Pfizer has secured European Commission approval to carry out updates to the summary of product characteristics (SmPC) for its pneumococcal conjugate vaccine (PCV) Prevenar 13, regarding its use in certain high-risk populations.
Now the updated label will have 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 label also indicates the usage of the vaccine in adults with human immunodeficiency virus (HIV) infection who were earlier treated 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, like 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 approval follows the European Medicines Agency's review of data submitted by Pfizer from many studies evaluating immunogenicity and safety of vaccination with Prevenar 13.
The US Food and Drug Administration (FDA) is currently reviewing the data from these trials.
Earlier in July 2013, the vaccine received an expanded indication in the EU to include adults aged 18 to 49 years for active immunization for the prevention of invasive disease caused by vaccine-type Streptococcus pneumoniae (S. pneumoniae).
The studies show that, 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).
