FDA Approval of Pfizer’s Prevnar Vaccine Delayed Until Jan 2012

According to Pfizer Inc., the US regulatory approval of its pneumococcal vaccine, Prevnar 13, for use in adults will take another three months.

Pfizer says that the FDA is now expected to take a decision by Jan 2012, and this additional time will be used to review supplementary data submitted by Pfizer that supports vaccine use in adults aged 50 and above.

With the world’s best-selling vaccine, Prevnar 13, Pfizer bagged worldwide revenues of $3.7 billion in 2010, and an expanded marketing approval is expected to advance its sales. This would help compensate for revenue losses from other products such as Lipitor, a cholesterol drug that loses patent protection on Nov 30.

The Prevnar 13 vaccine that provides protection from 13 pneumococcal strains, including those that cause ear infections, meningitis, and pneumonia, received FDA approval in February 2010 for its use in infants and young children. This prized component came in with the $68 billion acquisition of Wyeth by Pfizer in October 2009.

Although on Friday, Pfizer sales experienced a loss of 11 cents falling to $19.25, the stock was up 7 cents to $19.32 in aftermarket trading.