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FDA Approves First Covid-19 Vaccine
- eganist 5y agoMy biggest concern now is around seeing those who hedged their willingness to get the vaccine on its approval instead find a new reason not to get it. So with that in mind, I'm much more keen on seeing how employers will decide on vaccination mandates now that at least one vaccine is fully approved. Any news yet on whether any more employers are likely implementing mandates (if they haven't already this morning) based on the news? Guessing a few probably had their policies and news pre-written in anticipation.
- Saint_Genet 5y agoI guess the US military can now mandate it as they've said they will. Time to see how many of the people posting on social media that they'd rather take a dishonorable discharge will follow through.
- giantg2 5y agoIt's more likely that people eligible for retirement will take it earlier than they originally planned. That's basically what we're seeing in return to office attrition.
- eli 5y agoThey could have made it mandatory for the military regardless of full approval. This just makes it easier.
- ibejoeb 5y agoIt will likely be a medical separation.
- giantg2 5y ago"...instead find a new reason not to get it." Or continue an existing reason: "Information is not yet available about potential long-term health outcomes."
- ceejayoz 5y agoOf course, we don't have much info on the long-term health outcomes of getting COVID, either. It's like worrying about the long-term impact of breathing fire extinguisher powder while being engulfed by flames.
- c7DJTLrn 5y agoConcern? Why? The virus is under control in countries where the vaccine rollout has been swift. Why do you sound so keen to force something on people that they don't want, regardless of their reasons? Shouldn't people have the right to choose what they take? If people can lose their jobs over it then clearly they don't have that right - that's a form of coercion/blackmail. I think the focus on a small minority of people who don't want to take a vaccine is unhealthy.
- cle 5y ago> Shouldn't people have the right to choose what they take? It's not this simple. Not taking a vaccine during a pandemic has negative externalities, since you're increasing the risk of infection and death of those you interact with, you increase the likelihood of consuming scarce resources (such as ICU beds), etc. I largely agree with you, but framing it as a simple "individual choice" issue is reductive at best.
- c7DJTLrn 5y ago1. Those who are vaccinated have a significant reduction in risk of death (not to mention that the risk is very minute for young people anyway), so that's a moot point 2. Some vaccinated people have been found to carry the same levels of the virus as unvaccinated people, so stating that unvaccinated people could be increasing risk to others is also a moot point 3. Once the so called "R" rate is below one, the virus is on a path to fizzling out It's not as though unvaccinated people will be dying in their thousands for centuries to come. Herd immunity just needs to kick in which many countries have already achieved.
- eightysixfour 5y ago1) It isn’t a moot point when vaccinated individuals need ICU beds for other emergencies, which are still happening. This isn’t a theoretical, this is happening in the Southeastern US.
- deleted 5y ago
- jameshart 5y agoI’m surprised we haven’t seen more from health insurers - unless they’re gambling on being able to get out of paying for any long term care costs for COVID complications by claiming ‘preexisting condition’ or ‘government said they’d pay for COVID treatment’ they should surely be interested in incentivizing group plan holders (ie employers) to have vaccination programs. When having a vaccination mandate policy shows up as an actual tangible cut in your insurance bill, that will drive some real behavior changes in employers.
- avgDev 5y agoOn the contrary with the insurance profits capped at a percentage it is beneficial for them for the services to be as expensive as possible and patients to have as many as possible claims. They can just pass on the cost onto the consumer and raise their profits.
- Markoff 5y agoThis approval doesn't change a thing, about no known long term effects of viral vector vaccines (first time approved by any medical agency in world in November 2019) and mRNA vaccines (first time approved by any medical agency in world in December 2020). Sorry for not wanting to inject myself with unproven technology with unknown long term effects. Why politicians and certain pharma companies keep pushing these vaccines instead offering conventional inactivated virus vaccines? Heck maybe I'd go even for protein based one (Novavax). As healthy non-obese non-smoking relatively young person I'm not afraid of COVID, but I'd be willing to take safe vaccine with technology proven by decades of track record to make some people happy (though ideally everyone should have same rights vaxxed or unvaxxed and this should be entirely voluntary same as influenza, hepatitis and other vaccines nobody requires when you travel to neighboring country or visit restaurant). For instance these are currently my options in EU, if I want conventional vaccine against COVID approved by EMA or any COVID vaccine using any technology approved more than 2 years ago: EDIT: I wonder if all those people defending these new technoloy vaccines also use all their software running Alpha/Beta versions and don't wait for Stable version. But it seems when it comes to one's own health it's less important than software for most.
- ch4s3 5y agoTo be fair, we've been shooting mRNA into people for medical research since about 1992. Early attempts were for gene therapy, but the approach has been abandoned because the mRNA breaks down so quickly. Beyond that, the mRNA is telling your cell to produce structural proteins. We've been using structural proteins in vaccines for AGES. Random bits of structural proteins are circulation around your body, being broken down, recycled, and eliminated as waste all of the time. There's no reason to believe that this structural protein is dangerous by itself. I can't figure out what these vaccines do that could even have long term effects beyond getting your immune system to recognize the protein.
