MHRA approves Moderna's RSV vaccine for older adults

Moderna's respiratory syncytial virus (RSV) vaccine, mRESVIA, has received approval from the Medicines and Healthcare products Regulatory Agency (MHRA) for use in adults aged 60 years and older. This vaccine targets lower respiratory tract disease (LRTD) caused by RSV, a virus that is commonly spread and typically results in mild symptoms similar to a cold. While most individuals recover from the virus within a couple of weeks, it can lead to severe complications such as lung infections and pneumonia, particularly in older adults.

The elderly population is notably vulnerable to serious RSV-related complications. In the UK alone, the virus accounts for approximately 14,000 hospitalisations and 8,000 deaths annually among adults aged 65 and older. Darius Hughes, General Manager of Moderna in the UK, expressed the company's satisfaction with MHRA's approval, stating that the vaccine's authorisation is crucial given the severe consequences RSV can have on older individuals, sometimes resulting in hospitalisation and other serious outcomes.

The MHRA's decision was bolstered by promising findings from the ConquerRSV trial, a late-stage study involving roughly 37,000 adults aged 60 and above who were assigned to receive either the mRESVIA vaccine or a placebo. Results from the study indicated that approximately four months following vaccination, those who received Moderna's vaccine exhibited a 79% lower risk of developing RSV-induced LRTD compared to participants who received the placebo.

Stéphane Bancel, Chief Executive Officer of Moderna, highlighted the significance of the MHRA's approval, marking it as a pivotal milestone in Moderna's mission to enhance preparedness against respiratory diseases. Bancel also mentioned that production of the vaccine will occur at the Moderna Innovation and Technology Centre in Oxfordshire, which is anticipated to become fully operational later this year.

Coinciding with Moderna's approval, the UK government has recently implemented a national vaccination programme aimed at protecting both infants and older adults from RSV, utilizing Pfizer's vaccine, Abrysvo. Initiated in September, this programme involves offering a vaccine to pregnant women beyond 28 weeks of gestation to safeguard their newborns. It also includes a routine vaccination programme for individuals over 75 years of age and a one-time campaign targeting those between 75 and 79 years old.

Steve Russell, the NHS's National Director for Vaccinations and Screening, hailed the rollout as a significant advancement that is expected to save the lives of many who are most vulnerable to the virus. The comprehensive approach to vaccination underscores the importance of protecting at-risk populations from the serious health consequences associated with RSV.