Merck & Co – known as MSD outside the US and Canada – has announced that its adult-specific 21-valent pneumococcal conjugate vaccine has been approved by the European Commission (EC).
The vaccine, marketed under the brand name Capvaxive, has been authorised to prevent invasive disease and pneumonia caused by Streptococcus pneumoniae in individuals aged 18 years and older.
Invasive pneumococcal disease, including pneumonia, sepsis and meningitis, are major causes of mortality worldwide.
There are more than 100 different types of pneumococcal bacteria and Merck’s Capvaxive, which is administered in a single dose, is designed to help protect against the ones that are responsible for the majority of adult invasive pneumococcal disease.
The EC’s approval follows a recent recommendation from the European Medicines Agency’s human medicines committee and was based on positive results from the phase 3 STRIDE-3 trial, which compared 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.
Additionally, Merck’s vaccine elicited 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.
Results from the phase 3 STRIDE-4, STRIDE-5, STRIDE-6, STRIDE-7 and STRIDE-10 trials also supported the EU regulator’s decision.
Paula Annunziato, senior vice president, infectious diseases and vaccines, global clinical development at Merck Research Laboratories, said: “By focusing on the serotypes that have been responsible for an increasing proportion of adult invasive pneumococcal disease cases, Capvaxive allows us to offer protection specifically designed for adults.
“We are proud to bring Capvaxive to adults in Europe who may benefit from its broad protection and are eager to continue working with regulatory authorities to expand Capvaxive availability worldwide.”
The authorisation follows the US Food and Drug Administration’s approval of Capvaxive in June last year. The vaccine is also already approved in Canada and Australia.