- renaudg 5y agoThe mistake you're making is "omission bias" (https://en.wikipedia.org/wiki/Omission_bias https://en.wikipedia.org/wiki/Omission_bias) You're refusing the "beta" (installed by billions of users) version of something that can save your life because you (mistakenly) believe the choice is between that, and staying as you were before. It's not. That's no longer true with the Delta variant. Now it's really a choice between "carefully designed, just officially declared stable" vaccine with billions of users vs getting the "totally unstable, totally doesn't care about your health, completely unknown long term effects" SARS-CoV-2 virus forcefully installed on you. You will get antibodies one way or another, and there is orders of magnitude more risk and uncertainty associated with getting them through infection rather than controlled vaccination. Furthermore, there has never been in history any vaccine side effect that occurred later than a few weeks after administration at most. There is just no theoretical basis for why anything wrong would happen here. Are you demanding 100% certainty ? Sure, you won't get it here but you also didn't get it with anything else you ever did in medicine and you can live with that. With Delta, ICUs (and even more so long covid clinics) are full of unvaccinated "healthy non obese non smoking relatively young" guys like you. If you're not afraid of Covid, rationally you should be even less afraid of getting a vaccine. To put things in perspective, here are the odds in young males for the most talked about vaccine side effect (myocarditis, which usually resolves in a few days), vs the odds of getting severe Covid at your age : https://imgur.com/a/uW52E51 https://imgur.com/a/uW52E51
- zacharytelschow 5y ago"Clinical studies from Israel, the Cleveland Clinic, England and elsewhere have demonstrated beyond a doubt that natural immunity to SARS-CoV-2 provides robust and durable protection against reinfection comparable to or better than that provided by the most effective vaccines." source: https://www.wsj.com/articles/vaccine-mandate-natural-immunity-lawsuit-covid-19-coronavirus-11628281507 https://www.wsj.com/articles/vaccine-mandate-natural-immunit... (Referenced studies are linked in the article). Why should people who already have antibodies take marginal unnecessary risk for no gain?
- criticaltinker 5y agoTo further support your argument, we are on the verge legal precedent that it is unconstitutional for public institutions (e.g. public universities) to mandate vaccination - and predicate employment on it - for people who already have antibodies acquired through natural infection [1]. > Prof. Zywicki’s immunologist, Dr. Hooman Noorchashm, has advised him that, based on his personal health and immunity status, it is medically unnecessary to get a Covid-19 vaccine — and that it violates medical ethics to order unnecessary procedures. > the Policy is unmistakably coercive and cannot reasonably be considered anything other than an unlawful mandate. And even if the Policy is not deemed coercive, it still represents an unconstitutional condition being applied to Professor Zywicki’s constitutional rights to bodily integrity and informed medical choice, respectively. > GMU’s Policy infringes upon Professor Zywicki’s rights under the Ninth and Fourteenth Amendments to the United States Constitution [1] https://news.ycombinator.com/item?id=28262820 https://news.ycombinator.com/item?id=28262820
- thex10 5y agoWhy does reduction in death/hospitalization/severe illness keep being interpreted as "no gain" by the skeptics?
- l8rlump 5y agoIn the context of their statement, if natural immunity is as good as vaccination, then there is no gain from vaccination.
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- skocznymroczny 5y agoWhy are you so obsessed with forcing vaccinations on people? Can't you just get vaccinated and enjoy your perceived safety?
- thefunnyman 5y agoVaccinations are most effective if we reach herd immunity, which requires others to get vaccinated. The safety is not “perceived”, it’s scientifically verified by tracking hospitalization and death rates as it’s been rolled out at a global scale. The reason herd immunity is so important is that those that are immunocompromised _cannot_ safely get a vaccination and thus rely on there being enough vaccinated individuals to reduce the chance of catching it. Further, by many choosing to remain unvaccinated and allowing the virus to continue evolving we greatly increase risk it mutates into something the current vaccine cannot prevent.
- SergeAx 5y agoUnfortunately, with Delta variant transmission rate and vaccine breakthrough probability, and the fact that no vaccine yet has a sterilization effect, we will not reach herd immunity. This is a done deal. Let's work on alternative strategy.
- renaudg 5y agoDelta has won this particular battle but not the war. The existing mRNA vaccines were pretty close to having a sterilizing effect (unexpected and very good surprise) on the previous variants. There is still hope that the Delta-specific updates (Moderna is already testing theirs) will restore that level of efficacy, and there's also ongoing research on intranasal vaccines which should work even better for that.
- l8rlump 5y agoIt seems you're suggesting that the virus only mutates in unvaccinated people? Do you have any further reading on this?
- ginebra 5y agoPfizer was suposed to end fase III in April 2023, Moderna in October 2022... This is unbelievable!
