Pediatricians soon may have a pneumococcal conjugate vaccine (PCV) with broader coverage to protect children.
The Centers for Disease Control and Prevention’s (CDC’s) Advisory Committee on Immunization Practices (ACIP) voted Thursday to add the 20-valent vaccine as an option and expanded its definition of high-risk children to include those with moderate persistent and severe persistent asthma. In the first two days of its three-day meeting, the group also made changes to flu vaccine precautions for people with allergies to eggs.
The CDC director will review ACIP’s recommendations. Those that are approved will be published as official recommendations in the Morbidity and Mortality Weekly Report.
Pfizer’s PCV20 adds serotypes 8, 10A, 11A, 12F, 15B, which are not covered in PCV15. The Food and Drug Administration approved pediatric use of PCV20 in April. It already is being used in adults.
ACIP members on Thursday unanimously approved its use for children in four scenarios.
- Routine use: Children ages 2-23 months should get either PCV15 or PCV20 according to recommended dosing and schedules.
- Catch-up vaccination: Healthy children ages 24-59 months with incomplete PCV vaccination status and children ages 24-71 months with certain underlying conditions and an incomplete PCV vaccination status should receive either PCV15 or PCV20 according to currently recommended dosing and schedules.
- Children ages 2-18 years with any risk condition who have received all recommended doses before age 6 years do not need additional doses if they have received at least one dose of PCV20. If they received PCV13 or PCV15 but not PCV20, they should receive a dose of PCV20 or pneumococcal polysaccharide vaccine (PPSV23) using the previously recommended doses and schedule.
- Children ages 6-18 years with any risk condition who have not received any dose of PCV13, PCV15 or PCV20 should receive a single dose of PCV15 or PCV20. When PCV15 is used, it should be followed by a dose of PPSV23 at least eight weeks later if not previously given.
ACIP also added the following conditions to those that put children at high risk to be more consistent with adults: moderate persistent or severe persistent asthma, chronic liver disease and chronic kidney disease (excluding maintenance dialysis and nephrotic syndrome, which are included in immunocompromising conditions). They changed the language on chronic renal failure to specify children on maintenance dialysis.
In clinical trials of healthy children, three doses of PCV20 did not meet noninferiority criteria for several serotypes compared to PCV13. After the fourth dose, however, it was noninferior for all 13 shared serotypes and the additional seven. No studies were conducted in children with underlying conditions.
ACIP Chair Grace M. Lee, M.D., M.P.H., associate chief medical officer for practice innovation at Lucile Packard Children’s Hospital in Palo Alto, Calif., said there are not enough data to determine whether PCV20 should be considered the preferred vaccine.
“In this particular situation, I’m actually in favor of vaccine choice,” Dr. Lee said. “I do believe that implementation factors in the market will determine if there’s essentially a preference that happens over time, but I don’t think we have the data to make that determination today.”
The CDC presentation provides additional details and clinical guidance on using PCV20.
ACIP no longer finds it necessary for people with egg allergies to receive their flu vaccine in a medical setting. Members voted 14-0 in favor of removing the precaution, noting immunization best practice guidelines already call for all vaccine providers to be equipped to handle anaphylaxis. Any flu vaccine appropriate for the person’s age and health status can be used regardless of whether it is egg-based.
The CDC reviewed published reports on reactions after flu vaccination among people with egg allergies. While the data had limitations, there were no deaths, anaphylaxis or hospitalizations among 1,591 people receiving a seasonal inactivated influenza vaccine and 1,129 receiving live attenuated influenza vaccine. A clinical review of data from the Vaccine Adverse Event Reporting System showed seven reports of anaphylaxis and egg allergy from 2017-2022, but it was difficult to assess if the reactions were due to egg protein.
If approved by the CDC director, the removal of extra safety precautions would put the CDC in line with the AAP, American Academy of Allergy, Asthma & Immunology and American College of Allergy Asthma and Immunology.
The flu vaccines for the 2023-’24 season will have updated influenza A(H1N1)pdm09 components. The CDC is not making any other changes to its recommendations.
The AAP announced in March it would continue to recommend flu vaccine for everyone 6 months and older with no product preference for 2023-’24. It will release its full flu policy in the next few months.
ACIP was scheduled to discuss two products to protect infants from respiratory syncytial virus on Thursday afternoon. On Friday, it is schedule to discuss mpox, meningococcal and COVID vaccines as well as general vaccine safety. Watch aapnews.org for more coverage.