This morning I once again got caught in a Twitter debate about whether the FDA should have given the COVID vaccines full approval months ago.
Argument in favor: Months ago the FDA was saying that full approval was a sure thing and was recommending the vaccines to everyone. So why not just go ahead and give them approval, which would make things like vaccine mandates easier to implement?
Argument against: Lots of people are vaccine skeptics, and the fastest way to keep them skeptical is to simply declare the vaccines approved for political reasons.
Here's what's missing from this dispute: actual facts. What we need is either a domain expert or a good reporter to explain exactly what's involved in giving a drug full approval. Are there parts that could be skipped considering that millions of doses have already been given? Are there things that could be speeded up, or is the timetable hostage to absolute requirements like "12 months of data required from Phase 3 testing"? What kind of danger is there in rushing approval?
That's what I'd like to see. A detailed rundown of exactly what's involved, with both the history and science of drug approval explained. That wouldn't necessarily end the dispute, but at least it would put it on a more factual footing.
It doesn't cover all of the bases that you list, but: https://www.theatlantic.com/science/archive/2021/08/fda-pfizer-vaccine-full-approval/619870/
I feel the CDC, FDA and all of the other gov institutions are frightened spitless. They are damned if they do and damned if they don't. Pick your game.
I've been thinking a lot about the early stages of approval, and how our existing frameworks for approval are so ill-suited to a pandemic situation.
Since we currently only give it to people and wait and see how the vaccinated group performs versus the control group in normal exposure, we have the conundrum that if community spread is low, then it takes much longer to collect adequate evidence of efficacy.
Given that the safety concerns of mRNA technology is so different than attenuated virus based vaccines, I feel like there does need to be a re-examination of how to go about this.
Interestingly, the Covid contagion spread so quickly that it seems we could have gone from Emergency Authorization to Full Approval much quicker, based on the HUGE sample sizes involved.
The problem is that there is a collateral concern about potential time-delayed effects. No matter how many folks get the vaccination very quickly, there is no "one-year data" for any of them until a year has passed. You can't substitute 12,000 man-months of experience based on 12,000 people over 1 month as a surrogate for 1,000 persons over 1 year.
True, but as you get to 9-10 months without a signal, do you need to hold out 3 more months? Maybe... it's certainly possible there are adverse conditions that take time to present, but 12 months across the board seems to be just as arbitrary as 9 or 10.
The first Modernas were given in March of 2020 so we have a few year+ people. Not enough for a real sample size but at least none of them dropped dead ftom it.
I'm in the phase III trial and am just over one year in. So far so good, but I've avoided getting infected so far.
Do they test you for antibodies? Has the efficacy gone down?
As I understood it both Pfizer and Moderna were developing a booster that was specifically targeted to Delta. Are they suggesting a booster and do you know if it is just a third shot or a new formulation targeting Delta?
Thanks!
I'd love to see some background information about how observation of safety signals relates to the duration of a clinical trial. Are there really a lot of examples of counterindications that only arise 8 months after patients start taking a drug?
There might be, but I'd like to see the cost/benefit on that one.
There are quite a few cases of delayed effects with experimental drugs. Delayed effects with experimental vaccines (vaccines are NOT drugs) are almost unheard of, which is why full approval could be granted with only six months of data.
I'm not saying I accept it (not saying I don't, either) but there's a seemingly non-crazy case for so-called "challenge trials" to speed things up.
That could help to show effectiveness, esp. if case loads were low. However, we'd still have to wait to see about safety.
Even then, setting up a challenge trial is not as simple as it sounds. The challenge would have to be set up to mimic the real world to give meaningful results. The mode of infection may play a role in the severity of the disease, and a given vaccine may work better against one mode and not another. In other words, we'd only know the vaccine effectiveness under the challenge conditions, not real world ones--and need to do another study addressing that relationship.
If community spread is low, then the urgency of getting a vaccine approved is correspondingly low.
That being said, there was some discussion of "challenge trials" wherein volunteers would be deliberately infected with covid to see how well the vaccine worked. This was rejected on ethical grounds, since it would certainly lead to some deaths in the control group and possibly, depending on the effectiveness of the vaccine being tested, in the vaccine group as well.
I have a comment specifically about what Kevin wrote:
"Argument against: Lots of people are vaccine skeptics, and the fastest way to keep them skeptical is to simply declare the vaccines approved for political reasons."
Alternatively, the strongest way to keep them skeptical (and keep them refusing the vaccine) is to keep explaining...over and over, ad infinitum...that the vaccines are not yet fully approved, but it's fine to go ahead and take them anyway.
The people who refuse the vaccination are not scientists. They understand simple English, even when the issue is anything but simple. In simple English what they heard is that "we haven't had time to give full approval yet. It takes more time." So what they (a LOT of them) do is allow for more time. I'm so goddam tired of reading all the sob stories in the newspapers about another Covid victim who says "I wish I had taken the vaccine. I was just waiting to see if it got approved."
And now they'll say it was approved too fast for political reasons. Goalposts always get moved because its a justification.
Yes, with many or even most. And not even counciously. For some the real subconscious reason they do not want to get the vaccine is not something they admit to themselves ( like even stupid fear of needles) but their conscious justification has to be something that seems more reasonable. If you knock that down with a new fact, another reason will pop up.
