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Re:Pfizer submits Covid vaccine to FDA for approval, to dist... by bluGill on Friday November 20, 2020 @09:27AM (#25160683)
Too late for that - the beta testers have already found it good. A phase 3 trial is beta test.
Re:Pfizer submits Covid vaccine to FDA for approval, to dist... by diag on Friday November 20, 2020 @10:42AM (#25161485)
Phase 4 is like the RC, and by that point it seems to be pretty stable.
Re:Pfizer submits Covid vaccine to FDA for approval, to dist... by stjohnswarts on Friday November 20, 2020 @08:11PM (#25167051)
I think they add more age groups and diversity as a followup.
Re:Pfizer submits Covid vaccine to FDA for approval, to dist... by bmj on Friday November 20, 2020 @11:41AM (#25162101)
Phase 4 trials are typically post-approval and used to validate marketing claims ("Pfizer's Covid vaccine is also proven to promote weight loss," for example). The result of a phase 3 trial is a release candidate, and the FDA (or equivalent organization) stamps the RC as gold master.
Re:Pfizer submits Covid vaccine to FDA for approval, to dist... by gpm on Friday November 20, 2020 @12:19PM (#25162552)
The phase 3 trials is not over yet for another 2 years... which no one wants to wait for... hence the emergency use authorization.
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Re:Pfizer submits Covid vaccine to FDA for approval, to dist... by abootstrapper on Friday November 20, 2020 @10:09AM (#25161129)
I’ll let you know the long term effects of the vaccine, and you can let me know the long term effects of Covid-19.
Re:Pfizer submits Covid vaccine to FDA for approval, to dist... by bluGill on Friday November 20, 2020 @09:43AM (#25160849)
I'll take my chances.

My sister-in-law is dead. A brother-in-law is still unsure if we can talk across a room without fainting (6 months ago he was running several miles a day). This is just in my tiny circle of close family.

Thousands in a much larger sample of had the vaccine with no side effects anywhere near that bad.

Re:Pfizer submits Covid vaccine to FDA for approval, to dist... by dgritsko on Friday November 20, 2020 @10:48AM (#25161524)
I'm deeply sorry for your loss. It's discouraging to me to see people respond so dismissively to something so tragic when it has yet to affect them personally.
Re:Pfizer submits Covid vaccine to FDA for approval, to dist... by _Microft on Friday November 20, 2020 @09:48AM (#25160895)
If it cheers you up: I'll get myself vaccinated as soon as possible. Not just for myself but also because "The needs of the many outweigh the needs of the few" as Mr. Spock would say.
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Re:Pfizer submits Covid vaccine to FDA for approval, to dist... by fractionalhare on Friday November 20, 2020 @09:56AM (#25160989)
> I don't care about one persons experiences.

You're not wrong about anecdata. But there's a less callous way to respond to someone who just explained that two of their relatives are dead or seriously ill...

Re:Pfizer submits Covid vaccine to FDA for approval, to dist... by Mordisquitos on Friday November 20, 2020 @10:01AM (#25161040)
What about 35% of respondents in n=292 (https://www.cdc.gov/mmwr/volumes/69/wr/mm6930e1.htm?s_cid=mm...)?

"Interviews were conducted 14–21 days after the test date. [...] Among 292 respondents, 94% (274) reported experiencing one or more symptoms at the time of testing; 35% of these symptomatic respondents reported not having returned to their usual state of health by the date of the interview (median = 16 days from testing date), including 26% among those aged 18–34 years, 32% among those aged 35–49 years, and 47% among those aged ≥50 years. Among respondents reporting cough, fatigue, or shortness of breath at the time of testing, 43%, 35%, and 29%, respectively, continued to experience these symptoms at the time of the interview. These findings indicate that COVID-19 can result in prolonged illness even among persons with milder outpatient illness, including young adults."

