EC approves Pfizer’s Prevenar 20 to protect paediatric patients against pneumococcal disease
Betsy Goodfellow | March 13, 2024 | News story | Research and Development | EC, EMA, Infections and infestations, Prevnar 20, pneumococcal disease
Pfizer has announced that the European Commission (EC) has granted marketing authorisation for Prevenar 20, the company’s 20-valent pneumococcal conjugate vaccine.
The vaccine is approved for immunisation for the prevention of invasive disease, pneumonia and acute otitis media caused by streptococcus pneumoniae in infants, children and adolescent patients from six weeks to 18 years of age.
This approval follows a recent positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP), and is valid in all 27 EU member states, as well as Iceland, Lichtenstein and Norway.
Prevenar 20 gained US Food and Drug Administration (FDA) approval in April 2023, and has already gained approvals elsewhere, such as in Canada, Australia and Brazil.
This authorisation is based on evidence from a phase 3 cllinical trial programme, which demonstrated its safety, tolerability and immunogenicity.
Alexandre de Germay, chief international commercial officer and executive vice president at Pfizer, commented: “The EC’s authorisation of Prevenar 20 for infants and children represents a significant opportunity to improve public health by helping to protect against the 20 serotypes responsible for the majority of currently circulating pneumococcal disease in the EU. 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.”
Betsy Goodfellow
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