Pfizer got double good news Wednesday after the FDA approved Prevnar 13 (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]), the company's 13-valent pneumococcal conjugate vaccine. It is the updated version of Prevnar and protects against six additional strains of bacteria.
The same day, the CDC's Advisory Committee on Immunization Practices (ACIP) recommended the use of Prevnar 13 for healthy children between the ages of 2 and 59 months. ACIP also recommended that children who have started their immunization series with Prevnar should complete the series by switching to Prevnar 13 at any point in the schedule.
Prevnar 13 is indicated for active immunization of children 6 weeks through 5 years of age for the prevention of invasive disease--including sepsis, bloodstream infections and meningitis--caused by 13 Streptococcus pneumoniae.
The L.A. Times notes that Prevnar was the world's top-selling vaccine in 2008 with sales of $2.7 billion and was considered a key product in Pfizer's decision to purchase its rival Wyeth. And Matthew Herper of Forbes' health blog predicts that the vaccine could be Pfizer's top seller after Lipitor loses patent protection.
Pfizer expects to start selling Prevnar 13 in the U.S. during the first quarter. Already approved for infants and young children in 38 other countries, Prevnar 13 is also being studied in global Phase III clinical trials in adults, with regulatory submissions expected later in the year, according to a Pfizer statement. Earlier this year, the company said that Prevnar 13 sales in adults older than 50 could account for $1.5 billion in sales.
Pfizer's stock jumped 1.5 percent to $17.94 yesterday following the approval, according the Financial Times.
- see Pfizer's statement about the FDA approval
- check out the CDC announcement
- read the FT's coverage
- read the Forbes' blog post
- check out the L.A. Times' review