- nanis 5y agoAfter CDC stops updating stats on deaths/hospitalizations from Covid19 among those fully vaccinated against Covid19. As of August 9, net breakthrough deaths stood at 8/million and net breakthrough hospitalizations stood at 35/million, up 900% and 733%, respectively, since April 20. Current numbers: https://www.cdc.gov/vaccines/covid-19/health-departments/breakthrough-cases.html https://www.cdc.gov/vaccines/covid-19/health-departments/bre... Snapshots: https://archive.today/https://www.cdc.gov/vaccines/covid-19/health-departments/breakthrough-cases.html https://archive.today/https://www.cdc.gov/vaccines/covid-19/... Putting my Bayesian hat on, a reasonable conclusion is that if the breakthrough hospitalization/death rates had improved, they would not be holding them back on the eve of the approval of the vaccine. Also, interestingly, CDC stopped reporting breakthrough infection rates that do not result in hospitalization/death earlier. The page says: > Vaccine breakthrough cases are expected. COVID-19 vaccines are effective and are a critical tool to bring the pandemic under control. However, no vaccines are 100% effective at preventing illness in vaccinated people. There will be a small percentage of fully vaccinated people who still get sick, are hospitalized, or die from COVID-19. First, I must applaud them for the reasonable argument there. Now do Covid19. Second, it is not the absolute percentage that matters. It is the trend. Frankly, a vaccine where 1/100,000 who take it die of the disease it is supposed to protect against sounds a little far away from "vaccines are 95% effective". Also, deaths lag.
- DSingularity 5y agoWhat if it you compare that to a mortality rate of 1.7%? All of a sudden .001 % death rate seems pretty good. What do I know though — this isn’t my area.
- nanis 5y agoWhere exactly do you get the 1.7%? Is it computed the same way the breakthrough deaths are computed? What is the denominator in each case? I see, you are using this table[1] ... This is the case fatality rate (which is inflated depending on how many infections are never recorded). Using the numbers provided by the CDC, if we put the cases in the denominator and not the vaccinated population, we have: Hospitalized or fatal vaccine breakthrough cases reported to CDC 8,054 Deaths† 1,587 †341 (21%) of 1,587 fatal cases reported as asymptomatic or not related to COVID-19. Now, if the CDC had not stopped reporting the number of infections, we'd have the correct comparison. If we take cases as the cases reported by CDC, we have (1,587 - 341)/8,054 = 15.5% of the cases resulting in death from Covid19 of a person who is fully vaccinated against Covid19. Why did the CDC stop reporting total breakthrough infections (which would have allowed an apples to apples comparison of CFR here)? [1]: https://coronavirus.jhu.edu/data/mortality https://coronavirus.jhu.edu/data/mortality
- teeray 5y agoSo does this mean Moderna and J&J can’t be administered now since there is an approved vaccine?
- jasongill 5y agoThey can continue to be administered under their EUA's; having Comirnaty receive full approval doesn't impact the other vaccines status.
- acdha 5y agoI’m wondering what the odds are that people will pivot from “it’s experimental” to “it was rushed due to politics/greed”. I think a huge factor will be how many employers, colleges, etc. are now willing and legally able to require vaccination. It’s one thing to say you trust something you read on Facebook more than your doctor and quite another to walk away from a job because of it.
- cmpb 5y agoIt's also possible that its approval will result in more people getting the vaccine due to those people now having an out from their initial reaction that it was rushed (but still sticking to their convictions up to now in order to avoid embarrassment).
- cbg0 5y agoMore likely than not, they'll just move the goalposts farther and find a different excuse for not getting it.
- giantg2 5y agoOr continue an existing reason: "Information is not yet available about potential long-term health outcomes."
- bart_spoon 5y agoWhich still wouldn't be a logical argument, given that the same applies regarding long-term health outcomes regarding getting sick with Covid. But I suspect you are right.
- formerly_proven 5y ago"But Covid is something natural, while the vaccine is man-made."
- yalogin 5y agoThe approval is specifically for 12 and over. Any word/guesses on when it would be available for the rest?
- eli 5y agoIt's actually for 16 and over. No impact on the EUA for 12-16 year olds. I've heard "maybe september" for emergency approval for younger kids.
- bluGill 5y agoIt is 16 and over, not 12 and over. Nobody knows when under 12 will get an EUA: they need more data before they can apply. Rumor is they will have the data soon and so the EUA will happen by the end of September. This is just a rumor: it seems likely, but could be wishful thinking.
- rpowers 5y agoWith its approval, I'm going to ask my pediatrician to get them to approve use in our younger kid.
- xdennis 5y agoHow young are you trying to go? Should we individually vaccinate egg and sperm cells?
- Ensorceled 5y agoIn Ontario, children at 2 months get: DTaP-IPV-Hib: Diphtheria, Tetanus, Pertussis (Whooping Cough), Polio, Haemophilus Influenzae type B (Hib) Pneu-C-13: Pneumococcal Rota: Rotavirus So, I guess at 2 months if it's warranted and safe. People are so strange about this vaccine...
