The federal agency recommends using either PCV13 or PCV15 as part of a 4-dose series for pediatric patients between the ages of 2-59 months.
There are roughly 2000 cases of serious pneumococcal disease annually in patients less than 5 years of age. This is significantly lower than the 17,000 cases prior to introduction of the pneumococcal conjugate vaccine in 2000. Due to vaccinations, invasive pneumococcal disease rates between 1998 through 2019 decreased by 93% in children less than 5 years old.
The new 15-valent pneumococcal conjugate vaccine (PCV15) originally received FDA approval in July of 2021 for use in adult patients > 18 years of age. In June 2022, the FDA expanded its approval to include those aged 6 weeks to 17 years. The inclusion of pediatric patients in the FDA approval was based on antibody response studies comparing PCV15 to the 13-valent pneumococcal conjugate vaccine (PCV13).
Back in June, The Centers for Disease Control and Prevention’s (CDC) the Advisory Committee on Immunization Practices (ACIP) recommended use of PCV15 as an option for pneumococcal conjugate vaccination of persons aged <19 years.
The CDC has updated its recommendations regarding the use of in children for the PCV15, which was published in a recent edition of the CDC’s Morbidity and Mortality Weekly.
What the Data Says
Phase 2 and 3 randomized control trials compared PCV13 and PCV15 in varying pediatric populations, including healthy infants and children, those 5-17 years with sickle cell disease, and those 6-17 years with HIV. According to the MMWR authors, “PCV15 met criteria for noninferiority to PCV13 for the 13 shared serotypes regarding the response rate after dose 3 and GMC ratio after dose 3 and after dose 4.” Due to the additional serotypes, the use of PCV15 in children is expected to reduce the incidence of pneumococcal disease.
The 7-valent pneumococcal conjugate vaccine (PCV7) was the first pneumococcal conjugate vaccine recommended in children dating back to 2000, but was later replaced in 2010 by PCV13. PCV13 has since been recommended for routine vaccination for children aged 2-59 months, as well as for those 60-71 months with high risk for pneumococcal diseases and children 6-18 years with immunocompromising conditions.
When assessing the cost effectiveness between the PCV13 and PCV15, both the CDC and Merck economic models found that using PCV15 as a primary 4-dose series for children less than 2 years led to cost savings. The MMWR authors wrote, "The use of PCV15 had lower overall costs and improved health outcomes relative to the use of PCV13.”
Recommended Use of PCV in Children
Based on the expanded FDA approval, ACIP now recommends using either PCV13 or PCV15 as part of a 4-dose series for pediatric patients between the ages of 2-59 months. Furthermore, risk-based administration of PCV13 or PCV15 is recommended for patients aged 60-71 months with risk conditions and those 6-18 years with immunocompromising conditions, cerebrospinal fluid leak, or cochlear implant. PCV13 and PCV15 can be used interchangeably. Interruptions in the pneumococcal vaccine schedule do not require restarting the series or adding extra doses.
The PCV13 and PCV15 vaccines are both available in a single-dose prefilled syringe as a 0.5-mL dose administered intramuscularly. Either PCV13 or PCV15 can be administered at the same time as other routine childhood vaccinations, including COVID-19 vaccines, in separate syringes and using different injection sites.
As with all vaccines, any adverse event related to vaccination should be reported to the Vaccine Adverse Event Reporting System (VAERS).