Everyone I have talked to today is horrified that the CDC might only recommend the next COVID-19 booster for elderly and immunocompromised people, after we have been told for years to expect it to become like the seasonal flu shot, while we are waiting for better boosters, while cases are spiking and the long COVID research is damning. Please. Ask them to approve it for everyone. We have until Friday to comment. Pls boost. https://www.regulations.gov/document/CDC-2023-0060-0001
https://www.pbs.org/newshour/health/your-fall-guide-to-covid-rsv-and-flu-vaccines this article mentioned in passing: "The general public should not expect to need to receive the latest COVID booster, Offit said." This was a terrible shock to me and I keep talking to people and they ask why? Why isn't it like the flu shot? What about people on drugs like Humira? What about the risks of reinfection and what about long COVID?
Federal comment websites are a bit challenging to navigate. Can you help me understand what we are commenting on?
I gather that the pdf downloadable with the "Download" button is the document in question, but it's a bit hard to understand. I think it's just announcing that ACIP is having a meeting on September 12th and that people are invited to comment (I guess on any topic that might be discussed at such a meeting?).
For the record, I hunted high and low for an actual agenda, and any additional materials about what would actually be discussed. The instructions for writing a comment say to direct them specifically to what is in the regulatory document that's been proposed. I found fuck all on which to comment. So I just shot from the hip.
My read is that the checklist is generic and was written with actual policy proposals in mind, and that in this case we're just commenting on a document which says "ACIP is going to meet on September 12th."
I.e. add comments relevant to the meeting here. But... I could also be wrong.
So, you've heard some of my ranting about the CDC and how it conducts its business in ways that are difficult to disambiguate between flaky and mendacious (and I suppose cavalier should be on that list). It would not surprise me at all if they're supposed to have published an agenda, and just completely failed to put it someplace public or link to it, or to have a proposal document, and just failed to have one at all. That would be very in keeping in how they behave.
Ok, I'd thought maybe this whole experience was just the way regulations.gov is, but having gone to their main page and randomly clicked on one of the "trending" dockets from another agency....
Important detail! The person interviewed, this Offitt dude, is from the FDA, not the CDC. It is very much unclear to me how much he 1) knows what he is talking about, and 2) is in a position of influence.
The FDA and the CDC have a very interesting relationship with regards to the COVID vaccines and treatments. The FDA approves them, and the CDC determines what constitutes a high risk group.
So when you read the FDA's emergency use authorization (EUA) for, e.g., Paxlovid, it says it's for people at high risk for severe disease. It does not itemize who those people are or what criteria put them into that category. But over on the CDC website, they maintain a separate list of people at elevated risk for severe disease.
I think you've badly misunderstood my comment. I didn't suggest that he's an anti-vaxxer or anything like it, and I'm a little put out that you're trying to fit this discussion into that "with us or against us" pigeonhole. I assure you, all the idiot, arrogant physicians who were refusing to prescribe Paxlovid to their patients because they assumed they knew what categories of patient were high risk without actually checking the list were none of them anti-vaxxers, they were on "our side". They may even have clinical accomplishments to their credit.
@siderea@McBlondeLand@coreo The post I linked to is clearly and specifically not doing that. Ironic for you to start your reply with that first sentence.
@siderea@McBlondeLand@coreo So just fwiw and in case it’s useful to know, Paul Offitt isn’t FDA staff. He’s an advisor on the VRBPAC committee, and this has pretty much been his position from jump re: covid shots. I think the framing here by PBS is really unhelpful and confusing, unless they have reason to believe that Offitt is previewing CDC’s recs—which would contradict everything we’ve been hearing out of CDC (and exec admin) this year.
@siderea@McBlondeLand@coreo (There have absolutely been people advising both agencies against approval or recommendation of the shots for gen population (especially kids) all along, and I’m sure there will be again—you can watch the whole CDC meeting on Sept 12, if you’re into that—but it would be a surprise if those voices suddenly won out. It could happen, but I am not expecting it.)
One of the frustrating consequences of this state of affairs was that a huge number of physicians saw EUA and decided to come up with their own criteria of who was at elevated risk for severe disease, and it was a much shorter list than the CDC's, so were refusing to prescribe Paxlovid to many patients who qualified under the CDC's list.
(I spent quite a bit of time yelling at physicians about this over on Reddit, because I am a mental health professional and there's a whole bunch of mental health conditions on the CDC's list, and PCPs who are coming up with their own idea of who was at elevated risk never, ever included people whose risk factor was mental illness.)
So this Offitt dude at the FDA. I have no idea if he's saying they're going to change the criteria, or he's like every other physician I've argued with about Paxlovid, who just assumes that elevated risk means septagenarians and AIDS patients, and never actually reviewed the CDC's list.
@siderea, I linked to your comment (re: Offit, FDA, and CDC) to some people I know over on Discord, and one of them responded with the following:
"I recommend investigating Offit's background in opposing smallpox vaccination in 2002 and helping ultimately killing it at the political level after he was initially the only member of the CDC committee to vote against it."
This seemed like something you might want to chase down, so I'm passing it along.
By the way, if you want to drop research on the CDC's head, heretofore the age threshold for elevated risk wasn't 65, it was 55 (or 50? I forget), and the reason why was, well, see figure 1 in this research article from 2020: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7335648/ Note: only the top two graphs are COVID, the other two are other conditions it's being compared to.
@siderea I guess that's one way for Congress to save money on the Social Security expenses. 😠 Reminds me of the time in the beginning when Texas' Lt. Gov. Dan Patrick went on Fox and said “lots of grandparents” are willing to sacrifice themselves for the cause." His cause was $$$.
By some accounting, something like 80% of the American public have a condition that qualifies them to be prescribed Paxlovid. It includes, after all, being overweight, having diabetes, having depression, and/or having ever been a smoker. Which, yeah, is pretty much everyone.
So I have no idea what this Offitt guy is saying. There's more stringent definitions of elevated risk coming down? Or he's talking out of his ass because he's at the FDA and not at the CDC and has no idea what the CDC considers qualifying as elevated risk, and just assumes the elevated risk pool is really small?
Who knows. I suggest commenting about one's concerns to the CDC, with the understanding that maybe this dude is a total outsider to this process and maybe even irrelevant.
@siderea@McBlondeLand@coreo I find it unnerving that it was supposed to be available mid September and there has been no mention of who is eligible. Doesn’t smell right.
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