New Vaccine Offers Broad Protection Against Pneumonia adn Meningitis
A new weapon in the fight against pneumococcal disease has arrived. Capvaxive, a vaccine developed by Merck & Co. (known as MSD outside the U.S. and Canada), has secured approval from the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom. This single-dose vaccine is designed to protect adults aged 18 and older from illnesses caused by streptococcus pneumoniae bacteria, offering a shield against conditions like pneumonia and meningitis.
the Threat of Pneumococcal Disease
The world Health Institution (WHO) considers pneumococcal disease a major public health problem.
With over 100 different types of pneumococcal bacteria, developing a vaccine that offers broad protection is a significant challenge.capvaxive, a 21-valent vaccine, targets the specific strains responsible for the majority of adult invasive pneumococcal disease.
Fast-Track Approval and Robust Clinical Data
The MHRA’s decision to approve Capvaxive was expedited through the International Recognition Procedure, a process that leverages prior authorizations from other regulatory bodies. This followed the European Commission’s approval of the vaccine in March, signaling a growing consensus on its efficacy and safety.
The EU regulator’s decision was supported by compelling data from a phase 3 clinical trial. This trial compared Capvaxive to pfizer’s 20-valent vaccine (PCV20) in adults who had not previously received a pneumococcal vaccine. The results were promising:
- Non-inferior immune responses: Capvaxive induced immune responses comparable to PCV20 for all ten serotypes common to both vaccines in adults aged 50 and older.
- Superior immune responses: Capvaxive generated stronger immune responses for ten of its 11 unique serotypes.
- Comparable safety: The vaccine’s safety profile was similar to PCV20.
- Efficacy across age groups: Capvaxive elicited non-inferior immune responses in adults aged 18 to 49 years compared to those aged 50 to 64 years.
Statements from Regulators and MSD
The MHRA emphasized its commitment to ongoing monitoring, stating, As with any medicine, the MHRA will keep the safety and effectiveness of this vaccine under close review.
Emma Cerrone,vaccines business unit director,MSD UK,expressed enthusiasm about the approval: 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.
Global Availability
In addition to the EU and the UK, Capvaxive is also approved in the U.S., Canada, and Australia, making it available to a significant portion of the global population.
FAQ: Capvaxive Vaccine
- what is capvaxive?
- A vaccine to protect adults against illnesses caused by Streptococcus pneumoniae bacteria.
- Who is it for?
- Adults aged 18 years and older.
- How manny doses are needed?
- A single dose.
- Where is it approved?
- The UK, EU, US, Canada, and Australia.
