FDA Approves First Covid-19 Vaccine (opens in new tab)

I think the major talking point is covered by this info, which is meant for the general public. I'll make an assumption that the general public is also less educated on average than the users on HN on average. A flowchart that would satisfy a bunch of nerdy engineers (us HN users) with all possible paths would confuse the heck out of everyone else.

https://www.cnbc.com/2020/12/16/covid-vaccine-side-effects-c...

Claims can only go by "vaccine court" (yes that's a thing according to Wikipedia)...

https://en.wikipedia.org/wiki/National_Vaccine_Injury_Compen...

> "NCLA is pleased that GMU granted Professor Zywicki’s medical exemption, which we believe it only did because he filed this lawsuit. According to GMU, with the medical exemption, Prof. Zywicki may continue serving the GMU community, as he has for more than two decades, without receiving a medically unnecessary vaccine and without undue burden. Nevertheless, NCLA remains dismayed by GMU’s refusal—along with many other public and private universities and other employers—to recognize that the science establishes beyond any doubt that natural immunity is as robust or more so than vaccine immunity.”

https://www.federalregister.gov/documents/2020/03/17/2020-05...

The Secretary must also state that liability protections available under the PREP Act are in effect with respect to the Recommended Activities. These liability protections provide that, “[s]ubject to other provisions of [the PREP Act], a covered person shall be immune from suit and liability under federal and state law with respect to all claims for loss caused by, arising out of, relating to, or resulting from the administration to or use by an individual of a covered countermeasure if a Declaration has been issued with respect to such countermeasure.”

...

The PREP Act states that a “Covered Countermeasure” must be a “qualified pandemic or epidemic product,” or a “security countermeasure,” as described immediately below; or a drug, biological product or device authorized for emergency use in accordance with Sections 564, 564A, or 564B of the FD&C Act.

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...). 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.

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.

The statement is true. If you're not vaccinated, and you get COVID, there's a non-zero chance that you'll be the source of someone else's breakthrough case.

This statement is also true: If you're vaccinated, and you get COVID, there's a non-zero chance that you'll be the source of someone else's breakthrough case.

So, the quote is kind of useless. The unvaccinated probably do spread COVID faster and with more frequency. So, the directionality of the quote is fine. But it reads like a boolean statement, which is incorrect. COVID is almost certainly endemic at this point. Vaccines clearly help, but it's incorrect to blame all of the mutations and spread on the unvaccinated.

I'm pro vaccine, but even if everyone in the US got vaccinated in the next month we would still have to worry about vaccine-resistant variants coming in via other places.

Additionally, some people can't get vaccinated, or vaccines only work more weakly for them.

Also also, pandemics have knock on effects beyond just the people who get sick, in terms of economic impact, as well as societal rules and restrictions, e.g. schools closing down because of too many sick people, medical procedures getting delayed because the ICU is overwhelmed, etc.

No person is an island; even someone who hypothetically somehow had magical superimmunity from the start of the pandemic would still be facing its effects.

The goal is to reduce the load on the healthcare system. Expanding ICU capacity to always support COVID peak would be expensive, both from the infrastructure and staffing perspectives.

Since the Delta variant is making kids sick, and we don't have a vaccine for kids who are 12 and under yet, we're going to see more kids end up in the ICU.

Also, the Delta variant is 2-3x as transmissible as the COVID strains we've seen before.

The claims that vaccines put evolutionary pressure on the virus to create more virulent strains don't seem that credible when you consider India is seeing new strains develop with a 6% vaccination rate.

A rebuttal would be that we should get vaccinated so we don't die while taking up scarce resources for no real reason.

Covid has an animal host vector. Unless we start vaccinating deer, it's here to stay regardless.

https://www.govinfo.gov/content/pkg/FR-2020-03-17/pdf/2020-0...

"The voluntary phase is over" - Bill de Blasio

https://www.forbes.com/sites/jackkelly/2021/08/03/new-york-c...

NBC News: https://www.youtube.com/watch?v=sBMCXkjaMxQ&t=778s

I'm under the impression that the vast majority of mandates have exceptions for existing immunity, no?

We have made up a huge number of arbitrary rules, some at a very broad scale (for instance, that you must shoes and shirts to go into most businesses), others idiosyncratic and basically between one person and another (no cats in this apartment). They all restrict our choices and our freedom and our actions.

We have also set specific limits on what sort of rules we can make up. You can say "no cats" in an apartment, fine, but you can't say "no pregnant women". You can fire someone for showing up at work one day with a face tattoo but not for changing their religion.

"Not wanting to get a vaccine" or "not wanting to wear a face mask" is not currently a recognized protected class (although not being able to because of a medical condition probably is, but hey, of the many many things I am not, I am not a lawyer). There's nothing saying it couldn't be -- we didn't used to have a concept of "protected class", we just had to make it up at some point -- but that's one way to frame this discussion.

