CDC ACIP Provisionally Recommends Merck’s VAXNEUVANCE™-PNEUMOVAX®23 Sequential Regimen for Appropriate Adult Populations

Oct. 21, 2021 /BioonBIOON/ -- Merck & Co. recently announced that the Advisory Committee on Immunization Practices (ACIP) of the U.S. Centers for Disease Control and Prevention (CDC) unanimously voted in favor of updating recommendations for pneumococcal vaccination, which apply to adults aged 65 years and older, as well as individuals aged 19 to 64 years with certain underlying medical conditions (e.g., chronic diseases, such asDiabetes, chronic heart disease, chronic lung disease, or chronic liver disease, and HIV, an immunocompromising condition) or individuals with other disease risk factors (such as smoking, excessive alcohol consumption). Among these two populations,ACIP interim voting recommendations: (1) vaccination with a Vaxneuvance (15-valent pneumococcal conjugate vaccine, V114)–Pneumovax 23 sequential schedule; (2) alternatively, vaccination with a single dose of 20-valent pneumococcal conjugate vaccine.These updates will apply to adults who have not previously received a pneumococcal conjugate vaccine or whose prior pneumococcal vaccination history is unknown.

Additional details are available from the CDC. These interim recommendations will be reviewed by the CDC Director and the U.S. Department of Health and Human Services, and the final recommendations will be formally issued following publication in the *Morbidity and Mortality Weekly Report*.

This July,Vaxneuvance (15-valent pneumococcal conjugate vaccine, V114) receives USFDAApproved for use in 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, and 33F).Vaxneuvance was approved through the Priority Review program. Currently, the vaccine is also under review by the European Medicines Agency (EMA).

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 presentBacteriawhen it reaches the affected sites, 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, partly driven by pathogenic serotypes not covered by currently available pneumococcal conjugate vaccines. Serotypes 3, 22F, and 33F significantly contribute to the burden of IPD, with serotype 3 being the leading cause of IPD among adults in the United States.

Currently, Vaxneuvance is also in Phase 3 clinical development for the prevention of pneumococcal disease in the pediatric population. 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 patients aged 6 weeks through <18 years and adults aged 18 years and older.

Pneumococcal pneumonia (Image source: bigstockphoto.com)

FDAThe approval of Vaxneuvance was based on data from seven randomized, double-blind clinical trials. These trials evaluated the safety, tolerability, and immunogenicity of Vaxneuvance in the adult population. Clinical data demonstrated that, for the 13 shared serotypes, the immune responses induced by Vaxneuvance were non-inferior to those of the currently available 13-valent pneumococcal conjugate vaccine (PCV13, i.e., Prevnar 13 [Prevnar 13]), as assessed by opsonophagocytic activity (OPA) geometric mean titers (GMT).

Additionally,For the 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]), as well as the assessment of the key secondary endpoint for serotype 3 (GMT ratio = 1.62 [95% CI: 1.40, 1.87]). No randomized controlled trials have been conducted to evaluate the clinical efficacy of Vaxneuvance compared with PCV13.

PNEU-AGE (V114-019) Study Data

There are over 90 different types of pneumococci, which affect adults differently than children. Pneumococcal serotypes not included in currently marketed conjugate vaccines (e.g., serotypes 22F and 33F) are frequently associated with invasive pneumococcal disease worldwide. Currently, among adults aged 65 years and older in the United States, 13% of invasive pneumococcal disease cases are caused by serotypes 22F and 33F, whereas across Europe, these two serotypes account for 7%–12% of adult pneumococcal disease cases.

In addition,Serotype 3 remains one of the leading causes of invasive pneumococcal disease in adults and children., although it is already included in currently available pneumococcal vaccines. In the United States, serotype 3 still accounts for 15% of invasive pneumococcal disease among adults aged 65 years and older; this proportion ranges from 12% to 18% in adults across European countries.

The Phase 3 clinical development program for Vaxneuvance comprises 16Clinical TrialComposition, and studied the safety, tolerability, and immunogenicity of Vaxneuvance in different populations (including healthy elderly individuals, healthy pediatric populations, immunocompromised individuals, and patients with certain chronic diseases). (Bioon.com)

Original Source:CDC ACIP Unanimously Votes to Provisionally Recommend Merck’s VAXNEUVANCE™ (Pneumococcal 15-valent Conjugate Vaccine) in Series with PNEUMOVAX ® 23 (Pneumococcal Vaccine Polyvalent) as an Option for Pneumococcal Vaccination in Appropriate Adults