麻豆传媒

The CDC's Advisory Committee on Immunization Practices (ACIP) agreed unanimously on Thursday to include the 20-valent pneumococcal conjugate vaccine (PCV20; Prevnar) as an option for U.S. children.

All 14 members voted in favor of the following four proposals:

• Routine use in children ages 2-23 months: ACIP recommended either the 15-valent PCV (PCV15; Vaxneuvance) or PCV20, according to currently recommended dosing and schedules.
• Children with an incomplete vaccination status: PCV15 or PCV20 was recommended according to the current dosing and schedule as catch-up vaccination for healthy children ages 24 to 59 months and for kids 24 to 71 months with certain underlying medical conditions that increase the risk of pneumococcal disease.
• Children ages 2 to 18 years with a risk condition: For kids in this age group who are already up to date on all PCV doses before 6 years of age, no more doses were recommended if the children received at least one dose of PCV20. However, if these kids received the 13-valent PCV (PCV13; Prevnar 13) or PCV15, the recommendation is for one dose of PCV20 or the 23-valent polysaccharide vaccine (PPSV23; Pneumovax 23).
• Children ages 6-18 years with a risk condition who have not received PCV13, PCV15, or PCV20: For this group, a single dose of PCV15 or PCV20 was recommended at least 8 weeks after the most recent dose. If PCV15 is used, a follow-up dose of PPSV23 was recommended at least 8 weeks later.

ACIP also added new underlying conditions to the list of risk conditions: chronic kidney disease (excluding dialysis patients, as those are listed under immunologic conditions), chronic liver disease, moderate persistent or severe persistent asthma (under chronic lung disease), and those with renal failure on maintenance dialysis.

"Pneumococcal vaccines at the moment are messy, and we're trying to make them a little bit coordinated with what's already out there," ACIP member Sarah Long, MD, of St. Christopher's Hospital for Children in Philadelphia, explained prior to the voting.

During the meeting, the CDC presented data showing rates of invasive pneumococcal disease in winter 2022 exceeding 1.20 per 100,000 children under the age of 5 years, while rates for 2018 to 2021 were all well below 1 per 100,000.

"We never know when we will have a severe season as we did this season," said Katherine Poehling, MD, MPH, of Wake Forest School of Medicine in Winston-Salem, North Carolina, and chair of ACIP's work group on pneumococcal vaccines. "This winter we saw more cases of mastoiditis -- which is a serious complication of the ear infections and pneumonia requiring chest tubes -- than I have seen for the last 20 years."

PCV20 offers the broadest serotype coverage of any PCV, adding serotypes 8, 10A, 11A, 12F, and 15B to the PCV15 vaccine. The FDA in April, with data supporting the approval in children ages 2 to 23 months based on randomized phase II and phase III data comparing the vaccine to PCV13.

In these kids, PCV20 showed numerically lower immunoglobulin G geometric mean concentrations for the 13 shared serotypes with PCV13. After the third dose, noninferiority for PCV20 versus PCV13 was not achieved for serotypes 1, 3, 4, 9V, 23F, and 12F for one of the outcomes. After the fourth dose, noninferiority was achieved for all 13 shared serotypes. The results also showed noninferiority to PCV13 for the seven additional non-shared serotypes.

For kids ages 2 to 18 years with risk conditions, a single-arm phase III trial (involving healthy children who had received three doses of PCV13) supported the approval, demonstrating that a single dose of PCV20 was immunogenic for all 20 serotypes a month following vaccination.

Poehling expressed concern over the lack of clinical data for the new vaccines: "I think it's very important to remind everybody that all we have is immunogenicity data," she said. "We have no effectiveness and no efficacy data on either PCV15 or PCV20."

Notably, she said, PCV15 has increased immunogenicity to serotype 3, "which is an important cause of pneumococcal disease today."

ACIP chair Grace Lee, MD, MPH, of Stanford University School of Medicine in California, said the multiple vaccine options were important, given the lack of data available on efficacy, particularly in children.

"I don't believe we have enough data to make a preferential recommendation [between PCV15 or PCV20] at this time," said Lee.

All recommendations from ACIP are not considered final until published in the CDC's Morbidity and Mortality Weekly Report.

Comment