Wyeth submits authorisation application for vaccine

Wyeth has said its pharmaceuticals division has submitted a European Marketing Authorisation Application (MAA) for its 13-valent pneumococcal conjugate vaccine (PCV13).

The jab – for children aged between two months and five years old – includes the 13 most prevalent pneumococcal serotypes associated with pneumococcal disease.

Seven of these are included in Prevenar – the current global standard in prevention of the condition.

The review of the MAA is to be co-ordinated by the European Medicines Agency (EMEA) for all 27 countries in the union – including Iceland, Norway and Liechtenstein.

Emilio Emini, executive vice-president of vaccine research and development at Wyeth Pharmaceuticals, said: “Today’s submission is an important milestone for Wyeth and underscores the company’s commitment to help protect current and future generations.”

He added: “Prevenar has had a substantial impact on public health, dramatically reducing the rate of invasive pneumococcal disease.”

Pneumococcal disease describes a group of illnesses, all caused by the bacterium Streptococcus pneumoniae.

The condition includes invasive infections, such as bacteremia/sepsis and meningitis – as well as pneumonia and otitis media.

Last week, Wyeth announced Dr Michael Kamarck has been promoted to president of technical operations and product supply (TO&PS).

He will be responsible for all aspects of product supply and technical operations for the company.