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Sep 7, 2022·edited Sep 7, 2022

Expecting more than a "one size fits most" from the CDC and FDA would be asking too much. Patient self-advocacy is something that many people aren't aware of. It take a lot of reading but you can acquire sufficient knowledge to question your doctor's guidance and chart your own course. At 70 years of age, 1 booster/yr will not give me sufficient neutralizing antibodies to prevent infection from covid.

My goal is to avoid Long Covid. The only way to achieve that is to avoid infection. Until there is a booster that can achieve that, I'll continue wearing a KN-95 mask when indoors and plan on more than 1 booster/yr.

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Self-advocacy is certainly important, but the nuances of SARS-CoV-2 are many and difficult to parse. There was a good reason we referred to this as a Novel Coronavirus before we felt it sufficiently close to SARS-CoV(-1) to change the name. And it has still failed to behave as we'd expected... or hoped. CDC and FDA lost a tremendous amount of senior talent in 2017. Hahn at FDA got a clue much faster than Redfield; Azar may have seen a clue but didn't do nearly as well, at least on the public stage as Birx claimed in her book. Losing all that talent, skill, experience and ability to communicate hampered a lot of progress,

Without a pretty significant background in clinical medicine, virology and epidemiology, questioning your doc's guidance can be problematic. You can hope he's keeping up with the latest literature, listening to and participating in continuing education, and talking to colleagues. Unless you're prepared to spend several hours a day reading the journal articles and preprints, and have the background to discard or question studies that don't make complete sense, and have sufficient background to understand the language going back and forth, which looks and sounds like English but is really a nearly different language, you'll end up with assumptions that are inconsistent with current best practices and thinking. AND, it's possible even with the right background and basis you'll reach a different opinion than someone else. I know I've asked several big names for a better explanation, or worse, have frankly challenged their conclusions. That said, I'm old and have been around the block a few times.

Your plan, to continue wearing a good quality mask (please learn to fit test it correctly, and change it regularly if you're depending on it), and follow guidance on boosters all sounds reasonable and prudent. I've become a little more lax but I've always got an N95 in the truck with me and I evaluate the venue I'm heading into. I'm traveling tomorrow; I'll certainly wear a mask in the airport, but based on new recommendations from a medical expert on airplane travel, I'll rethink wearing it on the plane, save during boarding and deplaning. I'll be testing frequently, and will be responsible for evaluating a number of personnel during this training evolution.

<Soapbox> I'm not happy with recent WH and CDC guidance on testing, quarantine, isolation, etc. I think they're bowing to public pressure to declare endemicity but have not consulted the virus. I'd love to be wrong on this, but I'm waiting for the next variant of concern to drop on us.

This is a moving target.

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founding

Make room on your soapbox for me. As to PCPs, good luck with their "expert knowledge". Almost all of them are to busy with their scheduled 15 minute visits with patients (and usually running behind, so they really spend less 10) to possible read much of any detail about Covid. That's another reason why the lousy and shifting advice from the FDA and CDC is so damaging. For many, many doctors it's all they have to work with.

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YLE is absolutely right - we need Operation Warp Speed 2.0. Right now, I am told we have <$50 million for vaccine R&D + distribution of vaccines and tests for preparedness. Under Warp Speed we had $18 billion.

The Biden administration requested $22.5 Billion and $15 billion in COVID money was stripped out by congress. Most of this money was intended to pay for a new focus on vaccine research, testing and treatment. This funding, in my opinion, would have supported "Warp Speed 2.0." Given the lessons we have learned from Covid-19, I consider it congressional malpractice for congress to withhold this critically needed funding as 4-500 Americans continue to die each day. There is now a funding bill in the works, with a September 30 deadline, that has the real potential for restoring much of this funding.

Katelyn is right on target - "money will move mountains in science and research" and "we just need to fight for it." This new funding bill offers us a last chance to restore this funding for FY23 (which begins October 1). I'm writing to my Senators and U.S. representative and will learn about what APHA is doing about this. Again, we "need to fight for it."

