EC approves expanded indication for Merck’s Pneumococcal 15-valent Conjugate Vaccine

The European Commission (EC) recently approved Merck’s expanded indication for Vaxneuvance (pneumococcal 15-valent conjugate vaccine) to include active immunisation for the prevention of invasive disease, pneumonia and acute otitis media caused by Streptococcus pneumoniae (S pneumoniae) in infants, children and adolescents aged from six weeks to less than 18 years of age, a statement from Merck has notified.

According to the statement, the approval facilitates availability of Vaxneuvance for this population in all 27 European Union (EU) member states plus Iceland, Norway and Lichtenstein. Vaxneuvance is also indicated in the EU for active immunisation for the prevention of invasive disease and pneumonia caused by S pneumoniae in individuals 18 years of age and older. The use of Vaxneuvance in the EU should be in accordance with official recommendations.

“Vaxneuvance was developed to maintain a strong immune response to serotypes included in currently available Pneumococcal Conjugate Vaccines, or PCVs, while expanding coverage to disease-causing serotypes that can pose substantial risk to infants and children. With this approval, we are pleased to bring an important new PCV option to a vulnerable population in Europe, including infants less than one year of age, who typically experience the highest rates of disease,” said Dr Eliav Barr, Senior Vice President, Head, Global Clinical Development and Chief Medical Officer, Merck Research Laboratories.

The EC’s decision follows a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP), who reviewed data from eight randomised, double-blind clinical studies that enrolled approximately 8,400 individuals, including 5,400 who received Vaxneuvance. The studies evaluated the use of Vaxneuvance in various paediatric populations at risk for pneumococcal disease, including healthy infants, children and adolescents, pre-term infants and children living with HIV infection or sickle cell disease. The use of Vaxneuvance was also evaluated across a variety of clinical circumstances, such as interchangeable use following initiation of an infant vaccination schedule with the currently licensed 13-valent Pneumococcal Conjugate Vaccine (PCV13) or in a catch-up setting for older children who are either pneumococcal vaccine-naïve or who previously received an incomplete series of another PCV, noted the statement.

It also said that the data supporting the approval included findings from the pivotal PNEU-PED-EU-1 study which evaluated the safety, tolerability and immunogenicity of a two-dose infant series followed by a toddler dose of Vaxneuvance in healthy infants (n=1,184). Results showed that immune responses for Vaxneuvance were non-inferior to PCV13 for the 13 serotypes shared between the two vaccines and superior for the two additional serotypes in Vaxneuvnce, 22F and 33F, as assessed by serotype-specific anti-pneumococcal polysaccharide immunoglobulin G (IgG) response rates and Geometric Mean Concentrations (GMCs) at 30 days post-toddler dose.

In July 2021, Vaxneuvance received approval from the US Food and Drug Administration (FDA) for active immunisation for the prevention of invasive disease caused by S pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F in adults 18 years of age and older, and in June 2022, the FDA approved an expanded indication for Vaxneuvance to include individuals six weeks through 17 years of age, the statement concluded.