Are the FDA and CDC too slow to change their recommendations based on the latest science? Probably. They're big bureaucracies, after all, and big bureaucracies aren't famous for being nimble. Beyond that, though, are their procedures even more badly designed than you'd think? I hate to pick on James Surowiecki over this, but a tweet this evening exposes the problem perfectly:
I’m sure a few weeks from now - or maybe a couple of months - the CDC will finally revise its recommendations, and say that any vaxxed person who tests negative after 7 (or maybe even 5 days) can exit isolation. But given that that decision is inevitable, why not make it now?
— James Surowiecki (@JamesSurowiecki) December 24, 2021
"Inevitable." So if you think, say, that the FDA took too long to approve the first vaccines, you're basically saying they delayed approval past the point when it was inevitable and everyone knew they were going to do it. So why not just do it then?
But this just prompts another question: When do you know it's inevitable? And how do you know? It can't just be a gut feeling. It has to be based on something you can put down on paper.
In other words, a procedure. If you think the FDA was too slow, you need to suggest an alternate procedure for emergency approval of vaccines. In the case of isolation, you need to suggest an alternate procedure for deciding what evidence you need before moving from 10 days to 7. So I tweeted back, "On which day did it become inevitable?" Here is Suroweicki's answer:
It became inevitable on Tuesday, when Fauci floated the idea publicly.
— James Surowiecki (@JamesSurowiecki) December 24, 2021
That's pretty much what I was afraid of. This is obviously not a procedure of any kind at all, either good or bad. It's just a gut reaction.
I've never been opposed to the notion that the FDA could improve the way it does business. But when it comes to approving drugs or providing public health guidelines, it has to have procedures of some kind in place. It will always be possible to nitpick them after the fact, but that's just trash talk. You need to put procedures in place before the fact, and then follow them if you want the public to have any faith in your recommendations at all.
So if you think the FDA or CDC are too slow, that's fine. It's your God-given right to gripe about bureaucratic inertia. But if you want to be taken seriously, you need to demonstrate that you actually know what their procedures are now and then make proposals for how they should be changed. It's very, very rarely that I see anyone do that.
The same folks will fault the CDC for jumping the gun the first time they have to reverse course.
+1 Johnson & Johnson vaxxx pause
This is an esoteric post if ever I saw one. Short of saying 'we're all going to die,' it's got just about everything else. Makes me wish Trump was still president and we...something. [All those of us that survive will be better off, as usual.]
Makes you start wishing Trump were still president?
So, it's a day ending in y...
Kevin, everyone knows that had we just listened to hot takes on Twitter by people with no expertise in infectious disease over the past two years, this pandemic would be completely behind us by now.
And there would be a lot more room at nursing homes too.
Everyone (justifiably) shits on Andrew Cuomo's handling of convalescent care residents in New York State during COVID, but for all that, another Democrat governor, whose state actually had the first known COVID outbreak, got that handling exactly right: Jay Inslee in Washington. But it goes ignored. Just as his 2019 presidential campaign, predicated on combatting global climate change, was ignored by the Occupy Feinstein dipshits at Sunrise Saboteurs while they plumped for Bernie "Sierra Blanca" Sanders, Andrew Yang, & Tulsi Gabbard. (It's almost like Sunrise Movement, like Justice Democrats & #OurRevolution, don't actually give a shot about progress & actually are fifth columns of the Savushkina Street Bot Army.)
Big general issue: quietly avoiding having a big disaster means no coverage. The ideal is to have the disaster and then make yourself the face of dealing with it and do that at least somewhat successfully.
Being in NYC with much of the national news media is also critical.
But Noam Chomsky likes the Sunrise Movement.
Also an (unwitting) Internet Research Agency attache.
My mother was in a nursing home in Ohio in December 2020. She was infected and died on 12/22/2020 without having left the place. I don’t know if Cuomo knew what he was doing but there are plenty of dead folks like my mom who were put at risk by workers in those homes. Someone…I don’t know who, infected my mother and killed her. I don’t know what the answer is. Presidents and governors are often despicable jackasses (well, perhaps always!) and it is our actions which affect those around us. We ask to much of these incompetent fools in government. They really are useless.
