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Seems like this should have been a requirement before any emergency use authorization, and certainly before any mandates. The fact that this research is just n
by hitpointdrew 4y ago
Seems like this should have been a requirement before any emergency use authorization, and certainly before any mandates.
The fact that this research is just now being done ought to be enough to immediately revoke the FDA emergency use authorizations and pull the product from the shelves.
The covid vaccines have been a complete and utter disaster at every level. The erosion of trust in the institutions that are supposed to protect consumers has alone done exponentially more damage than the virus it self.
We now have victims of vaccine injury so scared of societal backlash they don't speak out, and doctors so scared of losing their license/job they ignore the evidence in front of them.
- GuB-42 4y agoI think most people misunderstand the point of emergency use. It was an emergency. At the time the vaccine got authorized, we were in a middle of a pandemic, millions of people with no immunity were getting sick, and we couldn't stop the spread even with heavy restrictions. It was clear that we will all have some immunity eventually. The point of the emergency use of vaccine was to give people immunity in a way that wasn't as bad at getting sick. Wait too much, and the vaccine would have been mostly useless. It was a game of how much uncertainty we allow vs how much more deaths if we do nothing. And I think the (fairly conservative) bet saved millions, maybe we could have saved a bit more if we actually vaccinated people before the end of phase 3. We are now in the end game, and the rules have changed. We are now almost all immunized in one way or another, the virus is now optimized for immune escape instead of raw speed, thankfully making it less deadly in the process. Because of that, the way we approach vaccination needs to change too. We can't compare today's situation with the beginning of 2021.
- wrycoder 4y agoAs soon as the EUAs were issued, the vaccine manufacturers shut down clinical trial followup and, in many cases, allowed vaccination of the control branch of the trials. Same for Paxlovid, where support for independent trials was refused.
- throwaway049 4y ago'allowed vaccination of the control branch' People in the control branch were told they were controls so that they had the option to get the newly-authorized vaccine for real. Standard practice for trials that go well.
- wrycoder 4y agoAnd so the long term effects of the treatment are uncontrolled. I think it's standard practice for therapeutics, but not for vaccines?
- pieter_mj 4y agoI, probably with many others, didn't realize this could be the consequence of an EUA until you mentioned it here. Thank you.
- snowwrestler 4y agoIt's not specific to EUA, this is commonly done when a Phase 3 trial shows a clear benefit. Essentially, once you're sure a medicine confers a real benefit, it becomes unethical to deny it to the control branch any longer.
- oezi 4y agoCitation?
- throwaway5959 4y agoStill glad I took my chances with the vaccine: https://www.google.com/amp/s/www.nytimes.com/2022/01/11/briefing/omicron-deaths-vaccinated-vs-unvaccinated.amp.html https://www.google.com/amp/s/www.nytimes.com/2022/01/11/brie...
- kitsunesoba 4y agoSeeing how family who got infected prior to vaccine availability are still suffering brain fog and lack of energy even now, I am too. The long term effects of covid concern me far more than those of the vaccine do.
- twerkmonsta 4y ago[flagged]
- Enginerrrd 4y agoI'm glad the emergency use authorization allowed people who are interested to get the vaccine. I don't think mandates were ever appropriate, and I think people should also have had a right to NOT get the vaccine. The emergency use authorization seemed absolutely like the appropriate course of action given the circumstances.
- vikingerik 4y agoRemember the right comparison regarding apparent long-Covid: What proportion of people would self-report brain fog and lack of energy anyway, with nothing to do with Covid?
- AnthonBerg 4y agoThis sort of claim has been made after a study was released that took the presence of SARS-CoV-2 antibodies as the source of thruth for whether people had gotten COVID-19. This sort of claim can’t be made on that basis because a lot of people do not produce antibodies after infection. Paper: “Predictors of Nonseroconversion after SARS-CoV-2 Infection” – https://wwwnc.cdc.gov/eid/article/27/9/21-1042_article https://wwwnc.cdc.gov/eid/article/27/9/21-1042_article Abstract: “Not all persons recovering from severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection develop SARS-CoV-2–specific antibodies. We show that nonseroconversion is associated with younger age and higher reverse transcription PCR cycle threshold values and identify SARS-CoV-2 viral loads in the nasopharynx as a major correlate of the systemic antibody response.” Please note that this was already known when the study which is taken to show that people are imagining long COVID was published. It’s not a good study. Quite a bit of research has been done since then which further pins down the fact that long COVID is very real and how to diagnose it with biomarkers, which turn out to correspond very well with people saying that a SARS-CoV-2 infection messed them up. Please also consider how harshly judgemental it appears when someone accuses a large number of people of imagining or making up a severe and disabling condition. You have to be very certain.
