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FDA Approves First Covid-19 Vaccine

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Re: FDA Approves First Covid-19 Vaccine

#701

Post by lettergram »

acdha wrote: post #6

I’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.

Here's the more detailed FDA approval letter: https://www.fda.gov/media/151710/download

Regarding your comment. I know several people who have already quit, many looking for new jobs and many who have shored up their finances. Many who have had the vaccine have explicitly stated they would never get their kids vaccinated. So there's also that...

I also know probably 10 families who have up and moved to Texas and Florida in 2021.

Here's follow up studies in specified in the letter:

4. Study C4591009, entitled “A Non-Interventional Post-Approval Safety Study of the Pfizer-BioNTech COVID-19 mRNA Vaccine in the United States,” to evaluate the occurrence of myocarditis and pericarditis following administration of COMIRNATY. We acknowledge the timetable you submitted on August 21, 2021, which states that you will conduct this study according to the following schedule:

- Final Protocol Submission: August 31, 2021

- Monitoring Report Submission: October 31, 2022

- Interim Report Submission: October 31, 2023

- Study Completion: June 30, 2025

- Final Report Submission: October 31, 2025

5. Study C4591021, entitled “Post Conditional Approval Active Surveillance Study Among Individuals in Europe Receiving the Pfizer-BioNTech Coronavirus Disease 2019 (COVID-19) Vaccine,” to evaluate the occurrence of myocarditis and pericarditis following administration of COMIRNATY. We acknowledge the timetable you submitted on August 21, 2021, which states that you will conduct this study according to the following schedule:

- Final Protocol Submission: August 11, 2021

- Progress Report Submission: September 30, 2021

- Interim Report 1 Submission: March 31, 2022

- Interim Report 2 Submission: September 30, 2022

- Interim Report 3 Submission: March 31, 2023

- Interim Report 4 Submission: September 30, 2023

- Interim Report 5 Submission: March 31, 2024

- Study Completion: March 31, 2024

- Final Report Submission: September 30, 2024

6. Study C4591021 substudy to describe the natural history of myocarditis and pericarditis following administration of COMIRNATY. We acknowledge the timetable you submitted on August 21, 2021, which states that you will conduct this study according to the following schedule:

- Final Protocol Submission: January 31, 2022

- Study Completion: March 31, 2024

- Final Report Submission: September 30, 2024

7. Study C4591036, a prospective cohort study with at least 5 years of follow-up for potential long-term sequelae of myocarditis after vaccination (in collaboration with Pediatric Heart Network). We acknowledge the timetable you submitted on August 21, 2021, which states that you will conduct this study according to the following schedule:

- Final Protocol Submission: November 30, 2021

- Study Completion: December 31, 2026

- Final Report Submission: May 31, 2027

8. Study C4591007 substudy to prospectively assess the incidence of subclinical myocarditis following administration of the second dose of COMIRNATY in a subset of participants 5 through 15 years of age. We acknowledge the timetable you submitted on August 21, 2021, which states that you will conduct this assessment according to the following schedule:

- Final Protocol Submission: September 30, 2021

- Study Completion: November 30, 2023

- Final Report Submission: May 31, 2024

9. Study C4591031 substudy to prospectively assess the incidence of subclinical myocarditis following administration of a third dose of COMIRNATY in a subset of participants 16 to 30 years of age. We acknowledge the timetable you submitted on August 21, 2021, which states that you will conduct this study according to the following schedule:

- Final Protocol Submission: November 30, 2021

- Study Completion: June 30, 2022

- Final Report Submission: December 31, 2022

10. Study C4591022, entitled “Pfizer-BioNTech COVID-19 Vaccine Exposure during Pregnancy: A Non-Interventional Post-Approval Safety Study of Pregnancy and Infant Outcomes in the Organization of Teratology Information Specialists (OTIS)/MotherToBaby Pregnancy Registry.”

- Final Protocol Submission: July 1, 2021

- Study Completion: June 30, 2025

- Final Report Submission: December 31, 2025

11. Study C4591007 substudy to evaluate the immunogenicity and safety of lower dose levels of COMIRNATY in individuals 12 through - Final Protocol Submission: September 30, 2021

- Study Completion: November 30, 2023

- Final Report Submission: May 31, 2024

12. Study C4591012, entitled “Post-emergency Use Authorization Active Safety Surveillance Study Among Individuals in the Veteran’s Affairs Health System Receiving Pfizer-BioNTech Coronavirus Disease 2019 (COVID-19) Vaccine.”

- Final Protocol Submission: January 29, 2021

- Study Completion: June 30, 2023

- Final Report Submission: December 31, 2023

13. Study C4591014, entitled “Pfizer-BioNTech COVID-19 BNT162b2 Vaccine Effectiveness Study - Kaiser Permanente Southern California.”

- Final Protocol Submission: March 22, 2021

- Study Completion: December 31, 2022

- Final Report Submission: June 30, 2023

Re: FDA Approves First Covid-19 Vaccine

#702

Post by sxcurry »

peakaboo wrote: post #94
cbg0 wrote: post #13

Earlier quoted context omitted.

More likely than not, they'll just move the goalposts farther and find a different excuse for not getting it.

Even if true, so what? It's their bodies. They should be allowed to choose, just like you are.

Because they're fouling up everything for everybody else. Where I live (Oregon) if I were to get hit by a car and need an ICU bed, odds are I'd be put on a stretcher in a hall somewhere. All the ICU beds are filled with unvaccinated people denying that they have Covid.

Re: FDA Approves First Covid-19 Vaccine

#703

Post by glial »

seriousquestion wrote: post #692
enragedcacti wrote: post #682

Earlier quoted context omitted.