KKKlay Travis & Nate "Loq Qabin" Silver have been yelling this into the void since February 2020.
It's also a trick of the mind.
That which work--well, it was inevitable.
That which doesn't work---I don't recall those.
A number of companies tried to make vaccines. Not all succeeded. When a company formally submits its package for approval, they think they will get approved--and the requirements for approval were announced ahead of time for the Covid vaccine. So why spend months reviewing the results? Because sometimes companies get things wrong. And to get approval to manufacture the vaccine takes time--and some makers run into problems there. J&J had trouble with the bottling. Novavax had/has (?) issues with protein purity levels, etc.
Of course, we've also been seeing status via press release too--many from small or just bad studies. Others, from "interesting" results--not that the drug worked, but it showed potential for development.
Surprised Elon Musk didn't hop on the vaccine development train in 2020.
https://www.microbe.tv/twiv/twiv-844/
thanks for the link...
I understand their point that getting unvaccinated vaccinated is what needs to be done, and that a booster is not essential in most cases since the two-shot regimen will prevent serious diseases and death.
Mild infections should be fine, except that still requires quarantines. And with delta and waning immunity, we're seeing ca. 25% of hospitalizations being break through cases. So some boosting is warranted. If everyone was getting vaccinated, then Covid could be treated as endemic, and boosters would be less of an issue.
Nope.
The flaws in the procedures for approving new COVID lateral flow tests have been very clearly laid out. FDA procedure requires comparison to PCR tests as the standard when they are known to have different sensitivity and aren’t intended to be used in the same way. They refuse to use an already approved rapid test as a better competitor or to use real world data for tests used thousands of times in other countries. As a result test manufacturers have to game their protocol design which either leads to long trials or rejection and is a direct reason why no one can find OTC tests right now.
yes, testing was a nightmare....
Unfortunately, it still is.
Vaccinations have gone remarkably well, even with the issues that have come up.
Remember back in December, 2020 when COVID-19 vaccines became available under TFG and distribution was an unholy mess? "I am not a shipping clerk!" TFG bellowed, and truer words were never bellowed. Nobody knew when vaccines would show up or how much they'd get, and it looked very strongly like kissing TFG's ample posterior was the main determination of whether your state would get doses. And they were as likely as not to just show up (or not) without warning... It was like that into January - a mess.
My wife and I were resigned to not getting our shots till the summer. Then Pres. Biden got the reins and our big local health care provider set up both testing and vaccination assembly lines and we got our first shot on March 10, scheduled the second dose on the spot, and got the second dose at the beginning of April. The hospital announced boosters as soon as approval was granted and we got those in October, just over 6 months after the second shot...
Exactly my experience, including early expectations and dates my wife and I got vaccinated.
Is the CDC/FDA too slow? I think it's more of a resistance to changing whatever the current thinking is when new info is introduced, and that's not limited to those groups; almost everyone falls into the conservatism bias. They want perfectly collected data, and lots of it.
Surely the other part of why it's so slow is because the process needs to be methodical so that people don't think it's being rushed to achieve a politically-beneficial outcome rather than a scientifically-driven outcome.
But remember, POTUS can make unilateral decisions. He can speed up the process of reviewing protocols, by putting a date on it and requiring the FDA/ CDC to figure it out by then.
Why didn't POTUS order the federal gov't to send out free weekly masks to every American who requests one? Even if at $0.50+ per N95 mask -- https://is.gd/Bcrv3h -- we're talking a cheap, effective means of controlling the spread of Delta and now Omicron. If you're going to make 500M tests available for free to all Americans, do the same for masks.
Even at 50 cents per mask, you're talking about something like $10 billion per year. In other words, you need a Congressional appropriation for it. Good luck getting that, given that you'll need the support of ten Senators from a party that considers any attempt to control the pandemic to be an infringement on their God-ordained liberty.
The USPS wanted to send (non-N95) masks to all postal customers in April 2020, but El Jefe's handpicked (via Bernie) Postmaster General Louis de Joy said, "Fuck, no".
