ACIP left COVID vaccines hanging
Disorder in the (kangaroo) court
No nationwide COVID summer surge yet Virus levels in wastewater have been fluctuating at very low-low for 5 weeks and the PCR-positive rate in clinical tests has hovered no higher than 3% for 2 months (Table 1).
COVID deaths have been at 0.3% of all causes of death for the 3rd week ending June 21 and fallen to 165/week in the 4 weeks ending June 14 (CDC).
The NB.1.8.1 Omicron subvariant has overtaken LP.8.1 in causing new infections, 43% to 31% (CDC). XFG is also on the rise at 14%. All these viruses came from JN.1 as we wait for CDC to decide on the vaccines for the upcoming fall.
Viruses abroad arriving at US airports the week of June 8 produced a 1.7%-positive rate for the passengers tested, the highest this year (Traveler-based Genomic Surveillance). Sequencing of samples collected in late May showed 34% NB.1.8.1, 28% XFG, and 14% LP.8.1.
Measles nearing quarter-century high as it slows down for the 5th week, now at 1227 confirmed cases as of last Tuesday with Oregon joining as the 36th state (CDC). The West Texas outbreak has stalled at 750 cases with active counties down to two and 34 additional cases elsewhere for a state total of 784 (TX DSHS).
Vaccines
• Disorder in the (kangaroo) court When you reconstitute a committee such as ACIP, you can't expect to just add water and up pops a fully qualified committee. When it met publicly last Wednesday and Thursday, procedure was ignored, conflicts of interest went undeclared, unvetted “evidence” was presented, a review of vetted evidence was removed, a concerning vote was held, and an important vote was not held.
• ACIP left COVID vaccines hanging without a vote on recommendations for the fall and winter. Is this only because of an unfinished evidence-to-recommendations CDC study due to the resignation of the study group head (https://covidandvaccineupdate.substack.com/p/kennedys-acip-shown-the-data)? Or does Kennedy plan to do another unilateral decision on COVID vaccines as he did in removing the eligibility of healthy kids and pregnant women (https://covidandvaccineupdate.substack.com/p/flurry-of-vaccine-policies-with-questions)?
What HHS under Kennedy has and has not allowed so far with COVID vaccines:
✓ FDA approved the mRNA vaccines, including Moderna’s new design, mRNA-1283 or mNEXSPIKE (https://covidandvaccineupdate.substack.com/p/covid-and-flu-still-nothing-to-sneeze), and Novavax’s protein shot.
✓ FDA recommended that manufacturers prepare vaccines for 2025-2026 to target the JN.1 line of Omicron subvariants with a preference for LP.8.1, the dominant virus in May (https://covidandvaccineupdate.substack.com/p/lp81-fall-booster).
With these two actions, FDA appeared to allow the updated fall vaccines to proceed without the additional clinical trials required for “new” vaccines.
✓ However, FDA also issued a quasi-policy “framework” restricting the eligibility for all COVID vaccines to only people 65+ (age eligibility) and younger populations 12 to 64 with at least one of the listed risk factors (risk-based eligibility) (https://covidandvaccineupdate.substack.com/p/new-rules-for-covid-vaccines-unleashed). An approved risk was pregnancy, which conflicted with Kennedy’s directive (https://covidandvaccineupdate.substack.com/p/flurry-of-vaccine-policies-with-questions).
So despite the dueling directives and the restrictive eligibility, it looks like who can get the fall jabs is settled, but which shots will be available without delays, e.g., by additional clinical testing, is still up to a vote unless Kennedy will decide by fiat.
• Absent a vote, all bets are off When the reconstituted advisors did vote Thursday on the flu vaccines for next season, they overruled FDA and essentially banned the use of flu jabs in multidose packaging containing thimerosal preservative and thus limited access to flu protection for some populations. This also set a precedent for ACIP to overrule FDA’s approval of the updated COVID vaccines.
The removal of the CDC scientists’ review of studies on the safety of thimerosal that countered a presentation by Kennedy’s new hire at HHS, an ex-president of the anti-vaccine Children’s Health Defense he founded, set another foreboding precedent that this committee has no problem with deleting evidence that contradicts their bias.
✓ ACIP could claim the updated vaccines are new and require more testing. For example, although Moderna’s new mRNA-1283 finished Phase 3 clinical trials worldwide, testing compared it to the original mRNA-1273, not a placebo that’s required by HHS’ gold standard.
The committee has pledged “to not hold a vote if there is not sufficient information to enable evaluation of the risks and benefits.” (CNN Health) And they seemed unconcerned that another meeting won’t be scheduled until September or even October.
There have been no updates from the manufacturers on which target they’re preparing for as the circulating viruses continue to change or on the schedules for delivery. And would any company be willing to do the clinical trials to extend eligibility to healthy people under 65?
© 2025 Henry A. Choy. All rights reserved.
Thanks for the updates, grim as they are. Better to know what’s fact and what’s uncertain.