The power to exclude is the power to coerce.

Society is coercing people into taking the vaccine by requiring it for any activities outside the home. Want to go to the grocery store? Get a vaccine or wear a mask. Want to go to Disneyland? Get a vaccine or wear a mask. Want to attend a conference? Get a vaccine or take a test and wear a mask. The mask and testing mandates are an effort to wear down anti-vaccine people instead of letting them be.

Compare: "You can murder someone, but then freedoms will be taken from you, because you could hurt someone with these freedoms. You won't get brainwashed out of it, but if you do commit murder, your freedoms are taken away."

Not arguing against the policy, but it in practice, it _is_ the same.

You don't get to dictate the health choices of others. And if we're going down that road (which you seem to embrace) a vaccine against a disease with such a low death rate hardly seems a logical place to start. But that's presuming logic is the starting point, a conclusion lacking evidence.

Also: I did take the vaccine.

You can probably find exceptions, but the widely spread examples I am aware of all then went on to talk about believing it when it came from the CDC and other authorities.

I would argue that there has been little flipping. Those who were not going to get the vaccine under President Trump are also not going to get it under President Biden. The recent "boo"ing of former President Trump at his recent rally when he recommended people get vaccines is just the latest evidence of that.

https://news.ycombinator.com/newsguidelines.html

For the unaware, there are multitudes of highly acclaimed scientists and academics around the world from top institutions including Nobel prize winners that are advising caution against the vaccine. You don't just get to choose which "science" you listen to. These voices are massively censored so the public doesn't really get to hear both sides of the argument. The whole "don't talk bad about the vaccine lest `vaccine hesitancy`" is evil and plain anti-science.

From a cursory search ~25% of Americans are a part of one.

Commentator: If the Trump administration approves a vaccine before or after the election should Americans take it? And would you take it?

Harris: If the public health professionals, if Dr. Fauci, if the Doctors, tell us we should take it, I'll be the first in line to take it, absolutely. But if Donald Trump tells us that we should take it I'm not taking it.

Harris is alluding to the fact that we should listen to people who actually have medical experience and know what they're talking about. You have to remember this was only a few months after Trump had tried to play doctor on TV by saying:

"So I asked Bill a question some of you are thinking of if you're into that world, which I find to be pretty interesting. So, supposing we hit the body with a tremendous, whether its ultraviolet or just very powerful light, and I think you said, that hasn't been checked but you're gonna test it. And then I said, supposing it brought the light inside the body, which you can either do either through the skin or some other way, and I think you said you're gonna test that too, sounds interesting. And I then I see the disinfectant, where it knocks it out in one minute, and is there a way you can do something like that by injection inside, or almost a cleaning. Because you see it gets in the lungs, and it does a tremendous number on the lungs. So it'd be interesting to check that. So you're going to have to use medical doctors, but it sounds interesting to me, so we'll see. But the whole concept of the light, the way it goes in one minute, that's pretty powerful."

I think this is a reasonable message of caution when talking about someone pushing HCQ and drinking bleach on the daily.

Kamala was saying that if the only person telling her she should get vaccinated was Donald Trump, then no, she would not take it.

The (very clear) implication is that she would prefer that people who actually know what they are talking about (i.e. virologists, doctors, nurses, scientists, the FDA, the CDC, NIH...etc) recommends getting the vaccine, then she would get it enthusiastically.

Is this really too hard to understand or are you really trying to use this extremely flimsy argument to accuse her of hypocrisy?

You have to remember at the time trump was recommending hydroxychloroquine as a preventative and miracle treatment for COVID-19. Sadly some of his followers still believe it (and now are looking at ivermectin as well).

    DTaP-IPV-Hib: Diphtheria, Tetanus, Pertussis (Whooping Cough), Polio, Haemophilus Influenzae type B (Hib)
    Pneu-C-13: Pneumococcal
    Rota: Rotavirus

People are so strange about this vaccine...

Based on Israel's vaccine data, we would need to see 2/100k 20-29 year olds or 6/100k 30-39 year olds die or experience side affects worse than severe covid for it to make sense to avoid the vaccine.

[1]: though 'include' carries a _lot_ of potential interpretations there :)

Political matter: What is the extent to which we want to allow people to make their own decisions when these decisions have an impact on the well-being of others?

Whatever your answer to the second question is (an exercise which I leave to the reader) is going to have an impact on the degree of inclusion and on the degree of accommodation that should be extended to people who choose not to vaccinate. Respect and love is possible and encouraged in all cases.

As a bonus, for further consideration...

Ethical matter: What is the moral value of an ill-informed decision, and is the moral value of an ill-informed decision sufficient to support the principle of individual autonomy?