Exactly. Moreover, COVID-19 was apparently confined to the "blue" states at the time, and there was political calculation that killing off potential Dem voters was a good plan.
Boomer Remover : #OurRevolution :: Nonwhite Extermination : MAGA.
Yep. Nothing is stopping POTUS from signing an EO to order DeJoy to follow through. Maybe he'd even quit to protest. 🤷
Heck, they could decide maybe just every other week was sufficient, or once a month. Probably 90% of the people I see are using cloth masks and we hit a stage of the pandemic, starting with Delta, where that's not going to cut it.
Actually, the FDA allowed/encouraged an accelerated approval cycle for the COVID vaccines WITHOUT leaving anything out. My understanding is that they allowed the final paperwork and approval process for each of the three test/document/approval (or rejection) phases to overlap with the start and initial trial work of the next phase.
Normally they are done serially because having to redo a phase and potentially have to redo early work on the next phase is risky in time and money and companies don't like that. So the FDA, at least, was open to changing the process timing while keeping all the approval checks in place.
This was back in September. It would take another 3 months before boosters were made available to everyone, which came only after Omicron had arrived. They had data showing a sharp decline in neutralizing antibodies after 6 months. Read the article. Dr. Fauci presented the data showing the sharply waning protection after 6 months.
Omicron moves so much faster than any previous variant, which compresses the amount of time available to have policy discussions and decisions. If the original Wuhan strain had hit us as Omicron, you wouldn't be saying many positive things about the FDA and CDC.
Did you forget that the CDC botched their own testing kits early on?
Did you read MJ?
Hindsight may be 20/20, but these are issues that were discussed contemporaneously, so, the FDA and CDC knew they were moving too slow.
Ha! If I got Covid, I’m sure I’d need to quarantine for a month. Those darn sniffles just never go away. Of course, my time off work is paid. More than a few of my coworkers seem to have taken advantage of this feature to get long paid vacations. Good for them!
But the "gut reaction" being demonstrated here is "Fauci knows what he's talking about." It presumes that Fauci is qualified and has an understanding of the procedures, so if he says something in public it's not just a gut reaction on his part.
In other words, Suroweicki has outsourced his "gut reaction" to Fauci, for whom it's not a gut reaction.
One can deny that Fauci is qualified or can be trusted, but the people who say that don't trust the FDA or CDC either, so they can be ignored in this discussion.
Even Fauci's gut, though it proved correct with vaccines, was presuming all the i's were dotted and t's crossed. That was the trust part--but the data submitted still needed to be verified.
The US would have had to do many things differently in the early going to emulate best-in-class responses among rich countries. I believe America possessed the wealth and technological capabilities to achieve this (Apple and Google supposedly had health status/contact tracing apps ready to go by early March), but it didn't possess the required degree of unity of purpose and political comity. Even if a Democrat had been president I doubt things would've been appreciably different (we'd have simply seen anti-science efforts directed against the federal government's policies, like we're seeing now, instead of that anti-science resistance substantially emanating from the federal government, as we saw throughout 2020).
Since Trump left the US has slipped behind some of its peers (UK, France, Italy, etc) in terms of deaths. But that's almost entirely due to vaccine and masking resistance. It's not because of the CDC.
In short, America's CDC, like any bureaucracy, isn't perfect. But it is a perfectly convenient scapegoat.
TLDR: The CDC's specific policies haven't moved the needle very much either way in terms of covid deaths. America's failures and successes during this pandemic are mostly related to its political culture and constitutional structure.
"America's failures and successes during this pandemic are mostly related to its political culture and constitutional structure."
Well said.
Anti-science??? Your mumbling dialectical nonsense. What was the science??? Lockdowns were antiscience at its finest. Especially by Alpha when it was known to be too contagious.
When Trumps hand picked advisers side lined Birx, and Faucci and we had knuckle heads like Navarro and Kushner leading the charge that this would affect blue states more than red states and that it could just wash all over us - I knew we were in trouble
Trump was careful NOT to go overboard on promoting vaccines because he knew that they could be delayed or not work at first, He didn't want that embarrassment. So his minions did it for him. They spoke FOR him, they REPRESENTED his Administrations "take" on all of this.
