Wyeth Pharmaceuticals, a division of Wyeth, have announcedthat the European Medicines Agency’s (EMEA) Committee for MedicinalProducts for Human Use (CHMP) has issued a positive opinion for thecompany’s pneumococcal conjugate vaccine, PCV13 (Prevenar 13)(Pneumococcal Polysaccharide Conjugate Vaccine [13-valent Adsorbed]).
The CHMP recommends approval of PCV13 for active immunisation ofchildren aged 6 weeks to 5 years for the prevention of invasivepneumococcal disease, as well as pneumonia and otitis media (middle earinfection) caused by 13 pneumococcal serotypes.
The CHMP’s opinion forPCV13 will now be forwarded to the European Commission and a finaldecision is expected in the coming months.
“The CHMP’s positive opinion brings us one step closer to providinginfants and young children in Europe with the broadest serotypecoverage of any pneumococcal conjugate vaccine,” says Emilio Emini, Executive Vice President, Vaccine Research and Development,Wyeth Pharmaceuticals.
“PCV13 builds on the scientific foundation ofour currently available vaccine and, if approved in Europe, willprovide coverage for the 13 most prevalent pneumococcal-disease causingserotypes, including serotype 19A, which has emerged as a seriouspublic health threat in Europe and around the world.”
The candidate PCV13 vaccine is designed to provide the broadestserotype coverage of any pneumococcal conjugate vaccine. It containsthe seven serotypes (4, 6B, 9V, 14, 18C, 19F and 23F) included inWyeth’s currently available vaccine, plus six additional serotypes (1,3, 5, 6A, 7F and 19A) that are responsible for the greatest remainingburden of invasive disease.