Pertussis Rebounds Across Europe as Infant Risk Rises With Falling Immunity and Maternal Vaccine Uptake

Public health agencies ramp up maternal immunization while novel vaccines—like BioNet’s recombinant booster and ILiAD’s intranasal candidate—gain traction across regulatory and clinical pipelines

• Pertussis cases surge: Over 60,000 reported in Europe; infants most at risk.
• Maternal vaccination expands: Finland, Norway, and UK updated pregnancy vaccine strategies.
• BioNet advances: Submitted recombinant pertussis vaccine to EMA; secured EU-GMP approval.
• Nasal vaccine progresses: ILiAD’s BPZE1 granted Innovation Passport; Phase 3 trial planned.
• Research backs safety: Maternal vaccines improve infant antibody quality without long-term trade-offs.
• Lower-dose trial: BioNet testing reduced-antigen pertussis booster for wider access.
• Strategic partnership: BioNet teams with Indonesia’s Bio Farma to expand ASEAN TdaP supply.
• Supply pressure: GSK faced delays; vaccine availability remains a regional concern.
• New tech rising: Recombinant and mucosal vaccines offer next-gen protection strategies.

(NEWS) BRUSSELS / PARIS / BERLIN / LONDON, 30-Oct-2025 — /EuropaWire/ — A sharp resurgence of pertussis (whooping cough) has been recorded across Europe in the past year, reaching levels not seen in a decade. During 2023 and early 2024, nearly 60,000 cases were reported in EU/EEA countries – a >10-fold increase compared to the pandemic years. Germany, for example, logged about 24,000 cases in 2023, the most since mandatory reporting began in 2013. The UK similarly saw almost 14,000 confirmed cases in the first nine months of 2024, and other countries like Poland and Italy have also faced spikes. Health officials attribute the surge to a convergence of factors: waning immunity, disrupted vaccination during COVID-19, and the natural 3-5 year epidemic cycle of pertussis. Crucially, infants under six months – too young to complete vaccination – remain at highest risk, accounting for most pertussis-related hospitalizations and deaths.

In response, public health agencies intensified immunization efforts. The European Centre for Disease Prevention and Control (ECDC) urged countries to boost routine vaccine coverage and especially promote maternal pertussis vaccination in the late second or third trimester. Maternal immunization, which passes protective antibodies to newborns, is now recommended in most EU states. Over the past 12 months, several countries expanded such programs. Finland – one of the last EU holdouts – introduced a dTap booster for pregnant women in August 2024 and has extended the campaign through April 2025 due to persistently high case rates. Finnish authorities reported 2,748 whooping cough cases in 2024 (significantly above the pre-pandemic baseline of ~200–500), the highest incidence in Finland in decades. Norway also rolled out free pertussis vaccination for all expectant mothers starting May 2024, offering the Tdap shot at the routine 24-week prenatal visit. Meanwhile, the UK – which has vaccined pregnant women since 2012 – confronted an uptick in cases amidst falling maternal vaccine uptake. In mid-2024 British health officials switched the recommended prenatal booster from GSK’s polio-containing Boostrix-IPV to Sanofi’s Adacel (Tdap) in an effort to optimize immune responses for infants. Authorities note that while both vaccines are safe, using a pertussis/diphtheria/tetanus-only shot (Adacel) avoids a polio component that might slightly “blunt” infants’ later polio vaccine responses. Across Europe, experts have framed the pertussis resurgence as a post-pandemic “normalization,” yet stress that it is a “serious disease, particularly in infants,” and emphasize the importance of boosting immunity in mothers and older children to shield newborns.

New Vaccines and Regulatory Milestones

Amid the whooping cough surge, Europe’s regulatory landscape has seen significant activity around next-generation pertussis vaccines. Notably, BioNet, a biotech with operations in France, advanced a recombinant acellular pertussis vaccine aimed at improving protection. In July 2024, BioNet’s French subsidiary submitted a centralized Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for its monovalent pertussis booster vaccine. This stand-alone shot – branded VacPertagen in Europe – is unique in targeting only Bordetella pertussis (for patients already immune to diphtheria and tetanus) and is touted to induce longer-lasting immunity than traditional combo vaccines. If approved, it would become the first pertussis-only booster available in the European market, addressing a niche for adolescents and adults who just need a pertussis update. The EMA review is ongoing; as part of that process BioNet achieved a key regulatory milestone in October 2025 when it received EU Good Manufacturing Practice (EU-GMP) certification for its pertussis vaccine production. Following an inspection by Ireland’s Health Products Regulatory Authority, BioNet’s manufacturing facilities were validated to meet stringent EU quality standards. This certification not only permits BioNet to produce its acellular pertussis vaccine at scale for Europe, but also “supports the ongoing centralized review” of VacPertagen by EMA. BioNet’s pertussis vaccine (already marketed in Asia as Pertagen®) is thus a step closer to European approval, bolstering supply options amid growing demand.