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Thank you so much for this excellent newsletter, I really upon it for real information!!

I'm ready to fight for a better Covid plan - but how? Which members of Congress are still interested in fighting this disease? I am ready to fight this fight!!

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I agree with you - the WH plan is nonsensical unless the goal is to perpetually enrich big pharmaceuticals.

We can't wish Covid away and it appears our national priorities, as reflected by our government's budget, are completely screwed-up. We have billions/trillions for fighting endless foreign wars ($12B recently appropriated to replenish Ukraine depleted DoD weapon/equipment stocks), but crumbs for public health and other public goods.

Mind boggling.

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I think our leadership is bowing to pressure from the public. To quote an overused theme, the public is done with the pandemic... the virus isn't done with us. Political capital wasted on trying to get compliance from a public as divided as ours is, and considering the divisive nature of current politics as well as science acceptance, is considered lost by the political leadership in this Administration. And recall: We have mid-term elections approaching: Failing to focus on a topic generally noted as unpopular (I reiterate: "The pandemic's over") reduces political liability. I am just hoping we don't see a new VOC between now and the elections, because of the false claims and distractions we'll see. That said, this new effort to simply accept the current public complete discounting of the nature of a pandemic viral disease is a bit disturbing.

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No disagreement with anything you are saying - it's pretty much herding cats in terms of getting the nation on the same page w/respect to Covid.

I did chuckle out loud reading this: "I think our leadership is bowing to pressure from the public."

The antithesis of leadership? Who is leading who? :-)

This notion of telling the public what they want to hear has led to a loss of institutional credibility when we need it most.

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Chicken/egg problem: Did we lose credibility and then started telling 'em what they want to hear to get them back to the fold, or did we tell them what they wanted to hear and lose credibility?

CDC lost a lot of senior scientific leadership in 2017, and Redfield did little to stop the exodus. Administration attempts to silence people like Messonnier, sideline Birx and Fauci, and promote untenable/questionable therapies and concepts also undermined both the CDC and science in general.

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Good questions.

Regardless what the motivations and rationale were at the time, the result was lost institutional credibility when the truth was uncovered.

Whether that truth fit one's narrative about the pandemic is another discussion.

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A LOT of this comes back to inadequate communication. My folks (scientists) overall failed to communicate convincingly with the public and were overwhelmed by opposing narratives that minimized science in favor of ideology. I was and remain guilty. This pandemic shifted me back into science mode, rather than clinical mode. In a clinical setting, I've always done pretty well at explaining and answering questions, but this time I've found myself answering questions in a manner that's somewhat put-offish, because I'm citing research a lot of folks can't or don't want to read, and I'm viewed as elitist because I do read the material. Were I to slow down and explain more completely, perhaps I'd have made a difference. In my organization, my explanations have to go through a copy editor before it goes to the humans.

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As did the refusal of the CDC to acknowledge immunity developed from infection - they totally ignored it

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Early on, we knew little about how immunity conferred by infection would stand to this virus. It was a new and novel virus, and a beta coronavirus, as well. Based solely on history, we could expect a short-lived immunity that might neutralize, or might moderate symptoms and severity. We actually saw much higher response in terms of neutralization for the mRNA vaccines, at a level that left many of us looking for answers as to "why is it so good?!"

Caution requires not racing to conclusions based on "prior knowledge". One of our sayings in this business is, when you've seen one pandemic, you've seen one pandemic. In other words, because naturally-conferred immunity might work for one virus, and might have long duration, it doesn't mean it'll work for another,

Another issue: Immunity conferred by infection by ancestral strains, eg, WU-1, Alpha, Beta, even Delta, provides almost no immunity to infection, severe disease or death if that's your sole source of immune response, when Omicron is concerned. One of Omicron's claims to fame is is evasion of prior rendered immunity. It's much more capable of evading ancestral-derived infection-conferred immunity than earlier variants were.

