MSD – known as Merck & Co in the US and Canada – has received approval from the Medicines and Healthcare products Regulatory Agency (MHRA) for its adult-specific pneumococcal vaccine Capvaxive.
The vaccine has been authorised to help protect adults aged 18 years and older against illnesses caused by Streptococcus pneumoniae bacteria, including pneumonia and meningitis, which are currently considered a “major public health problem” by the World Health Organization (WHO).
There are over 100 different types of pneumococcal bacteria and Capvaxive, a single-dose 21-valent-vaccine, is specifically designed to help protect against the ones that are responsible for the majority of adult invasive pneumococcal disease.
The MHRA’s decision on Capvaxive occurred through the International Recognition Procedure, a fast-track approval process that takes into account prior authorisations from other regulatory partners, and follows the European Commission’s approval of the vaccine in March.
Among the evidence supporting the EU regulator’s decision were results from a phase 3 trial comparing Capvaxive to Pfizer’s 20-valent vaccine (PCV20) in adults who had not previously received a pneumococcal vaccine.
Capvaxive was shown to induce non-inferior immune responses compared to PCV20 for all ten serotypes common to both vaccines in adults aged 50 years and older, and generated superior immune responses for ten of its 11 unique serotypes.
MSD’s vaccine was also shown to elicit non-inferior immune responses in adults aged 18 to 49 years compared to those aged 50 to 64 years and had a safety profile comparable to PCV20.
“As with any medicine, the MHRA will keep the safety and effectiveness of this vaccine under close review,” the UK regulator said.
Emma Cerrone, vaccines business unit director, MSD UK, said: “We are delighted with this decision. Pneumococcal infections can lead to serious complications requiring hospital treatment, however immunisation plays a vital role in prevention and can help adults live longer, healthier lives.”
Alongside the EU, Capvaxive is approved in the US, Canada and Australia.