October 28, 2011 — The European Commission has extended approval of Pfizer's 13-valent pneumococcal conjugate vaccine Prevenar 13 to adults aged 50 years and older.
"Prevenar 13, the first and only pneumococcal conjugate vaccine approved by the European Commission for use in adults, has the potential to prevent invasive pneumococcal disease in adults aged 50 and older — a time of life when the risk for contracting the disease begins to increase," said Emilio Emini, PhD, chief scientific officer, Vaccine Research, Pfizer Inc.
The vaccine is already approved for children in more than 100 countries. Pfizer is currently awaiting US approval for the vaccine in adults aged 50 and older. The US Food and Drug Administration Vaccines and Related Biological Products Advisory Committee is scheduled to discuss it on November 16.
European approval of Prevenar 13 follows a review of clinical safety and immunogenicity data in more than 6000 adults aged 50 years and older.
This indication covers the prevention of invasive pneumococcal disease caused by the 13 serotypes contained in the vaccine and is for a single dose of Prevenar 13 in adults aged 50 years and older.
Regardless of prior pneumococcal vaccination status, if the use of 23-valent polysaccharide vaccine is considered appropriate, Prevenar 13 should be given first, Pfizer notes in a statement.
The 13 pneumococcal serotypes in Prevenar 13 (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) are responsible for causing a significant proportion of invasive pneumococcal disease in older adults, including disease caused by antibiotic-resistant serotypes, the company notes.
Prevenar 13 is not expected to provide 100% protection against vaccine serotypes or protect against nonvaccine serotypes, the company says. "The approval of Prevenar 13 was based upon functional antibody responses in adults aged 50 years and older. An efficacy study in adults is ongoing," they add in a statement.
In clinical trials, the most commonly reported solicited local and systemic adverse reactions (≥20%) with Prevenar 13 were redness, swelling, tenderness, hardness, and pain at the injection site; limitation of arm movement; decreased appetite; headache; diarrhea; chills; fatigue; rash; and worsening of or new joint or muscle pain.
Hypersensitivity to any component of Prevenar 13 or any diphtheria toxoid–containing vaccine is a contraindication to the use of Prevenar 13.
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