Biologics

FDA to Convene Panel on Moderna’s mRNA Flu Vaccine

FDA is announcing a 6/18 advisory committee meeting to review Moderna’s mRNA-based seasonal influenza vaccine. The Vaccines and Related Biological Products Advisory Committee is scheduled to review Moderna’s MFLUSIVA (influenza vaccine, mRNA) for preventing influenza disease caused by influenza virus subtypes A and B represented in the vaccine in persons 50 years of age and older.

Moderna’s application faced a setback earlier this year when FDA initially rejected the filing over concerns that the company’s Phase 3 trial used an inadequate control group to demonstrate efficacy. The agency determined that Moderna should have compared its vaccine to a high-dose influenza shot in older adults rather than a standard-dose comparator used across all age groups in the trial.

The decision marked a reversal from prior regulatory alignment. During an End-of-Phase 2 meeting in 2024, FDA officials had agreed that a standard-dose flu vaccine would be an acceptable comparator for the Phase 3 study. Only after reviewing the late-stage data did the agency conclude that the control arm was insufficient.

That ruling landed in a politically charged environment surrounding mRNA-based vaccines, a technology that became widely known during the Covid-19 pandemic. While many scientists view mRNA as a platform with transformative potential, it has also become a lightning rod in partisan debates over vaccine mandates, pandemic policy and federal health authority, critics argue.

FDA quickly reversed its filing rejection, agreeing to review Moderna’s vaccine following what media reports described as an unusual, high-level meeting between agency leadership and the vaccine maker (see earlier story).

Earlier this month, Moderna reported that its flu vaccine outperformed conventional influenza vaccines in a late-stage international study involving more than 40,000 adults age 50 and older. If approved, the vaccine would become the first seasonal influenza shot in the U.S. developed using messenger RNA technology, the same platform used in Moderna’s Covid-19 vaccine.

An FDA regulatory decision is expected by 8/5.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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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