Kenya to take part in development of Mpox vaccine
With the disease already affecting many African countries, Africa CDC reports that there is an acute shortage of vaccines.
What you need to know:
- Mpox, formerly known as Monkeypox, is a viral zoonotic disease similar to smallpox, though less severe.
A pharmaceutical company based in the United States has announced a research partnership with the Kenya Medical Research Institute (Kemri) to develop and test a vaccine for Mpox.
The project worth Sh233. 1 million is likely to take up to two years to accomplish, according to Kemri.
Tonix Pharmaceuticals Holding Corporation will undertake Phase I clinical trial of TNX-801 in Kenya, focusing on assessing the vaccine’s safety, tolerability and immunogenicity.
The company will sponsor the trial, while Kemri will oversee the execution of the study.
Tonix CEO Seth Lederman expressed his optimism about the collaboration; saying with continued spread of Mpox, there is a need for a single dose vaccine.
“There is an urgent need for a durable, single-dose vaccine like TNX-801. Preclinical data has been highly encouraging, and we believe it aligns with the World Health Organization’s (WHO) preferred characteristics for Mpox vaccines,” said Dr Lederman.
He added: “Our goal is to contribute to the global effort to halt the spread of this infectious disease.”
Kemri Director General Elijah Songok said the partnership with Tonix Pharmaceuticals endeavours to address the global health threat posed by viruses.
“As an institute at the forefront of medical research in Africa, we recognise the importance of developing innovative solutions that are accessible and effective,” said Prof Songok.
He said the planned clinical trial of TNX-801 reflects ongoing commitment to advancing scientific research that will not only benefit Kenya but also contribute to global efforts to prevent and manage emerging infectious diseases.
“Together, we aim to make significant strides in ensuring the safety and well-being of communities at risk,” he said.
According to principal investigator of the project, Dr Matilu Mwau, researchers are in the stage of developing the protocols needed to conduct the phase 1 clinical trial of up to 60 participants.
"I believe we will be ready to submit these for regulatory and ethical approvals in January 2025. Perhaps we will start the phase 1 trial by July 2025," said Dr Mwau.
He noted that most Kenyans are not vaccinated for any of the pox viruses.
Only a few people, he said, have been vaccinated for small pox, which was done years ago
This means the population is at risk of small pox, monkey pox and other pox viruses.
"If a vaccine that shows efficacy in the Kenyan population is made available, it would really help protect the population from the kinds of surprises we are seeing, for example the Mpox pandemic, " he said.
Dr Matilu disclosed that TNX801 vaccine is intended to protect from both Mpox and smallpox.
"We believe the TNX801 vaccine will prove safe and efficacious and will meet this need. It has done very well in preclinical trials, " he said. He added: "A vaccine of this nature can reduce that level of susceptibility. In fact we think the reason we are susceptible to Mpox is because smallpox vaccination occurred so long ago that very little protection is left at the herd level."
The nature of the vaccine will be a single dose.
Other vaccines require more than one dose spaced a few weeks apart. That means one needs to go back for the boost. In this case, loss to follow-up, is therefore a real risk on top of costs associated with transportation and service delivery.
"Vaccines for Mpox can sometimes be difficult to produce at scale. TNX801 vaccine, however, is easier to produce at scale, " said Dr Matilu.
Once the phase 1 trials are completed, Kenyans will be the first beneficiaries of the vaccine.
This announcement comes as the WHO declared the recent rise in Mpox cases across Africa a Public Health Emergency of International Concern (PHEIC).
In Kenya, the first case was confirmed in July in Taita Taveta, a border of Kenya and Tanzania.
The first death was reported in October.
Cases of the newly identified Clade Ib Mpox have also been reported in non-endemic regions such as Sweden, Thailand, Singapore, and India, highlighting, the pandemic potential of the virus.
TNX-801 is a live-attenuated horse pox virus vaccine that is being developed to provide immune protection against Mpox.
It is designed to be safer and better tolerated than older smallpox vaccines derived from vaccinia viruses.
Pre-clinical studies have shown that TNX-801 can protect animals from lethal Mpox virus challenges with a single dose, reducing viral shedding and preventing clinical disease.
TNX-801’s stability at ambient temperatures and its ease of administration without special equipment also make it an attractive candidate for large-scale vaccination programmes, particularly in resource-limited settings.
Mpox, formerly known as Monkeypox, is a viral zoonotic disease similar to smallpox, though less severe.
The virus can spread from animals to humans and between humans, often causing fever, rash, and other systemic symptoms.
The 2022 Mpox outbreak, driven by Clade IIb, infected over 90,000 people worldwide.
The newer Clade Ib strain is primarily affecting African countries, including those neighboring the Democratic Republic of the Congo, such as Burundi, Rwanda, and Uganda.
eojina@ke.nationmedia.com
