Merck Scores FDA Approval for Vaxneuvance ( Pneumococcal 15-valent conjugate vaccine) for Ages 6 Weeks through 17 Years

Summary :

• The FDA today approved the pneumococcal 15-valent conjugate vaccine for the prevention of invasive pneumococcal disease in infants and children.
• Clinical data supporting approval demonstrated non-inferior immune responses for all serotypes shared with PCV13 following a four-dose series and superior immune responses for important disease-causing shared serotype 3 and unique serotypes 22F and 33F compared to PCV13
• With this expanded indication, VAXNEUVANCE is the first pneumococcal conjugate vaccine approved in almost a decade to help protect pediatric populations against invasive pneumococcal disease
• PCV15 (Vaxneuvance^®) is a sterile suspension of purified capsular polysaccharides from 15 serotypes of S. pneumoniae (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F) individually conjugated to a nontoxic variant of diphtheria toxin known as CRM197.

Today, Merck announced the US Food and Drug Administration (FDA) approval of an expanded indication for its pneumococcal 15-valent conjugate vaccine (Vaxneuvance; Merck) to include children aged 6 weeks through 17 years old. The active immunization is now indicated for the prevention of invasive disease caused by Streptococcus Pneumoniae serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F in those ages. This approval follows the December 2021 FDA Priority Review acceptance of Merck’s supplemental application.

About VAXNEUVANCE (pneumococcal 15-valent conjugate vaccine)

• Description : A pneumococcal conjugate vaccine containing 13 different strains of the bacterium Streptococcus pneumoniae, used in children and studied in immunocompromised patients for the prevention of pneumococcal disease.
• Indication 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 six weeks of age and older.
• Approval : The FDA initially approved VAXNEUVANCE in July 2021. The FDA previously granted VAXNEUVANCE Breakthrough Therapy designation and Priority Review for the pediatric indication.
• Dosage and administration for VAXNEUVANCE for infants and children : VAXNEUVANCE is for intramuscular injection only and each dose is 0.5 mL. Administer VAXNEUVANCE as a four-dose series at 2, 4, 6, and 12 through 15 months of age. Administer VAXNEUVANCE as a single dose in children and adolescents 2 through 17 years of age who have received an incomplete series of another pneumococcal conjugate vaccine.

Safety Information for VAXNEUVANCE for infants and children

• Do not administer VAXNEUVANCE to individuals with a severe allergic reaction (e.g., anaphylaxis) to any component of VAXNEUVANCE or to diphtheria toxoid.
• Some individuals with altered immunocompetence, including those receiving immunosuppressive therapy, may have a reduced immune response to VAXNEUVANCE.
• Apnea following intramuscular vaccination has been observed in some infants born prematurely. Vaccination of premature infants should be based on the infant’s medical status and the potential benefits and possible risks.
• 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% to 63.4%), somnolence (24.2% to 47.5%), injection-site pain (25.9% to 40.3%), fever ≥38.0°C (13.3% to 20.4%), decreased appetite (14.1% to 19.0%), injection-site induration (13.2% to 15.4%), injection-site erythema (13.7% to 21.4%) and injection-site swelling (11.3% to 13.4%).
• The most commonly reported solicited adverse reactions in children and adolescents 2 through 17 years of age 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%).
• Vaccination with VAXNEUVANCE may not protect all vaccine recipients.

Invasive pneumococcal disease (IPD) is an infection caused by the bacterium S. pneumoniae, or pneumococcus, according to the press release announcing the approval. Of the approximately 100 different types of S. pneumoniae, a smaller number of serotypes are responsible to IPD in children including serotypes 3, 22F, and 33F, among others. Examples of IPD include bacteremia—infection in the blood—and meningitis—infection of the coverings of the brain and spinal cord—which can result in long-term neurological complications. IPD can lead to hospitalization or death and children under the age of 2 are particularly vulnerable.

This FDA approval is based on data from 7 randomized, double-blind clinical studies examining the safety, tolerability, and immunogenicity of the company’s pneumococcal 15-valent conjugate vaccine in infants, children, and adolescents.

Following a 4-dose pediatric series in the pivotal study, it was shown to be noninferior to the currently available 13-valent pneumococcal conjugate vaccine (PCV13) based on “serotype-specific immunoglobulin G (IgG) geometric mean concentrations (GCMs),” according to the release. Additionally, a secondary analysis examining immune responses for the 15-valent vaccine showed that a 4-dose pediatric series were superior to PCV13 for shared serotype 3 and 2 serotypes unique to the pneumococcal 15-valent conjugate vaccine, 22F and 33F. Merck noted that randomized controlled trails assessing clinical efficacy of the pneumococcal 15-valent conjugate vaccine vs PCV13 have not been conducted.

Data supports the use of the vaccine concomitantly with other routine pediatric vaccines commonly administered and its use in special populations like pre-term infants, children living with HIV or sickle cell disease, according to the release.

“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, Department of Pediatrics, Jefferson Abington Hospital, 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 Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) is expected to meet today on the use of the pneumococcal 15-valent conjugate vaccine in pediatric populations.

About Invasive pneumococcal disease (IPD)

Invasive pneumococcal disease (IPD) is an infection caused by the bacterium Streptococcus pneumoniae, or pneumococcus. While there are approximately 100 different types of S. pneumoniae, called serotypes, a smaller number of serotypes are responsible for IPD in children. Serotypes 3, 22F and 33F are three of the top five serotypes causing childhood cases of IPD. IPD can lead to hospitalization or death. Some examples of IPD are bacteremia (an infection in the blood) and meningitis (an infection of the coverings of the brain and spinal cord), which can also result in long-term neurological complications. Children under the age of 2 are particularly vulnerable to IPD.

About Merck

At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities.

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