- wingineer 5y agoDoes this have any effect on the exemption from liability for this drug or is that still in effect until 2024? I haven't seen any language on this.
- ceejayoz 5y agoUnrelated to approval status. We handle vaccine injury compensation via a special court and system funded by a tax on vaccine doses so manufacturers don't nope out and threaten the production of vaccines entirely. https://en.wikipedia.org/wiki/National_Childhood_Vaccine_Injury_Act https://en.wikipedia.org/wiki/National_Childhood_Vaccine_Inj...
- giantg2 5y agoBut not all vaccines are covered under the program. I assume this one will be. Do you know if this one is?
- dragonwriter 5y agoThe National Childhood Vaccine Injury Act is irrelevant here; the liability protection for all COVID countermeasures, including vaccines, is not under the Vaccine Injury Compensation Program established by that act, but is instead under the Countermeasures Injury Compensation Program established by the Public Readiness and Emergency Preparedness Act.
- wingineer 5y agoYes, and as I understand it, the COVID vaccines under EUA are exempt from even this vaccine court system to date because of an HHS declaration in March 2020. So this isn't changing? https://www.govinfo.gov/content/pkg/FR-2020-03-17/pdf/2020-05484.pdf https://www.govinfo.gov/content/pkg/FR-2020-03-17/pdf/2020-0...
- ibejoeb 5y agoNow do Covaxin. Seriously: what's the hold-up? Why is the US still blocking this vaccine?
- giantg2 5y agoAre they blocking it? I thought they don't have the production numbers to be able to export.
- ceejayoz 5y agoThe US doesn't need it. Other countries are entirely free to approve it for their citizens.
- ibejoeb 5y agoThe US needs it if they want people who are spooked my mRNA tech to get vaccinated. They also need it if they want a vaccine that is the mostly likely to be safe for use in children.
- ceejayoz 5y agoThe US has the J&J vaccine for that.
- giantg2 5y agoIt's a similar mechanism, right? You're just using a virus to carry the genetic material, which also involves an extra transcription step in the cell (what is theorized as causing mutations in the spike and thus the stroke/clotting issues). Still quite different from the traditional inactive or protein based ones.
- rrock 5y agoTranscription causes mutations in the spike that causes clotting issues? Do you have any idea how much transcription happens in your cells, every moment of every day? You need to reconsider where you’re getting your information.
- hartator 5y agoInteresting that most comments focus on the social aspect of this instead of deciphering the science behind that approval.
- nl 5y agoThe switch from experimental to full approval is mostly about repeatable and certified manufacturing and logistics. There is no new science in this approval.
- bart_spoon 5y agoThere isn't much of a difference between the science behind this approval and that of an EUA. Its largely red-tape and bureaucracy.
- linuxftw 5y agoThat's not how the drug industry works. The companies fund and conduct their own efficacy and safety trials, the government just rubber stamps them. The FDA doesn't perform an actual science. They don't even require an impartial group to replicate the science. The FDA doesn't do really much of anything to collect safety data. There's seemingly no reason for the agency to exist.
- s1artibartfast 5y agoThe most interesting science is not public and probably never be. What, if any, internal debate was occurred at the FDA, their pre-approval questions for manufacturers, and their responses, ect. Without this, all we really have to go on is the public information that was release a year ago.
- matt_s 5y agoAn interesting, short read is the difference between Emergency Use Authorization (EUA) and the full FDA approval[0]. Basically it is manufacturing, funding and red tape being the difference, nothing about safety or clinical trials differs. In software terms, EUA is parallel tracked sprints for clinical trials and manufacturing at same time vs. regular approval is Waterfall where manufacturing occurs after approval. [0] https://healthtalk.unchealthcare.org/whats-the-difference-between-fda-emergency-use-authorization-and-fda-approval/ https://healthtalk.unchealthcare.org/whats-the-difference-be...
- vlovich123 5y agoWhy isn’t the EUA process the default then? It sounds like manufacturing being after approval would just be a cost thing producers could figure out without needing the FDA involved…? Edit: also why is there such a large lag between EUA and full FDA approval? That flow chart seems misleading.
- ceejayoz 5y agoVaccines are pretty low margin. Jumping straight to production for a vaccine that winds up not approved would prove pretty expensive, and most of them aren't an emergency scenario that would justify that risk.
- vlovich123 5y agoYou've answered why the government guaranteed purchases of the vaccine & why production was parallelized. That doesn't answer the question why this changes the FDA authorization flow because in the flow chart EUA & full approval happen at roughly the same time & the claim is they have the same safety requirements profile (i.e. I am free to burn money & produce something someone doesn't buy - why would the FDA be involved). Said another way, what was the extra steps that needed to happen between EUA & full approval?