For more context of that quote: > The Mayor will also be initiating a “Key to NYC Pass,” which is like the Covid-19 passport talked about a few months ago. It's a carrot-and-stick approach, as people will be required to show that they are vaccinated if they want to go to restaurants, gyms and other events. No vaccinations, no entrance. “If you want to participate in society fully, you’ve got to get vaccinated,” de Bl…

Do you see how this escalating though? Already concerns are being blithely dismissed, and it only starts as optional and non essential. 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.

Do you? Why not just forget what the tyrannical government is saying, and do your part to protect the health of yourself and your community?

Re: FDA Approves First Covid-19 Vaccine

#704

Post by criticaltinker »

dhanvanthri wrote: post #674
handoflixue wrote: post #645

Earlier quoted context omitted.

Just to be clear, by the standard you're proposing there's also no scientific evidence that posting on Hacker News is safe. There is no scientific evidence that the internet is safe. There is no scientific evidence that wearing a mask is safe. There is, of course, an INCREDIBLE amount of EVIDENCE for all of these things being safe (including the vaccine). There has simply never been a 100% complete full evaluation of…

Parachutes have not been subjected to rigorous evaluation by using randomized controlled trials. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC300808/ :D

Had to up-vote because this is hilarious, thanks for sharing. As a critique of evidence based medicine they've clearly demonstrated their point, but it's obviously philosophical and the tradeoffs of practical medical interventions are no where near as clear cut as the case of falling from the sky without a parachute.

Re: FDA Approves First Covid-19 Vaccine

#706

Post by xdennis »

ryandrake wrote: post #270
defaultprimate wrote: post #222

Earlier quoted context omitted.

There is a great chasm between direct action resulting in tragedy and inaction for the preservation of autonomy having an infinitesimally small probability of directly resulting in tragedy. Comparing choosing to drive drunk with not choosing to take a particular action that has an infinitesimally small probability of directly causing tragedy are not remotely comparable.

Inaction is a deliberate choice. It doesn't matter if it's driven by some misguided notion of "autonomy". Deliberately choosing not to get vaccinated is about as close a comparison with drunk driving as you can get. People are deliberately choosing to behave recklessly, with possible deadly results for others. The only difference is one reckless choice is against the law and one is not.

> some misguided notion of "autonomy"

The way the discourse has evolved in the past two years is unbelievable. You see people deride fundamental concepts of democracy like freedom, the right to protest, and bodily autonomy.

Re: FDA Approves First Covid-19 Vaccine

#707

Post by 015a »

albatross13 wrote: post #430
acdha wrote: post #6

I’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.

I'm already triple vaxxed (booster), but there are plenty of aspects to this that help drive people's fear: - Phase 3 trials for Pfizer not complete until May 2023: ( https://clinicaltrials.gov/ct2/show/NCT04368728 ) - Control group(s) were given vaccines after 14 days: ( https://www.npr.org/sections/health-shots/2021/02/19/9691430... ) - Pfizer generates 1.9bn in revenue off of 100m doses, just in the USA alone, cre…

Here's another interesting one I heard from a friend, pharmacist at CVS (and I have no source for it, so take what you will): Apparently, they no longer stock the J&J. Less efficacious, issues in production, sure whatever, that's not the biggest reason.

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').

Re: FDA Approves First Covid-19 Vaccine

#708

Post by nathas »

015a wrote: post #472
nathas wrote: post #307

Earlier quoted context omitted.

> the assumption that the probability of a covid transmission ending in harm crosses the same probability threshold if, say, drunk driving ending in harm. You do realize that drunk driving is illegal, right? Do you think drunk driving should be legal because it's "unlikely" to cause harm to others? > I say it doesn't. 628k confirmed deaths in the US from COVID. 37.8M confirmed infections. That's a death rate of 1.66%…

Your list of statistical errors: * 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 captu…

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

Yeah, so I went with the stats we did have data for. I didn't speculate since I'm not omniscient and that's ignorant at best, disingenuous at worst. Both COVID cases and deaths are under-reported.

> 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.

The link I gave called out that 111M people self-reported drunk driving. That's an unreliable stat, so I went with the arrest rate which is a known quantity.

I wasn't "convinced" of anything. I chose the closest stats that we can get, which are definitely NOT perfect. What real-world data is "perfect"? Only when systems are self-reporting is data even close (e.g. latency, HTTP status counts, etc) and even those can be wrong due to log loss, servers failing, networks failing, etc.

You work with the data you have, and try to make informed decisions, instead of wildly guessing.

Re: FDA Approves First Covid-19 Vaccine

#709

Post by kristjansson »

All 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?

Re: FDA Approves First Covid-19 Vaccine

#710

Post by mdp2021 »

pattrn wrote: post #257
antattack wrote: post #158

Earlier quoted context omitted.

"Even if true, so what? It's their bodies. They should be allowed to choose, just like you are." 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?

Yes. It's still true. Arguing otherwise requires applying that same logic universally. Any life decision that could result in worse health outcomes "takes a hospital bed away from someone else." Once you go down that road, you now need a way to define what is "healthy," so that you can legislate what to do with people who made poor health choices. If we delegate the definition of "healthy" to the FDA, then trying out…

I noted this mentally only a few hours ago. I commented on HN, using as a metaphor "Universal health care provided by the State: [you cannot abuse it, as a common good - ] if you drink soda, you lose entitlement for your diabetes to be treated at the same cost". Then I added, "stretched example". Then, thinking it more properly, it is not that stretched...

Those under the FDA do not have that social constraint (free healthcare), to others it is a reality (with responsibilities etc.). And in a way, like in the context of insurance, different personal histories are relevant. Job related health consequences? Unforeseeable consequences? Jamesdean consequences? Not the same.

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