GERMANY — Germany’s pioneering biopharmaceutical company, BioNTech, has embarked on a transformative journey in the realm of infectious disease prevention, partnering with the Coalition for Epidemic Preparedness Innovations (CEPI).

This formidable alliance holds the promise of ushering in a new era of vaccine development, with the potential to safeguard global populations against emerging threats, including the dreaded mpox.

CEPI has committed up to US$90 million in funding to bolster the research and development of this innovative vaccine, harnessing BioNTech’s cutting-edge mRNA technology.

Mpox, a zoonotic infectious disease precipitated by the monkeypox virus (MPXV), shares its lineage with the variola virus, responsible for the scourge of smallpox.

Clinical manifestations of mpox encompass skin rashes, mucosal lesions, fever, swollen lymph nodes, headaches, and sore throats, painting a vivid picture of its virulence.

Despite the presence of Bavarian Nordic’s Jynneos in the market, BioNTech and CEPI have, in a recent release, highlighted the necessity of bolstering the vaccine supply to confront future outbreaks.

The development of a new vaccine is poised not only to combat mpox but also to thwart the spread of other orthopoxvirus-based diseases, underscoring the significance of this groundbreaking initiative.

A timely initiative

The genesis of BioNTech’s vaccine, BNT166, coincided with the global proliferation of mpox in the summer of 2022.

An early-to-mid-stage trial, initiated in August, seeks to evaluate two closely related candidates, BNT166a and BNT166c, in patients with and without prior mpox infections.

Driven by the imperative to broaden the arsenal against this potentially lethal disease, BioNTech’s research also aims to illuminate the efficacy of mRNA technology in combating orthopoxviruses—a family of viruses that has plagued humanity for centuries, persisting as a formidable threat even today.

Richard Hatchett, M.D., the CEO of CEPI, expressed the profound impact of this collaboration in his statement, “Our work on mpox could broaden the portfolio of vaccines available against this potentially deadly disease, while building our understanding of how mRNA technology performs against orthopoxviruses.”

This funding infusion for BioNTech’s ambitious undertaking is an integral part of CEPI’s larger “100 Days Mission.”

This visionary initiative is designed to preempt future pandemics through agile vaccine development. The ultimate aspiration is to have vaccine developers poised to design and fabricate a new vaccine within a mere 100 days in the event of another cataclysmic infectious disease outbreak, akin to the rapid response to the COVID-19 pandemic.

CEPI’s recent US$80 million collaboration with researchers from the University of Cambridge, who played a pivotal role in crafting AstraZeneca’s COVID vaccine, underscores the gravity of this mission.

Notably, Moderna, another key player in the field of COVID vaccines, has also set its sights on developing an mRNA-based vaccine for mpox.

However, CEO Stéphane Bancel maintains a degree of skepticism regarding the public health threat posed by the disease.

Despite the initiation of a phase 1/2 trial in the U.K. in August, Bancel suggests a cautious approach, emphasizing, “I don’t think we would rush into a phase 3 because I don’t think it’s a high priority for us.”

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