News: FDA leadership overruled staff scientists on full pediatric Covid-19 vaccine approval.

The agency's internal review team recommended approval for all children. Instead, a Trump appointee vetoed it.

This is breaking news that has been reported by at least one other outlet, but is flying under the radar.

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The Trump administration’s newly-installed vaccine czar at the FDA, Dr. Vinay Prasad, overrode staff scientists’ recommendations for full approval of Moderna’s pediatric Covid-19 vaccine, a July 9 memo indicates. Instead, FDA leadership granted what it calls full approval to Moderna’s Covid-19 vaccine to individuals ages 6 months to 11 years old; In reality, the approval applies only to children with documented health conditions that increase the risk of severe Covid-19 illness, as discussed previously here in Inside Medicine. The latest decision memo echoes similar language in a previous “override memo” that similarly limited full approval of the Novavax vaccine for adults ages 12 to 64 to people with documented risks for severe Covid-19.

The memo explains in some detail—though without explicit evidence in many instances—the beliefs informing FDA leadership’s decision to ignore the data submitted by Moderna, chiefly its randomized, blinded, placebo-controlled clinical trial that included all children, not just those with increased risks. The memo also attempts to justify why leadership ignored its own scientists’ recommendations in various ways. Lacking, however, are any comprehensive analyses of the data, including explicit delineations of where Dr. Prasad believes FDA’s rank-and-file scientists got things wrong. Sadly, the analysis is very thin on data, and offers little insight into the analysis that led Dr. Prasad to disagree with his own scientists. That’s remarkable because national vaccine policy was changed via this memo.

Some of Prasad’s arguments are likely to be factually persuasive for some pediatric subgroups, though not all. Indeed, the memo states one side of the ledger on several topics, but not the other. For example, Dr. Prasad reports that severe Covid-19 rates are now lower than they have been in the past, including periods covered by Moderna’s clinical trial. However, his memo fails to offer actual data on modern risk-benefit assessments that could, if present, provide persuasive arguments.

I’ll write more on this soon, but I just wanted to get you this news and get the conversation going. Please take a look at the memo, and let me know what you think.

That’s all for now. Thanks for supporting science, facts, and the actual American way. Please help the cause by sharing this work…

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