FDA Approves Expanded Indication for Vaxneuvance Pneumococcal Vaccine


Vaxneuvance is now indicated 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 6 weeks of age and older.

The FDA has approved an expanded indication for pneumococcal 15-valent conjugate vaccine (Vaxneuvance; Merck) to include children 6 weeks through 17 years of age. Following the approval, Vaxneuvance is now indicated 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 6 weeks of age and older.

The FDA previously granted the vaccine with priority review for this indication.

“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,” Dr. Steven Shapiro, chairman, department of pediatrics, Jefferson Abington Hospital, and investigator for 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.”

Vaxneuvance is comprised of purified capsular polysaccharides from S.pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F individually conjugated to CRM197 carrier protein.

Vaxneuvance’s approval was based on data from 7 randomized, double-blind clinical trials evaluating the vaccine’s safety, tolerability and immunogenicity in infants, children and adolescents. The results showed that immune responses produced by Vaxneuvance after a 4-dose pediatric series were non-inferior to the currently available 13-valent pneumococcal conjugate vaccine (PCV13) for the 13 shared serotypes based on serotype-specific immunoglobulin G geometric mean concentrations, according to Merck.

A secondary analysis found that immune responses for the vaccine after a 4-dose pediatric series were superior to PCV13 for shared serotype 3 and for 2 serotypes unique to Vaxneuvance—22F and 33F. There have yet to be any randomized controlled trials to evaluate the clinical efficacy of Vaxneuvance versus PCV13.

The study investigators noted that data support concomitant use of Vaxneuvance with other routine pediatric vaccines in a variety of clinical settings, including interchangeable use after initiation of an infant vaccination schedule with PCV13 or in a catch-up setting for older children who are either naïve to pneumococcal vaccine or who were previously administered an incomplete series of another PCV. The trial data also support administration of Vaxneuvance in special patient populations, including preterm infants and children with HIV or sickle cell disease.

Vaxneuvance is contraindicated for those with a severe allergic reaction, such as anaphylaxis, to any component of the vaccine or to diphtheria toxoid.

The CDC’s Advisory Committee on Immunization Practices is expected to soon make recommendations on the use of the vaccine in pediatric populations.

“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,” Eliav Barr, MD, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories, said in a press release. “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.”


U.S. FDA Approves Merck’s VAXNEUVANCE™ (Pneumococcal 15-valent Conjugate Vaccine) for the Prevention of Invasive Pneumococcal Disease in Infants and Children. Merck. News release. June 22, 2022. https://www.merck.com/news/u-s-fda-approves-mercks-vaxneuvance-pneumococcal-15-valent-conjugate-vaccine-for-the-prevention-of-invasive-pneumococcal-disease-in-infants-and-children/

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