Moderna announced in January 2023 that its investigational mRNA vaccine candidate for respiratory syncytial virus (RSV), mRNA-1345, has been granted Breakthrough Therapy Designation by the US FDA. The designation was based on the positive data from the ConquerRSV Phase III trial.  

Breakthrough Therapy Designation 

Moderna describes the grant as a step to “expedite the development and review of drugs that are intended to treat a serious condition, and when preliminary clinical evidence indicates the drug or vaccine may demonstrate substantial improvement over available therapy on a clinically significant endpoint”.  

In August 2021 Moderna’s candidate was granted Fast Track designation. Moderna hopes to submit a license application for regulatory approval in “the first half of 2023”.  

The race continues 

As we have previously reported, both Pfizer and GSK are also developing RSV candidates, and are slightly ahead of Moderna in what Fierce Biotech describes as the “RSV regulatory sprint”. Applications for regulatory approval from both competitors were accepted by the FDA towards the end of 2022. Furthermore, Sanofi’s protective antibody for infants, nirsevimab, has also been submitted for approval.  

“The windfall of potential RSV preventatives marks a watershed moment in the fight against the virus, after years of failure have culminated in four encouraging candidates. Depending on when Moderna submits its application, all four could reach the market before the year ends.”  

Moderna’s CEO, Stéphane Bancel, commented on the importance of developing a vaccine to meet the “high unmet need” of RSV. 

“With this designation, we look forward to productive conversations with the FDA in the hopes of bringing our RSV vaccine candidate for older adults to the market safely and quickly.” 

He also commented on the success that the mRNA platform has had with “two positive Phase III infectious disease trial results”.  

“We continue to advance a portfolio of respiratory mRNA vaccines targeting the most serious diseases”. 

To hear from representatives from these key players in the RSV race, join us at the World Vaccine Congress in April for more updates.