Moderna’s RSV vaccine candidate receives FDA Fast Track Designation

The fast-track designation for older populations highlights the critical need for an RSV vaccine.

The American-based biotech, which made its name in 2020 with its COVID-19 vaccine, has been granted fast-track designation for mRNA-1345, which is under investigation as a single-dose vaccine for Respiratory Syncytial Virus (RSV) in adults older than 60 years of age. RSV is a common respiratory virus that affects the lungs and its bronchioles and usually causes mild, cold-like symptoms. Although most people recover in a week or two, RSV can be serious, particularly in infants and the elderly. The company has high hopes for the vaccine to prevent RSV infection in both young children and older adults. “We are pursuing an mRNA RSV vaccine to protect the most vulnerable populations – young children and older adults,” said Stéphane Bancel, Chief Executive Officer of Moderna.

Fast-track designations help speed up the review of therapies and vaccines for serious conditions that can fill an unmet need. To date there is no approved vaccine available for RSV on the market. Moderna is conducting a phase 1 study of mRNA-1345 covering children to the elderly to determine tolerability and the vaccine's ability to create antibodies to protect against the virus. According to interim results from one month post immunization released in April this year, the vaccine boosted neutralizing antibodies by at least 11-fold compared to baseline, the company said. In addition, the biotech plans to evaluate the potential of combinations of mRNA-1345 with its vaccines against other respiratory diseases in children and in older adults separately.