New guidance on using Vaxneuvance (15-valent) pneumococcal vaccine in children

The National Advisory Committee on Immunization has issued interim guidance on the use of Vaxneuvance (pneumococcal 15-valent conjugate vaccine) in children. This vaccine was originally authorized for use in adults (≥ 18 years of age) in November 2021. Authorization was extended to include use in children in July 2022. Vaxneuvance provides protection against two additional serotypes of Streptococcus pneumoniae (22F and 33F) compared to Prevnar 13 (pneumococcal 13-valent conjugate vaccine). It is indicated for active immunization of infants, children and adolescents from six weeks through 17 years of age (prior to the 18th birthday) and adults for the prevention of invasive pneumococcal disease, including sepsis, meningitis, complicated pneumonia with or without empyema and bacteremia, caused by S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F. Current routine immunization programs for healthy infants in Canada include the use of pneumococcal conjugate vaccines in a three-dose schedule (at 2, 4 and 12 months of age) or a four-dose schedule (at 2, 4 and 6 months of age, followed by a booster dose at 12 to 15 months). Provinces currently use Prevnar 13, with some use of a mixed schedule that includes Prevnar 13 and Synflorix (pneumococcal 10-valent conjugate vaccine). For infants at high risk of invasive pneumococcal disease due to an underlying medical condition, routine immunization programs in all provinces and territories currently use a pneumococcal conjugate vaccine in a four-dose schedule (at 2, 4 and 6 months of age, followed by a booster dose at 12 t0 15 months) plus one dose of Pneumovax (pneumococcal 23-valent polysaccharide vaccine) at 24 months of age (at least 8 weeks after the last dose of Prevnar 13). Children and adolescents at highest risk of invasive pneumococcal disease should also receive one booster dose of Pneumovax 23 vaccine. Vaxneuvance (pneumococcal 15-valent conjugate vaccine) NACI’s interim guidance on the use of Vaxneuvance (15-valent) reviews evidence for its safety and immunogenicity in children. The document also provides an interim recommendation on its interchangeability with Prevnar 13 for use in routine pediatric immunization schedules as well as for children at high risk of invasive pneumococcal disease. NACI notes that invasive pneumococcal disease due to the 13 serotypes in Prevnar 13 declined in all pediatric age groups between 2011 and 2020. However, during the same time period, cases due to the two additional serotypes (22F and 33F) present in Vaxneuvance increased in children. Currently, there are no efficacy or effectiveness data that allow a comparative assessment of clinical outcomes of vaccination with Prevnar 13 versus Vaxneuvance. However, Vaxneuvance has demonstrated comparable safety and immunogenicity to Prevnar 13, including in high-risk children. Like Prevnar 13, Vaxneuvance can be administered concurrently with other routine pediatric vaccines. NACI Recommendation Based on comparable safety and immunogenicity, NACI recommends that Vaxneuvance (pneumococcal 15-valent conjugate vaccine) may be used interchangeably with Prevnar 13 (pneumococcal 13-valent conjugate vaccine) in children (< 18 years of age). A pneumococcal vaccine series may be started or completed with either vaccine. (Discretionary NACI recommendation) For high-risk children, either Prevnar 13 or Vaxneuvance should be used in combination with Pneumovax 23, as described above (see For infants at high risk of invasive pneumococcal disease). NACI notes that Vaxneuvance has the potential to prevent up to about 20% more cases of invasive pneumococcal disease in children four years of age or younger compared to Prevnar 13. Introducing Vaxneuvance into routine vaccination schedules may also provide additional benefit through direct effects on noninvasive pneumococcal infections (e.g., acute otitis media, community acquired pneumonia). Further indirect benefits of Vaxneuvance due to broadened protection could also be expected in adults over time, as suggested by the reduction of invasive pneumococcal disease burden in older adults following the introduction of routine pneumococcal conjugate vaccination programs in children. The NACI statement includes a table that compares various features of the four pneumococcal vaccines authorized for use children in Canada (Synflorix, Prevnar 13, Vaxneuvance, Pneumovax 23). Reference 1. National Advisory Committee on Immunization (NACI). An Advisory Committee Statement (ACS). Interim guidance on the use of pneumococcal 15-valent conjugate vaccine (PNEU-C-15) in pediatric populations. (accessed March 28, 2023).

New guidance on using Vaxneuvance (15-valent) pneumococcal vaccine in children

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