FDA Approves First Covid-19 Vaccine

For the "vaccine court" you're just presenting a claim that vaccine X could cause condition Y, that you developed condition Y after taking vaccine X, and that there's no other reason you'd suffer from condition Y. If the court finds it plausible, you (and your lawyers) get paid, and everyone goes about their business the same as before.

https://www.indiatoday.in/coronavirus-outbreak/story/india-n...

https://medicalxpress.com/news/2021-08-sniffing-alternative-...

https://www.voanews.com/east-asia-pacific/researchers-begin-...

So many people talk about "vaccinated versus unvaccinated", but this dualistic framing is not conducive to scientifically accurate discussion. There are at least three groups of people to acknowledge:

A) vaccinated

B) immune via natural infection

C) immunologically naive (have never been exposed to the virus)

The A & B groups will have very similar characteristics in terms of individual risks and risks to others. Group C is what many people mean to refer to when they say "unvaccinated people spread COVID faster and with more frequency".

You're saying, confidently, that vaccinated people spread more COVID than un-vaccinated people? A bold strategy!

It's probably correct that lots of spread is happening because people feel OK, but that's because (especially with Delta) viral load typically peaks before symptoms show up[1]. That is, the most infectious period is probably before anyone feels symptoms, vaccinated or not. But of course the vaccines significantly reduce the chance of getting infected in the first place, and when you directly measure the secondary attack rate, instead of looking at a proxy like RT-PCR Ct, vaccination also seems to significantly lower that[2].

1. "Delta’s rise is fuelled by rampant spread from people who feel fine" https://www.nature.com/articles/d41586-021-02259-2

2. "Vaccine effectiveness against SARS-CoV-2 transmission and infections among household and other close contacts of confirmed cases, the Netherlands, February to May 2021" https://www.eurosurveillance.org/content/10.2807/1560-7917.E...

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.

This is false. The "leaked" internal discussion document has been repudiated by its author, and the group of hospitals discussing it.

This is why people who take immunosuppressants typically avoid going out in public, and when they do they wear serious masks intended to protect them from others.

But I'd rather be injected with a litre of smallpox than go vegan.

Does it need to be a law to be compulsory? How many Americans, including employees of numerous branches of the federal government that have said mandates, have the luxury of walking away from their jobs? Things like...

https://www.usnews.com/news/health-news/articles/2021-07-29/...

In Australia you can see the next step already where it’s being applied to grocery stores. You have to start pushing back before it gets to that.

Covid is a disease that overwhelmingly targets the obese.

But you can't go to a gym.

Do you consider working out an "optional" endeavor?

Not only is it essential to beating covid, but, working out keeps people sane. More young people have died from increased alcohol abuse, suicide, and drug overdoses than Covid. This all coincides with the insane push to de-humanize humans. We are social creatures. We are active creatures. For the past year and a half we have been denied these human needs. What is optional to you, is essential to others.

Personally, I don't care too much about losing the prospect of eating out, or hanging out in a bar. For others, especially young people seeing their entire social prospects evaporate before their eyes- this is life ending. For me, working out keeps me sane and not suicidal. I don't have the luxury of a home gym.

I chose to continue working out during the pandemic, training at "secret" gyms. For my health and my sanity.

All my other friends in my age group have put on weight and are more unhealthy than they've ever been. How does this help fight the pandemic?

Referring to authorities as "petty tyrants" or whatever probably doesn't count a personal attack unless the "petty tyrant" is personally present. I don't think those comments are very high quality, but this is the internet. Trying to raise comment quality is like trying to lift a tsunami. We do what we can.

I don't agree that personal attacks are "small". I think they are particularly poisonous to community.

OK, fine, it's not just mRNA. It's novel tech vs. well known tech like attenuated/inactivated virus.

Beyond that, Covaxin is the only that I'm aware of that is performing well under delta.

The naturally immunity thing is fraught. Accepting for argument that naturally immunity is exactly as good as the best vaccine, it's reasonable to equate vaccinated and recovered at a point in time. Covid has done all the damage it's going to do to the recovered group, and both are as protected as the other going forward (per assumption).

However, offering 'vaccine or recovery' as an option going forward is more harmful if there are any remaining unvaccinated/uninfected people. Some _will_ choose the 'recovery' option, at immense personal (illness, possible long-term damage, possible death) and societal (health-care over-burden, transmission effects, etc.) expense. Splitting the currently-recovered from uninfected/unvaccinated for policy-making purposes would require either faith in self-reporting or significant invasion into health records. Neither seem tenable in the US, for obvious reasons of culture and law. IIRC other countries are taking that route.