Other regulatory developments signal accelerated paths for novel vaccines. In late 2024, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) granted “Innovation Passport” status to BPZE1, an investigational intranasal pertussis vaccine. This designation (part of the MHRA’s ILAP fast-track scheme) recognizes BPZE1’s potential to fill unmet medical needs and offers enhanced regulatory support to speed its development. BPZE1, developed by US-based ILiAD Biotechnologies, is a live attenuated nasal spray vaccine designed to block B. pertussis colonization in the airway and thereby prevent infection and transmission. It has shown promising Phase 2 results, generating robust mucosal immunity in children with no interference when co-administered alongside standard Tdap shots. With the UK Innovation Passport (and a prior FDA Fast Track in the U.S.), ILiAD aims to bring this next-generation vaccine to market efficiently. European regulators’ support comes as pertussis rates hit 10-year highs on both sides of the Atlantic, underscoring the need for more effective vaccines. No brand-new pertussis vaccines have yet been fully approved in Europe in the past year; however, existing combination vaccines continue to be standard in national programs. Several countries have adjusted their product choices or schedules (as seen with the UK’s switch to Adacel), and health authorities are watching the EMA and MHRA pipelines closely for the first approvals of these novel candidates in the near future.

Research Breakthroughs and Clinical Trials

European scientists and companies have been at the forefront of pertussis vaccine research over the last 12 months, yielding insights to inform policy and new product development. A major international clinical study on maternal vaccination – with participation from Finland’s University of Turku – provided encouraging data on antibody protection in newborns. The randomized trial, conducted in The Gambia and published in Lancet Infectious Diseases (2024), found that Tdap vaccination during pregnancy is safe and significantly boosts both the quantity and quality of pertussis-specific antibodies in infants. Notably, while maternal immunization can cause a known “blunting” effect (reducing infants’ antibody response to their later DTaP shots), the study showed that the functional quality of the babies’ antibodies and their immune memory cells remained intact. These results reinforce the effectiveness of maternal boosters in protecting newborns, and help allay concerns about longer-term immunity trade-offs. European experts are using such evidence to optimize immunization schedules – for instance, adjusting which vaccine formulations are given in pregnancy (as the UK did) to minimize blunting. “It is highly effective in protecting newborn babies,” Finland’s THL chief physician Hanna Nohynek said of the maternal vaccine, noting roughly half of Finnish mothers had received it by early 2025, according to THL.fi.

On the vaccine development front, next-generation pertussis vaccines have made notable progress in clinical trials. ILiAD’s intranasal candidate BPZE1 advanced toward a pivotal trial with an unprecedented study design. In early 2025, ILiAD announced a collaboration with London-based hVIVO to launch a Phase 3 human challenge trial – the first ever such trial for pertussis. In this landmark study, healthy adult volunteers will be intentionally exposed to B. pertussis under controlled conditions after receiving either BPZE1 or placebo. By using a human challenge model (in which researchers don’t have to wait for natural outbreaks), the trial can efficiently assess BPZE1’s efficacy in preventing colonization and disease. The UK trial is slated to begin in the second half of 2025, pending final approvals. If successful, it could pave the way for regulatory filings of BPZE1 in both Europe and the U.S., potentially introducing a novel tool that induces mucosal immunity and breaks the chain of transmission. This innovative approach – championed by scientists at Institut Pasteur in France where BPZE1 was originally developed – addresses the shortcomings of current acellular vaccines, which protect against symptoms but don’t always stop bacterial carriage. As one researcher noted, despite high vaccination coverage, “current vaccines have not effectively controlled epidemics,” fueling interest in mucosal and genetically engineered solutions.

Meanwhile, BioNet has been leveraging its 25+ years of expertise in pertussis R&D to refine vaccine formulations. In addition to its EMA-submitted product, the company is exploring dose-sparing strategies that could expand access. BioNet and researchers at Chulalongkorn University (Thailand) recently launched a clinical study of a reduced-dose acellular pertussis vaccine, formulating the booster with 60% less antigen (2 µg instead of 5 µg) while aiming to maintain immunity. Early indications suggest this lower-dose shot could still confer robust protection. Such a “fractional dose” approach, if validated, would make vaccination more affordable and help stretch global supply – a consideration as many countries grapple with pertussis resurgence and periodic vaccine shortages. Vaccine manufacturers in Europe have generally been able to meet demand, though isolated strains have occurred (e.g. Poland’s stock of pertussis booster ran low amid its 2024 outbreak, until new deliveries arrived in autumn). The pursuit of more immunogenic and longer-lasting vaccines is also ongoing in academic labs: several EU-wide consortia (like the PERISCOPE project) have been studying novel adjuvants, whole-cell vs. acellular combinations, and broadening immunity against diverse pertussis strains. Overall, the past year’s research underscores a consensus that next-generation vaccines are needed to outpace the pathogen’s evolution. The combination of recombinant protein vaccines (like BioNet’s genetically detoxified pertussis toxin) and live attenuated nasal vaccines (like BPZE1) represents a multi-pronged pipeline to tackle whooping cough with greater efficacy.