Finally, the duration of the primary immune response (neutralizing antibodies) has been seen as highly variable in the overall population. And, early, there was little discerned by lab studies that were reproducible, about cellular immunity imprinting and training. These data are starting to become more clear, and it appears B cell response to the variants, at least from vaccination, is pretty robust. Similarly, CD-4+ T-cell response appears better and less subject to the dreaded "Antigenic Original Sin", a misnomer, which really represents the immune system working properly.

CDC did recognize the potential for infection-conferred immune response fairly early. That said, I'm reasonably certain I was infected in JAN 2020, but a qualitative antibody assay 6 weeks post-event failed to show any positive response. And, if I was, indeed, infected in January, it failed to prevent a documented infection in June/July.

Overall, CDC, and others have recognized a hybrid response, infection-conferred immune response as well as vaccine-conferred immunity, as the best solution.

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The early studies out of Israel showed the benefits of a hybrid response. It also makes sense when you consider that infection theoretically results in a response to the entire virus, or at least to those sites that are exposed, while the response to the vaccine is focused on the spike protein. Wouldn’t you think that a multi-valent mRNA vaccine that incorporated elements of the nucleocapsid protein, along with spike, wouid be advantageous?

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We can, have, and should do both. The DoD has a $100 MILLION slush fund every year that they are not required to provide receipts or outcomes for. We could have funded universal health care for ages now with a budget like that. But we can certainly put it towards COVID public health initiatives at the very least.

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Just looking around, the majority are acting as if COVID is over. Labor Day weekend in the US had more passengers than Labor Day in 2019. People for the most part aren't getting booster shots, aren't wearing masks, schools aren't updating ventilation systems. As more people have gotten infected in 2022, it has become more of the "yeah I was sick but it wasn't that bad" outnumbering the "I got sick and it was horrible."

It seems that this is more of a pragmatic approach than anything. It the "how can we get people to at least get one booster shot of some sort" when the vast majority of people are operating in the world as if the pandemic doesn't exist. One shot with the flu vaccine can help normalize an annual booster and can then be done at workplaces, community centers more easily. There is also a cost of producing shots. There needs to be a large enough number of people to get shots so they will make enough of them ala flu shots.

It really seems like the horse is way out of the barn, down the road and into the next town. COVID started with "get it and you might die, don't overwhelm hospitals." Now that fewer people die (comparatively to 2020), people just aren't that scared.

I think the big push for "more" will come when businesses are even more impacted with getting employees because long covid will depress the number of workers available. Already it seems to have a 1%-2% impact on worker availability. With a tight job market, that will make employers (and insurance companies) care, which means a push for Government to throw more money into boosters/filtration etc to prevent infection in the first place.

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The airline industry is currently impacted big time. You'd think they would go back to requiring masks considering since they dropped it, they've had to reduce routes owing to 1000s of staff being out with COVID.

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Thank you so much for these Newsletters. Without them, I would feel lost in the world of uneducated opinions and wishful thinking.

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Looking at the situation from a mathematical perspective it is immediately apparent that in a decision-space the virus has the upper hand in that it is not limited in the number of choices it has, but at the society level we have imposed numerous limitations on our choices, mostly irrational. In other words, no Nash equilibrium and the virus has the better of it

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Very well said, Michael.

It seems like we're being fed "spreadsheet advice," where decisions are made based on responses from large focus groups, and then the numbers are crunched on a nationwide scale. My guess is that more people are willing to get one booster per year, and less people are willing to get 2-3 boosters per year. The assumptions for different scenarios are run through a spreadsheet, and it is determined that there is less strain on hospitals if more people opt to get only one shot annually. The advice makes sense on a macro level, but may not be optimal protection on the individual level.

I want advice that's optimal protection for me, not advice that's geared at encouraging the masses to behave in a way that creates the most socially-optimal solution. I understand reducing strain on hospitals is important, but why can't we be told both - how to protect hospitals and how to protect ourselves?

I hope you're feeling better! 🌟

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As someone living with MS, I inject myself weekly. I would do the same with COVID if it meant protecting the myself and the collective.