- icegreentea2 5y agoEUA can be applied to many different product categories including diagnostics (basically every single PCR and antigen test in the US up to very recently was initially released under EUA), therapeutics (for example the FDA granted an EUA on chloroquine for threatment of COVID), other medical devices (for example PPE) and vaccines. The EUA rules for each category is different in how they differ from the categories baseline. For vaccines the gulf between EUA and full process was relatively small - the clinical dataset was basically equivalent. I found this article to be a better summary of the differences between EUA and BLA (https://blog.petrieflom.law.harvard.edu/2021/06/15/whats-the-difference-between-vaccine-approval-bla-and-authorization-eua/ https://blog.petrieflom.law.harvard.edu/2021/06/15/whats-the...). I think you are right - the diagram from the OP is somewhat misleading. There is absolutely nothing stopping a company from manufacturing whatever they want before they get a BLA - they just can't market it. In real terms, it looks like the two big time savers was reducing long-term effects follow up from 6 months to 2 months, and well as probably an abbreviated review of manufacturing processes.
- newbamboo 5y agoWithout an FDA commissioner this is worse than not approving as far as I’m concerned. Seriously, this is -1 for me.
- moolcool 5y agoWhy?
- newbamboo 5y agoBecause given the press announcement last week about the acting commissioner (the administration says she is unfit to nominate) it’s clear they’re setting her up as a scapegoat. That conveys, to me, an administration without foresight or ethics. Scapegoats that are obvious are not good scapegoats. Doing nothing could have been chalked up to typical sclerotic political mechanizations we’ve all come to expect. They could have, instead, put out a few tidbits in friendly media outlets about how easy it is to get a booster: you go to cvs and tell them you are unvaxxed. Run stories about how “everyone is doing it(tm)”. That’s a better way to stimulate demand IMO. Fewer long term consequences like permanent distrust of all vaccines, the administration and the fda.
- nickthemagicman 5y agoWeird. Phase 3 trials usually last year's. This only lasted 6 months. Seems legit...
- geoffjentry 5y agoThey usually last years as it takes that long to get enough participants to have enough power. There were so many participants, that wasn't necessary here.
- nickthemagicman 5y agoI guess that makes sense. If thalidomide trials had gone on a little longer there wouldnt have been widespread births of deformed babies. Or Lobotomy trials. So strange that lobotomies won the Nobel prize. Etc.
- deleted 5y ago[deleted]
- roody15 5y agoJust my two cents: This feels rushed and has serious potential to lead to more division and less faith in government institutions overall. (am vaccinated 2 doses Moderna)
- tantalor 5y agoCompared to what?
- symlinkk 5y agoI thought everyone was saying full approval of vaccines take years of clinical trials. This was done much more quickly than that.
- bluGill 5y agoMost of those years are not clinical trials they are getting funding to run a trail.
- purephase 5y agoThere are years of clinical trials for mRNA vaccines, as well as a countless studies done on SARS-COV viruses. This is just taking some existing technologies and knowledge of the vaccines and creating a new variant of what's been tested before. Also, we know have well over a year's worth of data on millions of people to look at as well.
- thehappypm 5y agoIt's been about 1.5 years of study, and a billion doses given, give-or-take. There's plenty of data. The FDA usually is a glacial, unmotivated bureaucracy, but for some reason I can't quite put my finger on, this got a little bump in urgency.
- mr_mitm 5y agoBut should feelings matter in this question? The vast majority of us has no intuition when it comes to vaccine approval processes, as is the case with most things that aren't every day experiences. (And even then intuition or gut feelings can be misleading.) Criticism should point out concrete failures to meet regulations or errors in the statistical analysis of the trials.
- hhsbz 5y agoIsn't this vaccine already grossly outdated?
- mikeyouse 5y agoNo.
- hhsbz 5y agohttps://www.forbes.com/sites/roberthart/2021/07/23/pfizer-shot-just-39-effective-against-delta-infection-but-largely-prevents-severe-illness-israel-study-suggests/?sh=4cd4f41a584f https://www.forbes.com/sites/roberthart/2021/07/23/pfizer-sh...
- mikeyouse 5y agoFrom your own article where it repeatedly emphasizes that the Pfizer vaccine is no way outdated: > The vaccine still provides very high levels of protection against hospitalization (92%) and severe illness (91%) caused by the Delta variant, the ministry said. .. > 91%. That’s how effective the Pfizer vaccine is at preventing serious illness and hospitalization caused by the Delta variant after two doses, according to the Israeli study. This is only slightly lower than against other variants. As this is the primary purpose of a vaccine, it is still highly successful, though it does mean it will likely not be sufficient to stop outbreaks on its own. In any case, there's clear evidence that immunity waned in people given two doses too close together 8 months ago and that a third dose basically regains full efficacy.
- 2OEH8eoCRo0 5y agoDo you hear that? It's the sound of millions of goalposts being moved.
- pensatoio 5y ago“It’s not FDA approved,” is a secondary objection aimed at urging someone think about the primary.
- TheFreim 5y agoYeah, everyone I've talked to who is not taking it used it as a secondary argument as to why people who don't have other concerns should still be cautious.
