Pfizer’s Prevenar 20 expands EU label for pediatric streptococcal pneumonia

Following a US Food and Drug Administration (FDA) approval in April 2023, the European Commission (EC) has awarded marketing approval to Pfizer’s Prevenar 20 (20-valent Pneumococcal Conjugate Vaccine) for the active immunisation and protection of infants and children against common pneumococcal diseases.

The latest EU approval is based on data from four Phase III studies evaluating the safety and immunogenicity of Prevenar 20 in pediatric patients and is accompanied by a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP). The vaccine is marketed as Prevnar 20 in the US.

Prevenar 20 is a 20-valent pneumococcal conjugate vaccine designed to stave off invasive pneumonia, and acute otitis media caused by 20 different serotypes of Streptococcus pneumoniae. While the vaccine is already approved for use in adults, the latest approval authorises its use in those between the ages of 6 weeks and 18 years.

As per the 13 March press announcement, the latest version of the vaccine expands on Pfizer’s Prevenar 13 and includes protection against serotypes 8, 10A, 11A, 12F, 15B, 22F, and 33F, which are global causes of invasive pneumococcal disease. Marketing authorisation of Prevenar 20 addresses “the majority of currently circulating pneumococcal disease in the EU and globally,” Alexandre de Germay, executive VP of Pfizer said in the announcement.

GlobalData’s consensus forecasts predict that Prevenar 20 will bring in $3.7bn in sales in 2028. GlobalData is the parent company of Pharmaceutical Technology.

Pfizer is not alone in the space to develop vaccines against streptococcal pneumonia. Hot on the pharma giant’s heels is MSD’s investigational 21-valent pneumococcal conjugate vaccine V116. The FDA is set to make a decision on the vaccine’s approval by the Prescription Drug User Fee Act (PDUFA) date of 17 June 2024.

MSD’s biologics licence application (BLA) is partially supported by data from the Phase III STRIDE-3 study (NCT05425732), which compared the safety, tolerability, and immunogenicity of V116 and Pfizer’s pneumococcal vaccine in adults who have not received prior pneumococcal conjugate vaccination. As per the trial findings, V116 induced non-inferior immune responses in both cohorts of the study. Data from the Phase III STRIDE-4, STRIDE-5, and STRIDE-6 studies also supplement the BLA.  

Sign up for our daily news round-up!

Give your business an edge with our leading industry insights.