New Pertussis Vaccine Set for Implementation

The Committee for Medicinal Products for Human Use (CHMP), a part of the European Medicines Agency (EMA), recently recommended approval of a pertussis vaccine for teenagers, adults and newborns.

According to the agency, VacPertagen could serve as an effective pertussis booster vaccine for kids aged 12 and above, helping prevent diagnoses of whooping cough. It could also offer passive protection to infants when administered to pregnant women in their 2nd or 3rd trimesters.

This is because the vaccine uses a blend of two refined pertussis antigens - recombinant pertussis toxin (PTgen) and filamentous haemagglutinin (FHA).

Currently available as prefilled syringes, this vaccine can trigger pertussis antibody responses in individuals with a single intramuscular injection.

The EMA has greenlighted the use of this vaccine following the success of its clinical trials.

The studies showed that VacPertagen could trigger an antibody response within 28 days of administration. This period remained the same even when the vaccine was administered to pregnant women in their second and third trimesters, after which they were transferred through the placenta to the newborns.

They also highlighted that the vaccine provided antibody persistence for up to 3 years in adults and 5 years in adolescents.

No serious safety concerns were identified in the trials. Reported side effects were mild and consistent with common vaccine reactions, such as injection-site pain, headache, nausea and fatigue.

With the CHMP’s positive opinion, the vaccine now awaits formal marketing authorisation. Rollout decisions will follow regional regulatory approvals and vaccination guidelines.

Source: Medscape