Maternal Immunisation and Passive Protection of Newborns

Maternal vaccination is a proven way to protect young babies from pertussis (whooping cough) during their first months of life, before they finish their primary vaccination series. BioNet’s pertussis‑only vaccine is approved for use in pregnancy to help newborns gain early protection through passive immunity.

Clinical data reviewed during the regulatory process showed that mothers vaccinated with the pertussis‑only vaccine produce antibodies that pass naturally to the baby through the placenta. These antibodies are present in the newborn at birth and may help reduce the risk of severe pertussis during early life, when babies are most vulnerable.

Including pregnant women in the clinical studies allowed regulators to directly evaluate how well the vaccine works in this group and to assess its safety. The results supported the authorised use of the pertussis‑only vaccine during pregnancy.

As part of its overall benefit–risk evaluation, the CHMP also considered the importance of maternal antibody transfer. The findings reinforce the value of giving pregnant women a booster dose as part of wider strategies to reduce pertussis in infants and to strengthen community‑level protection.

Read the full news: VacPertagen Receives EU Approval