FDA's delay in clearing Prevnar cramps Wyeth, says Zacks analysts

The delay in the US Food and Drug Administration's decision to approve Wyeth's Prevnar 13 (PV13) vaccine is a major blow to the company, according to analysts a Zacks  Equity Research. Wyeth had filed for FDA approval of the pediatric vaccine PV13 on March 31, 2009.  In May, the FDA granted the New Drug Application priority review with an expected six-month review period.

During late July, as requested by the FDA, Wyeth submitted additional information regarding the vaccine. Though the FDA was initially expected to respond by September 30, 2009, the agency has now pushed back the approval date by 90 days. The agency stated that it will need the extra time to review the additional information, which it considers to be a major amendment.

Prevnar is one of the world's best selling vaccines. It treats illness caused by seven strains of pneumococcal bacteria.  The vaccine recorded sales of about $2.7 billion in 2008, and the analysts expect $2.9 billion of sales in 2009. In an effort to build on the success of Prevnar, Wyeth has developed the PV13 for infants and toddlers. The new vaccine will block 13 strains including the original seven, they note. Earlier in July, PV13 received its first marketing approval from the regulators of Chile. The company is currently seeking approval for PV13 in about 50 countries.