Moderna has paused its mRNA RSV (Respiratory Syncytial Virus) vaccine trial for children after five infants were hospitalized with severe respiratory complications.
This comes just days after the FDA quietly admitted it had halted enrollment in similar trials, citing safety concerns for children under two years old.
The news broke during Thursday’s FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting, where panelists struggled to navigate the safety implications of Moderna’s findings, Fierce Pharma reported.
Henry Bernstein, a professor of pediatrics at Hofstra/Northwell, stated, “This all seems like an incredible conundrum with lots of unanswered questions remaining—lots to still learn.”
The halted trial, identified as mRNA-1365-P101, sought to evaluate the safety, tolerability, and immunogenicity of two mRNA-based vaccines, mRNA-1345 and mRNA-1365. The vaccines were designed to protect infants and toddlers against RSV.