Pfizer has recently launched a groundbreaking vaccine called PREVNAR 20® (20-valent Pneumococcal Conjugate Vaccine) to combat invasive pneumococcal disease (IPD) in children.
This vaccine has received approval from the U.S. Food and Drug Administration (FDA).
It specifically targets infants and children between six weeks and 17 years of age, offering protection against the 20 Streptococcus pneumoniae (pneumococcal) serotypes included in the vaccine.
Furthermore, the vaccine has been authorized for preventing otitis media, a common ear infection, in infants aged six weeks to five years, caused by the original seven serotypes contained in the previously approved PREVNAR® vaccine.
PREVNAR 20 builds upon the success of Pfizer's PREVNAR 13 vaccine by incorporating an additional seven serotypes (8, 10A, 11A, 12F, 15B, 22F, and 33F). These specific serotypes are associated with antibiotic resistance, heightened disease severity, increased invasiveness, and a higher incidence of pediatric pneumococcal disease.
Pfizer's novel vaccine represents a significant advancement in protecting children against the harmful effects of IPD and related complications.
Furthermore, the available data indicate that the seven additional serotypes included in PREVNAR 20 are among the most prevalent serotypes responsible for pediatric invasive pneumococcal disease (IPD) in countries such as the United States, where pneumococcal vaccination programs are implemented.
A study revealed that the inclusion of these seven serotypes alone accounted for approximately 37% of IPD cases in children under the age of five in the United States.
The approval of PREVNAR 20 by the FDA is primarily based on the results obtained from Phase 2 and Phase 3 clinical trials specifically conducted to assess the vaccine's efficacy and safety in the pediatric population.
The vaccine's safety, tolerability, and ability to trigger an immune response were evaluated through three significant Phase 3 studies involving children, including positive outcomes from the pivotal Phase 3 trial conducted in the United States (NCT04382326), which was previously announced.
Additionally, the FDA's decision was supported by favorable data from a Proof-of-Concept Phase 2 trial (NCT03512288) that examined the safety and immunogenicity of PREVNAR 20.