Biologics

FDA Wants mRNA Vaccines Tested in More Kids

FDA has asked Pfizer/BioNTech and Moderna to expand their trials of Covid vaccines to include several thousand school children before they seek final emergency use authorization for their vaccines. The Washington Post reports the changes to ongoing pediatric trials could delay the availability of the vaccines for children ages 5 to 11 beyond the hoped-for timeline of early fall, although it is unclear how much of a delay there could be.

The expanded testing is intended to assess whether a rare inflammation of the heart muscle that has been seen in young adults shortly after vaccination is more common in younger age groups.

An anonymous federal official told the Post that authorization of a vaccine for children ages 5-11 could come by late October or early November.

A Moderna spokesperson said the company is consulting with FDA on a proposal to expand its trial but had not settled on final numbers.

The article says FDA is likely to require two months of follow-up data for the 5-11 age group, as it did for adolescents and adults. For children under age five, it says, the agency might require four to six months of follow-up data, meaning vaccines are unlikely to be available for several months for infants and young children.

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FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

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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