Drugs

Advisory Panel to Discuss Pediatric RSV Vaccine Safety

FDA is convening its Vaccines and Related Biological Products Advisory Committee 12/12 to discuss whether currently available data indicate a potential safety concern in conducting respiratory syncytial virus (RSV) vaccine trials in infants and toddlers. The panel meeting was prompted by safety concerns raised in Moderna’s Rhyme Trial that evaluated two messenger RNA (mRNA)–based investigational vaccines (mRNA-1345 and mRNA-1365) for preventing RSV in infants and young children ages 5–23 months, according to an FDA briefing document.

Pediatric RSV vaccine clinical trials were put on hold in the 1960s after vaccine-associated enhanced respiratory disease, including two toddler deaths, were observed in investigational RSV vaccines. As RSV vaccine technology progressed, the advisory committee convened in 2017 to lay out safety-related criteria to allow pediatric RSV vaccine trials to resume.

During the recent Moderna Rhyme trial, “an imbalance in severe RSV cases was identified, based on a pre-specified study stopping criterion, among participants five months through eight months of age who received the lower mRNA vaccine dose,” the agency says. “In Cohorts 3 and 4, five cases (12.5% of participants) of clinically significant severe/very severe RSV were identified in the vaccine groups (all of whom had received one or two doses of a three-dose schedule), compared with one case (5% of participants) in the placebo group. The percentage of participants with symptomatic RSV disease in Cohorts 3 and 4 who progressed to severe illness was 26.3% in the vaccine groups compared with 8.3% in the placebo group.”

FDA says that based on the currently available evidence, it plans to ask committee members to discuss current nonclinical and clinical safeguards, and recommend whether any additional nonclinical and clinical information should be considered or precautions taken when evaluating pediatric RSV vaccine candidates.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome