Moderna Receives Medicines and Healthcare Products Regulatory Agency Marketing Authorization in the UK for RSV Vaccine

Moderna Inc announced that the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK has granted marketing authorization for mRESVIA (mRNA-1345), indicated for active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in adults 60 years of age and older.

“The MHRA’s authorization of our RSV vaccine is an important milestone for Moderna’s efforts toward respiratory disease preparedness,” said Stéphane Bancel, Chief Executive Officer of Moderna. “Our RSV vaccine will be manufactured at the Moderna Innovation and Technology Centre in Oxfordshire, which will be fully operational later this year.”

RSV is a highly contagious seasonal respiratory virus and a leading cause of lower respiratory tract infections and pneumonia. In the UK, RSV has an impact on elderly adults and is responsible for 175,000 GP appointments, 14,000 hospitalizations, and 8,000 deaths in adults 65 years of age and older per year.[i]

“Given the serious consequences of RSV for older people, which can lead to hospitalization and severe outcomes, we are delighted that the MHRA has authorized our RSV vaccine,” said Darius Hughes, UK General Manager of Moderna. “With the MHRA decision, mRESVIA becomes Moderna’s second approved product in the UK, further demonstrating the role of mRNA vaccines in helping to protect the public from respiratory diseases.”

The approval is based on positive data from the Phase III clinical trial ConquerRSV, a randomized, placebo-controlled, observer-blind, case-driven clinical study conducted in approximately 37,000 adults aged 60 years or older in 22 countries. No serious safety concerns were identified in the Phase III trial.