European Commission green light for MSD’s 15-valent Vaxneuvance * pneumococcal conjugate vaccine for the prevention of invasive diseases and pneumonia caused by Streptococcus pneumoniae in people aged 18 years and over. By virtue of the approval, the product can be marketed in all 27 member states of the European Union plus Iceland, Norway and Liechtenstein.
The decision of the Commission – explains the company in a note – follows the positive opinion of the Committee for Medicinal Products for Human Use CHMP of the European Medicines Agency EMA, which examined the data of 7 double-blind randomized clinical trials that evaluated 15-valent anti-pneumococcal conjugate vaccine in 7,438 adults with different clinical situations, including healthy people 50 years of age and older, 18-49 year-olds with risk factors for pneumococcal disease, and HIV-positive immunocompromised adults.
In the pivotal, double-blind, active comparator-controlled study in 1,205 immunocompetent pneumococcal vaccine-naïve adults aged 50 years and older, immune responses elicited by 15-valent pneumococcal vaccine were non-inferior to 13-valent pneumococcal vaccine (Pcv13) currently available for 13 shared serotypes, evaluated by opsonophagocytic activity through geometric mean titers at 30 days after vaccination. Furthermore, immune responses to the 15-valent vaccine were superior to Pcv13 for shared serotype 3 and the two unique 15-valent vaccine serotypes, 22F and 33F. No randomized controlled trials have been conducted to evaluate the clinical efficacy of the 15-valent vaccine against Pcv13.
“At MSD, our commitment is to help protect as many people as possible from invasive pneumococcal disease (Ipd), as well as pneumococcal pneumonia, the most common form of pneumococcal disease in adults,” he says. Roy Baynes, Senior Vice President and Chief Global Clinical Development, Chief Medical Officer, Msd Research Laboratories – With the 15-valent pneumococcal vaccine we have developed a conjugate vaccine that elicits a strong immune response to pneumococcal serotypes that contribute substantially to the disease burden, including serotype 3, a major cause of Ipd in the EU. ”
“This approval – he underlines – provides doctors and patients in the European Union a new option that can help protect against those pneumococcal serotypes that are responsible for approximately 40% of Ipd cases in adults over the age of 65 in major EU member states“.
In July 2021 – the note recalls – the 15-valent conjugate anti-pneumococcal vaccine received approval from the American drug agency Fda for active immunization for the prevention of invasive disease caused by serotypes 1, 3, 4, 5 , 6A, 6B, 7F, 9V, 14, 18C of Streptococcus pneumoniae, 19A, 19F, 22F, 23F and 33F in adults 18 years and older.
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