In June 2021, Wyeth pharmaceuticals received FDA approval for Prevnar 20 (PCV20) vaccine, a 20-valent pneumococcal conjugate vaccine, which added seven additional strains (8, 10A, 11A, 12F, 15B, 22F, and 33F) to the PCV13 vaccine. The vaccine was approved to be administered as a single dose in adults 18 years of age and older.
Merck Sharp & Dohme Corp. received FDA approval for VAXNEUVANCE (PCV15) vaccine, a 15-valent pneumococcal conjugate vaccine, in July 2021. The vaccine was approved to be administered as a single dose in adults 18 years of age and older for prevention of invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F.
On October 20, 2021, ACIP voted to recommend that all adults 65 years of age and older who had not previously received a dose of pneumococcal conjugate vaccine be given a dose of PCV15 or PCV20. If PCV15 is administered, the CDC recommended that a dose of PPSV23 be given one year or more following administration of PCV15. The interval, however, could be shortened to eight weeks in persons with immunocompromising conditions. Individuals aged 19 through 64 years with pre-existing health conditions that put them at an increased risk of invasive pneumococcal disease and who had not previously received a dose of pneumococcal conjugate vaccine were also recommended vaccination with PCV15 or PCV20.
On June 17, 2022, the FDA licensed VAXNEUVANCE (PCV15) for use in individuals six weeks and older. Five days later, on June 22, 2022, the CDC’s ACIP voted to approve the vaccine in individuals under the age of 19 years as an option to PCV13 in accordance with the current recommended pneumococcal conjugate vaccine schedule.
The FDA approved Prevnar 20 (PCV20) in April 2023 for use in individuals six weeks of age and older for the prevention of invasive disease caused by S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F and in infants and children aged six weeks through five years of age, for the prevention of otitis media (ear infection) caused by S. pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F. The approval of the vaccine was based on clinical trials that compared both the safety and immune responses in healthy children who received PCV20 to those who received PCV13. In June 2023, the CDC recommended PCV20 for use as an option to PCV13 and PCV15 according to the currently recommended pneumococcal vaccine schedule for healthy infants and children. PCV20 was also recommended for use in children aged two through 18 years at increased risk for pneumococcal disease.
In June 2024, the FDA approved CAPVAXIVE (PCV21), manufactured by Merck, for the prevention of invasive disease caused by S. pneumoniae serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A,15B, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B and for the prevention of pneumonia caused by S. pneumoniae serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20A, 22F,23A, 23B, 24F, 31, 33F, and 35B in individuals 18 years of age and older. According to the CDC, CAPVAXIVE targets 81 percent of the most commonly seen pneumococcal serotypes among adults. On June 27, 2024, the CDC’s ACIP voted to recommend CAPVAXIVE as an option for use in adults 19 years and older for whom a pneumococcal conjugate vaccine has been recommended.
