Wyeth Receives Positive Opinion From European Regulators For Prevenar 13

Wyeth Pharmaceuticals has announced that the European Medicines Agency’s (EMEA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for the company’s pneumococcal conjugate vaccine, Prevenar 13 (Pneumococcal Polysaccharide Conjugate Vaccine [13-valent Adsorbed]).

The company said that CHMP recommends approval of Prevenar 13 for active immunization of children aged 6 weeks to 5 years for the prevention of invasive pneumococcal disease, as well as pneumonia and otitis media (middle ear infection) caused by 13 pneumococcal serotypes. The CHMP’s opinion for Prevenar 13 will now be forwarded to the European Commission and a final decision is expected in the coming months.

The company claims that Prevenar 13 is designed to provide serotype coverage of any pneumococcal conjugate vaccine. The vaccine contains the seven serotypes (4, 6B, 9V, 14, 18C, 19F and 23F) included in Prevenar (Pneumococcal Saccharide Conjugated Vaccine, Adsorbed).

Emilio Emini, EVP of Vaccine Research and Development at Wyeth Pharmaceuticals, said: “The CHMP’s positive opinion brings us one step closer to providing infants and young children in Europe with the broadest serotype coverage of any pneumococcal conjugate vaccine.

“Prevenar, our currently available vaccine, has both proven clinical efficacy and documented effectiveness, which has resulted in a significant public health benefit. Prevenar 13 builds on the scientific foundation of Prevenar and, if approved, will provide coverage for the 13 most prevalent pneumococcal-disease causing serotypes, including serotype 19A, which has emerged as a serious public health threat in Europe and around the world.”