MHRA approves Merck's adult pneumococcal vaccine Capvaxive

Merck & Co, operating as MSD outside of the United States and Canada, has secured approval from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for its pneumococcal vaccine, Capvaxive, tailored specifically for adults. This vaccine aims to protect individuals aged 18 and above from diseases caused by the Streptococcus pneumoniae bacteria, such as pneumonia and meningitis, which are recognized by the World Health Organization (WHO) as significant public health challenges.

The pneumococcal bacteria are diverse, with over 100 identified strains, and Merck’s Capvaxive is a single-dose 21-valent vaccine formulated to safeguard against those responsible for the majority of invasive pneumococcal diseases in adults. The approval by the MHRA was facilitated through the International Recognition Procedure, a streamlined mechanism that incorporates previous authorizations from other regulatory bodies. This decision follows the European Commission’s endorsement of the vaccine earlier in March.

The vaccine’s approval in Europe was supported by evidence from a phase 3 clinical trial, which compared Capvaxive with Pfizer’s 20-valent vaccine, PCV20, in adults without prior pneumococcal vaccination. The results demonstrated that Capvaxive provoked immune responses that were not inferior to those of PCV20 for the ten serotypes common to both vaccines in individuals aged 50 and over. Moreover, it showed superior immune responses concerning ten of its eleven distinctive serotypes.

Additionally, Merck’s vaccine exhibited comparable immune responses across different adult age groups. Specifically, the immune response in adults aged 18 to 49 was shown to be non-inferior to that in those aged 50 to 64. The safety profile of Capvaxive was also found to be similar to that of PCV20, as stated by the MHRA.

The UK regulator emphasized that, similar to any medication, the safety and efficacy of Capvaxive would be under continuous scrutiny. Emma Cerrone, who heads the vaccines business unit at MSD UK, expressed satisfaction with the MHRA’s decision, noting the serious complications pneumococcal infections can cause, which often necessitate hospital care. She highlighted the critical role of vaccination in preventing such infections, thereby contributing to longer, healthier lives for adults.

Beyond the European Union, Capvaxive has also received approval in countries including the United States, Canada, and Australia, broadening its availability to protect more adults globally from pneumococcal disease.