BioNTech is collaborating with the Coalition for Epidemic Preparedness Innovations (CEPI) to develop mRNA vaccine candidates for mpox, a global infectious disease. The partnership aims to ensure preparedness for potential future outbreaks. CEPI will provide up to $90 million to support the development of BioNTech’s vaccine, BNT166, which has entered Phase 1/2 study.
CEPI is an organization focused on accelerating the development of vaccines and products to combat epidemics and pandemics. They played a significant role in the development of multiple vaccine candidates during the Covid-19 pandemic.
Mpox, also known as monkeypox, is caused by the monkeypox virus and presents symptoms such as rash, fever, headache, and muscle pain. It can be transmitted through skin-to-skin contact with an infected individual. The virus belongs to the Orthopoxvirus genus, which includes the smallpox virus. Although smallpox was eradicated through vaccination in 1980, global immunity against this viral family has been diminishing.
Currently, two vaccines are available for mpox. Jynneos, developed by Bavarian Nordic, received FDA approval in 2019 for both smallpox and monkeypox. ACAM2000, manufactured by Emergent BioSolutions, was approved for smallpox in 2007 and made available for mpox prevention under expanded access investigational new drug application. These vaccines use a live version of vaccinia, a virus related to smallpox but causing milder disease, to stimulate antibody production against smallpox.
BioNTech’s mpox vaccine candidates, similar to their Covid-19 vaccine, utilize messenger RNA (mRNA) to prompt the immune response by expressing antigens specific to the monkeypox virus. Two vaccines have been selected for evaluation in a Phase 1/2 clinical trial involving 196 healthy volunteers, including those who have previously received a smallpox vaccine. The study will assess safety, immune response, and potential adverse effects.
The partnership between BioNTech and CEPI contributes to CEPI’s “100 Days Mission” to accelerate vaccine development against potential future pandemic viruses. If successful, the collaboration could lead to larger supplies of mpox vaccines for future outbreaks. Additionally, data generated from the trials may advance the development of mRNA-based vaccines against other Orthopoxviruses.
CEPI CEO Richard Hatchett emphasizes the importance of gathering knowledge and data about mRNA platforms in order to respond rapidly to emerging infectious threats. The work on mpox vaccines not only expands the vaccine portfolio against this disease but also increases understanding of mRNA technology’s effectiveness against Orthopoxviruses, which continue to pose a threat to humanity.
– Coalition for Epidemic Preparedness Innovations (CEPI)
– National Institute of Allergy and Infectious Diseases (image)