Maybe even their are some liberals who truly are sceptical of the vaccine for many of the exact same reasons that some conservatives are. But do not want to admit that. So I am waiting for full.approval .
This is not going to cause the big voluntary rush that some expect
Laurie Garrett and Ed Yong would both be good journalists for the job.
On reading this post, my first thought was, "Kevin Drum has written about this. You should go see what he had to say."
Then I remembered where I was.
It's unfortunate that we're currently running a huge experiment on tens of millions of people in this country, and we're collecting very little data from it. The FDA/CDC don't have a reliable way to know if you're vaccinated, and if post-vaccination you have a relevant health outcome (positive or negative) they are not provided that information unless it's proactively reported. The technology exists, it's easy enough to provide opt-in opportunities, and it's easy enough to deidentify, we're just not doing it.
After I got my vax, I reported my status on a CDC phone app daily for a couple of weeks and then weekly for a while after that. They're collecting data.
Did the CDC actually have resources to screen and verify the data? Self-reporting is not that reliable without that.
I suppose they could have had me come back for a medical exam every day for two weeks. Seems impractical.
Really? I wonder what all those text messages from the CDC that I responded to about my health after my vaccination were for?
The health authorities have the raw numbers of those who have a reaction and since they are very, very small they don't really need case-by-case details. The evidence is overwhelming that the vaccines are safe.
I think what Kevin wants here might be unobtainable. The whole process is just so technical and complicated that it would take a real expert to try to go through all of the fda process and technical data to try to determine whether the final approval was rushed and not warranted or was justified.
What we are going to be able to do, even if we get what Kevin wants, is a complicated confusing process full of technical details that we will not fully be able to understand. But we will be able to get pieces.
And those who have a bias or reason to believe that approoval was a good thing and biden would never improperly influence the fda to fully approve the vaccine will see the parts that would support that and point to them. While anyone who is suspicious that Biden is corrupt and would politically manipulate this will see parts that support their belief and sieze on that.
And the exact opposite re the initial approoval of the vaccine last year when trump was president.
I guarantee that there are good honest scientists at the fda who did conclude that the process was rushed and final approval should not be granted. This is not a cookie cutter, feed data in, push a button process.
Many conservatives will be suspicious of this simply because full approval served biden's political interests and feel biden ( or corrupt liberal scientists at the fda) cut corners and rushed the approval. And no data here is going to ever be clear enough to allay that suspicion. And the same thing would have applied to liberals last year ( except for worrying about too many conservative fda scientists ).
So the argument is pointless. Liberal suspicion of trump vaccine last year was inherently to do with distrust of trump, not some specific part of the process they understood was flawed. And same thing now In reverse .
And one sort of example.
Kevin points to the fact that the fda said approval was a sure thing months ago ( i will take that as given though cannot remember actually seeing that myself ). And, I think correctly in counter argument , says that approving outside strict timeline would just make vaccine sceptics suspicious. But his context is based on a presumption that such suspicion is not warranted and it really would be a good idea to approve it early for policy ( his objection is strategic only ).
But you can easily see how the fda saying it was a "sure thing " in advance just indicates " the fix was in. The approval was predetermined ". Kevin in his analysis just disregards that as a possibility.
And using high level logic, I think that honestly stupid statement is more evidence that the process was NOT fixed and manipulated.
If the administration or fda scientists were corruptly fixing the process for political reasons , with that sort of intent, that is exactly what they would not do. Someone deliberately cheating will almost always do everything they can to make it appear that everything is exactly normal.
And, if it was fixed for policy reasons, because they believed it was for the greater good, they would have rushed approval much earlier when they felt extra vaccines would do more good ( instead of now when perhaps almost all unvaccinated are going to be infected before this changes anything for them.
Who would be politically stupid enough at the fda to announce that aprooval is a sure thing in advance? A scientist oblivious to politics.
Well, I don't know what the full approval process is like, but the EUA process is relatively simple. Once the vaccine companies completed their Phase III trials, they slice and dice all data, and they compile the results into TWO documents (using a format that the FDA gave them). These two docs...
(A) enumerate the types of VAERS and the percentage of people who experienced type of adverse reaction (broken down by demographics, etc.), and...
(B) calculate the effectiveness of the vaccine (using the parameters defined by the FDA).
The pharmaceutical companies do all the data heavy lifting and statistical analysis.
Each of the documents they deliver to the FDA's VRBPAC (Vaccines and Related Biological Products Advisory Committee) is about a 100 pages long (with lots of charts and graphs).
The members of the committee (who are MDs, immunologists, etc.) are given a few weeks to digest the documents. And the FDA sets a meeting about three weeks out. This irked more than a few people who were in the know, because people were dying at the rate of 2-3K per day during the period between when Pfizer submitted their documents and when the committee finally got around to meeting. And it wasn't like the documents would take long to study (because the data is laid out VERY clearly).
The day of the meeting, the pharmaceutical company gives a Powerpoint presentation summarizing the trail data in a couple of dozen slides, and the committee gets to ask questions. Then they go home and sleep on it. And they make their decision the next day.
People think the approval process is the FDA sifting through all the raw data. Basically the FDA is just a facilitator to put the drug companies in touch with the scientists who do the approval. Well, at least that's how it worked for the EUA.
