My wish for the new admin is to address the postmarket study commitments for the mRNA COVID vaccines, which are shown in these screenshots.
-Have the results of submitted studies been published?
-Why are many studies running behind or not started yet?
-Why were some released?
1/3


2/3

Ok, this clip is funny. That said, I still grapple with how much the "revolving door" issue is being pinned as the crux of problems that are actually much greater.

https://twitter.com/rustyrockets/status/1721941788842180807

One of these days l must force myself to try to write something nuanced about this, from the perspective of someone who worked at FDA, approaching it as a sponge, after working in industry, who then went on to work for a small tech company before it was acquired by Big Data. So many thoughts ...

FULL APPROVAL. This is what the news media needs to also pick up on. FDA didn't merely authorize a new COVID booster; They elevated boosters from being authorized for emergency use, which applies a lower evidentiary bars than full approval, to FULL APPROVAL. I think this is a big deal because here the FDA is saying the benefit:risk profile has been adequately characterized. FDA has previously made this determination for the initial vaccine based on data from randomized, controlled clinicial trials. However, at the time of approval they required postmarket studies of subclinical myocarditis for a reason.

Short version: It looks like I won't hear back from FDA about my FOIA request for information about the subclinicial myocarditis studies of mRNA COVID boosters until at least early Sep.

Long version: I submitted the FOIA request on Jul 4th and requested expedited processing, asserting a "compelling need" for information prior to the next vaccination campaign this fall. I was noticed by FDA on Jul 10th that my request for expedited processing had been denied. After a call with an FOIA Officer about the relevant regulations, I submitted an appeal on Jul 26th. On Jul 31st, FDA sent an acknowledgement letter and told me that the appeal was deemed to fall under "unusual circumstances" per 45 CFR 5.24(f) (see pic). I was informed today by an FOIA Officer at FDA that an appeal response package is currently being reviewed by the Office of Chief Counsel (OCC). She does not expect to hear back from them until early September.
The referenced CFR:

https://twitter.com/RxRegA/status/1678420254484049931

More context on the “unusual circumstances” determination from FDA’s letter: “Pursuant to 5 U.S.C. § 552(a)(6)(B)(i) and 5 U.S.C. § 552(a)(6)(B)(iii) of the FOIA and 45 CFR 5.24(f) of the HHS FOIA regulations, your appeal falls under “unusual circumstances” in that our office will need to consult with another office that has substantial interest in the determination of the appeal. The actual processing time will depend on the complexity of the issues presented in the appeal."
The other Office being consulted is the Office of Chief Counsel. The letter didn’t specify the substance of the substantial interest of the other office.
Hopefully, the package that is currently under review and expected by early September will provide clarity.

FDA has changed the status of Pfizer's subclinical myocarditis study of a 3rd dose of Comirnaty in 16-30 year olds from ongoing to delayed. The original projected completion date was Dec 2022. Moderna's study of Spikevax in 18+ is still listed as ongoing, even though its due date was Jun 2023.

On July 26th, I appealed FDA's denial to expedite processing of my FOIA request to obtain these study reports, or in the case they're not submitted yet, then for correspondence regarding these studies, as well as correspondence that mentions sublinical myocarditis in association with these BLAs. I assert that there exists an urgency to report on these studies before the next fall vaccine campaign for updated boosters.
Also, on July 14th, FDA said in an email that they'd respond to my inquiry dated July 11th "soonest" but I haven't heard from them since.

Each discussion Q could be posed as a vote, to make the Jun 28 VRBPAC more productive. Instead FDA goes w/ a single, overly broad voting Q that seems primed for a unanimous vote. VRBPAC politics are disheartening. The goal isn't a unanimous vote but a poll and the clearest input. Yes, members will still get to speak in discussion, but w/out a vote for each, the outcome is less likely covered fully by most of media, who hasn't well been messaging their nuanced input.
This said, unfortunately my life is pulling me away from covering this mtg to much degree.

“Misinformation & disinformation are now arguably the leading causes of death in America” This again?

https://twitter.com/DrCaliff_FDA/status/1540443007593349120

I want FDA+gov to compile & release iron-clad info backed by detailed data & sourcing that stand on its own. I don’t want them policing info by Americans whose right is to take a view. Untruths are best counteracted by high-quality, truthful, transparent info which is enough work

Maybe I'll start a podcast called "What the F...DA?" which questions the FDA, an agency I mostly still respect, but for whom I have some questions. Episode 1: Where are the F-ing briefing documents, F...DA? You're not always hitting the 2-day-before-meeting mark. fda.gov/advisory-commi…

Woah, looks like a few key #VRBPAC members who've been participating in past FDA AdCom meetings for COVID vaccines had terms that ended yesterday: Kurilla, Meissner, & Offit. These are standouts. There may be more members, but I haven't had a chance to compare all w/ ended terms. However, I believe that they can be brought in to serve as temporary members. The panel makeup will be interesting to follow. Here's the current standing #VRBPAC roster: fda.gov/advisory-commi…

Waiting for @US_FDA to fix their SpikeVax webpage now that it’s fully approved. Goes to error fda.gov/vaccines-blood… Approval PR fda.gov/news-events/pr… $mrna Meant to cc @FDASpox

There it is! FDA PR: FDA Approves First COVID-19 Vaccine fda.gov/news-events/pr… @US_FDA Link to PI not working fda.gov/about-fda/page…