The MHRA has approved a Type II variation giving vaccine product Vaxneuvance (PCV15) a new indication to prevent invasive disease, pneumonia and acute otitis media caused by Streptococcus pneumoniae in infants and children aged between six weeks and 18 years.

The vaccine is already indicated for the prevention of invasive disease and pneumonia caused by S. pneumoniae in individuals aged 18 years and over.

This is the first paediatric pneumococcal vaccine to be approved in 10 years, manufacturer MSD said. The MHRA reviewed data from eight randomised double-blind clinical trials involving more than 8,000 individuals evaluating the use of PCV15 in a number of paediatric populations.

Professor Andrew Cant of the paediatric immunology team at the Great North Children’s Hospital said: “Immunisation plays a vital role in protecting children from pneumococcal meningitis and pneumonia. 

“However, our very success in preventing infection with dangerous strains of pneumococcus creates an opportunity for other strains of pneumococcus to emerge and take their place as new dangerous strains.

“This ongoing struggle between microbes and immunity means that despite our best efforts, we can never take it for granted that our current vaccines will remain wholly effective, but must continually innovate and improve our pneumococcal vaccines of we are to save children from these diseases and their life threatening and life changing consequences.

“I therefore very much welcome the news of the licensure of PCV15 for the paediatric population which gives protection against further strains of pneumococcus and adds to the range of vaccines available.”

MSD UK & Ireland’s Dilruwan Herath said: “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.

“As the first new PCV in over a decade, we hope to see the new generation of pneumococcal vaccines assessed holistically by the UK health system.”