I don't think anybody at the FDA ever said approval was a "sure thing"; that was outside commentators. All that was officially said was that the data looked good but they were going to have to examine it in detail. Of course, the question of exactly who said what is subject to historical revision by anybody with an ax to grind.
You're looking at this the wrong way. The FDA's charge is to make sure drugs are "safe and effective." That's it. The entire procedural apparatus of drug approval and post-approval monitoring is designed to ensure safety and efficacy -- and nothing else.
Usually, FDA approval starts with a drug candidate for which safety and efficacy are an open question. It's up to the manufacturer to make that case convincingly, which takes time -- six months in cases of "priority review" and about a year for every other drug candidate, assuming the process goes smoothly, which doesn't always.
What's different this time is that the Pfizer vaccine's safety and efficacy was already established -- and with FAR more certainly than is offered by data from a couple of Phase 3 trials. That's unprecedented. With safety and efficacy already assured -- a fact no one denies -- then approval was a foregone conclusion. And if approval was assured, it should have been granted much more quickly.
Why wasn't it? Because the FDA is extremely process driven (normally a good thing) and it didn't have a procedures ready to handle such an odd case. It just ran Pfizer's application through its business-as-usual SOPs and worked as fast as it could. The FDA worked hard and -- by standards that would apply to a normal situation -- quickly.
But the whole thing was absurd. Everyone knew what the outcome (and the correct outcome) would be -- unprecedentedly justified approval. But we all had to wait for the processes to run their course. While people suffered and died.
What would have been better? The FDA should have started by acknowledging reality -- the vaccines are safe and work well and, for that reason, should be approved. With that truth as its starting place, it should have then spent the time leading up to Pfizer's formal application drafting and re-drafting the vaccines' labels (i.e., the instructions/warnings and other information doctors get along with the vaccine itself) and settling on whatever post-approval requirements for monitoring and additional testing it thought prudent. Data from those requirements would be incorporated into future versions of the label. The FDA does this all the time.
With that work done in advance, approval would have followed immediately upon Pfizer's application. Result: same (excellent) safety and efficacy; many, many people spared misery and death due to bureaucratic sclerosis.
Well, I'm told there's one step that the FDA does in final approval that's not done in the EUA, and that is they need to inspect the vaccine manufacturing facilities. Back in the days of polio, a vaccine factory accidentally started packaging doses that had live polio virus. So I think that was when the FDA decided it needed to inspect the manufacturing plants. I don't know what's involved in this process, nor how long it takes.
Withholding approval was dumb. Normal drug tests may involve small numbers at first, so approval has to be delayed until further testing and use. There could be meaningful harmful effects. But after the main covid vaccines had been distributed to hundreds of millions without harmful effects, there was no real reason to withhold approval.
But refusing vaccination was even dumber - the facts (as above) were available to everyone. Lack of final approval was just an excuse for the people who were going to refuse on partisan or other grounds. The army and others were also dumb to not mandate vaccination supposedly on grounds of non-approval. Those who should have mandated vaccines were afraid of partisan backlash, but that would not have been avoided even if there had been final approval.
"Lack of final approval was just an excuse for the people who were going to refuse on partisan or other grounds."
You are mistaken about that. There are large numbers of people with three-digit IQ who are not expert in (a) statistics, (b) vaccine technology, (c) public health policy, or (d) virology. Many of them simply felt "if the FDA isn't ready to approve it, then I'm not ready to take a chance on it."
We will know in a week or so whether you or skeptonomist is correct. If you are right, there will be a rush of people seeking vaccines who were just waiting for final approval. If skeptonomist is correct, there will not be.
There is also a possibility that skeptonomist is correct but that there will be a rush of people seeking vaccines because employers have been awaiting final approval to require it. However, if that happens, it should be fairly easy to figure out that a whole lot of surly people are getting vaccinated because otherwise they will be fired.
I've already encountered someone who did not want get vaxed under the emergency use authorization because "it's experimental." Now that the authorization is final, his concern is for "long-term side effects" and he wants to wait a few years. Some people just won't get vaccinated.
He should do some research on this Covid thing that's going around. I hear that has some "long term side effects" as well.
Lots of facepalming these days....
As Kevin says the approval process has to be reviewed and re-evaluated, but really the whole process of manufacturing and distributing vaccines has to be vastly beefed up and improved and speeded up. The government and economic processes have not kept up with the technical advances.
There really should be much more international cooperation on this. Reliance on "free market" processes just doesn't work fast enough or with enough global scope.
Well....except for the problem with some of the J&J batches being processed in Baltimore (?).
You're right about "free market" responses being delayed--and Operation Warp speed did help prevent that (at least for vaccines).
It's not at all clear that free market processes could be speeded up. The mRNA vaccines in particular are new technology. That means their supply chains are not robust or well established and will need to be ramped up if production is to increase. The production facilities themselves are time consuming to build; the machinery they use is not "off the shelf"; it has to be ordered well in advance and custom built, by one of a very limited number of suppliers. Finally, the people who are presently trained to operate mRNA vaccine production facilities are all working in those facilities; opening a new facility means training a new crew. Training a new crew means taking experienced workers away from existing facilities to do the training.
The quality standard for vaccines is perfection; zero errors are tolerated. That means that even after you open a new production facility with a new crew, you are going to spend time producing vaccines and throwing them away while the bugs are worked out of the machinery and the crew develops enough experience to avoid mistakes.
