u/StockEnthuasiast

>Late last year, former CBER director Vinay Prasad claimed in a leaked internal memo that “at least 10 children have died after and because of receiving COVID-19 vaccination.” The FDA, after much blowback from the industry and independent experts, promised to disclose its analysis by the end of 2025, but the agency largely kept its specific findings under wraps.

but then

>The FDA’s report, dated Dec. 5, flagged 96 “unique” pediatric deaths in the U.S. as of Aug. 14, 2025, as reported to the agency’s Vaccine Adverse Event Reporting System (VAERS). Of these, “no cases were classified as certain in relation to COVID-19 vaccination,” the report read—a stark contradiction to Prasad’s initial claim of causality.

https://www.biospace.com/fda/fdas-own-report-shows-no-child-deaths-definitively-caused-by-covid-vaccination

OTHER DEPARTURES ​EXPECTED

Hoeg's departure would come amid a broader shake-up of the health department. The White House has exerted more control over the ​department in recent months as polls show Kennedy's efforts to rewrite U.S. vaccine policy could prove costly with voters in November's midterm elections that will decide whether Republicans retain control of Congress.

Source: https://www.reuters.com/world/fda-drug-center-head-expected-leave-after-commissioners-exit-sources-say-2026-05-15/

Deeper dive: FDA shake-up: Makary loyalists in limbo - Politico .

X post from Adam Cancryn, White House reporter at CNN:

>New: Trump officials want to recommend a new pick for FDA commissioner to the president by early June—a quick timeline that comes as they race to stabilize the agency.

>But first: More senior-level exits likely at FDA soon as today amid a broad review of Makary's leadership team

Credit to u/LogicalReasoning1 for pointing this out to me. It looks like the Novavax/Sanofi's phase 4 COVID vaccine trial has finally been updated, and they appear to have recruited all planned participants after all. I wasn’t expecting this.

Sanofi taking over clearly changed the equation. Recruiting 6,500 participants is probably not that difficult for Sanofi, especially compared with the much larger 25,000-plus participant commitments from Pfizer/BioNTech and Moderna.

That said, I am still skeptical that completed recruitment automatically means they can capture enough cases for an efficacy readout by May 30. The key issue is not just enrollment. It is whether a 6,500-participant trial can generate enough infection events quickly enough, especially now that infection rates are much lower than during the pandemic phase.

The trial had appeared dormant from the public ClinicalTrials.gov record because it had not been visibly updated for months. Now that it has finally been updated, the picture looks better than I expected, but that does not fully answer the case-accrual question.

The BioNTech case is still a useful comparison. Reuters reported that Pfizer/BioNTech halted their U.S. COVID vaccine study after recruitment struggles, with enrollment at around 5,240 despite a much larger original target. If a 5,000 to 6,000-ish participant cohort were clearly enough to capture meaningful efficacy cases, the BioNTech recruitment shortfall probably would not have been treated as such a meaningful problem and Reuters would have nothing to report then.

That comparison matters even more because BioNTech appears, from the public ClinicalTrials.gov record, to have reached its 5,000-ish enrollment level faster than Novavax/Sanofi reached 6,500. So while Novavax/Sanofi reaching 6,500 is better than I expected, I am not convinced that it automatically solves the case-accrual question by May 30. And to be fair, I would be equally doubtful that BioNTech’s 5,000-ish cohort could do so either.

More broadly, I think the current FDA is signaling that manufacturers need to make a good-faith effort to comply with their commitments if they still want to keep selling their vaccines. On that front, Sanofi deserves some credit. Whatever my skepticism about the eventual case count, stepping in and getting Novavax to the 6,500-participant target is not nothing. It clearly improves Novavax/Sanofi’s position compared with where it seemed to be before. Still, the actual case count is the part to watch.

Not financial advice, obviously. This is just my personal read of the situation.

May 12, 2026 11:20 AM PT

The timing of this conference is interesting. With the current hantavirus news cycle, Moderna may get a natural chance to comment on the broader infectious disease angle without making it look forced.

Otherwise, it would probably be awkward for Moderna to address it directly.