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The Medicines and Healthcare products Regulatory Agency (MHRA) has on 15th May, 2025 approved a vaccine (Capvaxive) for people aged 18 years and older to help protect against illnesses caused by bacteria called Streptococcus pneumoniae or pneumococcus.
The marketing authorisation was granted on 15th May, 2025 to Merck Sharp & Dohme (UK) Limited.
Illnesses caused by Streptococcus pneumoniae bacteria include lung infection (pneumonia), inflammation of the brain and spinal cord (meningitis) and infection in the blood (bacteraemia). The vaccine works by helping the body to make its own antibodies, which protect against these diseases.
This vaccine has been approved through the International Recognition Procedure (IRP). The IRP allows the MHRA to take into account the expertise and decision-making of trusted regulatory partners for the benefit of UK patients.
The MHRA conducts a targeted assessment of IRP applications and retains the authority to reject applications if the evidence provided is not considered sufficiently robust.
As with any medicine, the MHRA will keep the safety and effectiveness of this vaccine under close review. Anyone who suspects they are having a side effect from this medicine are encouraged to talk to their doctor, pharmacist or nurse and report it directly to the MHRA Yellow Card scheme, either through the website (https://yellowcard.mhra.gov.uk/) or by searching the Google Play or Apple App stores for MHRA Yellow Card.
The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgments to ensure that the benefits justify any risks.
The MHRA is an executive agency of the Department of Health and Social Care.
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