FDA Extends PDUFA Date for Pneumococcal 15-valent Conjugate Vaccine


Vaxneuvance was previously granted FDA Priority Review and Breakthrough Therapy designation for the prevention of invasive pneumococcal disease.

The FDA has extended the Prescription Drug User Fee Act date to July 1, 2022, for a supplemental biologics license application for Merck’s pneumococcal 15-valent conjugate vaccine (Vaxneuvance) for use in infants and children.

The regulatory agency requested additional analyses of data from pediatric studies of the vaccine, which was submitted to the FDA for review. However, the agency did not ask for any new studies to be conducted regarding Vaxneuvance, which was previously granted FDA Priority Review and Breakthrough Therapy designation for the prevention of invasive pneumococcal disease in individuals aged 6 weeks through 17 years.

The FDA accepted Merck’s application for Vaxneuvance in December 2021 to prevent invasive pneumococcal disease in children aged 6 weeks through 17 years.

“We are confident in the strength of the data from our pediatric studies with Vaxneuvance and will continue to work expeditiously with the FDA to bring this important vaccine forward to infants and children in the United States as soon as possible,” said Dr. Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories, in a press release.

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. The vaccine is indicated for active immunization of adults 18 years of age and older to prevent invasive disease caused by the S. pneumoniae serotypes contained in Vaxneuvance. The medication is currently being evaluated in a pediatric population.

Vaxneuvance should not be administered to individuals with a severe allergic reaction, such as anaphylaxis, to any component of the vaccine or to diphtheria toxoid.

Certain patients with altered immunocompetence, including those being administered immunosuppressive therapy, may have a decreased immune response to Vaxneuvance.

The most frequently observed adverse events (AEs) with Vaxneuvance among individuals aged 18 through 49 years were injection site pain (75.8%), fatigue (34.3%), myalgia (28.8%), headache (26.5%), injection site swelling (21.7%), injection site erythema (15.1%) and arthralgia (12.7%).

The most common AEs in those 50 years of age and older were injection site pain (66.8%), myalgia (26.9%), fatigue (21.5%), headache (18.9%), injection site swelling (15.4%), injection site erythema (10.9%) and arthralgia (7.7%).

Vaxneuvance may not protect all individuals administered the vaccine.


Merck Provides Update on FDA Review of Supplemental Biologics License Application for VAXNEUVANCE™ (Pneumococcal 15-valent Conjugate Vaccine) for Use in Infants and Children. News release. April 4, 2022. https://www.merck.com/news/merck-provides-update-on-fda-review-of-supplemental-biologics-license-application-for-vaxneuvance-pneumococcal-15-valent-conjugate-vaccine-for-use-in-infants-and-children/

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