The European Commission has granted Pfizer Inc. (NYSE: PFE) a European
marketing authorization for its pneumococcal conjugate vaccine, Prevenar
13 (Pneumococcal Polysaccharide Conjugate Vaccine [13-valent,
adsorbed]). Prevenar 13 is indicated for active immunization for the
prevention of invasive disease, pneumonia, and acute otitis media caused
by 13 Streptococcus pneumoniae serotypes in infants and children
from 6 weeks to 5 years of age. Invasive pneumococcal disease includes
sepsis, meningitis, bacteremia, bacteremic pneumonia, and empyema.
Prevenar 13, built on the scientific foundation of Prevenar
(Pneumococcal Saccharide Conjugated Vaccine, Adsorbed), provides the
broadest serotype coverage of any pneumococcal conjugate vaccine. It
includes the seven serotypes (4, 6B, 9V, 14, 18C, 19F, and 23F) in
Prevenar – the standard in pneumococcal disease prevention in infants
and young children – plus six additional serotypes (1, 3, 5, 6A, 7F, and
19A), which together represent the most prevalent invasive
disease-causing strains in young children worldwide. Prevenar 13 is the
only pneumococcal conjugate vaccine to include serotypes 3, 6A, and 19A.
Both Prevenar and Prevenar 13 use CRM – a carrier protein which has been
used in various approved pediatric conjugate vaccines for more than 20
years. Available in Europe since 2001, Prevenar is currently
available in more than 100 countries and more than 300 million doses
have been distributed worldwide.
“Although the incidence of pneumococcal disease has been significantly
reduced in European countries and elsewhere where Prevenar is routinely
used, pneumococcal disease remains a serious threat to children in
Europe as strains such as serotypes 19A and 6A are increasing in
prevalence and frequently resistant to antibiotics,” says Emilio Emini,
Ph.D., chief scientific officer, Vaccine Research, Pfizer Inc. “By
providing the broadest serotype coverage of any pneumococcal conjugate
vaccine, Prevenar 13 is poised to help reduce the serious public health
risk and economic burden associated with pneumococcal disease.”
The European Commission’s authorization of Prevenar 13 was based on a
clinical trial program of 13 core Phase III studies involving more than
7,000 children. Data from the Phase III trials support the
safety and efficacy of Prevenar 13 for the prevention of pneumococcal
disease in infants and young children. Clinical trial data indicate
Prevenar 13 has a safety profile similar to that of Prevenar, and can be
administered with all routine pediatric vaccines studied.