- aspaceman 5y agoIt's kinda fun seeing it happen in real-time in the comments though. Lol. These people will be the joke of history books. I can imagine the line already: "While many were hopeful that FDA approval would assuage the large amount of vaccine skepticism, it did not seem to change the narrative." I will continue laughing at their pathetic graves and funerals while being frustrated at their impact on me.
- ezekg 5y agoHow quickly we've gone from "comply to save just one life" to "laughing at their pathetic graves and funerals." Like... what the hell? Do we not see a problem here?
- seoaeu 5y agoWhy should I have sympathy for those who have displayed a such reckless disregard for the well-being of their fellow neighbors? The best I can muster is some pity for them falling victim to disinformation. So many of us endured personal sacrifice over the last 18 months to help prevent the spread of covid, and now these people refuse to take even the simplest steps?
- throwawayboise 5y agoDoes this end the waiver of liability that was granted under the EUA?
- appleflaxen 5y agoAny physician may prescribe any FDA-approved medication outside the scope of the label if it's indicated in their medical judgment. That means that it may be prescribed to individuals <18 in some circumstances, and that it's legal to do so (explicit emergency authorization notwithstanding).
- xiphias2 5y agoCan I now travel to the US and pay for one if I want as a non-US resident? So far that was impossible.
- s0rce 5y agoUndocumented people have been able to get the vaccine in California without paying so you can get it and don't need to pay.
- rafaelm 5y agoCan confirm, lots of people from my country have been traveling to Miami to get the shot. Some go for 10 days to get the Johnson shot (single dose), because they can't/don't want to spend a month for the two doses. According to what I've heard, you can just walk into any Walgreens/pharmacy to get it, without paying or getting an ID check. Not sure how legal that is though. I understand that those should be for tax-paying citizens.
- kccqzy 5y agoDoes that actually inflate the vaccination rate in Miami then? I don't think vaccine access should be limited to citizens (let alone tax paying ones) but at least the statistics should be clear in pointing out whether or not the vaccinations are for residents, or for tourists. The real vaccination rate among residents in Miami could be much lower then.
- xiphias2 5y agoI traveled to Miami in May, went through a long line and didn't get the Pfizer shot as they were checking people :( I wouldn't want to spend so much money flying there without a guarantee. Anyways, I will probably be able to get something (looking for a 3rd Pfizer shot), I just don't like to depend on getting lucky.
- deleted 5y ago[deleted]
- menduza23 5y agoOften people use the argument that this vaccine was really rushed and there could potentially be side effects to such a rushed vaccine. There is one example of this actually happening. Have a look at what happened with the pandermix vaccine: narcolepsy.org.uk/blog/important-ruling-pandemrix-case https://www.theguardian.com/world/2019/nov/20/swine-flu-vaccine-case-settled-but-hopes-for-legal-precedent-dashed https://www.theguardian.com/world/2019/nov/20/swine-flu-vacc...
- mr_mitm 5y agoIt is my understanding that simply waiting for a longer time would not have helped. This side effect did not come much later after the vaccination, but only in very rare cases, which is why it took some time to notice it. Considering how many people we vaccinated with the Covid vaccines, we should have seen (and have seen, with myocarditis, trombosis) such rare side effects. Plus, it is likely that the disease itself would have a similar effect on patients, because it is an interaction of the immune system with the nervous system. The vaccine itself is cleared from the body within weeks, after all, so it's not like medicine that is taken over a long period of time and can build up. So what you need is not longer trials, but trials with more people. Which is what is done in so called phase 4 trials after approval.
- cies 5y agoSide-effects may develop only after a while: a good reason for longer trials.
- thepasswordis 5y agoPeople don’t want to take the vaccine because others are trying to force them to. They would say “it’s not FDA approved!” not as the core of their hesitancy, but because they were trying to be appeal to pro-vax peoples decision making framework. I don’t think we should be able to require them to. To many of you here: imagine the Trump admin trying to require you to take the vaccine in November of last year. Cities would have burned over it. And honestly: I was one of the first to take it, but the desire to almost force me to take a booster, and the weird, Orwellian ways that the government talks about it, has turned me against the booster. It ends up feeling less like the decisions are guided by science and more like they’re guided by petty tyrants wanting to control what others do. Anybody who has ever lived under an HOA will recognize this.
- pornel 5y agoHere's the deal: you don't have to take the vaccine, but promise to stay away from people, and not burden hospitals when you get covid. It's not your personal choice when it can harm other people (e.g. immunocompromised people who can't get the vaccine themselves, other people who need ICU beds).
- thepasswordis 5y agoI will happily stay away from hospitals if they stop regulating drugs, and medical treatments. Also: I did take the vaccine.
- thehappypm 5y agoDo you honestly think a world with unregulated drugs and medicine is a better one?
- thepasswordis 5y agoNo.