Which leaves you, I think, where your comment started. Are the external costs of assuming the risk large enough that policy should proscribe that option and mandate vaccines?

https://www.youtube.com/watch?v=09maaUaRT4M

70% is enough for the original Covid. Covid moved the goalposts to Delta which needs different numbers. This is not experts moving the goalposts, this is Covid changing on us - as was always expected to happen and why experts said we don't know what % is required until Israel showed 70% was enough for the original Covid strain.

Herd immunity happens when a disease can't spread because all people surrounding the infected person have enough immediate immunity to stifle its progress. Delta seems to be able to spread to people in the gap before the immune system recognises it, so it may be something that can't be stopped by herd immunity.

Other models are certainly possible, but only work in places where people have higher trust in their government, and think about collective welfare over their own individual selfishness. Unfortunately, people in the US (and much of the West) care too much about "mah lib-ur-tee" than doing their part to help keep their neighbors healthy.

Also I think your focus on Japan is a little weird; they went through their own bad time with COVID, and even consider the recent case of the large flare-ups surrounding the Olympics.

While I'm a big fan of people having a choice, due to the large amount of misinformation out there people are dying. We have people in my country that could have gotten the vaccine but didn't because of Facebook conspiracies and are now refusing oxygen in hospitals because they're afraid their lungs will explode - due to Facebook conspiracies.

There's no good reason for the majority * of people to avoid the COVID vaccines. They're making a dumb decision.

* Of course there are exceptions, but it's a small percent

For those of us who got the vaccine, we’re still having to take precautions because of the delta variant spikes, largely from people who didn’t get a vaccine. Where is our choice?

Is this still true if unvaccinated takes a hospital bed away from someone else or increases insurance costs to everyone else due to more expensive care?

You're welcome to choose not to get vaccinated, and not to go to any such employers, colleges, etc.

I know I wouldn’t want to work in person at any place that didn’t have a vaccine mandate. Once vaccines are approved for children, I think people’s options should be to either vaccinate their child or homeschool them, since if I had children I wouldn’t want them exposed to the unvaccinated. The federal and state governments forcing everyone to get the shot would be a step too far for me, but I’m very much in support of it being hard to be a part of society if you refuse to take one of the most basic steps to protect other people in it.

See how silly that sounds?

I care because humanity has been screwed over by this virus for a year and a half now, and the virus could be completely controlled by now in any country with a sufficient vaccine supply. But it's not, because people refuse to do their part in helping to take care of their community. That's disgusting and unforgivable to me. The blame for any COVID-related death that occurs in the US now falls squarely on the shoulders of the unvaccinated.

The vaccine hesitant's tendency to move the goalposts when their reason du jour for refusing vaccination is invalidated is based on misinformation and unfounded fear. The exact opposite of good reasons to change your mind about something.

This is why getting spread under control is so important: each time the virus replicates there’s a chance of a new advantageous mutation making the problem harder. Wearing masks and vaccination are how we break that cycle.

"mRNA vaccines have been tested in humans since 2011"

So barely 10 years. A study on a dozen or so participants, all white, college aged men with largely identical diets. I guarantee you that not one participant in the 2011 study was pregnant. (Btw, I looked at your reference. A Bush era press release was less manipulative. There wasn't a single peer-reviewed reference. All press releases and from interested parties)

Compare that with other vaccine technologies for which we have centuries of data, and inoculation in general for which we might have a thousand years worth of safety data.

Or did we forget about all the inconvenient facts about drug testing? We appear to have forgotten all the research done about regulatory capture and all the ineffective and unsafe pharmaceuticals the FDA approves.

But, nvm. #BelieveTheScience and de-platform anyone who asks inconvenient questions. And let's compartmentalize away the replication crisis modern science is going through.

Also, for some of us 10 years is not very impressive at all. "It's not new, nRNA has been around since the 90s!" is a massive value judgement for the word "new". Not all of us work developing webpages with 3 month old technology stacks!

I'm talking about the mRNA vaccines. Others are more complex. They are also more studied though so your objection seems to be to the mRAN ones.