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Am feeling better, thank you! It's nice to be back home, be it ever so humble. Good points you make above. I agree with them and experience frustration too. Our pandemic strategies have wobbled from close to optimal all the way over to self defeating. Yet no one is really to blame and I doubt any society our size could have done any better if that's any consolation!

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Well, no matter what the future holds, I'm celebrating the present, with a Moderna bivalent booster in my arm since 9:05 AM!

Thanks for all your efforts to educate. I've actually had some of my own patients quote you recently!

May I humbly present to you this sticker of appreciation, as I'm awash in the good will of science and public health again, on yet another vax night!

https://bucketeer-e05bbc84-baa3-437e-9518-adb32be77984.s3.amazonaws.com/public/images/5303605f-9dda-4764-85b4-2fa76c1edb14_1080x1080.png

(From my substack - these image URLs look shady. Anyway, also on my front page...

Good night, off to let my immune factories do their thing overnight :)

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Wonderful! Good luck!

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Thank you for your honesty not only in this post, but throughout the trying past few years.

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Thank you to the call to action to affect public policy and for lifting your voice. We all really need to participate in this with communication to our policy leaders from the local level on up that we need an Operation Warp Speed 2.0 and more attention to COVID, rather than wishing it away and looking through rose colored glasses at what is still a pandemic. I also wonder about the major philanthropy players in the US (and world)—where are they in terms of investing in new tools?

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founding

Great review of the state of vaccine development and rationale for use. It is hard to contemplate how much even an omnicompetent vaccine would be accepted in the current irrational environment. We are certainly not out of the woods yet with 500+ people dying each day.

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Problem is, there's a subpopulation who've normalized that level of mortality and because they can't envision that many deaths in their experience, see it as "not a problem".

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Sep 7, 2022·edited Sep 7, 2022

Thank you for another great post. By asking the right questions, you make the process better.

I’m confused why determining the future schedule for Covid boosters would now be under the purview of The White House. Is Biden himself the one making the decision to move to an annual schedule? Do the CDC and medical community agree? Is this an election year maneuver to make it appear that the pandemic is more under control than it really is?

Unfortunately, this looks like a decision backed by political - not medical - reasoning.

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The usa is done with sarscov2- even if it is not done with Americans.

Only the respiratory therapists see its daily toll.

And they are quitting in droves.

This is the American way- pretend things we don’t want to address don’t exist.

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Pretty good summary. I think the WH announcement is anticipatory, though, of events that haven't happened. I fear we're creating a false sense of expectation for a virus that hasn't shown us a recent variant. There are too many in the public who fail to grasp your point that SARS-CoV-2 is mutating 4x faster than influenza, and worse, your comment regarding random vs directed (ladder-like) mutation is totally foreign to them. Limited by their experience, "it's obvious" the pandemic's over, and those of us who focus on the epidemiological aspects are fear-mongering.

The release of Convidecia Air is encouraging, but I wonder about the approval process and testing rigor. I strongly concur we need a combined flu-COVID vaccine to increase, hopefully, acceptance.

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I thought it was interesting that he was suggesting that we get our flu shots and covid shots at the same time at the beginning of the season. It's by no means obvious to me that it makes sense for everyone to be getting vaccinated at the same time. Surely, if part of the goal is to reduce the strain on public health systems, then we should be carefully choreographing our shots so that our antibodies aren't all waning at the same time.

For instance, in a household it might make more sense to stagger shots throughout the year. I hope that people research this kind of thing!

That's the only way I could imagine a world in which one shot a year would be enough.

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founding

Thanks for this one. It's great to see you laying out the "magical" thinking that the "powers that be" are engaging in. I hope the Republicans who have been blocking more Covid spending will reconsider and I hope that Moderna and Pfizer will share some of their patented information so that researchers will be able to test the development of nasal and other vaccines. If not, the Congress should threaten them with the loss of patent protection entirely for the mRNA drugs. Watch them jump!

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