magic bullet” and other public health measures were also important.

Looking at the statistics available, it certainly appears that the approved vaccine is clearly not a magic bullet.

The MVA-BN vaccine can be given in two doses to people 18 years and older, four weeks apart, which has an estimated 82 per cent effectiveness.For infants, young children, pregnant women and immunocompromised people, the vaccine may be used in situations where the benefits of the vaccine are greater than potential risks.In instances where the vaccine supply is limited, the health organization recommends distribution in single doses, which is 76 per cent effective.

The good news is that there have been no recent reports of the more virulent Clade 1b mpox cases outside of Africa since the Thai case. Hopefully, the containment program will stem the current outbreak within Africa.

The COVID response has already damaged WHO’s reputation heavily. Failure in this situation will further erode any remaining trust in “global health” responses that may currently exist in trace amounts.

Tags: Africa, Medicine, Monkeypox, Science, World Health Organization (WHO)

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