Now that Trump lost, and is slowly losing his grip on the GOP he gets booed when he promotes vaccines taking "credit" fo them when in fact, Pfizer was not part of Operation Warp Speed - they just took advantage of it. He then criticized the timing of their vaccine rest results.
But the CDC was rendered useless by Trump, He USED Birx and Faucci as pinatas. If they did something right, it was at HIS direction, if they screwed up it was their fault. In the end Faucci achieved the "rock star" status in fighting the pandemic while Trump and Navarro went home with their tail (Or UV light) stuck between their legs and up their butts.
The CDC is alright - WE are wrong.
If you are posting here trying to phrase your post to appear on point and appear to be pro vax, anti vax, pro herd immunity or anti herd immunity then you LOSE me.
This is science and sometimes (like in dealing with something new) it can be wrong. Scientists know this - politicians do not
I know Deb Birkx is retiring from NIH.
I hope in her declining years she can find some level of peace as singer in an Aerosmith tribute band.
In hindsight the vaccine approval process is clearly too slow. But this a conclusion reached only after the mRNA vaccines were developed almost instantly and proved to have no harmful effects. The process should be revised based on the new knowledge, but this does not say that the process was wrong based on knowledge at the start of the pandemic. There were good reasons for the process based on pre-pandemic conditions. Of course it's easy to criticise decisions after the fact, but it's another thing to be making decisions in real time when a wrong one could have major consequences. Reporters do not have to propose specific new procedures - that's the job of specialists. But it should be possible to point out that things should be faster in the future without pointing the finger at officials, or even at bureaucracy in general.
"Inevitable" probably means "will happen if nothing bad turns up", but the CDC and other approval agencies have to consider the possibility that something bad will turn up - pundits don't have this problem. If something bad does turn up that will be the subject for another column or tweet criticising the agency or individuals.
In hindsight the vaccine approval process is clearly too slow.
I don't think it's "clear" at all save because of hindsight: we (now) know they work. But we didn't know this with certainty in, say, July of 2020.
(America started vaccinating people all of — hold on to you hat — four days after the UK.)
PS—One massive incongruity in all of this is the seeming obliviousness to the fact that vaccines have generally taken years and years in the past. This one took all of nine months! In fact we've all lived through not a miserable failure but a miraculous achievement of science.
It was not just science. The process always had the potential to be this fast but that required risks no private enterprise was ever willing to take. Avoiding that risk meant to shell out federal money to compensate for that risk; an idea that originated with Bill Gates or someone near him and was--miraculously--picked up by someone in the Trump administration. Then Trump invented a catchy name for it (which he "fell in love" with) and things were on their course.
Good points. And it wasn't just developing the vaccines-- both producing to scale, and organizing delivery of arms to doses, were non-trivial tasks. The money thrown at development was in large part also for ramping up production and a minimal element of distributing to states, but at least here in PA actual administration of the first two doses was nearly complete chaos, rooted in the chaos of the trump administration.
Based on the timings of the clinical trials for the vaccines, that is, the testing to find out if the vaccine candidates were actually vaccines, was done about as quickly as it could be. The 2020 summer lull in infections definitely slowed the testing, but it's hard to consider a lull in infections a bad thing. Once Phase III met its end points, the data had to be collated and analyzed. Clinical trials are full of pitfalls, so statisticians and others needed to time make sure the submitted data was in good order. Then, knowledgeable people at the FDA had to go over the whole thing, maybe 80,000 pages, presumably online. Meanwhile, there was the whole issue of ramping up a novel method of producing vaccines and then validating the process which meant site inspections and a variety of testing to make sure the proper procedures were in place.
In hindsight, it was a heroic job. It was less than a year from the first detected cases of COVID to the first vaccines being approved.
I work in small g (gov). The public always complains but never understands any of the hurdles that get in the way of getting things done. One of the entity's I support has been sued so many times it's a running joke. Sure, some of the times it did something stupid, but it has a constituency that sues it so often I'm not even surprised when I see a lawsuit in the newspaper.
It's also always easy to do an after-action report, or sit in the bleacher seats, and "by god they should of done this, if I was in charge...". Or the inevitable review that points out every dumb thing that happened in whatever it was that went wrong at some point.
