Moderna’s respiratory syncytial virus (RSV) vaccine mRESVIA has been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) to protect adults aged 60 years and older against lower respiratory tract disease (LRTD) caused by RSV.
RSV is a common contagious virus characterised by several mild, cold-like symptoms. Although most people can recover within a week or two, some can experience more severe problems, including lung infections and pneumonia.
Older adults are at a higher risk of serious RSV complications, with the virus responsible for 14,000 hospitalisations and 8,000 deaths in adults 65 years and older every year in the UK.
Darius Hughes, UK general manager of Moderna, said: “Given the serious consequences of RSV for older people, which can lead to hospitalisation and severe outcomes, we are delighted that the MHRA has authorised our RSV vaccine.”
The UK regulator’s decision was supported by positive results from the late-stage ConquerRSV trial, which randomised approximately 37,000 adults ages 60 years and older to receive either mRESVIA or a placebo vaccine.
The study found that around four months after vaccination, individuals who received Moderna’s vaccine had a 79% reduction in the risk of developing LRTD caused by RSV compared with those who were given placebo.
Stéphane Bancel, Moderna’s chief executive officer, said: “The MHRA’s authorisation of our RSV vaccine is an important milestone for Moderna’s efforts toward respiratory disease preparedness.”
Bancel added that the vaccine “will be manufactured at the Moderna Innovation and Technology Centre in Oxfordshire, which will be fully operational later this year”.
The UK government recently launched a national vaccination programme to protect infants and older adults against RSV with Pfizer’s Abrysvo.
The new initiative, which launched in September, includes a vaccine for pregnant women over 28 weeks to help protect their babies, a routine programme for those aged over 75 years and a one-off campaign for people aged 75 to 79 years.
Steve Russell, NHS national director for vaccinations and screening, described the rollout as “a huge step forward [that] will undoubtedly save the lives of many of those most at risk”.