MSD’s – known as Merck & Co in the US and Canada – Vaxneuvance (PCV15) has been approved in the UK for the prevention of invasive disease, pneumonia and acute otitis media caused by Streptococcus pneumoniae (S pneumoniae) in children aged six weeks to less than 18 years old.
The decision from the Medicines and Healthcare products Regulatory Agency (MHRA) marks the regulatory body’s first approval of a new vaccine for this indication in a decade.
The vaccine is already indicated for the prevention of invasive disease and pneumonia caused by S pneumoniae in adults aged 18 years and older.
Pneumococcal disease is an infection caused by the bacterium S pneumoniae, or pneumococcus. While there are more than 100 different types of S pneumoniae, called serotypes, a selected number of serotypes are responsible for the majority of pneumococcal infections.
Invasive pneumococcal disease can cause serious and potentially life-threatening infections, including pneumonia and meningitis, and has been on the rise among infants and children.
“Infants less than one year of age typically experience the highest rates of disease, therefore this approval provides an important new option to protect and reassure families across the UK,” said Dr Dilruwan Herath, executive medical affairs director, MSD UK & Ireland.
“As the first new pneumococcal conjugate vaccine (PCV) in over a decade, we hope to see the new generation of pneumococcal vaccines assessed holistically by the UK health system,” Herath added.
The approvals were supported by eight randomised, double-blind clinical studies evaluating 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.
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 PCV (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.
Moreover, 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 in healthy infants, showed that immune responses were non-inferior to PCV13 for the 13 serotypes shared between the two vaccines and superior for the two additional serotypes in PCV15, 22F and 33F at 30 days post-toddler dose.