Pfizer’s 20-valent pneumococcal conjugate vaccine has been approved by the European Commission (EC) to help protect infants and children aged six weeks to less than 18 years against pneumococcal disease.
The updated vaccine has specifically been approved for the prevention of invasive disease, pneumonia and acute otitis media, an infection of the middle ear, caused by Streptococcus pneumoniae bacteria.
Diseases caused by Streptococcus pneumoniae are considered a “major public health problem worldwide” by the World Health Organization.
There are 100 known serotypes of Streptococcus pneumoniae, but only a minority produce the majority of pneumococcal infections.
Prevenar 20 builds on Pfizer’s Prevenar 13 vaccine and includes seven more serotypes of Streptococcus pneumoniae, which have been associated with antibiotic resistance, high case-fatality rates and meningitis.
Together, the 20 serotypes included in Prevenar 20 are responsible for the majority of currently circulating pneumococcal disease in the EU and globally, Pfizer said.
The EC’s decision on the vaccine follows a recent recommendation from the European Medicines Agency’s human medicines committee and was supported by positive results from a late-stage clinical trial programme comprising four core paediatric studies.
Alexandre de Germay, chief international commercial officer, executive vice president at Pfizer, said: “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.”
De Germay added that the company was “proud to now provide the broadest serotype coverage of any pneumococcal conjugate vaccine for children in Europe”.
Prevenar 20 is already approved in the EU for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae in individuals 18 years of age and older.
The vaccine was also approved by the US Food and Drug Administration in April last year, under the trade name Prevnar 20, to protect infants and children aged six weeks to 17 years against invasive pneumococcal disease, and for the prevention of otitis media in infants aged six weeks to five years.
The vaccine is also approved in the US to prevent invasive disease and pneumonia caused by Streptococcus pneumoniae strains in adults.