VCBeat Health Contact Us
Home Merck's 15-Valent Pneumococcal Conjugate Vaccine Vaxneuvance (V114) Receives Positive CHMP Opinion for Use in Adults Aged 18 and Older in the EU

Merck's 15-Valent Pneumococcal Conjugate Vaccine Vaxneuvance (V114) Receives Positive CHMP Opinion for Use in Adults Aged 18 and Older in the EU

Oct 17, 2021 03:11 CST Updated 03:11
MSD

Pharmaceutical R&D and Manufacturer

European Medicines Agency

The European Medicines Agency (EMA) is a decentralized agency of the European Union (EU), located in London. It began operations in 1995. The agency is responsible for the scientific evaluation, supervision, and safety monitoring of medicines developed by pharmaceutical companies for use in the EU. By ensuring that all medicines available on the EU market are safe, effective, and of high quality, the EMA protects public and animal health in the 28 EU Member States and countries of the European Economic Area.

Committee for Medicinal Products for Human Use

Committee for Medicinal Products for Human Use (CHMP)The Committee for Medicinal Products for Human Use (CHMP) is the committee within the European Medicines Agency (EMA) responsible for human medicines. The CHMP replaced the former Committee for Proprietary Medicinal Products (CPMP) in May 2004.The CHMP plays a vital role in the authorization of medicines in the European Union (EU). In the centralized procedure, the CHMP is responsible for: 1) conducting initial assessments of marketing authorization applications across the EU; assessing modifications or extensions to existing marketing authorizations (“variations”); considering recommendations from the Agency’s Pharmacovigilance Risk Assessment Committee regarding the safety of medicines on the market, and, where necessary, advising the European Commission to amend the marketing authorization of a medicinal product, or to suspend or withdraw it from the market.The CHMP also evaluates medicines authorized at the national level that are referred to the EMA, with the aim of maintaining a harmonized position throughout the EU.Furthermore, the CHMP and its working groups promote the development of medicines and pharmaceutical regulation by: providing scientific advice to companies researching and developing new medicines; developing scientific and regulatory guidelines to assist pharmaceutical companies in preparing marketing authorization applications for human medicines; and collaborating with international partners to harmonize regulatory requirements.


Pneumococcal vaccine (Image source: firstcry.com)

Oct. 16, 2021 /BioonBIOON/ -- Merck & Co. recently announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending approvalVaxneuvance (15-valent pneumococcal conjugate vaccine, V114): Indicated for active immunization of 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).

Now, the CHMP opinion will be submitted to the European Commission (EC) for review, which is expected to make a final decision by the end of this year.In the United States, Vaxneuvance was approved this July., for active immunization in adults aged 18 years and older for the prevention of invasive disease caused by the 15 pneumococcal serotypes covered by the vaccine.

Pneumococcal disease is an infection caused by Streptococcus pneumoniae. The different strains of this bacterium are called serotypes. When Streptococcus pneumoniae invades the body, it is usually not presentBacteriaWhen it reaches these 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 rising, partly driven by pathogenic serotypes not covered by currently available pneumococcal conjugate vaccines. Serotypes 3, 22F, and 33F have a significant impact on the burden of IPD.

Vaxneuvance is a 15-valent vaccine, consisting of pneumococcal polysaccharides from 15 serotypes and CRM197Carrierconjugated to a protein, including serotypes 22F and 33F, which are commonly associated with invasive pneumococcal disease worldwide., but is 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 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 the pediatric population aged 6 weeks to <18 years and the adult population aged ≥18 years.

Pneumococcal pneumonia (Image source: bigstockphoto.com)

FDAThe approval of Vaxneuvance, along with the CHMP's positive opinion, was based on data from seven randomized, double-blind clinical studies. These studies evaluated the safety, tolerability, and immunogenicity of Vaxneuvance in adults. Clinical data demonstrated that for the 13 shared serotypes, the immune response elicited by Vaxneuvance was non-inferior to that of the currently available 13-valent pneumococcal conjugate vaccine (PCV13, i.e., Prevnar 13), as assessed by opsonophagocytic activity (OPA) geometric mean titers (GMT).

In addition,For the shared serotype 3 and the two Vaxneuvance-specific serotypes 22F and 33F, the immune response induced by Vaxneuvance was superior to that of PCV13.. In the pivotal Phase 3 PNEU-AGE (V114-019) study, the superiority of Vaxneuvance over PCV13 was based on a statistically significantly higher OPA GMT ratio 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]), along with the evaluation 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 assess the clinical efficacy of Vaxneuvance compared with PCV13.

PNEU-AGE (V114-019) Study Data

There are more than 90 distinct pneumococcal serotypes, which affect adults differently than children. Pneumococcal serotypes not covered by currently marketed conjugate vaccines (e.g., serotypes 22F and 33F) are commonly associated with invasive pneumococcal disease worldwide. Currently, in the United States, serotypes 22F and 33F account for 13% of invasive pneumococcal disease cases among adults aged 65 years and older, while across Europe, these two serotypes are responsible for 7% to 12% of pneumococcal disease cases in adults.

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 accounts for 12% to 18% among adults in European countries.

The Phase 3 clinical development program for Vaxneuvance comprises 16Clinical Trialcomposed of, and evaluated the safety, tolerability, and immunogenicity of Vaxneuvance across various populations (including healthy elderly adults, healthy children, immunocompromised individuals, and patients with certain chronic diseases). (Bioon.com)