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FDA Approves First Covid-19 Vaccine

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Re: FDA Approves First Covid-19 Vaccine

#111

Post by sithlord »

ceejayoz wrote: post #65
throwawaysea wrote: post #48

Earlier quoted context omitted.

It’s not a pivot for me, particularly since I got the vaccine, but I think there are legitimate reasons to be hesitant and removing one reason doesn’t invalidate other reasons people may bring up. The big one in my mind is how do Pfizer, BioNTech, or the FDA validate safety of the vaccine over the long term? For instance what if it turns out that something approved today turns out to be carcinogenic twenty years from…

> The big one in my mind is how do Pfizer, BioNTech, or the FDA validate safety of the vaccine over the long term? By looking at other vaccines historically and seeing that side effects tend to happen in the first few weeks. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/expect/af... > Vaccine monitoring has historically shown that side effects generally happen within six weeks of receiving a vaccine dose.

I'll start by saying I am vaccinated, got it the first week immunocompromised people could:

But I do not believe that this is valid at all, being that this is the very first mRNA vaccine.

>By looking at other vaccines historically and seeing that side effects tend to happen in the first few weeks.

I feel like what you are saying is basically like someone asking "How do we know that self driving cars will be safe on the road" and you responding with, "well obviously by looking at the history of cars, we have been doing them for a century!"

Re: FDA Approves First Covid-19 Vaccine

#113

Post by cbg0 »

tasogare wrote: post #34
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.

Exactly like governments are moving goalposts with their measures: one lockdown... second one... wait no, a third one is necessary; herd immunity will be reached at 70% vaccination + infected, ah no actually only vaccinated count and it's 90%... did I say 99%? No, it will be 100%! Meanwhile in Japan: people living freely their lives with no lockdowns, no forced vaccination, no vaccine pass. Another model is possible…

This is a pretty odd comparison to make. Governments are reacting to spikes in cases with restrictions in order to keep the public health system functioning within certain limits - ICUs becoming full is a serious issue which leads to loss of life for those that need an ICU bed, regardless of whether they need it because of Covid or something else.

Re: FDA Approves First Covid-19 Vaccine

#116

Post by gthtjtkt »

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.

Comment expired.

Re: FDA Approves First Covid-19 Vaccine

#117

Post by icegreentea2 »

vlovich123 wrote: post #43
mattbrewsbytes wrote: post #31

An 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. […

Why 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.

EUA 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...). 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.

Re: FDA Approves First Covid-19 Vaccine

#118

Post by rrock »

throwawaysea wrote: post #91
bluGill wrote: post #66

Earlier quoted context omitted.

mRNA is a basic building block of life. Your body makes and breaks it down constantly. If there was any worry about it life itself wouldn't be possible.

The vaccine contains other ingredients as well.

As does the virus itself. Many, many ingredients.

Re: FDA Approves First Covid-19 Vaccine

#119

Post by nanis »

spywaregorilla wrote: post #92
nanis wrote: post #52

Earlier quoted context omitted.

> I think you put on your tinfoil hat by mistake there buddy. Condescension is not helpful. > Net breakthrough deaths, ..., is not a real metric. What terminology would you recommend for getting the number of people who died from Covid19 after being fully vaccinated against Covid19? >> Deaths† 1,587 (20%) >> †341 (21%) of 1,587 fatal cases reported as asymptomatic or not related to COVID-19. The numbers are from the…

> What terminology would you recommend for getting the number of people who died from Covid19 after being fully vaccinated against Covid19? "Breakthrough deaths" not "Net breakthrough deaths" Your post is flagged and unreadable now but I'm pretty sure you were claiming 8 million breakthrough deaths. That's obviously wrong because it's two times larger than the total number of deaths globally among all people. > Since…

> Breakthrough deaths" not "Net breakthrough deaths"

That is nonsense.

This is the "gross" figure reported by CDC[1]:

>> Deaths† 1,587

The footnote is:

>> †341 (21%) of 1,587 fatal cases reported as asymptomatic or not related to COVID-19.

So the net number of deaths due to Covid19 in people with breakthrough infections is 1,587- 341.

"Breakthrough deaths" would use the gross figure, and result in a breakthrough death rate of 1,587/166 = 9.6/million (or 10/million if you round up). I did not want to overstate, so I used the number of deaths net of those where the cause of death was noted not to be related to Covid19.

> I'm pretty sure you were claiming 8 million breakthrough deaths.

That is complete and utter nonsense. I guess people flag without reading. I said:

>> 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.

Note *8/million* commonly read as "eight per million" (I rounded up from 7.5/million).

[1]: https://www.cdc.gov/vaccines/covid-19/health-departments/bre...

Re: FDA Approves First Covid-19 Vaccine

#120

Post by eightysixfour »

c7DJTLrn wrote: post #78
cle wrote: post #59

Earlier quoted context omitted.

> 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.

1. 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 i…

1) 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.
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