mRESVIA RSV vaccine approved to protect patients aged 60 and over

The Medicines and Healthcare products Regulatory Agency (MHRA) has approved an mRNA respiratory syncytial virus (RSV) vaccine (brand name mRESVIA) to protect patients aged 60 and over against lower respiratory tract disease caused by RSV.

RSV is a common virus that spreads very easily and causes respiratory tract disease in people of all ages. RSV infection can be mild, with cold-like symptoms including blocked nose, cough, and/or sore throat. However, the virus can also cause more serious problems, such as lung infections and pneumonia. Older adults are at risk of more serious complications that can lead to hospital admission and even death.

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

“Keeping patients safe and enabling their access to high quality, safe and effective medical products are key priorities for us.

“We’re assured that the appropriate regulatory standards for the approval of this medicine have been met.

“As with all products, we will keep its safety under close review.”

This vaccine is administered as an intramuscular injection in the top of the arm by a doctor, pharmacist, or nurse. The recommended dose is 0.5 mL.

The vaccine works by preparing the body to defend itself against RSV. It contains an active substance called messenger ribonucleic acid (mRNA) to carry instructions that cells in the body can use to make the same protein that is also present on the virus. This protein stimulates the body’s natural defences (immune system) to produce antibodies which help protect against lung diseases caused by RSV.

This national approval is supported by evidence from a study in over 35,000 adults who were age 60 or older. In this study, participants were given either a single dose of the RSV vaccine or a placebo (dummy) injection.

The study found that around 4 months after vaccination, people who received the RSV vaccine had a 79% reduction in their risk of getting lower respiratory tract disease caused by RSV, compared with those who received placebo.

The most common side effects of the vaccine, which may affect more than 1 in 10 people, include swelling/tenderness in the underarm, headache, muscle ache, joint aches, pain at the injection site, tiredness, and chills.

As with any medicinal product, the MHRA will keep the safety and effectiveness of this RSV vaccine under close review. Anyone who suspects they are having a side effect from this vaccine are encouraged to talk to their doctor, pharmacist, or nurse and report it directly to the 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.

Notes

1. The new marketing authorisation was granted on 27 February 2025 to Moderna Biotech Spain.
2. More information can be found in the Summary of Product Characteristics and Patient Information Leaflets which will be published on the MHRA Products website within 7 days of approval.
3. For more information can be found on the NHS website about respiratory tract disease and RSV
4. 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.
5. The MHRA is an executive agency of the Department of Health and Social Care.source