MHRA approves first vaccine in ten years to protect children against pneumococcal diseases

The Medicines and Healthcare products Agency (MHRA) has approved the first new vaccine in a decade to protect children against pneumococcal diseases.

On 9 November 2022, the manufacturer MSD announced that the MHRA had approved an extension to the indication for Vaxneuvance (PCV15) in the UK 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 6 weeks to less than 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 older.

The approval, which follows a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use and European Commission, was supported by eight randomised controlled trials, enrolling more than 8,000 people in total.

The vaccine is not currently included within existing national immunisation programmes, but MSD said it understood that the Joint Committee on Vaccination and Immunisation (JCVI) would be looking to undertake an assessment of the pneumococcal national immunisation programmes “in the coming months” to assess whether any changes were warranted.

“Only upon ministerial approval of a JCVI recommendation will any new vaccine be included within a national immunisation programme,” the company added.

Commenting on the approval, Steve Tomlin, associate chief pharmacist at Great Ormond Street Hospital told The Pharmaceutical Journal: “Pneumococcal disease is not only something that increases during winter months and affects bed capacity of the NHS, it can also be a life-threatening issue, particularly for the very young.

“Therefore, we are hopeful that this is a real, needed, update to the current vaccine and should improve child health above the current vaccine, but should hopefully save lives as well,” he added.

Also commenting on the decision, Kieran Hand, national pharmacy and prescribing clinical lead for antimicrobial resistance (AMR) at NHS England, said preventing infection through vaccination was a “high priority” for NHS England’s AMR Programme “to reduce the need for antibiotics and thereby reduce the risk of antimicrobial resistance emerging, as well as reducing adverse drug reactions and disruption to the microbiota in children.”