ACIP Backs 20-Valent Pneumococcal Vaccine for Children-New high-risk conditions added as well, including chronic kidney disease and asthma

 

The endorsement of the 20-valent pneumococcal conjugate vaccine (PCV20; Prevnar 20) as a viable option for children in the United States has received unanimous agreement from the Advisory Committee on Immunization Practices (ACIP) of the CDC. All 14 committee members voted in favor of the following four proposals:

1. Routine administration for children aged 2-23 months: ACIP recommends either the 15-valent PCV (PCV15; Vaxneuvance) or PCV20, following the currently recommended dosing and schedules.
2. Catch-up vaccination for children with incomplete immunization status: PCV15 or PCV20 is recommended, aligning with the current dosing and schedule. This applies to healthy children aged 24 to 59 months and children aged 24 to 71 months with specific underlying medical conditions that heighten the risk of pneumococcal disease.
3. Risk-conditioned children aged 2 to 18 years: If these children are up to date on all PCV doses before the age of 6, no further doses are required if they have received at least one dose of PCV20. However, if they have received the 13-valent PCV (PCV13; Prevnar 13) or PCV15, the recommendation is to administer one dose of PCV20 or the 23-valent polysaccharide vaccine (PPSV23; Pneumovax 23).
4. Risk-conditioned children aged 6-18 years who have not received PCV13, PCV15, or PCV20: For this group, a single dose of PCV15 or PCV20 should be administered at least 8 weeks after the most recent dose. If PCV15 is used, a follow-up dose of PPSV23 should be administered at least 8 weeks later.

ACIP has also expanded the list of risk conditions to include chronic kidney disease (excluding dialysis patients, as they are categorized under immunologic conditions), chronic liver disease, moderate persistent or severe persistent asthma (under chronic lung disease), and renal failure on maintenance dialysis.

Dr. Sarah Long, a member of ACIP from St. Christopher's Hospital for Children in Philadelphia, emphasized the need for better coordination among pneumococcal vaccines, stating, "Pneumococcal vaccines at the moment are messy, and we're trying to make them a little bit coordinated with what's already out there."

During the meeting, the CDC presented data indicating a surge in rates of invasive pneumococcal disease during winter 2022, exceeding 1.20 per 100,000 children under the age of 5. In contrast, rates from 2018 to 2021 remained well below 1 per 100,000.

Katherine Poehling, MD, MPH, of Wake Forest School of Medicine in Winston-Salem, North Carolina, chair of ACIP's work group on pneumococcal vaccines, highlighted the impact of the severe season witnessed: "This winter we saw more cases of mastoiditis -- which is a serious complication of ear infections and pneumonia requiring chest tubes -- than I have seen for the last 20 years."

PCV20 provides the broadest serotype coverage among PCVs, with the addition of serotypes 8, 10A, 11A, 12F, and 15B to the PCV15 vaccine. The FDA granted approval for PCV20 in April, specifically for infants and children, based on randomized phase II and phase III data that compared the vaccine to PCV13 and supported its use in children aged 2 to 23 months.

For children in this age group, PCV20 demonstrated lower immunoglobulin G geometric mean concentrations for the 13 shared serotypes with PCV13. Noninferiority between PCV20 and PCV13 for serotypes 1, 3, 4, 9V, 23F, and 12F was not achieved in one of the outcomes after the third dose. However, noninferiority was observed for all 13 shared serotypes after the fourth dose. The results also showed noninferiority to PCV13 for the seven additional non-shared serotypes.

In the case of children aged 2 to 18 years with risk conditions, the approval of PCV20 was supported by a single-arm phase III trial involving healthy children who had received three doses of PCV13. The trial demonstrated that a single dose of PCV20 provided immunogenicity against all 20 serotypes, with positive results observed a month after vaccination.

Dr. Poehling expressed concern regarding the absence of clinical data for the new vaccines, stating, "I think it's very important to remind everybody that all we have is immunogenicity data. We have no effectiveness and no efficacy data on either PCV15 or PCV20." She particularly highlighted the increased immunogenicity of PCV15 against serotype 3, which is a significant cause of pneumococcal disease at present.

Dr. Grace Lee, ACIP chair from Stanford University School of Medicine in California, emphasized the significance of multiple vaccine options due to the limited data on efficacy, especially in children. She stated, "I don't believe we have enough data to make a preferential recommendation [between PCV15 or PCV20] at this time."

It's important to note that all recommendations made by ACIP are subject to publication in the CDC's Morbidity and Mortality Weekly Report and are not considered final until then.