In March 2024 Pfizer announced that the European Commission (EC) has granted marketing authorisation for the company’s 20-valent pneumococcal conjugate vaccine, which is marketed in the EU as PREVENAR 20, for active immunisation for the prevention of invasive disease, pneumonia, and acute otitis media caused by Streptococcus pneumoniae in infants, children, and adolescents between the ages of 6 weeks and 18 years.
The authorisation is valid in the 27 EU Member States along with Iceland, Lichtenstein, and Norway. This announcement comes shortly after a positive opinion from the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) and is almost a year after the approval of PREVENAR 20 for children and infants by the US FDA in April 2023. Further approvals have been granted in countries such as Canada, Australia, and Brazil.
PREVENAR 20
PREVENAR 20 includes 13 serotypes from PREVENAR 13 with seven new serotypes, all of which are “global causes of invasive pneumococcal disease” (IPD). They are associated with “high case-fatality rates, antibiotic resistance, and/or meningitis”. The 20 serotypes contained within the vaccine are responsible for “the majority” of currently circulating pneumococcal disease both in the EU and globally.
Pfizer states that the EC authorisation has been informed by evidence from the Phase III clinical trial programme that comprises four core paediatric studies, which collectively enrolled more than 4,700 infants and 800 toddlers and children of all ages.
A significant opportunity
Alexandre de Germay is Pfizer’s Chief International Commercial Officer and Executive Vice President and described the authorisation as a “significant opportunity to improve public health”.
“PREVENAR 20 builds on Pfizer’s decades-long commitment to develop vaccines to help prevent potentially life-threatening infections, and we are proud to now provide the broadest serotype coverage of any pneumococcal conjugate vaccine for children in Europe.”
Pfizer’s Dr Kara Bickham will participate in a panel on the future of novel pneumococcal vaccines at the Congress in Washington this April, so do join us for this to learn more about Pfizer’s programme and ambitions, and don’t forget to subscribe to our newsletters here.
