LONDON, April 22 -- The government of the United Kingdom issued the following news:

The Medicines and Healthcare products Regulatory Agency (MHRA)has today, 22 April 2026approvedthe medicineEnflonsia(clesrovimab-cfor)for theprevention ofrespiratory syncytial virus (RSV) lower respiratory tract disease innewbornsand infantsup to 12 months of agethroughout their first RSV season.

RSV is a common and highlycontagious seasonalillnessthat usually causes symptomssimilar tothe commoncold andcan also affect the lungs.Almost all childrenget an RSV infectionbefore theyare two years old.RSV can lead tolife-threatening pneumonia and infant bronchiolitis(a lung infection).

The active ingredient inEnflonsia,clesrovimab, is an antibody (a protein that helps the bodyto fight harmful germs)thathelps prevent lung disease caused by RSV.

Julian Beach, MHRA Executive Director, Healthcare Quality and Access, said:

"It'simportant that wedo our best toprotectournewbornbabies and infantsespecially throughoutRSV season.

"Part of thisisenabling access to high quality, safe and effective medical products are key priorities for us.

"As with any medicine, the MHRA will continue to closely monitor the safety and effectiveness ofclesrovimab."

Clesrovimabisasingle injection administeredonceby a healthcare professional.

The most common side effectsassociated with thismedicineinclude pain, swelling,redness, or rashesatthe injectionsite.

Anyone who suspects their child ishaving a side effect from this medicineisencouraged to talk to their doctor, pharmacist,or nurse,and report it directly to the Yellow Card scheme, either through thewebsite(https://yellowcard.mhra.gov.uk/) or by searching the Google Play or Apple App stores for MHRA Yellow Card.

Notes toeditors  

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Thenew marketingauthorisationwasgranted on22 April 2026toMerck SharpDohme(UK) Limited.

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More information can be found in the Summary of Product Characteristics and Patient Information leaflets which will be published on theMHRA Products websitewithin 7 days of approval.  

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For more information about RSV, visit:https://www.nhs.uk/conditions/respiratory-syncytial-virus-rsv/

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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 judgements to ensure that the benefits justify any risks.  

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The MHRA is an executive agency of the Department of Health and Social Care.  

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For media enquiries, please contact thenewscentre@mhra.gov.uk, or call on 020 3080 7651.

Disclaimer: Curated by HT Syndication.