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A new pertussis booster and maternal vaccination option has received positive regulatory support in Europe, with the aim of strengthening whooping cough prevention for adolescents, adults, and newborns.
On November 14, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion for VacPertagen for use as a pertussis booster for individuals aged 12 years or older, and for passive protection of infants when administered to pregnant women.
VacPertagen combines two refined pertussis antigens: recombinant pertussis toxin (PTgen) and filamentous haemagglutinin (FHA). The vaccine comes as a ready-to-use suspension in prefilled syringes. A single intramuscular injection triggers enhanced antibody responses specific to pertussis and FHA.
For pregnant women vaccinated during the second or third trimester, maternal antibodies cross the placenta and provide infants with early protection against whooping cough, when the risk for severe disease and complications is highest.
Clinical Evidence and Safety Profile
The EMA’s decision was based on clinical trials that established VacPertagen’s effectiveness.
A key study in adolescents showed the vaccine effectively triggered antibody production within 28 days, followed by trials demonstrating antibody persistence up to 3 years in adults and 5 years in adolescents. In a parallel maternal study, pregnant women mounted immune responses by day 28 and transferred antibodies to infants with measurable levels up to 2 months of age. Additionally, another study in nonpregnant adult women showed strong antibody generation within 28 days.
Common adverse effects encompassed injection site pain, headache, fatigue, muscle pain, joint pain, general discomfort, and nausea.
Implementation
Healthcare providers should follow official vaccination guidelines when using this vaccine.
Comprehensive usage instructions for VacPertagen will appear in the summary of product characteristics, published on the EMA website in all official European Union languages once the European Commission approves marketing authorization.