For 20 year-olds, kind of the opposite currently. Costs very little to use this choice as a political signaling gesture. But if the cost increases, as you say, behaviors will change and people will change their position. Talk is cheap, it’s easy to say “never” when it costs you ~nothing to do so.

But in short, I do strongly agree that mandates will be more persuasive than just approval alone. But I think full approval will still be beneficial in places that won’t make mandates.

I like Gary, but on the issue of cholesterol is more complex than he portrays.

It is absolutely the case that LDL-C is correlated with heart disease at the population level. It is absolutely the case that LDL-P is correlated with heart disease at the individual level. Beyond the correlation, there is considerable mechanism of action evidence that small particle lipoproteins are the driver of atherosclerosis.

The primary issue with statins / LDL is that they are prescribed based on LDL-C, which is not appropriate at the individual level and are thus considerably over proscribed. LDL-C only matters at the population level, not individual. When lowering LDL-C for the population, you will only see small benefits since most people get little to no benefit from the drug.

However, people with high LDL-P will absolutely see a benefit from statins. You need only look at the FH groups to see this.

https://en.m.wikipedia.org/wiki/Rubella_vaccine

Until it makes it into Debian stable repositories.

I wouldn't really call that "soon after it is administered".

And the same is also true for covid's long term effects. I'm still reading new articles/conclusions about those effects.

If there is nothing that will change one's position, it's not worth engaging because the outcome is set.

What the question your parent poses can do is get to the root of the objection your conversation partner has. "What would make you change your mind" forces the conversation in the direction of uncovering the true source of the disagreement. It helps to avoid talking about "symptoms" or issues that you might find important but are not important to your partner. It helps avoid talking past each other. It helps identify what issues are important to the other person.

Understanding that base fear will help bridge the divide between groups.

When it comes to the vaccine, I got the first shot (Moderna) and had such a terrible week following it that my doctor was fairly convinced I probably already had COVID. Everyone I know had a much stronger reaction to the second shot than to the first, so I've opted to remain partially vaccinated.

With Delta in full swing, I'm now reconsidering that, but am making arrangements in advance to be out of work for another week or two, as that's my expectation going in.

All of that said, the folks I know who are unvaccinated have either already had COVID, so they're just trusting their immune system, or they are in a relatively low-risk group, and are concerned about long-term vaccine side-effects. All of them are fully vaccinated in all other regards, just not with COVID. Make of that what you will, but very few of them fall into the caricatures I see bandied about in the comments here.

Incidentally, I'm also concerned about long-term side effects, but I figure at this point, we'll have to solve that problem as a society, if they ever show up enmasse.

It can only hypocritical if it is the same people making both arguments.

That said, I'm absolutely getting _my_ booster as soon as I'm eligible. That isn't hypocritical; at that point the decision was made and if I don't take the booster it won't be sent to sub-Saharan Africa.

Unless you’re dealing with an extraordinary individual or the issue is relatively trivial then you won’t be told sufficient reasons. A lot of what motivates us is deep down and dumb and we rarely want to admit it even if we’re aware of it which is even rarer. I find that examining reasons to change my own mind is much more fruitful because it’s harder to lie to myself albeit still far too easy.

Instead, they are treated as if they are a threat. As if they are the ones who are overstressing the health care systems. When often instead they are the frontline workers these systems depend on. Many give care in nursing homes and at hospitals (in the case of nurses, a large percentage of whom still refuse the vax).

How many health care resources does the average unvaxxed healthy 26 year old consume? A lot less than the chronic smoker, the morbidly obese, the elderly, etc.

I've been living normally without lockdowns or masks for about 18 months now. So has the rest of my country Sweden. So excuse me if I'm not running around fearing for my life anymore. I'm pretty much convinced we all have natural antibodies by now.

Eric Clapton took both doses. He suffered some severe adverse reactions. What’s the misinfo?

It boils down to a really muddy mix of small things that all sum up to a decision against it.

For instance, I'm not the risk group and, due to being super medically conservative for _everything_ (to a fault!), I tend to not take medical interventions I don't strictly require.

I think that the vaccines are overwhelmingly safe from an absolute risk perspective, but among the least safe things we've deployed into wide usage from a relative risk perspective. It's tough for me to convince myself to take an intervention I don't need. Stack onto this things like the PREP act, guaranteed orders, big pharma's history, this being the first mRna vaccine to get through Phase III, and more hesitancy gets added on my side. As data from other countries rolls in, the efficacy side is also interesting, but that's a different topic.

