Pfizer wins Europe approval for new vaccine

NEW YORK — The European Commission has granted Pfizer Inc. a European marketing authorization for a more protective form of its vaccine Prevnar 13, which protects against pneumonia, the company announced Dec. 11.

The newly approved product is a form of the vaccine to prevent infections among infants and children ages 6 weeks to 5 years.

It is designed to protect against 13 serotypes, or forms, of a bacterium called Streptococcus pneumoniae (pneumococcus) that can cause diseases ranging from ear infections to pneumonia and meningitis.

“By providing the broadest serotype coverage of any pneumococcal conjugate vaccine,” said Emilio Emini, chief scientific officer of vaccine research at Pfizer. “Prevenar 13 is poised to help reduce the serious public health risk and economic burden associated with pneumococcal disease.”

Available in Europe since 2001, Prevenar is available in more than 100 countries and more than 300 million doses have been distributed worldwide.

To date, Prevenar 13 has been approved for use in infants and young children in three countries.

A U.S. advisory panel endorsed Prevnar 13 in November and a decision by the Food and Drug Administration is due by Dec 30.

According to a World Health Organization 2002 estimate, pneumococcal disease is a leading cause of vaccine-preventable death worldwide in children younger than 5 years old. Pneumococcal disease describes a group of illnesses that affect both children and adults. These illnesses include invasive infections such as bacteremia/sepsis and meningitis, as well as pneumonia and acute otitis media.