Standalone Vaccine Offers New Hope in Fight Against Resurgent Whooping Cough

BRUSSELS, BELGIUM – November 18, 2025

A new standalone vaccine against pertussis, commonly known as whooping cough, has received a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP), paving the way for potential marketing authorization across the European Union. The vaccine, developed by BioNet Europe, offers a targeted approach to bolstering immunity against the highly contagious respiratory illness, which is experiencing a worrying resurgence across the continent.

Addressing a Growing Public Health Concern

Cases of pertussis have surged dramatically in recent years, with nearly 60,000 reported in the EU/EEA from January 2023 to March 2024 – a tenfold increase compared to 2021 and 2022. This resurgence is driven by a combination of factors, including waning immunity from existing vaccines, decreased natural boosting during the COVID-19 pandemic, and the cyclical nature of the disease. Infants under six months are particularly vulnerable, facing the highest risk of severe complications, hospitalization, and even death. “The current situation is deeply concerning,” stated one public health official. “We’re seeing a significant rise in cases, and it’s critical that we have effective tools to protect vulnerable populations.”

The current standard of care relies heavily on combination vaccines, which protect against multiple diseases simultaneously. While effective, these vaccines administer antigens even if a patient is already protected, which raises concerns about potential side effects and immune overload. “There’s a growing recognition that a more targeted approach might be beneficial, especially for certain populations,” explained an infectious disease specialist. “A standalone vaccine allows us to address pertussis specifically, without unnecessarily exposing individuals to other antigens.”

The Science Behind VacPertagen

BioNet’s vaccine, known as VacPertagen, utilizes a novel approach. It is an acellular vaccine that relies on recombinant Pertussis Toxin (PTgen) and filamentous haemagglutinin (FHA) produced through advanced molecular engineering and delivered via a nanoparticle-based formulation. This refined technology aims to induce a stronger and more durable immune response. Clinical trials have demonstrated promising results in adults, adolescents, and pregnant women, with antibody persistence observed for up to five years in some cases.

“The key differentiator here is the focus on precisely engineered antigens,” explained a leading vaccinology expert. “By using recombinant technology and optimizing the delivery system, BioNet has created a vaccine that appears to be both highly effective and well-tolerated.” The vaccine's standalone nature also offers flexibility in immunization strategies. For pregnant women who are already up-to-date on diphtheria and tetanus vaccinations, VacPertagen provides a targeted boost against pertussis, enhancing maternal antibody transfer to the developing fetus and providing early protection for the infant.

Market Dynamics and Future Implications

The European vaccine market is dominated by established pharmaceutical giants like Sanofi and GSK, who offer a range of combination vaccines. While these products remain the cornerstone of national immunization programs, the emergence of VacPertagen represents a potential shift in the landscape. “Competition is healthy, and it drives innovation,” stated a healthcare analyst. “A standalone pertussis vaccine offers a valuable alternative, particularly for specific populations and immunization strategies.”

BioNet’s success in obtaining a positive CHMP opinion is a significant milestone for the company. The vaccine represents the culmination of a decade of research and development in recombinant pertussis vaccines, and it positions BioNet as a key player in the European vaccine market. While the company is privately held and detailed financial information is limited, it has garnered support from organizations like CEPI, underscoring its commitment to innovation in infectious disease prevention. Looking ahead, the availability of VacPertagen is expected to bolster pertussis prevention efforts across Europe and potentially beyond. “This vaccine offers a new level of precision in our fight against whooping cough,” stated a public health advocate. “It’s a welcome addition to our toolkit, and it promises to protect vulnerable populations for years to come.