Industry Partnerships and Market Dynamics

The European pertussis vaccine landscape has also been marked by new partnerships and shifts among biotech and pharma companies. Historically, the market for pertussis-containing vaccines in Europe has been dominated by large manufacturers (GlaxoSmithKline’s Boostrix/Infanrix and Sanofi’s Adacel/Pentaxim lines). In the past 12 months, however, emerging players have gained traction by aligning with global partners. BioNet, for instance, forged a strategic Memorandum of Understanding with Indonesia’s state-owned vaccine producer Bio Farma to co-develop and distribute a TdaP combination vaccine in Southeast Asia. The pact, signed during a French state visit to Jakarta, combines BioNet’s recombinant pertussis antigen technology with Bio Farma’s manufacturing muscle, aiming to cut vaccine rollout times in ASEAN from a decade to under five years. While this deal focuses on Asian markets, it highlights European firms’ growing role in the international pertussis arena and could eventually expand production capacity for Europe as well. BioNet’s CEO in Europe noted that by “aligning strengths,” such collaborations enhance global health security and resilience.

In the UK, hVIVO’s partnership with ILiAD Biotechnologies (US) on the BPZE1 challenge trial exemplifies transatlantic cooperation to advance pertussis solutions. HVIVO, a British CRO known for human challenge studies, will conduct its largest-ever trial to test ILiAD’s vaccine, reflecting confidence in the product and the UK’s supportive regulatory environment. The collaboration also brings investment and attention to Europe’s clinical trial sector. Moreover, the UK’s designation of BPZE1 for the Innovation Passport/ILAP pathway sends a signal to the market: Britain is positioning itself (post-Brexit) as a hospitable market for innovative vaccines, potentially leading to earlier availability of BPZE1 there than in the EU.

Among established pharma, Sanofi and GSK have maintained their vaccine supply, but competition is quietly heating up. Sanofi’s Adacel gained a higher profile after the UK chose it for pregnant women in 2024. GSK, on the other hand, faced challenges such as meeting sudden surge demand – for example, reports from Poland’s outbreak noted that new GSK pertussis vaccine shipments were only expected by October 2024, though authorities managed to avoid stockouts. These events have put a spotlight on supply chain resilience and may create openings for alternate suppliers. BioNet’s anticipated entry with VacPertagen could be a game-changer in Europe’s pertussis booster market, introducing a third major source. The company’s EU-GMP accreditation in 2025 means it is now fully compliant to manufacture in Europe, and pending EMA approval, BioNet could begin supplying its vaccine – potentially easing pressure during outbreaks and adding “a best-in-class vaccine” option for adults and maternal boosters. Industry analysts note that having a monovalent pertussis vaccine might also allow more flexible immunization strategies (for instance, topping up pertussis immunity without redundant doses of tetanus/diphtheria).

Finally, public health initiatives have intersected with market movements. Governments in several countries have run awareness campaigns to counteract declining vaccination rates among both children and expecting mothers. In the UK, where maternal coverage had fallen to ~60% (and under 40% in some regions), officials launched targeted outreach in 2024 to encourage pregnant women to get the whooping cough jab amid the ongoing infant deaths. Some countries are considering whether booster shots for teens and young adults should be accelerated or made more frequent to curb transmission; for instance, Denmark (which introduced maternal Tdap during a 2019 outbreak) continues to offer adolescent boosters and is monitoring immunity duration closely, according to a Danish national cohort study 2019–2023 published on ScienceDirect. At the EU level, the ECDC has not recommended new mandates but emphasizes sustaining high childhood DTP coverage and timely boosters as essential to prevent pertussis cycles. UNICEF and WHO reports in 2024 did flag that routine vaccination rates in parts of Europe have stagnated or slightly declined, urging renewed commitment to immunization programs. The overall picture is that European health systems are mobilizing on multiple fronts – bolstering immunization programs, fast-tracking vaccine innovations, and fostering collaborations – to combat a re-emerging pathogen that had been quieted during COVID-19 lockdowns. As one ECDC official summed up during the spring 2024 outbreak: “Every action we take today shapes the health of tomorrow… We have a responsibility to protect the most vulnerable from the deadly impact of this disease.”

The past year’s developments suggest that Europe’s pertussis vaccine landscape is adapting rapidly, driven by both the urgency of current outbreaks and the promise of scientific progress.