In a press release on June 22, 2022, the manufacturer, Merck, announced that the FDA approved an expanded indication for Vaxneuvance (pneumococcal 15-valent conjugate vaccine) to include children aged 6 weeks through 17 years. Vaxneuvance is now indicated for active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F in individuals aged 6 weeks and older. The approval follows the FDA's Priority Review of Merck's supplemental application. Vaxneuvance is contraindicated for individuals with a severe allergic reaction (e.g., anaphylaxis) to any component of Vaxneuvance or to diphtheria toxoid.

"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," stated Dr. Steven Shapiro, chairman of the department of pediatrics at Jefferson Abington Hospital in Abington, Pennsylvania, and investigator for the PNEU-PED trial. "With the robust clinical data supporting Vaxneuvance and this FDA approval, Vaxneuvance will be an important new option to help advance protection for children."

The FDA's approval was based on data from seven randomized, double-blind clinical studies evaluating safety, tolerability and immunogenicity of Vaxneuvance in infants, children, and adolescents. Clinical data from the pivotal study revealed that immune responses elicited by Vaxneuvance following a four-dose pediatric series were noninferior to the currently available 13-valent pneumococcal conjugate vaccine (PCV13) for the 13 shared serotypes based on serotype-specific immunoglobulin G geometric mean concentrations.

In a secondary analysis, immune responses for Vaxneuvance following a four-dose pediatric series were superior to PCV13 for shared serotype 3 and the two serotypes unique to Vaxneuvance, 22F and 33F. Randomized, controlled trials evaluating the clinical efficacy of Vaxneuvance E compared with PCV13 have not been conducted.

The data from the clinical program also support the use of Vaxneuvance concomitantly with other commonly administered routine pediatric vaccines, and in a variety of clinical settings, such as interchangeable use following initiation of an infant vaccination schedule with PCV13 or in a catch-up setting for older children who are either pneumococcal vaccine-na•ve or who previously received an incomplete series of another PCV. Additionally, data support the use of Vaxneuvance in special populations, such as in preterm infants and children living with HIV infection or sickle cell disease.

The most commonly reported solicited adverse reactions in children vaccinated with a four-dose series at 2, 4, 6, and 12 through 15 months of age, provided as a range across the series, were: irritability (57.3%-63.4%), somnolence (24.2%-47.5%), injection-site pain (25.9%-40.3%), fever >38.0°C (13.3%-20.4%), decreased appetite (14.1%-19.0%), injection-site induration (13.2%-15.4%), injection-site erythema (13.7%-21.4%) and injection-site swelling (11.3%-13.4%).

The most commonly reported solicited adverse reactions in children and adolescents aged 2 through 17 years vaccinated with a single dose were 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%).

Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories, stated, "Our goal with Vaxneuvance is to expand coverage of key invasive disease-causing serotypes and provide a strong immune response to serotypes that pose substantial risk to infants and children. With this approval, we bring forward our first pediatric pneumococcal conjugate vaccine, and the first pediatric pneumococcal conjugate vaccine to be approved in almost a decade, building on our commitment to preventing invasive pneumococcal disease and on our legacy in pediatric vaccine development. We thank the investigators and the families of our clinical trial participants for participating in the research studies and the role they played in this milestone."

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