World Health Organization
NEW YORK — Pfizer Inc. announced Dec. 30 that the U.S. Food and Drug Administration has not yet completed its review of the biologics license application for Prevnar 13, its candidate pneumococcal conjugate vaccine.
As a result, Pfizer stated in a press release that the review would continue beyond the prescription drug user fee action date of Dec. 30.
“We remain confident that the data in the BLA support the approval of Prevnar 13,” said Emilio Emini, chief scientific officer of vaccine research at Pfizer. “We will continue to work closely with the FDA to help expedite the completion of its review of our BLA.”
Pfizer wants to market Prevnar 13 for immunization of infants and toddlers for the prevention of invasive disease and otitis media caused by the 13 Streptococcus pneumoniae serotypes in the vaccine.
On Dec. 11, the European Commission granted marketing authorization for Prevnar 13 for use in infants and children from 6 weeks to 5 years of age.
To date, Prevnar 13 has been approved for use in infants and young children in 34 countries.
According to an estimate by World Health Organization in 2002, pneumococcal disease is the leading cause of vaccine-preventable death worldwide in children younger than 5 years.
