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New pneumococcal conjugate vaccine a preview of things to come

January 25, 2023

The world of pneumococcal conjugate vaccines is changing.

The Centers for Disease Control and Prevention (CDC) published updated guidelines last September for the use of a new 15-valent pneumococcal conjugate vaccine (PCV15, Vaxneuvance, Merck) in children. The AAP Red Book chapter on Streptococcus pneumoniae (Pneumococcal) Infections has been updated with the new recommendations.

The CDC recommends routine use of PCV15 for children ages 6 weeks and older as an option for pneumococcal conjugate vaccination, including children who are at increased risk for serious pneumococcal disease. PCV13 and PCV15 can be used interchangeably.

The Food and Drug Administration (FDA) approved PCV15 for use in children ages 6 weeks and older in June 2022 following approval for adults ages 19 years and older in July 2021. PCV15 contains serotypes 22F and 33F in addition to the PCV13 serotypes. It was approved based on demonstration of noninferior antibody responses compared to PCV13 for shared serotypes and improved antibody responses to serotypes 22F and 33F.

The CDC’s Advisory Committee on Immunization Practices (ACIP) reviewed all available safety and effectiveness data for PCV15 using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach to guide recommendations. This approach incorporates considerations beyond the benefits and harms of a new vaccine, including the public health importance, the target population’s values and preferences, resource use, equity, acceptability and feasibility. No new or significant safety concerns were identified with PCV15 compared with PCV13.

In addition to PCV15, several other new conjugated pneumococcal vaccines may be available for use in children in the next few years. The first likely additional vaccine is PCV20, which has been authorized by the FDA for adults. Both PCV15 and PCV20 are routinely recommended for use in adults ages 19 and older.

Conjugate pneumococcal vaccines are crucial since pneumococcus continues to be a frequent cause of serious disease (e.g., pneumonia, bacteremia and meningitis) and is responsible for many cases of otitis media and sinusitis.

It is anticipated that new pneumococcal conjugate vaccine guidelines will be coming this year after the FDA approves the PCV20 vaccine for children.

Dr. Sawyer is an associate editor of the AAP Red Book.


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