Finally, there's just general disposition. Whether lockdowns, restrictions, or vaccinations, people seem to fall into one of two groups: those who favor public heath above all else, and those who favor personal liberty above all else. Due to some wrongthink, I fall into the latter camp. The behavior of those in the former camp pushes me away from my medically hesitant "wait and see" position, into one of, frankly, staunch dismissal out of pure curiosity to see how willing society is to marginalize those who made a 'wrong' medical decision.

Because it's not like they live in a representative democracy, right?

There's nothing about any sort of technique that is inherent to objects and not people. Techniques are something used to achieve a goal, and if a person is involved in that goal, there's nothing wrong with using that sort of verbiage.

>thus we "must" manipulate, coerce or the very least impress conclusions down their throats.

You've made any attempt to change someone's mind out to automatically be something that's naturally evil. Ridiculous.

You cannot, with 100% accuracy, model a virus that is mutating in a population that includes the entire planet. We have things we know worked in the past, we try them, and we then modify our next move based on the results. We don't say "well we got that one wrong so now we're just not going to try anything". If every scientist took the approach you're suggesting we'd still be eating raw meat and living in caves.

Why is suing vital? What's insufficient about the existing National Vaccine Injury Compensation Program? https://www.hrsa.gov/vaccine-compensation/index.html (I'm genuinely unfamiliar with any flaws it might have)

> Many rights have been taken away (some permanently)

What rights have been permanently removed? For that matter, what RIGHTS have been even temporarily suspended?

Telling someone you'll fire them if they don't get a shot isn't quite holding them down and jabbing them but it's not really a free personal choice either. Many people aren't in a position to just hop down the street into a new job.

Yes, but obviously that's not a representative sample. My point was that the population of genuine libertarians for whom this seems like a first principles argument is dwarfed by the general population of Q-adjacent social conservatives who are happy to adopt libertarian framing but really just want the government to do what they want.

You've introduced a new assumption though: that a unvaccinated person has and transmits covid. You must apply the probabilities to that initial assumption as well. Probability of having covid * probability of transmitting covid * probability that the person you transmit to has series harm done.

>Also vaccine requirements aren’t anything new

This is an argument that I've also seen but think appeals to "well we've been doing something similar already." I don't think that justification holds much water, especially in this time period where we are questioning a lot of foundational social assumptions.

To your direct question about bar for acceptance, I think people can generally establish a good bar, but they have to be given accurate probabilities, and those have been hidden from us in favor of vague fear mongering.

* Millions of COVID cases were never counted in those statistics; people who never got tested, due to being asymptomatic, low-symptomatic, having poor access to testing due to a vulnerable socioeconomic status, catching it before tests were widely available, and the natural rate of false-negatives due to self-swabs. It is very likely that, actually, the official statistics don't capture the majority of total COVID cases. This isn't a clerical rounding error; the real denominator in that death rate is somewhere 2x-10x lower than published, and we'll never know exactly where. [1] [2]

* This situation has not improved since the beginning of the pandemic. While testing is far more widely available now, the secondary issue of non-sterilizing vaccine immunity is now in play; the vaccines are by-and-large "leaky", but tend to result in far less severe, oftentimes even asymptomatic, infection. Many of these people are not getting tested, but are still getting COVID, and thus the count is underreported. Or, maybe they do get tested, and it comes back positive, but should that test actually be included in the overall COVID death rate? After-all, because the vaccines are good at reducing the chance of death, the COVID they have isn't quite the same as the COVID an unvaccinated individual would have. I don't know, but its a valid question which the broad statistics do not care about; its COVID, its included in the aggregates.

* Here's an interesting fact most people don't know about: testing sites, of course, gather data about the patient before a test. One of those pieces of information is: are you vaccinated, when were you vaccinated, which vaccine. Pretty basic stuff. Except, the systems CVS and Walgreens (two of the largest testing providers in the US) used to gather this data, for many months early in the vaccination cycle, did not ask this, or did not ask for all three pieces of information. It was only within the last month that Walgreens started asking for all three.

* Let's continue down this path of "fun reporting": I had COVID four weeks ago. The first question everyone asks is: Oh, you got a positive test, which variant was it? I've been asked this dozens of times, which makes me think many people don't generally realize: the nasal swabs cannot determine the variant. In fact, states do not run variant tests on every swab! Generally, they run variant tests in aggregate on a statistically significant subset of swabs, then report the data in a range of once a week, to once a month.