- yucky 4y agoThe actual FDA approval letter[0] calls out in the document that all long term testing will not be completed until May 2027. Pointing that out has always gotten one branded as an antivaxx conspiracy nutter, rather than a person who might want to ensure that, well, long term testing data is actually in before injecting something into their bodies. [0] https://www.fda.gov/media/151710/download https://www.fda.gov/media/151710/download
- bluGill 4y ago> long term testing data is actually in before injecting something into their bodies. You don't get a choice about COVID getting into your body, and that is far worse than whatever possible long term effects of the vaccine might be. There may be concerning long term effects, but keep persepcive, the worst possible case is still better than the known case of COVID. And of course long term studies on COVID are also still in progress with all signs pointing to even more bad effects of COVID coming out in the coming years.
- yucky 4y agoYou don't get a choice about COVID getting into your body, and that is far worse than whatever possible long term effects of the vaccine might be. That is actually yet to be determined, which is the point. And I only mean that as it relates to specific demographic cohorts, not overall. If I were elderly, diabetic, immunocompromised etc. I don't think I'd hesitate. But the data I've seen on my demographic cohort is a toss-up at best, or even shows the vaccine to be riskier.
- jaywalk 4y ago> You don't get a choice about COVID getting into your body, and that is far worse than whatever possible long term effects of the vaccine might be. You don't know that, because we don't know what the "long term effects of the vaccine" actually are.
- ceejayoz 4y agoThat's true in both directions.
- AnimalMuppet 4y ago> Seems like this should have been a requirement before any emergency use authorization Well... if you think that there's a case for an emergency use authorization, then you kind of can't wait to determine long-term risks. If there's a Covid epidemic threatening to kill millions of people in 2019, you can't wait for a study of long-term consequences that terminates in 2027. You have to decide with the information you have in 2019. Was there a case for an emergency use authorization? Covid did in fact kill millions of people, so arguably yes. > ... and certainly before any mandates. Yeah, there I'm with you.
- ivraatiems 4y ago> The covid vaccines have been a complete and utter disaster at every level. Sure, except for the 20+ million lives they saved: https://www.thelancet.com/journals/laninf/article/PIIS1473-3099(22)00320-6/fulltext https://www.thelancet.com/journals/laninf/article/PIIS1473-3... https://www.cidrap.umn.edu/news-perspective/2022/06/covid-19-vaccines-saved-estimated-20-million-lives-1-year https://www.cidrap.umn.edu/news-perspective/2022/06/covid-19... > The erosion of trust in the institutions that are supposed to protect consumers has alone done exponentially more damage than the virus it self. Source needed. Reading these comments, one would think nobody ever died of COVID. One would think we didn't have hospitals crammed to the gills with them.
- anon291 4y ago> Sure, except for the 20+ million lives they saved: There is no reason to expect 20 million people in the United States would have died if we had taken a european approach to vaccination approvals.
- frant-hartm 4y agoWhat was different in EU? Didn't we approve the same vaccines few weeks later?
- 4y ago
- queuebert 4y agoCovid has killed millions. How many have died of myocarditis? While I agree with your sentiment, it's hyperbolic to claim the vaccine has done "exponentially more damage than the virus".
- anon291 4y ago
- flir 4y agoWell that's surgery out the window.
- TehCorwiz 4y agoChemo Therapy is literally poisoning you just enough to kill the cancer. The anti-arthritis medications I take cause terrible side effects. These options are still better than the underlying problems. Throwing out pithy feel good quotes doesn't capture the nuance of the line that doctors walk when trying to treat illnesses. "Do no harm" is the ideal. In reality it's to do less harm than the disease.
- chedca21 4y ago
- ceejayoz 4y agoIoannidis was wrong, though. Drastically so. Analyzing excess deaths make it very clear it's not the same severity as severe flu; see the chart half-way down on https://www.cdc.gov/nchs/nvss/vsrr/covid19/excess_deaths.htm https://www.cdc.gov/nchs/nvss/vsrr/covid19/excess_deaths.htm. At the time, he wrote (https://www.statnews.com/2020/03/17/a-fiasco-in-the-making-as-the-coronavirus-pandemic-takes-hold-we-are-making-decisions-without-reliable-data/ https://www.statnews.com/2020/03/17/a-fiasco-in-the-making-a...): > Some worry that the 68 deaths from Covid-19 in the U.S. as of March 16 will increase exponentially to 680, 6,800, 68,000, 680,000 … along with similar catastrophic patterns around the globe. Is that a realistic scenario, or bad science fiction? How can we tell at what point such a curve might stop? It did exactly that.
