ACIP Unanimously Recommends Use of Pneumococcal 15-Valent Conjugate Vaccine for Infants and Children

Vaxneuvance was approved for an expanded indication by the FDA on June 22, 2022, for active immunization in children 6 weeks of age and older.

The CDC Advisory Committee on Immunization Practices (ACIP) unanimously voted to provisionally include Merck’s pneumococcal 15-valent conjugate vaccine (Vaxneuvance) for vaccination in infants and children, including routine use in children under 2 years of age.1

According to a press release, ACIP voted to recommend that Vaxneuvance may be used as an option to the currently available 13-valent pneumococcal conjugate vaccine (PCV13) for children younger than 19 years of age, based on currently recommended PCV13 dosing and schedules. Furthermore, the committee unanimously voted to include Vaxneuvance in the Vaccines for Children program.1

Vaxneuvance was approved for an expanded indication by the FDA on June 22, 2022, for active immunization for the prevention of invasive disease caused by the Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F in individuals 6 weeks of age and older. The FDA had previously granted priority review for this indication.2

“Despite decreases in incidence of invasive pneumococcal disease in children, certain key serotypes continue to cause serious illness that can lead to death in children under the age of 5, with serotypes 3, 22F, and 33F responsible for more than a quarter of all invasive pneumococcal disease cases in this population,” said Steven Shapiro, DO, chairman of the department of pediatrics at Jefferson Abington Hospital and investigator in the PNEU-PED trial, said in a press release. “With the robust clinical data supporting Vaxneuvance and this FDA approval, Vaxneuvance will be an important new option to help advance protection for children.”2

The FDA approval was based on data from 7 randomized, double-blind clinical trials evaluating the safety, tolerability, and immunogenicity of the vaccine in infants, children, and adolescents. Data show that immune responses produced by the vaccine after 4 doses were non-inferior to PCV13 for the 13 shared serotypes based on serotype-specific immunoglobulin G geometric mean concentrations.2

Safety data were evaluated in children vaccinated with a 4-dose series at 2, 4, 6, and 12 through 15 months. The most commonly reported solicited adverse reactions were irritability, somnolence, injection site pain, fever, decreased appetite, injection site induration, injection site erythema, and injection site swelling. Apnea following intramuscular vaccination has been observed in some infants born prematurely, and vaccination in premature infants should be based on the infant’s medical status as well as potential risks and benefits.1

The most commonly reported solicited adverse reactions in children and adolescents 2 through 17 years of age vaccinated with a single dose included injection site pain (54.8%), myalgia (23.7%), injection site swelling (20.9%), injection site erythema (19.2%), fatigue (15.8%), headache (11.9%), and injection site induration (6.8%).1

“Vaxneuvance includes key serotypes that continue to cause serious disease in children under 5 years of age, specifically the 13 serotypes shared with PCV13, and the 2 unique serotypes, 22F and 33F,” said Eliav Barr, MD, senior vice president, head of global clinical development and chief medical officer at Merck Research Laboratories, in the press release. “Today’s vote reinforces the importance of Vaxneuvance as an option to help reduce the burden of invasive disease in the pediatric population.”1

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