All of this means that it takes a minimum of a year or two to bring a new production facility on line from the time funds are committed and the plan finalised. I understand that Pfizer is preparing to build a new facility in Africa, but it will take time to get it up and running.
I think it would be a good idea post-pandemic to review our drug approval procedures and tweak them if necessary. Surely we've learned a few things in this pandemic that we would want to do differently in the next one.
I don't think it's wise to fiddle too much with the rules in the middle of a pandemic. I don't trust us to make wise choices about which shortcuts are safe in the middle of a pandemic.
I don't think giving full approval then or now or any time will have any impact on vaccine hesitancy. People generally don't know and don't care about the actual process -- I doubt many could have told you it didn't have full approval already, and the ones who could only knew because of outlets like Fox harping on it. But Fox and its viewers are just looking for any excuse to spread doubt about the vaccine. There's not much you can do to sway people that won't get an enormously effective, thoroughly tested vaccine but are willing to take animal deworming medication.
Agreed. Most hard core vaccine skeptics will remain just that -- "full" approval doesn't mean diddly to these people. (Although some will change their tune if they can't get on a plane or stay employed, so, to the extent full approval may embolden some institutions, I'm all for it).
We really need to rebuild our medical systems and emergency response capabilities from the ground up, staging the transitions appropriately. TFG did tremendous damage to the CDC and pandemic response capabilities starting shortly after he took office.
Our general medical infrastructure is in about the same state as our roads and bridges. Even in areas where we have outstanding individual institutions, we're way underfunded and equipped to deal with serious and wide spread emergency situations. Standardized medical reporting and communications capabilities don't really exist.
Treating health care as a market commodity is one of the stupidest ideas since "evaporating all our fossil fuels into the air".
This is going to be expensive. Not doing it is going to be catastrophically expensive.
I'm with Kevin on this one. And the thing is, the executive branch (and Congress, too if it wanted to legislate) had legal authority to employ mandates as a tool to boost vaccinations (at least in some circumstances, ie, air travel). Their timidity shouldn't be blamed on the FDA.
I think at this point all these arguments re vaccine mandates and masking etc. are largely meaningless for covid. Most of the differences they could have made are in the past. Today, not much is going to change the end result as much.
At most , this approval and any mandates might end up meaning that a few of those who do not want the vaccine and never got covid get coerced into it and maybe they have a slightly lower chance of dying as compared if they get covid now. But that is a smaller and smaller pool of people every day as the unvacinated get infected. And forcing a vaccine on someone to lower their own chance of dying is hard to morally justify.
As those who want to be vaccinated now already are, or had plenty of opportunity, and the risk of dying is so low if vaccinated, the community good ( externalities) of vaccination is shrinking and what is left is mainly re other vaccine resistors.
But maybe we need to start thinking to the future and the next virus. Which will be my next post
And forcing a virus on someone to prove something, something, FREEDUMB! is easy to morally justify?
Public health is a field for a reason - back during the Spanish flu public health officers were actually armed - someone posted a sampling of articles from 1918 about draconian measures - some of which were still around as late as the 1950 and early 60s. One of the articles was about a man who attacked a public health officer who told him to "mask up". The officer shot him (but didn't kill him - so better trained than a lot of today's police.)
There's something about masks that just makes people crazy, and I think it's deeply psychological.
Plenty of people have phobias about clowns, for example. My daughter is one. From her earliest days, she has always been freaked out by clowns, costumes, mascots, etc. For some reason, some people have a visceral reaction.
Uh.
Read what I said. I was saying that forcing a vaccine on someone to lower their OWN chance of dying is morally indefensible.
In contrast to lowering the chance that that person getting vaccinated lowers someone else's chance of dying. That MAY be morally defensible if the benefit really is extraordinarily high enough to justify that violation of that person to control their own body. You should not be forcing a vaccine on someone because you think just maybe it might help someone else- the threshold needs to be higher.
To quote pro choices. My body my choice. Not always but you better have a really compelling argument otherwise.
So for covid vaccine, the extent it helps to reduce the chance you will get infected and pass it on to someone else- relevant to whether you should be able to force the vaccine on someone. But the effectiveness of the vaccine in preventing death of the taker is not a reason to force them to take it.
If the covid vaccine was shown to have zero effectiveness at preventing spread ( which is not true but was the stupid meme being pushed for a while to justify masks for vaccinated), then zero justification for forcing a vaccine.
Our society has never recognized the right to control your own body. There used to be all sorts of funny laws about the sexual acts that were, and were not, permissible. There are anti-prostitution laws. There are drug laws. The Constitution was actually amended to give the government the power to forbid people from consuming alcohol. You must wear a seat belt when riding in a car. You must wear a helmet when riding a motorcycle, and in many places when riding a bicycle.
It's true that laws telling what you must not do with your own body are more common than those that tell you what you must do, but the principle is the same both ways. You don't have, and never have had, absolute bodily autonomy.
I was saying that forcing a vaccine on someone to lower their OWN chance of dying is morally indefensible.