Like... what the hell? Do we not see a problem here?

Not that this is a silver bullet that automatically leads to peace and harmony, but it's a step in the right direction.

This line of thought leads to the sentence immediately following the one you quoted: if there are a large percentage of people who were hesitant due to sincere safety concerns, the mountain of data showing that the vaccines are low-risk will translate into more of them getting vaccinated but if they're motivated by factors which are not affected by scientific data then the primary mechanism for ending the pandemic will be the kinds of requirements which are made possible by full approval. That either gets people vaccinated or removes them from many contexts where they pose risk to everyone else.

Right now there are a lot of concerns raised about vaccine safety on political and social media. Some of those are devout anti-vaccination activists but I believe that they are still a relatively small fraction of the hesitant. When not being vaccinated comes with a direct personal cost we'll see how sincere those beliefs are.

This. One hundred times, this. I realize in many regards they already tell us what to do, and that does not make the next time more palatable.

Is government regulatory authority really the "real debate"? That too seems like an projected excuse, trivially proven by the fact that the same people who are most invested in the libertarian framing are the ones who believe a secret government agent has been working for the last four and a half years to extrajudiciously round up pedophiles and liberals.

I'm not saying that's what you think. Maybe you're a pure libertarian. But a whole ton of people on "your side" of this debate are quite clearly not serious about regulatory overreach.

Obviously there are exceptions. Some people can objectively look at the situation and come to the conclusion that there are good reasons to start on both sides, and it really depends on your priorities. But those people are not part of the noise, it is the people who are desperate to feel part of a group who are the loudest.

For me the major issue with the vaccine is the extremely fast track from inventing it to getting it out the door.

An FDA approval will not change my mind on the safety of the vaccine, only time can do that.

By that i mean that we need more time to assess the long-term effects, something that many pro-vaccine people seem unwilling to accept. That is unfortunate.

It has been clear for a while now that the Pfizer vaccine works and is safe. Just because Pfizer has chosen to keep collecting data doesn't make that there is any doubt about that. This is also why control groups have been given the option to get vaccinated too. It would be highly questionable to prevent them from getting vaccinated when we know that some of them might die without the vaccine.

And Pfizer doesn't "make" 1.9b of 100m doses. They might have 1.9b in revenue but producing the vaccines isn't free. And 1.9b is a tiny drop in the bucket compared to the savings we have already seen thanks to the vaccine.

Moderna was approved on December 18, 2020.[0]

Moderna phase 3 trial started on July 27, 2020.[1]

IE, the control group was offered the vaccine more than five months after the trial began. This is before completion of the trial (Oct 2022 for Moderna, IIRC), which is an issue, but this "14 day" as written seems to be suggesting that it was 14 days after the trial began, when it's actually five month.

Additionally, when a treatment proves to be highly effective, it's normal and appropriate to start providing that treatment to the control group early, because leaving them to die or otherwise suffer an illness is considered unethical. This isn't something unique to the COVID vaccines.

[0] https://www.fda.gov/coronavirus-disease-2019-covid-19/modern...

[1] https://www.cidrap.umn.edu/news-perspective/2020/07/phase-3-...

20 bucks? Cheep! Hopefully this drives up vaccine investment.

The biggest reason is: J&J's biggest advantage early on was how much cheaper it is. One shot, simpler manufacturing process (which they've screwed up several times anyway, granted), it would be the one to get widely distributed because the cost-per-fully-vaccinated individual is far lower.

The issue is, the government is paying for all this, and they write blank checks. CVS administers a Pfizer/Moderna; insurance or the government refunds (I'm told) $50. They administer a J&J, they get (again, hearsay) $10. Vaccination clinics are actively incentivized to stock the most expensive vaccines, because the profit per vaccine is higher. So, some have stopped stocking J&J (which, coincidentally, is the one vaccine I've heard many anti-vax people say they'd actually consider, as its kinda-sorta-not-really-but-good-enough more traditional. at least one person i've talked to has said 'well, i'd get the J&J, but the closest clinic that has it is 30 minutes away, so i just haven't gotten around to it').

May I ask why? I've had two shots without much hesitation but this whole booster thing came out of nowhere and gives me "fool me twice" vibes. I understand getting a flu shot every year to target new strains but this would be the exact same shot as 8 months ago.

Second, Pfizer’s vaccines in terms of value produced are worth trillions. Even making $10 billion is completely worth it.

In terms of what we as a society should value and pay for, I would rather us pay a lot of money to Pfizer to develop life saving vaccines than 100’s of billions for ads or weapons.

I actually would like for Pfizer to have made even more money than they are making now.

I saw some conspiracy theory that said this weeks ago and just shook my head at how ridiculous that would be. At least it seemed like a conspiracy theory because my view of control group was apparently something else.

