Pfizer has received European Commission approval for updates to the summary of product characteristics (SmPC) for its pneumococcal conjugate vaccine (PCV) Prevenar 13, regarding its use in certain high-risk populations.
The updated label now contains information about the use of Prevenar 13 in preterm infants, children and adolescents with sickle cell disease who were earlier treated with the 23-valent pneumococcal polysaccharide vaccine.
The new label also indicates the vaccine’s use in adults with human immunodeficiency virus (HIV) infection who were earlier vaccinated with the 23-valent pneumococcal polysaccharide vaccine.
Pfizer vice-president of vaccines, global medicines development group and scientific affairs Luis Jodar said people with conditions that compromise the immune system, such as HIV, those with sickle cell disease, and infants born prematurely, are all at an increased risk of pneumococcal disease.
"The Prevenar 13 label in the European Union now includes important information about appropriate use of the vaccine for the prevention of pneumococcal disease for health care professionals who care for these patients," Jodar said.
The move follows the European Medicines Agency’s review of data submitted by Pfizer from many studies evaluating immunogenicity and safety of vaccination with Prevenar 13 in these three risk groups.
Data from these trials is currently under review by the US Food and Drug Administration (FDA).
In July, the vaccine received an expanded indication in the European Union (EU) to include adults aged 18-49 years for active immunisation for the prevention of invasive disease caused by vaccine-type Streptococcus pneumoniae (S. pneumoniae).
Prevenar 13, which is previously approved in the EU for use in infants, young children and adolescents aged six weeks to 17 years, and adults 50 years of age and older, is currently the only pneumococcal vaccine in the EU that provides protection against invasive pneumococcal disease from infancy through adulthood.
According to the studies, preterm infants (gestational age 19 to 36 weeks) have an increased risk for pneumococcal disease compared to infants born full-term (gestational age 37 to 42 weeks).
The Phase IV study of Prevenar 13 administered at two, three, four and 12 months to around 100 preterm infants (born at 26 to 36 weeks) showed a less robust immune response among preterm infants compared with term infants.
Image: Streptococcus pneumoniae in spinal fluid. Photo: courtesy of CDC/Dr MS Mitchell.
