Europeans in the European Union (EU) may soon have the choice to get vaccinated against whooping cough with a new pertussis-only vaccine that is about to hit the market.
On January 9, 2026, the EU Commission granted Marketing Authorisation to BioNet for its new acellular pertussis vaccine VacPertagen. This follows the favourable opinion issued by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) on November 13, 2025.
The approval marks VacPertagen as the first and only standalone pertussis vaccine on the market. VacPertagen has been engineered to target the toxin that is responsible for severe pertussis disease symptoms (pertussis toxin) with strong neutralising responses. VacPertagen is approved for active booster immunisation of teenagers (12 years and older) and adults, and that of pregnant women to passively immunise newborns1-6.
The CHMP recommendation was based on data from three main randomised controlled clinical trials and nine studies providing supportive evidence. The studies unanimously show that it is safe to give VacPertagen to teenagers, adults, and pregnant women, and in all populations VacPertagen consistently elicits higher and longer-persisting neutralising antibody responses compared with acellular pertussis, diphtheria and tetanus containing combination vaccines (Tdap) licensed in the EU.
How VacPertagen works
VacPertagen contains small amounts of two important proteins from the pertussis bacteria (pertussis toxin and filamentous hemagglutinin). Vaccination with VacPertagen activates the immune system to produce antibodies against these proteins. If a vaccinated person becomes infected, the antibodies stop the infection from progressing and causing severe disease. Or in the case of vaccinated pregnant women, antibodies are transferred to the infant during pregnancy via the placenta to provide protection during the first months of life until infants get their own vaccinations.
VacPertagen does not contain any new components that are not included in other acellular pertussis vaccines. However, the use of DNA technologies to inactivate the pertussis toxin component in VacPertagen so that it can be safely given to people is different from methods used in other vaccines. The result is that VacPertagen induces a robust and long-lasting antibody response with high neutralising antibody titres against pertussis toxin. It is expected that this is associated with longer lasting protection.
The benefits of a pertussis-only vaccine
Until now, people seeking or needing re-vaccination against pertussis could only get Tdap vaccines even though they might not need or want to be re-vaccinated against tetanus or diphtheria. VacPertagen gives consumers for the first time the option to be re-vaccinated against whooping cough without co-vaccination against tetanus and diphtheria. VacPertagen may especially be beneficial to groups receiving frequent pertussis boosters such as pregnant women who are recommended to get a pertussis booster each pregnancy, and health care workers who may need repeated boosters every 5-10 years. But also to other population groups VacPertagen offers an alternative for pertussis vaccination, such as family or friends of young families expecting a new baby, or people at greater risk of pertussis such as elderly or people with chronic morbidities who would benefit from pertussis vaccination. Instead of exposing individuals to vaccines as tetanus and diphtheria that they do not need, VacPertagen gives the option of just receiving the required pertussis booster and nothing else.
Why pertussis vaccination is important
Pertussis, also known as whooping cough, is a highly contagious respiratory disease caused by the bacterium Bordetella pertussis. It spreads easily through droplets from coughing and sneezing. Pertussis can be serious and especially dangerous in babies. Protecting babies and pregnant people from infections is an important health priority.
Whooping cough often leads to severe coughing fits and the cough can linger for weeks or months. People with whooping cough can be contagious for several weeks and spread the disease to others they have contact with. Whooping cough can spread quickly in homes, schools, and other settings. Getting vaccination is the best protection.
Vaccination
- protects against serious illness with whooping cough
- when received during pregnancy, protects babies after they are born
- lowers infection rates in the community
- helps to protect babies who are not old enough to be fully vaccinated and other people with low immunity.
References
- Sricharoenchai S, Sirivichayakul C, Chokephaibulkit K, et al. A genetically inactivated two-component acellular pertussis vaccine, alone or combined with tetanus and reduced-dose diphtheria vaccines, in adolescents: a phase 2/3, randomised controlled non-inferiority trial. Lancet Infect Dis. 2018;18(1):58-67.
- Blanchard Rohner G, Chatzis O, Chinwangso P, et al. Boosting teenagers with acellular pertussis vaccines containing recombinant or chemically inactivated pertussis toxin: a randomized clinical trial. Clin Infect Dis. 2018;68(7):1213-22.
- Chokephaibulkit K, Puthanakit T, Bhat N, et al. A phase 2 randomized controlled dose-ranging trial of recombinant pertussis booster vaccines containing genetically inactivated pertussis toxin in women of childbearing age. Vaccine. 2022;40(15):2352-61.
- Chokephaibulkit K, Puthanakit T, Chaithongwongwatthana S, et al. Effective and safe transfer of maternal antibodies persisting two months postpartum following maternal immunization with different doses of recombinant pertussis-containing vaccines. Vaccine. 2024;42:383-95.
- Pitisuttithum P, Sirivichayakul C, Dhitavat J, et al. Pertussis Immunity 5 Years After Booster Vaccination With Recombinant Pertussis Vaccines. JAMA Netw Open. 2024;7(12):e2449182.
- Fortuna L, Chaithongwongwatthana S, Soonthornworasiri N, et al. Enhanced post-licensure safety surveillance of a new recombinant acellular pertussis vaccine licensed as a monovalent (aP, Pertagen) and tetanus, reduced-dose diphtheria combination (TdaP, Boostagen) vaccine for immunization of adolescents and adults in Thailand. Vaccine. 2020;38(51):8194-9.