Emergency use authorization, for a vaccine that was never tested on humans, and both Pfizer and Moderna eliminated the control groups?

What the hell!? There must be… other or new control groups right? You can’t really have phase3 trials and reference nothing for control can you? What will they reference?

We have all known people who will double down on their arguments after being proven wrong because they've gone too far. This could give them an out.

I think it was a big mistake not to keep that as some kind of trial but my primary reason for that is because it encourages faulty conflations like yours. The message we should take from this is that the problem was NOT following the standard process rather than drawing any conclusions about the process which wasn’t followed.

That story was all over the headlines not because it was normal. It was in headlines, and in the front of your mind, because it was the exception that proves the rule. That’s not typical.

Regardless, the FDA approval was mostly about assessing safety of the drug in controlled trials and follow-ups. Likewise, the vaccine studies were rigorous examinations of safety and an in-depth search for warning signs that might indicate problems in small populations. The correct interpretation of this approval is to see that it has been thoroughly examined for safety in the field.

Finally, we already have mountains of evidence that the vaccine is effective. That much is not in question after administering an incredible number of doses globally and observing the outcomes. Proving efficacy was the least of the FDA’s concerns at this point.

Looks like NYC Public Schools are going to mandate all staff be vaccinated (https://www.nytimes.com/2021/08/23/nyregion/nyc-schools-empl...). I would expect most hospitals/health care organizations to pretty quickly mandate it as well.

There is very little incentive for a large organization to take on the added costs of allowing a large percent of their staff/members to remain unvaccinated now.

And despite all the stories/articles about the desperate, angry anti-vax people, they are really just a small minority who are good at being noisy, and the rest of us are becoming increasingly impatient with them.

There is of course also the issue that mandates come with legal liability for consequences that manufacturers are seemingly not liable for. However, when you mandate or pressure your employees, you are violating several laws, let alone fundamental human rights, and you are also not just taking responsibility for the effects/impacts but you are unnecessarily grabbing hold of that liability when it is not at all necessary. It is kind of mind boggling that we are facing a situation where people, companies, and organizations are increasing their legal risks by purposefully taking on legal liabilities they would not have by doing nothing.

I know someone with a totally inexplicable, debilitating, possibly neurological issue (but no one can tell her after ~5 months) that started with the injection. She chose to submit herself to the experimental treatment and is therefore personally liable even if it kills her. The manufacturers have been given immunity, but that liability will be taken on by employers that choose to mandated/coerce the injections.

I don't think people, organizations, and corporations are taking that into account adequately and are rather mindlessly rushing to grab the legal liability bag that the manufacturers were exempt from.

It's rather irrational and actually quite insane. I cannot make sense of why it is happening. One guess is that it is the effects of moral hazard after decades of nearly zero consequences for the administrative and ruling class. There are never consequences, so why not jump in head long that has never produced meaningful consequences and also in most casts has been quite profitable. Of course you would sycophantically rush to be the most obsequious to the system.

Nothing else makes any sober sense to me.

This is not new: only the most libertarian fringes reject the idea that living in a society comes with obligations. We avoided millions of life-altering diseases with vaccination and politicizing medical care is going to go down in history as the worst move since the CIA decided to use public health workers as a cover story.

There are a lot of assumptions in that counterargument that people will hope you don't examine, for example, the assumption that the probability of a covid transmission ending in harm crosses the same probability threshold if, say, drunk driving ending in harm. I say it doesn't. And since the stakes are so high with what we're talking about allowing the government to do, the burden of proof is on needing to prove the individual's likelihood for serious harm being high.

See for example https://fivethirtyeight.com/features/unvaccinated-america-in...

There’s a pretty stable “never” population at 14%, and you see that as time goes on the hesitants have been gradually been getting won over.

I’m sure some in the “never” camp are using “it’s not been approved” as their current first-line given reason. But I think you need to break down the groups a bit more. There are genuinely people who are not fundamentally anti-vax that are just nervous about how fast the vaccines were developed or scared about what having “RNA” in the vaccine means (I don’t share these concerns but I understand where they come from). Some of these people will at the margin be persuaded by things like full approval.

And there's zero evidence supporting that premise. The US has historically been superior to Europe when it comes to vaccinations for example (look at Europe's long history of bad measles outbreaks). It's the difference between garbage propaganda slung at the US and reality. In reality the US has a tremendous long-term track record of making and utilizing vaccines, which is also why the US didn't disregard developing and distributing vaccines for this pandemic, and in fact was one of the world leaders in both categories.

Note that they're NOT mandating/requiring vaccination (which may turn out to violate constitutional rights here) -- it's still the customer's choice -- but you're gonna pay more, just like if you smoke tobacco.