fizer has been boosted by the news that regulators in Europe have approved the use of Prevenar 13, the pneumococcal conjugate vaccine it bought as part of its $68 billion acquisition of Wyeth.
The European Commission has granted marketing authorisation for Prevenar 13, which is indicated for the prevention of invasive disease, pneumonia, and acute otitis media caused by 13 Streptococcus pneumoniae serotypes in children from six weeks to five years of age. Invasive pneumococcal disease includes sepsis, meningitis, bacteremia, bacteremic pneumonia, and empyema.
The approval was based on a clinical trial programme of 13 Phase III studies involving more than 7,000 children. Pfizer will be hoping for a similar approval for the treatment, where it is known as Prevnar 13, soon across the Atlantic as last month, the US Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee voted 10 to one for approval. The agency will make a final decision before the end of the year.
Emilio Emini, chief scientific officer of vaccine research at Pfizer, said that although the incidence of pneumococcal disease has been significantly reduced in European countries and elsewhere where Prevenar, Wyeth’s original 7-valent pneumococcal conjugate vaccine, is routinely used, However, the disease remains a serious threat to children in Europe as strains such as serotypes 19A and 6A “are increasing in prevalence and frequently resistant to antibiotics”.