* Many state reporting agencies are actually really bad at differentiating between "positive tests" and "positive individuals". In other words, the most "responsible" citizens, those who get tested at the start, then once or even twice at the end of the 10 days, are in many jurisdictions actually screwing up the statistics.

* Many deaths were counted in those statistics. Oftentimes, over-counted, at least in the context you're using those statistics in (what is COVID's death rate?). First world hospitals, having pretty excellent access to these tests as the pandemic entered its teenage stage, entered a pattern of testing every admittance, even for symptoms unrelated to COVID. If they were positive, and they died for any reason, COVID was, of course, listed on their chart; it then got counted as a comorbidity, not the true cause of death. State reporting agencies still count it as a COVID death; they don't discriminate.

* But, of course, many deaths were undercounted; especially those who died before seeking medical care, or before testing was widely available.

* And that's not taking into consideration tertiary deaths caused by the state pandemic response, not COVID itself; millions of people delayed seeking regular and even urgent medical care due to fear of the virus. Many of these cases were not even at the behest of the patient, but rather due to medical offices delaying appointments or moving to virtual appointments, which offer a far lower standard of care. The impact to generalized mental health, social development of children, adolescents, and young adults, socioeconomic development of young adults, and many other facets of our society, will continue to be studied for the rest of our lives. Let's say it turns out that a broad, authoritarian lockdown saved a million lives, but it is also directly or indirectly traced to 20 million new cases of clinical depression; is a lockdown a good idea? Even with hard numbers like that its actually not obviously clear one-way or the other, and the worst part is: the people making these decisions never have the numbers. They're always acting on intuition; it takes years to even realize that this possibility even exists, at any magnitude, and we never know the true numbers. Did you know suicide is the 10th leading cause of death? Did you know that social isolation increases rates of clinical depression, which is positively correlated with suicide? Quarantine saved lives; how many did it cost? How many will it cost? But we're super duper sure it was the right call... right?

* Drunk driving is far, far, far more common than the arrest rates would suggest. Like, its actually insane how common drunk driving is. Cops are not gods. They do not catch everyone. One million people were arrested in 2016 for drunk driving; its likely that 50 million+ people drove above the legal limit in that same year, multiple times each.

This is just me, outlining the uncertainty of our world. Because here's the kicker, here's the Topic Of Choice: We should mandate vaccinations. You sure? Are you absolutely certain, beyond any doubt, knowing how much we don't know, that its actually the right call for our society?

You've thought through the medical consequences. There probably won't be any en mass, sure. What about social ones? We've got a nation of tens of millions of people who don't want to be vaccinated, where personal freedoms run deep for all its pros and cons, and you so strongly believe that our society will be Better if we force these people to undergo a medical treatment they don't want. Do you actually think this is such an easy decision? That there wouldn't be social consequences? That the mandate would go out, and everyone will forget that the government just shit all over their perceived freedoms (whether or not those freedoms are legitimate is irrelevant; they believe they have them, we live in a democracy, and there are 500 million+ guns in America).

The world is very, very complicated. You're making broad, authoritarian suggestions based on an unbelievably erroneous analysis of data, yet you were totally convinced you're right. The people in charge are totally convinced they're right. No one is right. No one has access to all the information. We live in a very complex, very scary world where even the most equipped, powerful, rich states cannot have even 2% of the information they need to make the right decisions.

[1] https://www.nature.com/articles/s41467-020-18272-4

[2] https://www.sciencedirect.com/science/article/pii/S221137972...

The best argument for treating COVID more seriously is that we have a better understanding of influenza’s long-term effects. In both cases, however, I’d argue that it makes sense to require vaccination simply to reduce the impact on childcare and education: even if dying from the flu is relatively low-risk, it’s stressful and disruptive when it rips through a class and vaccination is quite cheap in comparison.

Given that both Pfizer and Moderna have virtually no side effects why wouldn’t you get it at these efficacy rates, even if lower?

https://news.ycombinator.com/item?id=27472107

https://news.ycombinator.com/item?id=27469092

https://news.ycombinator.com/item?id=27468756

Err, that sounds really scary and wrong to me. Seems to me that a drug should be approved when all the side effects are known, results are well characterized among a large sample set over a sufficiently long time frame, and it is determined that the drug is "safe" in the absolute sense.