It really depends on what is meant by "force" – and even then there may be exceptions. "Force" in the form of coercive societal "pressure" (access to jobs, travel, etc) seems eminently acceptable in the case of something as dangerous as covid: Society really does have an utterly compelling interest in reducing and hopefully ending this pandemic. Actually using physical "force" to put needles into arms against a person's will is a different story. But even then I'd say it wouldn't be completely off the table if we were ever dealing with a far more deadly pathogen (something along the lines of ebola, say).
There are consequences of low vaccinations rate that go beyond the risk to unvaccinated of getting COVID-19 and getting hospitalized and dying. Right now in Alabama, because the cases and hospitalizations are the highest they have ever been since this whole thing has started, there are more ICU patients than ICU beds. That doesn't just apply to the unvaccinated, that means for EVERYONE. Unvaccinated, vaccinated, wearing masks, not wearing masks, needing treatment for COVID or needing treatment for something else, the resources and ability to get quality treatment is currently negatively impacted.
Honestly if the consequences of not getting the vaccinated were truly limited to the individual, I would at this point be like 'hey, if you want to spin the wheel with COVID, go for it'. But the consequences aren't just limited to the individual and it goes beyond the chances of getting COVID itself.
The latest wave may be cresting in some places, but it is still swelling in others...
LA is at 100 new cases/day/100K, down from 126. Vaccinations are up to, now 48% have at least once dose.....
Lowest vax rates: ID and WY at 44%. MS was the worst, but now has 45% of total population getting at least 1 dose.
ME doing the best right now, 12.1 new cases/day/100K, with numbers rising (infection rate: 1.16). No other state below 15. Next closest in CT at 16 with infection rate at 1.04. SD was doing well for a while, but now has 24.6 new cases/day/100K and infection rate at 1.26 with positivity over 20%.
Golak-
This is 8 or 9 days AFTER the Sturgis SD motorcycle rally
They brought the virus with them and left SD to deal with it,
Someone posted a good chart showing the COVID case per day rate for Sturgis last year and this year. The difference is scary. Last year it took (as close as I could eyeball) 2 1/2 months to reach a cases per day rate that took two weeks to attain this year. And this year the rise in cases started fast and went up at a much steeper slope - getting pretty near vertical at the point the chart cut off.
So for the future I think we need to have more approval categories and to consider the context more in the process. Which means a more " rushed" or uncertain process if the virus threat is more serious.
So maybe first " approval " #1 is just saying that the fda is not yet reccomending it for anyone. But the virus threat looks serious enough for some that we are going to release the vaccine for use for anyone who wants to take it voluntarily at their own risk. Basically the fda thinks there is still a good chance that the vaccine dangers outweigh the benefits but also a good chance that the vaccine is worthwhile. We just do not know yet , but we will let you have freedom to choose. Just don't blame us later. Plus you are performing a social good by testing the vaccine.
And maybe here you also want volunteers for challenge trials, in the groups where the virus danger is low enough that trying the vaccine is personally not worth the risk. And even allow maybe death row prisoners to volunteer for some form of commutation.
Step #2 after seeing enough ( largely from those who voluntarily took it in step #1), you now approove it for general use but without a strong reccomendation . So totally OK to take but for now you pay for it not the govt.
Step #3 you now see enough to strongly reccomend it and even subsidize it.
Step #4 maybe like full approval where you really have enough to say with almost full assurance that it is safe enough that absolutely without a doubt a good idea ( i.e. any skepticism is beyond a reasonable doubt - sort of like criminal conviction level of proof) .
Step #5 with graduating levels, the virus threat and the community benefits ( not personal benefits) are so high that the govt is going to start applying some coercion like mandates if you want to do certain things .
Step #6 the threat is so severe that we are going to hold you down and vaccinate you by force
So , for covid, my best timeline is
Step #1 allow it voluntarily. As soon as the threat became clearly significant.
Maybe by March of 2020!
I consider my mom in a nursing home . She has almost died a few times the last five years. We thought she was passing last year - the covid restrictions themselves were killing her depressing sitting alone in her room with no visitors. She rallied when she was allowed visitors to let them say goodbye as the doctors thought she was dying. She is old enough and weak enough thar she very likely will not live another five years.
So take a chance on a vaccine not fully tested - she has little to lose if it does kill her and if it works she live more normally for the time she does have.
And when was it likely that the mnra vaccines would be worthwhile..back in January 2020 they thought that.
Step 2 probably by summer 2020 as we see more data from those taking it in Step #1. I am probably getting it then. And so would a good number and it would then have been more republican.
Step 3 likely by early fall 2020 . Where we got in December but here have so much data earlier. So we now can go to mass govt paid vaccinations earlier.
Step 4 by maybe spring 2021.
Step 5 probably never because the earlier vaccination might make it unnecessary.
So Pfizer got approved and many here are applauding it's safety and efficacy.
Safety I agree with
Efficacy is debatable given the Israeli situation
Our CDC decided in MAY to track breakthrough cases ONLY if they resulted in hospitalizations. Israel in tracking breakthoughs tracked both serious and non serious cases of COVID REDUX.
Is this important?
The argument seems to be that a vaccines job is to prevent serious illness and/or death. They all seem to do that.
But if you are marketing a vaccine you have a problem if you are Pfizer because CV19 can mutate so long as it is being carried and spread.
