European regulators have approved the use of Pfizer’s Prevnar 13 in children and adolescents aged six to 17 years, making it the only Pneumococcal conjugate vaccine cleared for this age group.
Extension of the jab’s use means that Prevnar 13 is now available in the region to protect against invasive disease, pneumonia and acute otitis media caused by vaccine-type S. pneumoniae in infants and children from six weeks to 17 years, as well as from invasive pneumococcal disease in adults aged 50 years and older.
The decision by the European Commission to expand its label was based on data from a Phase III trial involving 592 healthy children and adolescents, including those with underlying conditions such as asthma, which demonstrated its safety and efficacy, the firm said.
According to Pfizer, its vaccine “offers the broadest serotype coverage of any currently available pneumococcal conjugate vaccine for prevention of pneumococcal disease”, and the firm said it will “continue working with health authorities worldwide in an effort to provide access to Prevenar 13 to those at risk of disease”.
