Pharmaceutical giant Pfizer Inc. announced on Wednesday that the European Commission has approved the marketing of its 20-valent pneumococcal conjugate vaccine for proactive immunization against pneumococcal disease in infants and children.
In the European Union, the vaccine is sold under the brand name PREVENAR 20. It is actively used to immunize and prevent invasive disease, pneumonia, and acute otitis media that are caused by Streptococcus pneumoniae in infants, children, and adolescents ranging from 6 weeks to less than 18 years of age.
This approval steps on the heels of a recent positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use, or CHMP. The authorization is valid across all 27 EU member states, along with Iceland, Lichtenstein, and Norway.
Moreover, it adds to the prior approval of PREVNAR 20 for infants and children by the U.S. Food and Drug Administration in April 2023. Approvals in multiple other countries including Canada, Australia, and Brazil also precede this latest authorization.
The European Commission's nod for PREVENAR 20 is backed by evidence from a Phase 3 clinical trial program which includes four central pediatric studies. These studies contributed to an expanded data set on the safety, tolerability, and immunogenicity - or the vaccine's ability to provoke an immune response - of the vaccine.
In addition to this, Pfizer revealed that regulatory applications for the pediatric indication of PREVENAR 20 have been submitted to various other countries globally.
The company noted that in February 2022, the European Commission Decision was made to adopt APEXXNAR, another 20-valent Pneumococcal Conjugate Vaccine, for the prevention of invasive disease and pneumonia caused by the 20 S. pneumoniae serotypes in the vaccine in adults aged 18 years and older.
Pfizer is rebranding APEXXNAR to PREVENAR 20 following the expansion of its indication to include individuals from as young as 6 weeks of age and older.
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