- zacharytelschow 5y ago
- vvilliamperez 5y agoLike someone else mentioned, I think the core issue is "Should the government have the right to mandate medical procedures?" In my mind, I'm vaccinated, so what does it matter to me if others are not?
- eddieroger 5y agoI had to be vaccinated to enter first grade, and again in college. Since I went to a public school, doesn't that already kind of answer this question?
- walterbell 5y agoMMR vaccines are sterilizing, i.e. you take them once and done. No lifetime booster subscription. Current Covid vaccines are non-sterilizing. They do not provide immunity that is equivalent to the MMR vaccine. A future (nasal) Covid vaccine may offer long-term mucosal and blood/serum immunity.
- Apofis 5y agoWhy isn't the nasal vaccine being produced?
- deleted 5y ago[deleted]
- walterbell 5y agoSome are in trials. https://www.indiatoday.in/coronavirus-outbreak/story/india-nasal-coronavirus-vaccine-soon-trials-begin-nagpur-1756780-2021-01-07 https://www.indiatoday.in/coronavirus-outbreak/story/india-n... https://medicalxpress.com/news/2021-08-sniffing-alternative-scientists-nasal-mist.html https://medicalxpress.com/news/2021-08-sniffing-alternative-... https://www.voanews.com/east-asia-pacific/researchers-begin-trials-covid-19-nasal-spray-vaccine https://www.voanews.com/east-asia-pacific/researchers-begin-...
- a_imho 5y ago
- Markoff 5y agoQuestion for everyone defending and promoting mRNA (1st ever approved 2020) and viral vector vaccines (2019) - do you also use all your software in Alpha/Beta versions and never wait for Stable? Or is it just your body you DGAF, but you have higher requirements for software?
- ceejayoz 5y agoClinical trials are the alpha. Emergency Use Authorization was the beta, and like Gmail's, probably went on far longer than it really had to stay in that state. Full approval is the stable. Being on an older Mac OS is also unlikely to get me killed.
- queuebert 5y ago"Comirnaty"? What does that even mean? Do marketing people just play Flappy Bird all day?
- thehappypm 5y agoCommunity + mRNA, if I'm remembering right. Marketing is a joke for these ones. Every government agency on earth is doing the marketing for them for free.
- TameAntelope 5y agoI literally think so, yes. Honestly, one of my life goals is to somehow tap into creating a plausibly excusable place for companies to dump their marketing dollars, I feel like that's one of the secrets to an easy life.
- b0tzzzzzzman 5y agoHacker news is turning into Reddit style comments section. Can we talk about natural immunity and the path forward?
- Qub3d 5y agohttps://news.ycombinator.com/newsguidelines.html https://news.ycombinator.com/newsguidelines.html > Please don't post comments saying that HN is turning into Reddit. It's a semi-noob illusion, as old as the hills.
- postalrat 5y agoNot as old as reddit.
- hall0ween 5y agoCan you point to any papers demonstrating natural immunity? I ask as my virologist friend, working on covid-related projects, says to me that it hasn't been shown to be plausible. Which, intuitively, makes sense because of (1) the positive effects vaccines have on reducing severity of the disease and (2) the cycle of variants we see and its path forward.
- ghiculescu 5y agohttps://www.wsj.com/articles/vaccine-mandate-natural-immunity-lawsuit-covid-19-coronavirus-11628281507 https://www.wsj.com/articles/vaccine-mandate-natural-immunit... was linked in another comment, it points to 3 studies on the topic.
- president 5y agoYes, the whole argument of vaccines, lockdowns, masks are moot when you consider that the default position should have always been - if you're scared of the virus, stay home. If the virus was that dangerous, we would not need a global marketing campaign to tell us to how to be safe. The last 2 years defies all logic and common sense.
- balb0a 5y agoFrom ones body perspective. What is the reason to take vaccine risk if you are healthy <~50/have no disease that complicate covid recovery? From societal perspective, why would you do it if you can transmit it in the same amount as if you are not vaccinated? Doesn't makes sense to me, but well.. I do think that it's a good thing for people that have disease that can complicate covid recovery and older generations.
- jnwatson 5y agoThe risk of dying or long-term complications from COVID if you're under 50 is not insignificant, especially on the upper end. Here's a pretty good graph of the estimated IFR by age [1]. (So far, there hasn't been a significant difference in lethality in the new strains). The graph shows about a .1% chance of death at age 50 if you catch COVID-19. The chance of hospitalization and potential long-term symptoms is a multiple of that. Vaccinated folks have a lower chance of catching COVID, so as a whole, they have a lower chance of spreading it. 1. https://pubmed.ncbi.nlm.nih.gov/33289900/#&gid=article-figures&pid=fig-3-uid-2 https://pubmed.ncbi.nlm.nih.gov/33289900/#&gid=article-figur...
- balb0a 5y agoIf you check my comment you will see that I agree that its good thing for people with associated diseases that can complicate recovery:). So age and associated diseases should be deciding factor for every person. Or are you proposing something else?:)
- zabatuvajdka 5y agoWhoever named it Comirnaty needs to stop taking Hydroxychloroquine.
