European Medicines Agency Issues Support for New Recombinant Pertussis Vaccine
- by Amber Baker
- Published
- Vaccines
A new pertussis vaccine, which has been designed to be used as a booster and for vaccinating pregnant women, has received “positive regulatory support” from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP). Marketed under the name VacPertagen, the recombinant pertussis vaccine—formulated with genetically engineered proteins rather than inactivated whole bacteria—was among 10 other medicines the committee recommended for approval on November 14, 2025. The CHMP’s support of VacPertagen—the first single-antigen pertussis vaccine to date—was reportedly based on a small set of clinical trials alleged to have “established effectiveness.”1
Among the clinical trials, one 2024 study published in Lancet Child & Adolescent Health evaluated whether the genetically engineered (recombinant) pertussis shot to prevent whooping cough worked as well as the traditional Tdap vaccine typically given to adolescents. While the recombinant vaccine did generate higher antibody responses in the 2024 study, it did not measure critical real-world outcomes, such as whether teens actually avoided pertussis infections, the rate of infections, or whether transmission of whooping cough from vaccinated persons to others actually decreased. It also did not establish long-term safety, despite PTgen—the core antigen technology used in VacPertagen—being a fundamentally different, genetically modified toxin never previously used in humans. No active long-term follow-up was conducted beyond 11 months, and no autoimmune, neurological, or chronic health outcomes were assessed.2
A second study was a 2024 JAMA Network Open follow-up of adolescents who had previously received the recombinant vaccine. While researchers found that antibody levels remained elevated five years after vaccination, the study suffered from a 65 percent loss to follow-up, with only 159 of the original 450 participants returning. The entire analysis was based on a single blood draw, without any active safety monitoring, medical record review, clinical assessments, or tracking of new diagnoses over the five-year period. No data were collected on whether participants contracted pertussis during those five years, nor were autoimmune disorders, neurological issues, or reproductive health outcomes evaluated. In essence, the study demonstrated long-term antibody presence—not long-term protection or long-term safety.3
Clinical Trial of New Pertussis Vaccine Lacks Proof of Long-Term Maternal and Infant Safety
A third study, conducted in pregnant women who were given the experimental vaccine, was published in Vaccine in 2023, and is particularly concerning given that maternal vaccination is a major intended use of VacPertagen. Although the recombinant vaccines produced high maternal and cord blood antibody levels, the trial was not designed to detect rare but serious pregnancy complications such as preeclampsia, stillbirth, fetal growth restriction, placental abnormalities, or preterm birth. Mothers were only monitored until two months postpartum, and their infants were monitored for roughly three months—far too short a period of time to detect neurodevelopmental issues, autoimmune conditions, respiratory problems, or any delayed safety signals.4
Importantly, all participants received an active vaccine (the recombinant formulation or Boostrix), meaning there was no unvaccinated control group to determine whether adverse events were attributable to vaccination or background rates (or, how often an event normally happens in the population even when no vaccine is given). Given that PTgen is a genetically modified toxin being introduced into a pregnant population for the first time, the absence of long-term maternal and infant safety data represents a notable gap.4
Clinical Trial Study Authors Were Employees of VacPertagen Manufacturer
The fourth study, a Phase 2 trial in women of childbearing age, is often portrayed as “pre-pregnancy safety data,” yet it was not designed to evaluate fertility, menstrual health, early pregnancy loss, hormonal changes, or long-term immune effects. Like the other trials, its primary focus was antibody generation and short-term reactogenicity. Follow-up was brief and limited to common post-injection symptoms; no reproductive, endocrine, or long-term health endpoints were assessed. And again, the comparator was an active vaccine rather than a placebo or unvaccinated group, limiting the ability to detect true vaccine-related reactions.
Notably, several study authors were employees of BioNet-Asia, the manufacturer of VacPertagen, raising potential conflicts of interest in the study.5
In summary, the body of evidence used to support approval of VacPertagen relies heavily on short-term antibody studies, narrow study populations, limited follow-up, and virtually no long-term safety surveillance, particularly in pregnant women and infants—the very groups the vaccine is being marketed toward. Across all four trials, none evaluated carcinogenicity, autoimmune risk, fertility effects, reproductive outcomes, or long-term infant health, despite the introduction of a genetically engineered pertussis toxin that differs fundamentally from existing vaccines. While antibody levels may rise after vaccination, the clinical and long-term safety implications remain largely unstudied and unproven.2 3 4 5
Reevaluating Multi-Antigen (Combo) Shots in the U.S.
The introduction of VacPertagen also comes at a moment when multi-antigen (combination) vaccines are facing heightened scrutiny in the United States. Since taking office, Secretary of Health and Human Services Robert F. Kennedy, Jr. has announced plans to overhaul the nation’s vaccine safety monitoring system and reevaluate long-standing assumptions about combination vaccines—products like DTaP, Tdap, and the MMRV vaccine, which bundle several different antigens into a single dose. These vaccines have historically been positioned as convenient and efficient, but they also carry different reactogenicity profiles and risk considerations than single-antigen formulations. 6
Federal Policy Shifts Related to Combination Vaccine Recommendations
In August 2025, the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) voted to stop recommending the MMRV vaccine for children under age 4, citing a higher risk of fever-related seizures in toddlers. This move signaled a change from decades of combination-vaccine policy and pushed federal advisers to revisit earlier safety assumptions. The decision also intensified attention on other multi-antigen vaccines—including DTaP and Tdap—which remain standard in the U.S. despite long-standing questions about adjuvants, preservatives, and cumulative multi-antigen exposure.6
Currently in the U.S., there is no single-antigen pertussis vaccine. Instead, the CDC recommends combination, or multi-antigen, vaccines: DTaP for infants and young children—a five-dose series beginning at two months of age—and Tdap for preteens, teens, adults, and pregnant women. Both are combination products, meaning each dose contains three antigens: diphtheria, tetanus, and acellular pertussis.7
Discussions around thimerosal—a mercury-containing preservative historically used in whole cell and acellular pertussis containing vaccine formulations—have resurfaced, giving renewed attention to a 2013 study reporting an association between thimerosal-containing DTaP and development of autism spectrum disorder (ASD) in some children. 8 The CDC’s public messaging on thimerosal, which alleges that mercury containing vaccines do not cause harm, has also contributed to growing public skepticism.
On a Frequently Asked Questions page, the agency declares that thimerosal is safe, stating: “Thimerosal has been used safely in vaccines for a long time… Scientists have been studying the use of thimerosal in vaccines for many years. They haven’t found any evidence that thimerosal causes harm.” Yet the CDC simultaneously acknowledges that thimerosal has been removed from all routine childhood vaccines since 2001, noting that it only remains in certain flu vaccines.9
As skepticism of combination vaccines and increased attention to neurotoxic vaccine ingredients like thimerosal and aluminum—a bioactive adjuvant still present in DTaP and Tdap shots—continue to grow, the shift toward single-dose formulations is becoming a focal point of vaccine policy discussions. VacPertagen enters the European market positioned as the first single-antigen pertussis vaccine option. However, the lack of methodologically sound studies demonstrates that evidence supporting its approval in Europe remains narrow, short-term, and incomplete.
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