This is why Israels situation is so dangerous. They are taking the vaccine and measuring its effectiveness against people KNOWN to either had the vaccine previously or had CV19 previously and their numbers are far worse than ours are being reported. Our CDC is ONLY tracking serious re-infections
I can't help but wonder if in fact Pfizer does NOT want us to know about non-serious break through cases.................and why
A person who has been vaccinated THINKS they are protected - and in many cases they think its a years worth of protection. Now the Israelis are saying get a Pfizer booster after NOT 8 months as our CDC says but after 6 months.
And the Israelis used Pfizer almost exclusively
Now, we had no idea how long the antibodies would last when we first started jabbing people and the vaccines were developed based upon Alpha, and Beta versions of CV!9 - which were far less "catchy" than DELTA currently is.
But we did know they were safe - just not as good as advertised.
The problem with the Israeli situation is what they consider a case. Should asymptomatic cases count???? This has been my problem with case counts this summer. Removing asymptomatic cases really reduce total cases.
Absolutely yes for many purposes.
For worrying and seeing how much spread increases, including to those who are unprotected, they count to the extent asymptomatic can still infect others. Which they surely can ( one of the things that makes covid a problem) but at a lower rate.
Hard to tell as no great studies but appears that being asymptomatic reduces infectiousness by perhaps well over 50% in isolation. But it is not in isolation. The fact you are asymptomatic means you are not home by yourself sick in bed and you may not know even that you are infectious. So, even if you have less virus spewing out of you, you are more likely to be around people spewing it. So hard to tell where the end result lies as to whether asymptomatic cases are better or worse for spread. Probably someday better but not huge 30% less at best maybe .
And does not really matter anyway if cases are a consistent % of all cases. If you count all cases and 1000 cases means 10 deaths , OK. But say 50% are asymptomatic consistently. I can not count them and say now great only 500 cases. But they cause the same 10 deaths. So the point has no meaning.
Same for determining how herd immunity is increasing where asymptomatic probably means less natural immunity. But I can count all cases and try to infer x amount of natural added immunity from them , or only symptomatic cases and infer a greater amount per case.
Where you have a better point is whether we should be discounting breakthrough cases in vaccinated. We should ( with different amounts based on which purpose). Because they are not a consistent % age of cases.
No, it's not vaccine's in general, but the Covid "vaccine". Let's be very clear about that. The Covid vaccine is really not a traditional vaccine at all. It's more like the flu shot.
spades
And COVID is not a traditional flu at all.
We are getting variants every 90 to 120 days - not annually
Why is the flu shot not a traditional vaccine?
Because when people think of vaccines, they think polo, dpt's, TB, measles, mumps, small pox. Diseases with high% chance of doing serious damage. Not a novel virus like the common cold. Which also runs its course when new strains go global.
Lol, flu outbreaks historically are worse than coronavirus ones. Educate yourself.
I think you are off base here.
Coronaviruses like covid mutate less than flu viruses. The flu seems to be constantly mutating which is what makes it so hard to get the vaccinations right. But a very dangerous mutation is rarer. Does not occur every year. But does many years.
To say that covid is more of a problem because it is more of a mutation risk than the flu is wrong.
Flu variants are not paid as much attention to because;
1) we have them all the time and they have become commonplace. The ones that do become a noticeable problem get a name like the delta variant. Such as the Hong Kong flu . Somehow now with covid it became politically incorrect to reference that it came from China so all variants must have names not referring to where it arose ( but nobody cared when it was the uk).
2) since covid started off as more deadly than an average flu , of course any worse variants are going to be even scarier .
But note that the Spanish flu was a flu varjant and it was worse. And things like Hong Kong flu were not all that less serious than covid
3) flus have been around forever and have already mutated many times trying all kinds of tricks. So immune systems have seem most of the possibilities and it gets hard for the virus to find a good mutation.
Covid, being new, had all of the potential mutations avaliable to it. The flu is running out of dirty trick mutations to try
4) more cases more mutation chance . Covid has more cases than a normal flu.
But it should become harder and harder for the virus to find a good mutation as it uses up the optimal changes. Delta might be about as far as it can go easily. After all, it was an extraordinarily good mutation.
Why is the flu shot not a traditional vaccine?
spades-
I am not a medical person by any means
It seems to me that CV19 is being spread by people shedding the viral load out of their noses and into the air
So Asymptomatic cases should be COUNTED as cases because at some point one of the vaccines will be found to have a higher degree of effectiveness against the current variant. How do you measure its effectiveness? You measure all who might carrying it.
CV19, like the flu spreads when people are too close together and a person goes out and about when they are sick. CV19 spreads BEFORE and DURING the onset of symptoms happens which is why I suspect Israel may be closer to the efficacy truth than we are
DELTA is 6 times more likely to spread than the first 3 were
Is the next one gonna be twice as likely to spread as DELTA? Will it overcome vaccine or disease antibodies?
You can get the disease with no symptoms and carry the antibodies and never know you spread it or even had it
The Israelis tested earlier and more often
The Israelis vaccinated earlier and more often
They have a very homogeneous society. I would trust their numbers more so than our unfortunately
I don't agree. Who cares if it is being spread. The case is dead. It doesn't develop into anything. It's why outside southern areas of the U.S. despite higher case counts yry hospitalization is higher yry. Your thinking is out of date.
spades-
This is what rational posted above:
"4) more cases more mutation chance . Covid has more cases than a normal flu."
