Merck's 15-Valent Pneumococcal Conjugate Vaccine Vaxneuvance (V114) Receives FDA Approval for Adults Aged 18 and Older to Prevent Invasive Pneumococcal Disease
Jul 18, 2021 03:09
CST Updated
03:09
MSD
Pharmaceutical R&D and Manufacturer
FDA
U.S. Food and Drug Administration
Pneumococcal vaccine (Image source: firstcry.com)
July 18, 2021 /BioonBIOON/ -- MSD (Merck & Co.) recently announced that the U.S. Food and Drug Administration (FDA) ApprovedVaxneuvance (15-valent pneumococcal conjugate vaccine, V114)，Indicated for adults aged 18 years and older for the prevention of invasive pneumococcal disease (IPD) caused by 15 Streptococcus pneumoniae serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F). Vaxneuvance was approved through the Priority Review program. The vaccine is also currently under review by the European Medicines Agency (EMA). The Advisory Committee on Immunization Practices (ACIP) of the U.S. Centers for Disease Control and Prevention (CDC) is expected to convene in OctoberMeeting, discuss the use of Vaxneuvance in the adult population and provide recommendations.
Pneumococcal disease is an infection caused by *Streptococcus pneumoniae*. Different strains of this bacterium are referred to as serotypes. When *Streptococcus pneumoniae* invades parts of the body where it is not normally present...BacteriaWhen it invades the site, invasive pneumococcal disease (IPD) occurs. Approximately 80% of the adult IPD burden occurs in individuals aged 50 years and older.
Globally, the incidence of pneumococcal disease in adults is increasing, driven in part by pathogenic serotypes not covered by currently available pneumococcal conjugate vaccines. Serotypes 3, 22F, and 33F contribute significantly to the burden of IPD, with serotype 3 being the leading cause of IPD among adults in the United States.
Vaxneuvance is a 15-valent vaccine composed of pneumococcal polysaccharides from 15 serotypes conjugated to CRM197Carrierconjugated to a protein, including serotypes 22F and 33F，These two serotypes are commonly associated with invasive pneumococcal disease worldwide but are not included in the pneumococcal conjugate vaccines currently licensed for adults.
Currently, Vaxneuvance is also in Phase 3 clinical development for the prevention of pneumococcal disease in pediatric populations. Previously, the United StatesFDAVaxneuvance has been granted Breakthrough Therapy Designation (BTD) for the prevention of invasive pneumococcal disease (IPD) caused by vaccine serotypes in pediatric populations aged 6 weeks to <18 years and adults aged ≥18 years.
Pneumococcal pneumonia (Image source: bigstockphoto.com)
FDAThe approval of Vaxneuvance is based on data from seven randomized, double-blind clinical trials. These studies evaluated the safety, tolerability, and immunogenicity of Vaxneuvance in the adult population. Clinical data showed that,For the 13 shared serotypes, the immune response induced by Vaxneuvance was non-inferior to that of the currently available 13-valent pneumococcal conjugate vaccine (PCV13, i.e., Prevnar 13 [Pei'er 13])., which was assessed by the geometric mean titer (GMT) of opsonophagocytic activity (OPA).
In addition,For shared serotype 3 and the two serotypes unique to Vaxneuvance (22F and 33F), the immune response induced by Vaxneuvance was superior to that induced by PCV13.In the pivotal Phase 3 PNEU-AGE (V114-019) study, the superiority of Vaxneuvance over PCV13 was based on statistically significantly higher OPA GMT ratios for serotype 22F (GMT ratio = 32.52 [95% CI: 25.87, 40.88]) and serotype 33F (GMT ratio = 7.19 [95% CI: 6.13, 8.43]), and the assessment of the key secondary objective for serotype 3 (GMT ratio = 1.62 [95% CI: 1.40, 1.87]). No randomized controlled trials have been conducted to evaluate the clinical effectiveness of Vaxneuvance compared with PCV13.
Coordinating Investigator of the PNEU-AGE trial,Clinical TrialDr. Jose Cardona of the Indago Research and Health Center (IRHC) stated: "Some adults, including older adults or those with certain chronic conditions or immunocompromising conditions, are at increased risk for pneumococcal disease and its serious, sometimes life-threatening complications."FDA“The approval of Vaxneuvance was based on Phase 2 and Phase 3 studies evaluating immune responses in a broad adult population. The market approval of this vaccine provides an important new option for the prevention of invasive pneumococcal disease.”
Dr. Roy Baynes, Chief Medical Officer, Senior Vice President, and Head of Global Clinical Development at Merck Research Laboratories, stated: “At MSD, we are committed to helping protect more people from invasive pneumococcal disease. That is why we set out to develop a conjugate vaccine covering up to 15 serotypes that elicits a robust immune response, with each of these 15 serotypes constituting the greatest health threat.”FDAThe approval of Vaxneuvance builds on MSD’s more than 40 years of experience in pneumococcal disease prevention. This new 15-valent conjugate vaccine incorporates serotypes that cause a significant disease burden in adults, such as serotype 3, as well as serotypes 22F and 33F, which are associated with highly invasive andAntibioticsrelated to drug resistance.”
PNEU-AGE (V114-019) Study Data
There are more than 90 different types of pneumococcus, which affect adults differently than children. Pneumococcal serotypes not included in currently marketed conjugate vaccines (such as 22F and 33F) are generally associated with invasive pneumococcal disease worldwide. Currently, among adults aged 65 years and older in the United States, 13% of invasive pneumococcal disease is caused by serotypes 22F and 33F, while across Europe, these two serotypes account for 7% to 12% of adult pneumococcal disease.
Furthermore, serotype 3 remains one of the leading causes of invasive pneumococcal disease in both adults and children, despite its inclusion in currently available pneumococcal vaccines. In the United States, 15% of invasive pneumococcal disease cases among adults aged 65 years and older are still caused by serotype 3; this proportion ranges from 12% to 18% among adults in European countries.
The Phase 3 clinical development program for Vaxneuvance consists of 16Clinical Trialcomposed of, investigated the safety, tolerability, and immunogenicity of Vaxneuvance in various populations (including healthy elderly individuals, healthy children, immunocompromised individuals, and individuals with certain chronic diseases). (Bioon.com)