Three things wrong with .gov, employees, management and the public (voters).
There is no way a government agency can be nimble when it's faced with these kinds of restraints, especially at the national level.
But saying such probably does inflate your retweets in some circles.
Thanks for this.
"Process shall set you free from the need for rational thought"
- Me
Actually, a huge chunk of the process is to enforce the use of rational thought. That's why we needed to do randomized controlled trials rather than simply approving an untested vaccine. That's why those trials needed carefully defined endpoints agreed on before the testing started. That's why there was so much fuss about production facilities and procedures.
Process is what allows you to make rational decisions rather than basing decisions emotional reactions and gut feelings. No one's gut is that good.
When process isn't hidden behind, agreed. But my DC-upbringing has left me with a different mind-set about how often that happens to be the case.
Which Dischord band were you in?
https://amp.cnn.com/cnn/2021/12/24/health/cloth-mask-omicron-variant-wellness/index.html
The interplay between FDA and CDC is very confusing to outsiders and very poorly explained to the public. Apparently FDA has its approval process, then CDC has to go through its own processes and make its recommendations? Because of pandemic circumstances both are now very public events.
So I think the administration needs to set one person in charge of talking about it. Having too many official and semi-official sources only compounds public confusion about the whole situation and frustration with the apparatus, and it makes people more receptive to carping from the peanut gallery by people like Surowiecki.
It’s worth noting that CDC has no regulatory authority. CDC issues recommendations and reports.
The airlines could likely go ahead and lower the time period to 7 days on their own in some way— but then they would be the ones responsible for any consequences. It’s a lot easier to cancel 200 flights and blame CDC.
Here's some HAPPY news this Christmas Eve
https://www.businessinsider.com/how-long-does-booster-protection-omicron-covid-last-study-2021-12
{snip}
Booster protection against symptomatic illness caused by the Omicron variant dropped by up to 25% within 10 weeks, new real-world data found — though it's not yet clear whether everyone may need further doses in 2022.
The UK Health Security Agency said protection against symptomatic COVID-19 caused by the variant dropped from 70% to 45% after a Pfizer booster for those initially vaccinated with the shot developed by Pfizer with BioNTech.
In the same analysis published on Thursday, the agency found the effectiveness of Moderna's booster paired with two doses of the Pfizer vaccine held at 70% to 75% for up to nine weeks, though not many people in the study received this regimen, which could affect the accuracy of the finding.
For those fully vaccinated with AstraZeneca's vaccine, booster effectiveness dropped from 60% to 35% with a Pfizer booster and to 45% with a Moderna booster after 10 weeks, the UKHSA said.
Eric Topol, the director of the Scripps Research Translational Institute, tweeted on Thursday that the UK findings were a "replication" of what had been seen in Israel.
{snip}
So, if the protection wanes BEFORE it is safe to get ANOTHER shot what are the folks supposed to do.
I was boostered 4 weeks ago.
If you think this is OVER think again. Omicron is very VERY different than Delta. And with southern states still not in Omicrons cross hairs it's conceivable that the Northeastern states could get the wave, it last 8 weeks only to be re-infected as the south rages with Omicron later.
10 weeks?
So we went from 8 months to a year for vaccine protection and ONLY the aged need it
To 6 months and maybe ALL immuno-compromised need it
To 5 months for boosters
To now 10 weeks? With a variant that evades post infection immunity as well?
Now not one but 2 COUNTRIES confirm the data first seen in South Africa.
And Omicron mutated so differently from Delta in such a short time.
Be wary be VERY wary.
Shut down ALL non-essential travel (cruise lines etc)
Keep restrictions on air travel - it may happen anyway.
This is going to be fun to watch
Lol, nope. Omicron is a nothing. More hype than real. No matter of vaccination status, 40% of all cases are asymptomatic. Sorry, nothing you said makes sense and you need your nostril detached. The pain would be educational for you.
Do what ever Israel does. They've been leading for a while now and clearly ahead of the US CDC. Currently they are going with shot #4.
Anyhow might be useful to look at their process.