It may be the case that we are better off taking a vaccine in a pandemic _even though we are not 100% sure it is safe_ due to the opportunity cost, and that's what emergency authorizations are for.

Even if the FDA really did their due diligence here, it will not convince anyone who was not already convinced; it is obvious that they were going to approve it no matter what, because the political fallout of not approving it after so many people have taken it would permanently destroy what trust remains in the US public health system.

Weren't extremely generous provisions like that offered by the US government last year in order to jumpstart vaccine development and production ASAP?

Wouldn't this be standard language in any contract? If I buy a widget and they ship it to me, if it gets damaged in transit, or lost in transit I still have to pay the producer, I then go after the delivery company (and/or their insurance) for compensation.

Imagine you volunteered for a very experimental trial for the greater good and then were told that you were given a placebo and now cannot receive a vaccine for several years and will have to be more cautious. You can see in the article that a volunteer from the trial is strongly advocating for giving the participants access to vaccines.

Obviously this complicates the statistical analysis (you can try to use a double-blind crossover study to get some statistical power out of this, but clearly the messaging gets more complicated), but I'm not seeing anything about a "14 day" timeline.

It's also worth noting that any study participant can just freely choose to break the study and go in and get vaccinated (lowering the measured efficacy of the vaccine)_whenever they want. Giving them a concrete date is a good alternative to that.

It seems you can force people to get a vaccine in the middle of a pandemic. France is dealing with massive unrest [0] and are hemorrhaging medical staff [1] because they mandated vaccines for medical professionals (which doesn't make sense, the vaccine doesn't prevent a person from spreading the virus [2]).

[0] https://spectator.org/french-health-pass-riots/

[1] https://www.reuters.com/world/europe/we-have-rights-french-h...

[2] https://www.realclearpolitics.com/video/2021/08/06/cdc_direc...!

At the time they dissolved the control group, the fatality rate in control and placebo were the same. By their very own data they did not have a strong case that they would be "condemning...a fraction of the control group to die.". One would have to make a leap. A plausible leap, but a leap nonetheless.

Let's assume though that the fatality rate across the population for COVID was 1%, a very high number, to be conservative. So in that case you'd expect ~150 preventable fatalities in the control group. We now have ~that many fatalities, in a single state (Massachusetts), from COVID-19, in people who were "fully vaccinated".

You can do the math and extrapolate that there are now orders of magnitude more deaths from "breakthrough infections" than might have been in the placebo control group. If we had known that the efficacy of these vaccines was going to fall significantly, might some of those deaths have been prevented? I think there's an argument to be made there.

Now we have statisticians scrambling over themselves with complex methods to figure out what the hell is going on, when we could have had the gold standard which would be quite simple to interpret, if we had kept those control groups.

Now some argue it would have been completely impractical to maintain that control group amidst a mass vax campaign (I think we should have tried, regardless). I think there's room to debate that. But in that case I think we need a vast upgrade to our data infra, because giving up the placebo control group was a huge loss (for truth and science, at least).

That doesn’t actually seem right though. You have control groups at least through all phases of trials to make sure “the treatment works”. That’s literally the point of the control.

Especially now that we know the vaccines don’t completely work to stop infection or prevent symptoms or spread.

I’m all for the vaccines, but it seems crazy that they didn’t even wait until phase3 was over for a new type that has never been tested on humans before.

If the argument is “the control petiole were at risk”, they should have been told their vaccine was placebo and ask for volunteers to remain in control, seems like flat out offering them real shot defeats the point, doesn’t it?

Many drug and vaccine approvals in the past have been done before the trial has run its full course. Many drug and vaccine trials have given the placebo group the real drug once safety and efficacy is clear - before the end of the trial.

This is not new, and frankly I’m a little surprised to see such conspiracy theories on HN.

1. The FDA requires six months of clinical data to establish safety before FDA approval. The normal requirements for FDA approval absolutely were followed

2. With longer-term studied it's not like we don't know anything about them until it's complete. Data is released on a rolling basis so we know how the results of the studies so far, and (surprise!) data so far say it's safe.

Evidence?

I feel like people keep forgetting the definition of "public health crisis."

Time is lives. And economic dollars.

The standard process is designed around limiting harm. Not rapid delivery. Not maximizing good.

In times of business as usual, that's fine. In times of public health crises, it's not.

If we'd rapid approved HIV / AIDS treatments in the 1980s, the world as a whole would have been better.