Wyeth reports positive CHMP opinions on Prevenar

Wyeth Pharmaceuticals has announced that it has been granted two positive recommendations from the Committee for Medicinal Products for Human Use (CHMP) of the European Union for Prevenar (onemococcal saccharide conjugated vaccine, adsorbed).

These positive opinions are for an extension of the indication of the compound as an immunising agent against acute otitis media and pneumonia.

Prevenar is currently approved for the immunisation of children against bacteraemic pneumonia, bacteraemia caused by a number of Streptococcus pneumoniae serotypes, meningitis and sepsis.

Peter Paradiso, vice-president of scientific affairs at Wyeth Vaccines, said: “S pneumoniae is the leading cause of bacterial pneumonia in humans beyond the first few weeks of life and is a major cause of death and illness worldwide.”

He added that the bacterium is also a cause of middle ear infection, which can lead to mastoiditis and meningitis if left untreated.

Wyeth commented that the expansion of this indication, if approved by the European Union, will highlight the benefits of Prevenar in protecting children from diseases caused by the S pneumoniae.

Last November, Wyeth expressed its support for the decision from the Gavi Alliance regarding the funding of pneumococcal vaccines in developing countries.