- joefife 5y agoA large number of those objecting to the vaccine have serious needle phobia and don't wish to admit this publicly. The most common presentation is mild anxiety, but in more serious instances, a needle phobic person may pass out or be genuinely convinced they are having a cardiac arrest. There are alternative delivery methods being tested, such as by Pharmajet. I suspect that when needle phobia is addressed in a less hostile light, you may find an increase in uptake.
- the_doctah 5y agoThis is a legitimately preposterous take.
- rpowers 5y agoGreat. When can my younger kid get it?
- kristjansson 5y agoAll of these comments following the pattern "I'm vaccinated but [insert vaccine hesitancy content here]" sound quite a lot like the "I'm a democrat but [insert pro-trump content]" comments that abounded in the last cycle. I don't know what to make of it. Is this a rhetorical strategy that really works? A tic of people experiencing cognitive dissonance?
- AnimalMuppet 5y agoI think it's "please don't reflexively ignore the opinion that I am about to express, which is the kind of opinion that people on the other side reflexively ignore".
- criticaltinker 5y agoYes this is exactly why people are prefacing their comments with such details, because after participating in enough HN discussions on topics like these you'll quickly realize how reflexive people can be - down-voting and flagging without any charitable interpretation or engaging in nuanced and informed responses that tease out the important themes of the discussion.
- 015a 5y agoIts totally healthy to both believe that the vaccine makes sense for you, and still respect, love, include, and accomodate people who decide it isn't right for them. We're all different, and the world is very complicated; that's what makes life so awesome.
- kristjansson 5y agoThat's a nice sentiment[1], but why couch it in such an odd construction? "I took it, but here's a bunch of reasons not to" doesn't come across as an argument for equanimity and individual decision making, it comes across as an argument not to take it. [1]: though 'include' carries a _lot_ of potential interpretations there :)
- 5y ago
- megous 5y agoThere are people with long term issues starting right after vaccination. Not safety issues, which everyone and their dog studies, just multi-month constant pain that will not kill you but just disables you from your normal life for months, that is not solvable by regular NSAIDs, as usual, and that you'll get no compensation for from anyone. I'm just interested in how common this is after vaccination, and perhaps when may this end, so I again spent a few hours yesterday to try to find some significant (N > 5000, preferably more) independent prospective studies of "mild" side effects like these of this vaccine. So much vaccination going on, so why not just give every 5th person vaccinated in some large center a link and a code to enter observed side effects after 1 day, 3 days, week, and a month, and then maybe 3 months after into some website. Maybe ask for a phone number and call them to ask, if they don't fill the form in time. Even such a stupid study design would satisfy me. No such thing on google scholar. There are barely any studies that track side effects over time. It's almost all just binary X,Y,Z side effects after vaccine - yes/no. All studies I could find are < 1000 people or in that range. The small amount of studies that actually tracked side effects over time, just track for 7 days and end with 4% people still having side effects after a week. One Czech study I found tracked side effects for a month! With 2% having still issues after a month. Well, good! No, not really, N<1000 again, and a biased survey style study. Also the fucking irony of search returning about 5-10x more so called "hesitancy" studies per a side effect survey, despite me not search for it. I'm fully vaccinated, and there's no shortage of studies about efficacy, so no problem there. But people that proclaim how well the side effects are studied, because of how many millions of people were already vaccinated just sound ridiculous to me now. Where are all the actual studies? From what can be found it just seems that very little fuck is given about serious study of so called "mild" side effects, and some guidance given on how to mitigate them, based on results. ("no compensation for from anyone" is because my country actually passed a law that allows for compensation for covid vaccine gone wrong; but with no proof of some statistical relationship, this was just another bullshit anti-hesitancy stunt from the government, and will be of no real help to the affected)
- lokar 5y agoWhen I got vaccinated I started getting surveys on my condition from the CDC. Daily at first, then weekly and monthly
- dang 5y agoTo read all the 1000+ comments in this thread you need to click More at the bottom or on links like this: https://news.ycombinator.com/item?id=28275509&p=2 https://news.ycombinator.com/item?id=28275509&p=2 https://news.ycombinator.com/item?id=28275509&p=3 https://news.ycombinator.com/item?id=28275509&p=3 (Comments like this will eventually go away. Sorry for the annoyance.)
- throwawaay_3424 5y agoI don't get why people are so afraid of the VaaS model (vaccine as a service). If we already buy all our entertainment on a monthly basis, then I don't see an issue in mandating quarterly or biannual immune system boosters to protect against the virus. Vaccine passports are a different issue. I would probably sign up for VaaS, but governments could use mandates aggressively, and it's not far off to imagine how people end up in concentration camps from there. As Plato put it, democracy ends in tyranny, so this is to be expected/embraced
- umvi 5y agoThe real question is whether covid or all the in-fighting around politicization of covid is doing more harm to society. I almost think it's all the in-fighting and social discord.