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European Commission approves pneumococcal conjugate vaccine for use in adults

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The European Commission today approved an expanded indication for the 13-valent pneumococcal conjugate vaccine to include adults aged 18 to 49 years for the prevention of invasive pneumococcal disease caused by vaccine-type Streptococcus pneumoniae, according to a press release from the manufacturer.

The pneumococcal conjugate vaccine (PCV13; Prevnar 13, Pfizer) was previously approved in the European Union for use in infants, young children and adolescents aged 6 weeks to 17 years, as well as adults 50 years of age and older.

The decision to approve this label expansion for PCV13 was based on data from an open-label phase 3 trial of the vaccine in healthy adults aged 18 to 49 years. The study showed the vaccine is at least as immunogenic in this age group as it is in adults aged 60 to 64 years, as measured one month after vaccination. PCV13 also showed a favorable safety profile and was generally well tolerated, according to the manufacturer.

PCV13 is marketed as Prevenar in Europe.