Pfizer shares slip after Prevnar FDA delay

NEW YORK, Dec. 31 (UPI) -- Pfizer Inc. shares slipped 1 percent Thursday after the company said U.S. regulators had not yet decided on the company's new pediatric vaccine, Prevnar 13.

The stock, part of the Dow Jones Industrial Average, closed down 31 cents, or 1.68 percent, at $18.19, on the New York Stock Exchange.

A U.S. Food and Drug Administration decision on Prevnar 13 had been expected by Wednesday, but Pfizer said late that day the FDA had not yet completed its review of Pfizer's market application.

"We will continue to work closely with the FDA to help expedite the completion of its review," Pfizer said, adding it remained "confident" the data it supplied would support its Prevnar 13 application.

Prevnar 13 is administered to infants to help prevent a variety of serious illnesses, including meningitis. The pneumococcal conjugate vaccine protects babies against more bacterial strains than regular Prevnar, a widely used pediatric vaccine that Pfizer, the world's largest drug company, introduced in 2000.

Prevnar 13 was approved by European regulators earlier this month.

In the United States, vaccination with Prevnar is recommended for all children younger than 2 years and for unvaccinated children between 24 and 59 months old who are at high risk for pneumococcal infections.

"The Prevnar 13 review appears to be another example of missed deadlines at the FDA, as Pfizer has indicated the FDA has not pointed out any issues with the application," BMO Capital Markets analyst Robert Hazlett said in a research note.