Kenya has joined global efforts to develop a vaccine for Mpox, a viral disease affecting many African countries. With an acute shortage of vaccines reported by the Africa CDC, this collaboration between the Kenya Medical Research Institute (Kemri) and the United States-based Tonix Pharmaceuticals Holding Corporation marks a significant step in addressing the health crisis.
The project, valued at Sh233.1 million, aims to create a single-dose vaccine, TNX-801, to protect against Mpox and smallpox. According to Kemri, the development and testing process is expected to take about two years. The pharmaceutical company will sponsor the Phase I clinical trials, while Kemri will oversee the execution of the study. The trials will assess the vaccine’s safety, tolerability, and immunogenicity in humans.
Seth Lederman, CEO of Tonix Pharmaceuticals, expressed optimism about the collaboration, emphasizing the urgent need for a durable vaccine to combat the spread of Mpox. He noted that preclinical data has been highly promising, meeting the World Health Organization’s (WHO) preferred characteristics for Mpox vaccines. Dr. Lederman stated that the project represents a global effort to curb the spread of infectious diseases, highlighting the potential of TNX-801 to simplify vaccination efforts with a single dose.
Kemri Director General Elijah Songok reiterated the importance of the initiative, describing it as a critical response to emerging health threats. He noted that Kemri’s role in advancing medical research aligns with the goal of protecting not only Kenyan communities but also populations globally. Professor Songok underscored the institute’s commitment to finding effective, accessible solutions to mitigate the risks posed by infectious diseases like Mpox.
Dr. Matilu Mwau, the principal investigator of the project, shared details about the preparation for the Phase I clinical trials. Researchers are in the process of developing protocols necessary to conduct the study, which will involve up to 60 participants. Dr. Mwau stated that they plan to submit these protocols for regulatory and ethical approvals by January 2025, with the first phase of trials expected to begin in July 2025.
According to Dr. Mwau, most Kenyans are not vaccinated against pox viruses, leaving the population vulnerable to infections like smallpox and Mpox. While smallpox vaccinations were administered decades ago, the protection they provided has waned over time, increasing susceptibility to related viruses. He emphasized the importance of developing a vaccine that can protect against both Mpox and smallpox, explaining that such an initiative would help prevent unexpected outbreaks.
Dr. Mwau highlighted the advantages of TNX-801, noting its single-dose nature as a key factor in improving vaccination coverage. Unlike multi-dose vaccines that require follow-up visits, which often result in logistical challenges and increased costs, a single-dose vaccine simplifies the process for both patients and healthcare providers. He added that preclinical trials have shown encouraging results, raising confidence in the vaccine’s potential to provide robust protection.
The initiative comes at a time when the Mpox disease has emerged as a growing concern in Africa, with limited vaccine supplies complicating containment efforts. Mpox, formerly known as Monkeypox, is a viral disease similar to smallpox but less severe. It is transmitted to humans through close contact with infected animals, humans, or contaminated materials. Symptoms include fever, swollen lymph nodes, and a characteristic rash, which may lead to severe complications in some cases.
Kemri’s involvement in this vaccine development project underscores Kenya’s growing role in advancing health research. The collaboration with Tonix Pharmaceuticals is expected to yield benefits beyond the immediate Mpox threat, as it contributes to building capacity for responding to future health challenges. By focusing on innovative approaches and ensuring the vaccine is suitable for local populations, the partnership is poised to make a lasting impact on public health.
Dr. Mwau emphasized the potential of the TNX-801 vaccine to significantly reduce the population’s vulnerability to Mpox and other pox viruses. He explained that smallpox vaccinations in the past helped reduce the prevalence of similar diseases, but the lack of recent immunizations has left many at risk. The new vaccine aims to address this gap by offering a solution that is both effective and sustainable for communities in Kenya and beyond.
As the protocols are finalized and preparations for trials progress, there is hope that Kenya’s participation in this initiative will lead to the successful development of a vaccine capable of curbing Mpox and safeguarding public health. Researchers and health officials are optimistic that this effort will strengthen the global fight against emerging infectious diseases, ensuring that communities are better equipped to face similar threats in the future.
