The Food and Drug Administration (FDA) has approved Vaxneuvance™ (pneumococcal 15-valent conjugate vaccine) for the prevention of invasive pneumococcal disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F in adults 18 years of age and older.
Vaxneuvance consists of pneumococcal polysaccharides from 15 serotypes, including serotypes 22F and 33F, which are associated with invasive pneumococcal disease. The approval was based on data from the Company’s clinical development program which consisted of 7 randomized, double-blind clinical studies that assessed the efficacy and safety of Vaxneuvance in healthy adults and those at increased risk of pneumococcal disease (eg, chronic medical conditions, 65 years and older).
The pivotal double-blind, active comparator-controlled phase 3 PNEU-AGE (ClinicalTrials.gov Identifier: NCT03950622) study compared the safety, tolerability and immunogenicity of Vaxneuvance to PCV13 (Prevnar® 13) in 1205 healthy adults 50 years of age and older who were pneumococcal vaccine-naïve. Findings showed that Vaxneuvance was noninferior to Prevnar 13 for the 13 shared serotypes and elicited superior opsonophagocytic activity (OPA) geometric mean antibody titers (GMTs) for shared serotype 3 and for serotypes 22F and 33F (the 2 serotypes not included in PCV13).
Additionally, the double-blind, descriptive phase 3 studies, PNEU-PATH (ClinicalTrials.gov Identifier: NCT03480763) and PNEU-DAY (ClinicalTrials.gov Identifier: NCT03547167), compared the safety, tolerability and immunogenicity of Vaxneuvance to PCV13. The PNEU-PATH study included 652 healthy adults aged 50 years or older who received Vaxneuvance or PCV13 followed by Pneumovax® 23 one year later. The PNEU-DAY study included 1514 adults aged 18 to 49 years at increased risk of pneumococcal disease who received Vaxneuvance or PCV13 followed by Pneumovax 23 six months later.
Results from the PNEU-PATH study demonstrated comparable immune responses following vaccination with Pneumovax 23 in both treatment groups for the 15 serotypes in Vaxneuvance. Findings from PNEU-PATH and PNEU-DAY showed that Vaxneuvance generated immune responses comparable to PCV13 for the 13 shared serotypes and higher immune responses for serotypes 22F and 33F at 30 days postvaccination, based on OPA responses.
As for safety, Vaxneuvance was found to be generally well tolerated. The most commonly reported solicited adverse reactions were injection site pain/swelling/erythema, fatigue, myalgia, headache, and arthralgia.
“The FDA’s approval of Vaxneuvance is based on robust phase 2 and 3 studies assessing immune responses in a broad range of adult populations and provides an important new option in protection from invasive pneumococcal disease,” said Dr Jose Cardona, Indago Research and Health Center, coordinating investigator for the PNEU-AGE trial.
Vaxneuvance is supplied in single-dose prefilled syringes containing 0.5mL suspension for intramuscular injection.
- Merck announces US FDA approval of Vaxneuvance™ (pneumococcal 15-valent conjugate vaccine) for the prevention of invasive pneumococcal disease in adults 18 years and older caused by 15 serotypes. News release. Merck. Accessed July 16, 2021. https://www.businesswire.com/news/home/20210716005480/en/Merck-Announces-U.S.-FDA-Approval-of-VAXNEUVANCE%E2%84%A2-Pneumococcal-15-valent-Conjugate-Vaccine-for-the-Prevention-of-Invasive-Pneumococcal-Disease-in-Adults-18-Years-and-Older-Caused-by-15-Serotypes.
- Vaxneuvance [package insert]. Whitehouse Station, NJ: Merck & Co., Inc.; 2021.