Moderna’s RSV Vaccines Face Safety Concerns Over Severe Infections in Infants
Safety Concerns:
The FDA has identified severe side effects in two of Moderna's experimental mRNA-based respiratory syncytial virus (RSV) vaccine candidates, mRNA-1345 and mRNA-1365, intended for infant immunization12.
Severe Infections:
At least five cases of severe or very severe RSV lower respiratory tract infections were reported in infants immunized with these vaccines, particularly in those aged 5 months to less than 8 months15.
Study Pause:
Moderna enacted a "study-wide pause" after being informed of the safety findings, which triggered one of the study's pause criteria1.
Advisory Committee Meeting:
The FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) will discuss these safety findings to determine their implications for ongoing and future pediatric development of non-live attenuated RSV vaccines1.
Market Impact:
These safety concerns could affect Moderna's position in the RSV vaccine market, where GSK's Arexvy and Pfizer's Abrysvo are leading competitors12.
Broader Safety Concerns:
The FDA's findings suggest a potential safety concern that could be applicable to the evaluation of RSV vaccine candidates in infants and toddlers more broadly25.
Sources:
1. https://www.biospace.com/drug-development/modernas-rsv-vaccines-run-into-safety-roadblock
2. https://endpts.com/cases-of-severe-rsv-in-two-moderna-vaccine-candidates-trials-raise-questions-about-future/