FDA documents reveal that Moderna has had to shut down its clinical trial of experimental mRNA vaccines for respiratory syncytial virus (RSV) in babies, after the shots were linked to severe side effects.
The FDA’s vaccine advisory committee will discuss concerns about the vaccine, which the agency fast-tracked in 2021.
Meanwhile, trials for investigational RSV vaccines for babies and some children have now been put on hold.
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The Defender reports: The U.S. Food and Drug Administration (FDA) disclosed this week in a briefing document that rather than protecting babies as anticipated, the vaccine likely caused higher rates of severe RSV illness among the vaccinated babies enrolled in the Phase 1 clinical trials.
The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet Thursday “to discuss considerations for RSV vaccine safety in pediatric populations” based on Moderna’s clinical trial data.
Although the FDA never cites Moderna by name in the document as the company that made the vaccine in question, the agency lists the investigational vaccines, mRNA-1345 and mRNA-1365, and describes trial outcomes.
The FDA document also stated that enrollment is now on hold for all investigational trials for RSV vaccines for infants and toddlers under age 2 and children ages 2 through 5 who haven’t previously had RSV illness.
In September, Moderna announced it had put the brakes on its plan to roll out its mRESVIA RSV vaccine for babies, “based on emerging clinical data.”
This is not the first time that an attempt to develop an experimental RSV vaccine for children caused severe illness. The FDA said a formalin-inactivated RSV vaccine trialed in the 1960s led to two toddler deaths, and 80% of vaccine recipients required hospitalization for severe RSV.
The illnesses were attributed to vaccine-associated enhanced respiratory disease (VAERD) — a phenomenon that occurs when vaccination promotes immune responses that exacerbate the disease caused by subsequent infection with the pathogen the vaccine was meant to protect against.
The trials were halted in 1967, and clinical RSV vaccine research stalled until recently.
In 2023, the FDA gave Moderna the green light to move ahead with its clinical trial, also called the Rhyme Trial, to test the safety and immunogenicity of its two investigational mRNA RSV drugs in children ages 5-23 months.