European Commission Approves Merck’s VAXNEUVANCE (15-valent Pneumococcal Conjugate Vaccine) for Adults Aged 18 and Older to Prevent Invasive Pneumococcal Disease
Dec 18, 2021 10:36
CST Updated
10:36
MSD
Pharmaceutical R&D and Manufacturer
European Commission
The European Commission, abbreviated as the EU Commission, is a supranational body under the European Union. Within the EU political system, the European Commission primarily undertakes executive tasks, thus being roughly equivalent to the government in a national system. However, the European Commission has other functions as well. In particular, except for the few circumstances specified in the treaties, the European Commission is the only institution with legislative power in the EU legislative process.
Pneumonia Vaccine (Image source: firstcry.com)
December 18, 2021 /BioValleyBIOON/ -- MSD (Merck & Co.) recently announced that the European Commission (EC) has approved Vaxneuvance (15-valent pneumococcal conjugate vaccine, V114): for active immunization in individuals aged 18 years and older to prevent invasive pneumococcal disease (IPD) caused by Streptococcus pneumoniae. The approval allows Vaxneuvance to be marketed in all 27 EU member states as well as Iceland, Norway, and Liechtenstein. In the EU, the use of Vaxneuvance should be in accordance with official recommendations.
Vaxneuvance is a 15-valent vaccine, consisting of pneumococcal polysaccharides from 15 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F) conjugated with CRM197.VectorProtein-bound, including serotypes 22F and 33F, which are commonly associated with IPD globally.
In July 2021, Vaxneuvance received approval from the U.S. FDA for use in adults aged 18 years and older to prevent invasive pneumococcal disease (IPD) caused by the aforementioned 15 pneumococcal serotypes. The adult indication for Vaxneuvance was approved through the priority review process. Currently, a supplemental Biologics License Application (sBLA) for Vaxneuvance for use in pediatric populations aged 6 weeks to 17 years is under priority review by the FDA. Previously,FDAVaxneuvance has been granted Breakthrough Therapy Designation (BTD) for the prevention of IPD caused by vaccine serotypes in pediatric populations aged 6 weeks to under 18 years and in adult populations aged 18 years and above.
Pneumococcal Pneumonia (Image Source: bigstockphoto.com)
Pneumococcal disease is an infection caused by the bacterium Streptococcus pneumoniae. Different strains of this bacterium are called serotypes. When Streptococcus pneumoniae invades parts of the body where it is not normally present,BacteriaWhen it occurs in certain parts of the body, invasive pneumococcal disease (IPD) happens. About 80% of the adult IPD burden occurs in people aged 50 and above. Globally, the incidence of pneumococcal disease in adults is on the rise, partly driven by pathogenic serotypes not covered by currently available pneumococcal conjugate vaccines, including serotypes 22F and 33F, which are commonly associated with invasive pneumococcal disease worldwide.
The Phase 3 clinical development program for Vaxneuvance consists of 16Clinical TrialComposition, the safety, tolerability, and immunogenicity of Vaxneuvance were studied in different populations (including healthy elderly individuals, healthy pediatric populations, immunocompromised individuals, and those with certain chronic diseases).
The EU approval of Vaxneuvance was based on data from seven randomized, double-blind clinical studies. These studies evaluated the safety, tolerability, and immunogenicity of Vaxneuvance in 7,438 individuals from various adult populations and clinical settings, including healthy adults aged 50 years and older, adults aged 18-49 with risk factors for pneumococcal disease, and immunocompromised adults infected with HIV.
In the pivotal, double-blind, active-controlled study PNEU-AGE (V114-019) conducted among 1,250 adults aged 50 years and older who were immunocompetent and had not previously received a pneumococcal vaccine, the data showed:For the 13 common serotypes, the immune response induced by Vaxneuvance is not inferior to the currently available 13-valent pneumococcal conjugate vaccine (PCV13, i.e., Prevnar 13 [Pneumovax 13]).，This is assessed by measuring the geometric mean titer (GMT) of opsonophagocytic activity (OPA) 30 days after vaccination.
In addition,For the shared serotype 3 and the two serotypes 22F and 33F unique to Vaxneuvance, 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 statistically significantly higher OPA-GMT ratios for serotypes 22F (GMT ratio=32.52 [95% CI: 25.87, 40.88]) and 33F (GMT ratio=7.19 [95% CI: 6.13, 8.43]), as well as 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 efficacy of Vaxneuvance versus PCV13. (Bioon.com)