FDA Greenlights Pfizer’s Pneumococcal Vaccine in Infants and Children

BIOMARKER

Gray Frame Corner
Gray Frame Corner

1. The FDA has approved Pfizer's Prevnar 20 pneumococcal conjugate vaccine for use in infants and children aged six weeks to 17 years.

Gray Frame Corner
Gray Frame Corner

2. Prevnar 20 is designed to prevent invasive pneumococcal disease (IPD) caused by 20 serotypes of Streptococcus pneumoniae included in the vaccine.

Gray Frame Corner
Gray Frame Corner

3. The vaccine can also be used for the prevention of otitis media caused by seven of the 20 serotypes in children aged 6 weeks through 5 years.

Gray Frame Corner
Gray Frame Corner

4. The approval of Prevnar 20 offers an expanded vaccine option providing broad serotype protection for children.

Gray Frame Corner
Gray Frame Corner

5. The new vaccine builds on the real-world impact of Pfizer's previous pneumococcal vaccines, Prevnar and Prevnar 13.

Gray Frame Corner
Gray Frame Corner

6. Pfizer's first pneumococcal vaccine, Prevnar, was licensed by the FDA in 2000 and covered seven S. pneumoniae serotypes.

Gray Frame Corner
Gray Frame Corner

7. In 2010, Pfizer extended the vaccine's coverage with Prevnar 13, which offered protection against IPD caused by 13 S. pneumoniae types.

Gray Frame Corner
Gray Frame Corner

8. The supplemental Biologics License Application (sBLA) for Prevnar 20 was backed by data from a Phase II study and several Phase III pediatric trials.

Gray Frame Corner
Gray Frame Corner

9. Phase II data showed the 20-serotype vaccine to be as safe as the previously approved 13-serotype version, and it elicited immune responses against all 20 serotypes after the third dose.

Gray Frame Corner
Gray Frame Corner

10. Topline data from a pivotal Phase III study demonstrated that a four-dose series of the 20-valent vaccine led to robust immunity against all serotypes with a favorable safety and tolerability profile.

Gray Frame Corner
Gray Frame Corner

Swipe up for more BIOMARKER news!