So yes UNTIL we get both symptomatic and asymptomatic cases under control mutations can and will occur
Correct?
PS - I am NOT afraid or insulated to be wrong about something just show me where I'm wrong
Both flu and CV19 are SARs viruses are alike in SOME ways
The newness of CV is something to be worried about.
In terms of respiratory illnesses we are just getting started with CV
Yes no cases no mutation. And that is just as true with the flu as covid or more so.
Also ( do not see this noted much) it really is more virus reproducing more mutation chance.
So a breakthrough case in a person with immunity where the viral load might be less, less mutation chance. So all cases not equal. And a case in a child with fewer viruses is less mutation threat. And lengthy of infection matters. If you take a month to recover, you might have fewer virus at one time but more cumulative
And a mutation is only an issue if it spreads. Maybe I get covid and the super covid with an R of 10 mutates in me. But if I stay home and isolate until my immune system kills it and never infect anyone, nobody will ever know that that mutation happened. Delta probably did evolve earlier and died out . Only a tiny % age of viruses in a body will ever infect someone else. So 100,000,000 cases in nations where people are isolating is much less of a threat than 50,000, 000 where they are not.
Rational-
You said:
"So a breakthrough case in a person with immunity where the viral load might be less, less mutation chance. So all cases not equal"
Agreed not all cases equal.
But if we have a virus that is double the viral load of the original virus but our immunity has now decreased since it's been 8 months or longer since our last dose would this be almost equal to someone having NO immunity from the Alpha variant? Like it was at the beginning?
I get the fact that we would have MORE immunity since we got vaccinated - but those vaccines are based upon the viral load of Alpha and Beta - NOT Delta.
And the science of CV is still evolving because it is still NOVEL. But compared to 1918 our science is advanced by a factor of 100.......
I might clarify what you said although I think you meant this.
You said covid spread when a person goes out and about when they are sick.
But the whole point is that covid can spread when they are NOT sick.
If you have an asymptomatic case, you are not " sick" by definition. But you are still contagious, just to a lesser extent.
And maybe you are only half as potentially contagious as someone with symptoms. But if you them still are going out and about spending twice as much time with twice as many people as you would if sick, you are effectively equally contagious.
This is what made covid so insidious.
There are also asymptomatic flu cases where you can still infect . And you are infectious with the flu before symptoms. But nowhere near to the extent of covid.
With the flu, if everyone just stayed home and isolated when sick, we might be able to drive it extinct even without vaccinations. Not so with covid ( and some idiots are going to parties with symptoms because they feel OK enough).
Maybe what might come from covid is the social pressure that nobody ever should be out in public with any symptoms.
Rational
Thanks for explaining my words better than I did🤣
One thing that is different is that with normal cold and flu seasons you very seldom see masks - especially here in the U.S.. Now we're seeing them all over the place.
But as I have opined before I have seen too many stories where scientists and virologists are expressing surprise at the latest mutation.
THIS is where the Israeli situation comes to light
As stated, they tested a much greater % of their population and vaccinated a much great % of their population. Then when cases came down, they threw and ill advised national party - right when DELTA with a much higher level of infectiousness than the first two waves had.
Do I think we are near the end? I will make no prediction on that mostly due to the surprise that our scientists are showing towards any new variant. Couple THAT with the politics of it all and we have a recipe for several more waves
But in the context of vaccine efficacy we need to base it on real numbers and Israel seems to have better more thorough information to work with, than we do and the vaccine of choice in Israel is Pfizer's
light overview: https://www.fda.gov/drugs/development-approval-process-drugs
more detail: https://www.fda.gov/drugs/information-consumers-and-patients-drugs/fdas-drug-review-process-continued
That document suggests the primary delay is reviewing the data from the clinical trials and writing up the results. This sounds like it involves multiple people each writing up a report. Manufacturing facilities may also need to be reviewed and inspected. But it's not clear whether 8 months is a reasonably fast timeframe for that sort of activity.
https://www.theatlantic.com/science/archive/2021/08/fda-pfizer-vaccine-full-approval/619870/
The Atlantic says that it took 4 months from application to approval, so apparently the application came after the emergency use authorization. And The Atlantic says this is an entirely new drug (mRNA) and the approval was incredibly rapid for a new type of drug.
The Atlantic says hundreds of thousands of pages of data needed to be reviewed, as well as testing and reviewing the quality of an entirely new manufacturing process.
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******This is NOT peer reviewed as of yet************
https://www.cnn.com/2021/08/01/health/uk-scientists-covid-variant-beat-vaccines-intl/
{snip}
The scientists write that because eradication of the virus is "unlikely," they have "high confidence" that variants will continue to emerge. They say it is "almost certain" that there will be "a gradual or punctuated accumulation of antigenic variation that eventually leads to current vaccine failure."
They recommend that authorities continue to reduce virus transmission as much as possible to reduce the chance of a new, vaccine-resistant variant.
They also recommend that research focus on new vaccines that not only prevent hospital admission and disease, but also "induce high and durable levels of mucosal immunity."
{snip}
Interesting............
I know - replying to my own post.........
This is getting even more curious
Today the CEO of Pfizer said this:
https://news.yahoo.com/pfizer-ceo-says-vaccine-resistant-205325099.html
{snip}
Pfizer CEO Albert Bourla told Fox it was likely a vaccine-resistant variant would emerge.