- NaturalPhallacy 4y ago[flagged]
- Fomite 4y agoFlu shots target several strains of one virus, not several viruses. There is no credible epidemiologist who wouldn't call the COVID-19 vaccines a vaccine. And there are a number of vaccines with limited reduction in transmission but effectiveness against more severe outcomes.
- deleted 4y ago[deleted]
- UncleOxidant 4y agoIsn't he risk of myocarditis actually higher if you get infected with covid compared with getting a covid vaccine? https://www.heart.org/en/news/2022/08/22/covid-19-infection-poses-higher-risk-for-myocarditis-than-vaccines https://www.heart.org/en/news/2022/08/22/covid-19-infection-...
- Fomite 4y agoIt is. With the exception of a very narrow age range of young men, the COVID vaccine is protective against heart disease alone, even ignoring all other outcomes.
- ifyoubuildit 4y ago> the COVID vaccine is protective against heart disease alone Wait, what? As in people should just take it as a prophylactic for heart disease, without even taking covid into consideration? It seems like this would be shouted from the rooftops if it were true.
- Fomite 4y agoNo - it's protective against negative COVID-19 outcomes just if you consider cardiovascular outcomes, ignoring all the others.
- wiredearp 4y agoYoung men on the other hand appear to face the biggest increase in COVID related heart attacks according to https://www.cedars-sinai.org/newsroom/covid-19-surges-linked-to-spike-in-heart-attacks/ https://www.cedars-sinai.org/newsroom/covid-19-surges-linked..., so perhaps the vaccine remains their best option.
- Fomite 4y agoIndeed. In that group, it's merely...murky...rather than "This is definitively a bad idea".
- 4y ago
- spfzero 4y agoIt also seems like, in the absence of assurance of long-term safety, you would recommend the vaccine for at-risk groups only. It's known now that the risk to young people (under 19) is minimal: IFR < 3/1,000,000. And that was during the much more dangerous early strain of Covid-19, not the ones circulating now. Yet here we are in 2022 with a recommendation from the CDC to vaccinate ages 5 and up, regardless of health condition.
- xracy 4y agoIt is wild to me that people look at a number like 3/1,000,000 and don't think wow, that's 1900 Children who could die from something we have a vaccine for, that actively prevents the cause. Also, can you imagine losing a child to something that was preventable? You can play numbers and statistics all day, but we're talking about children's lives. You're probably not a parent? But for reference, go find examples of people who are parents that have lost children to some cause, and see what they're doing now? I would bet 9/10 times they're trying to prevent that from happening to others.
- dwmbt 4y agosame. it's also interesting that many of the folks commenting are not likely to be in the most vulnerable group at risk of developing myocarditis from the vaccine [0] -- that unfortunate category is one that i belong to. as a young man, i spoke about this risk nearly a year ago to the tee [1]. since then, i've also found out i am particularly vulnerable, as i had a history of heart issues as a young child (heart murmer -> arrhythmia). it will be nice to see more data available, but i don't regret any of the vaccines in the slightest. there are plenty of comments here that speak to the general age recommendation other countries have provided, but i have yet to see people connect the other MAJOR group of people that should, by all means, totally, 100% consider getting their nth vaccination -> anyone with a comorbidity! if you are a young man with diabetes, the risks you face from the vaccine vs a covid infection are no longer as murky. [0] https://news.ycombinator.com/item?id=33480849 https://news.ycombinator.com/item?id=33480849 [1] https://news.ycombinator.com/item?id=29221924#29223881 https://news.ycombinator.com/item?id=29221924#29223881
- 4y ago
- oezi 4y agoNo, that gets it totally backwards. The miniscule risks of the vaccine are blown out of proportion by bad reporting and people reading the statistics wrong. In converse: we should have skipped phase 3 trials (effectivity) and should have started vaccination after safety was approved. If anything the vaccination campaign has shown that sometimes acting fast can be tremendously helpful.
- 35amxn35 4y ago[dead]
- speeder 4y agoI think now I can finally write this in public: I didn't take COVID vaccine at all, because for coincidental reasons, my dad ended taking it first. Despite the fact he is already 50+ he had really severe, but thankfully mostly temporary cardiac side effects (mostly, because even months later he needed to go to his cardiologist and change his cardiac-related medicine, because since the vaccine his blood levels changed and he kept having weird symptoms). Since my dad had his health go so poorly after the vaccine, I decided to not risk it, specially considering my existing conditions.
- dempseye 4y agoThe erosion of trust is actually a good thing, because those institutions are undeserving of trust.
- TheBigSalad 4y agoYou do realize the virus was like super deadly and stuff, right?