Pfizer gets US FDA approval for Prevnar 13, a Wyeth drug with blockbuster sales outlook

The US Food and Drug Administration yesterday gave its approval for global drug behemoth Pfizer's Prevnar 13, a pneumococcal 13-valent conjugate vaccine for infants and young children aged six weeks through five years. It is the successor to Prevnar 7, the pneumococcal 7-valent conjugate vaccine licensed by the FDA in 2000 to prevent invasive pneumococcal disease (IPD) and otitis media. The new vaccine extends the protection to six additional types of the disease causing bacteria.

The vaccine, which came along with Pfizer's $68 billion acquisition of fellow drug major Wyeth last year and generates annual turnover of around $3 billion, was considered by observers as a key product in Pfizer's decision to buy the firm. It is already approved in around 38 other countries.

Prevnar 13 - which Pfizer says will be launched within the next few weeks - will cost $108, 30% more than the current Prevnar 7 vaccine, which costs $83 a shot, but it protects against strains of the pneumococcus bacteria that the existing vaccine does not. This price increase accounts for much of the projected increases in sales of Prevnar.