Bourla said Pfizer could make a shot tailor-made for such a variant within 95 days of its discovery.
The CDC director said the virus could be "a few mutations" away from evolving to evade vaccines.
Pfizer CEO Albert Bourla told Fox News on Tuesday that he believed it was "likely" a vaccine-resistant coronavirus variant would eventually emerge.
"Every time that a variant appears in the world, our scientists are getting their hands around it," Bourla said. "And they are researching to see if this variant can escape the protection of our vaccine.
"We haven't identified any yet, but we believe that it is likely that one day, one of them will emerge."
{snip}
This YouTube video is a discussion about decreasing vaccine effectiveness
https://youtu.be/tKDt_HEgWIo
So, we have a Medical society in GB telling the government that they believe a vaccine resistant strain will emerge
WE have the CEO of the company with the ONLY (so far) FDA approved vaccine saying there will be vaccine resistant variants, and soon
And we can't even count real break through cases:
(Take this with a grain of salt - its Politico)
https://www.politico.com/news/2021/08/25/cdc-pandemic-limited-data-breakthroughs-506823
{snip}
“We report what we have, but we know that it's limited because it's based on a direct report from a provider — as opposed to taking a data set of all hospitalizations and matching that against our vaccine registry,” said Sokol, the Louisiana epidemiologist. “We're not able to do that for hospitalization. We rely on individual reports from hospitals. And some report well, others do not. So we know that it's not complete.”
State health officials say their comprehensive data on breakthrough infections suggests the rate of these cases in their jurisdictions is greater than the hospitalization counts show. And the number of new infections continue to rise.
[snip}
My my MY !!!!!!!
The more we learn - the worse I feel about CV19
If you feel like you don't want to get vaccinated FINE but be prepared to pay the price:'
https://gizmodo.com/delta-air-lines-will-make-unvaccinated-employees-pay-2-1847556666
{snip}
Enough is enough: Delta Air Lines is leveraging the damn healthcare plan to get employees vaccinated. If you want to work on their planes, and you’re on their health insurance, you’ll have to get the jab or pay $200 a month.
In an employee memo sent today, Delta CEO Ed Bastian framed the decision as a security deposit for potential covid-19-related medical bills, which oddly might be a more palatable argument for people railing against commie mandates.
“The average hospital stay for COVID-19 has cost Delta $50,000 per person,” Bastian said. “This surcharge will be necessary to address the financial risk the decision to not vaccinate is creating for our company.” He added that every Delta employee who’s been hospitalized due to covid-19 was not vaccinated. The company will start requiring the fee on November 1st, which is plenty of time to get two doses.
{snip}
But even after this some company's are testing regularly to MAKE SURE no surprises ae lurking in their workforce:
https://www.businessinsider.com/goldman-sachs-will-require-weekly-covid-tests-for-vaccinated-staff-2021-8
{snip}
Goldman Sachs will require staff in its US offices to take weekly COVID-19 tests even if they are fully vaccinated, the New York Times reported.
The banking giant told staff in a memo Tuesday that employees who were not fully vaccinated by September 7 must work from home, per The Times.
The memo said that employees should wear masks at all times at the company's San Francisco and Washington offices unless they are eating or drinking, per The Times.
The bank also said in the memo that it would require anyone entering its US offices to be fully vaccinated, including clients, per The Times.
{snip}
Forget republican versus democrat. Forget Trump versus Biden
Businesses are now saying enough is enough and a sick employee is more costly to us so WE WILL be the communists here
No matter which way you slice it or dice it.
The pandemic isn't over - not by a long shot
SPECIAL ADDENDUM
I am reading on other message boards that Israel has reported that 59% of CURRENT hospitalizations are those that are FULLY vaccinated
I went looking and found this:
https://www.beckershospitalreview.com/public-health/nearly-60-of-hospitalized-covid-19-patients-in-israel-fully-vaccinated-study-finds.html
{snip}
Of 514 patients in Israel hospitalized with COVID-19 as of Aug. 15, 59 percent were fully vaccinated, according to an Aug. 16 article from Science that cited national data tracked by Israel's largest health management organization. The figures suggest breakthrough infections may be more common than the term implies, the report suggests.
Most of the vaccinated patients who were hospitalized, about 87 percent, were at least 60 years old.
{snip}
Pfizer was the vaccine of choice there
And NOT part of operation Warp Speed - which is interesting in it's own right
And the CDC is confirming my fears that they are moving the goal posts again and recommending 6 month boosters instead of the previously reported 8 months
The long post above from me contains this very positive statement from PFizer's CEO:
"Bourla said Pfizer could make a shot tailor-made for such a variant within 95 days of its discovery."
So - lets keep this in perspective:
https://www.nbcnews.com/news/us-news/south-dakota-covid-cases-quintuple-after-sturgis-motorcycle-rally-n1277567
{snip}
Two weeks after the annual motorcycle rally in Sturgis, South Dakota, reported Covid infections in the state have risen nearly sixfold
South Dakota counted 3,819 new cases in the past two weeks, including seven deaths, up from 644 cases in the 14 days preceding it. That makes it the state with the largest percent increase in Covid cases in the past two weeks.
{snip}
so the virus is spreading 76 days ahead of Pfizers rosy picture of when they could get their vaccine to market
Not comforting at all