FDA delays new Prevnar 13 approvals

Pharmaceutical giant Pfizer, Inc., recently announced that regulators from the U.S. Food and Drug Administration will take three additional months to consider approving its Prevnar 13 pneumococcal vaccine for use in adults.

The FDA now expects to have a decision ready by January 2012, according to The agency intends to use the extra time in order to consider additional data Pfizer supplied supporting the vaccine’s use in adults over the age of 50.

Prevnar 13 is currently the world’s best-selling vaccine, taking in $3.7 billion globally for Pfizer in 2010. Expanded marketing approval from the FDA would significantly boost its sales. Pfizer is seeking to make up for a loss in revenue from other products, such as the cholesterol drug Lipitor, which will lose its patent protection in November.

The drug protects against 13 strains of pneumococcal disease, which are capable of causing ear infections, meningitis and pneumonia, reports. The FDA approved Prevnar 13 for use in infants and young children in February 2010.

The vaccine was a key component in Pfizer’s acquisition of the pharmaceutical company Wyeth for $68 billion in 2009. Wyeth was founded in Philadelphia in 1860 by a pair of brothers who opened a small research lab in their drugstore and soon began supplying medicine to the Union army during the American Civil War, according to