Re:Pfizer submits Covid vaccine to FDA for approval, to dist... by vonmoltke on Friday November 20, 2020 @10:51AM (#25161549)
To be fair, GGP said six months (~180 days). That 35% is by 21 days, so not comparable at all. It is concerning, though, and I hope some of these observational studies are continuing to follow the people still experiencing symptoms for longer periods of time.
Re:Pfizer submits Covid vaccine to FDA for approval, to dist... by SpicyLemonZest on Friday November 20, 2020 @10:09AM (#25161128)
Is this a surprising statistic? Even with milder illnesses such as the flu, it's common to experience cough, fatigue, or shortness of breath for weeks.
Re:Pfizer submits Covid vaccine to FDA for approval, to dist... by floatingatoll on Friday November 20, 2020 @10:18AM (#25161234)
It’s not common for 35% of flu patients to experience those symptoms after 14-21 days have passed, as it is with Covid.
Re:Pfizer submits Covid vaccine to FDA for approval, to dist... by SpicyLemonZest on Friday November 20, 2020 @10:34AM (#25161408)
Is it not? I'd be interested to see statistics on this, because I was coughing for weeks after 2 of the 3 times I can remember catching the flu.
Re:Pfizer submits Covid vaccine to FDA for approval, to dist... by floatingatoll on Friday November 20, 2020 @10:39AM (#25161455)
Flu characteristics are well understood and you should encounter no obstacles in doing that research yourself.
Re:Pfizer submits Covid vaccine to FDA for approval, to dist... by dahfizz on Friday November 20, 2020 @10:55AM (#25161602)
Okay:

> Uncomplicated influenza signs and symptoms typically resolve after 3-7 days for the majority of people, although cough and malaise can persist for >2 weeks, especially in elderly people and those with chronic lung disease.

https://www.cdc.gov/flu/professionals/acip/clinical.htm

Seems like over 14 days of flu symptoms is common.

Re:Pfizer submits Covid vaccine to FDA for approval, to dist... by floatingatoll on Friday November 20, 2020 @11:04AM (#25161690)
“can persist” is not specified with a percentage of flu patients, and thus cannot be inferred to be “common” as you state from the evidence provided alone.

Precisely what overall percentage of flu patients across the general population experience continuing symptoms after 14-21 days?

(Any common influenza in any typical year in the past decade is fine.)

Re:Pfizer submits Covid vaccine to FDA for approval, to dist... by SpicyLemonZest on Friday November 20, 2020 @11:01AM (#25161660)
I'm not sure why you're assuming bad faith here. I attempted to and found no source indicating a proportion of flu cases with lingering symptoms, with most sources only giving vague statements that symptoms can persist. If you've done the research and found it easy, would you be interested to share the results?
Re:Pfizer submits Covid vaccine to FDA for approval, to dist... by floatingatoll on Friday November 20, 2020 @11:16AM (#25161802)
You indicated that a given data point would be interesting and relevant to the conversation, and then didn’t indicate that you had invested any time in researching that data point to contribute it to the conversation. It’s poor form to shrug off that effort into others when your participation in this specific discussion on HN suggests you are both familiar enough and capable enough to attempt to look it up yourself. That you attempted to do so and couldn’t find the answer would have been relevant to mention in your comment, and knowing that now, I’m happy to retract my reply.

(However, regardless, I do not consider researching your line of reasoning to be a valuable use of the time I have available for this discussion, so I will not be doing so. It’s not personal at all, though I imagine that’s of no comfort. Perhaps someone else will do so; I see someone trying in another branch.)

Re:Pfizer submits Covid vaccine to FDA for approval, to dist... by ijidak on Friday November 20, 2020 @09:58AM (#25161004)
> I don't care about one persons experiences

While your math is sound, your empathy is horrendous.

How about, "I'm so sorry about your loss. But it doesn't change the fact that..."

Re:Pfizer submits Covid vaccine to FDA for approval, to dist... by bluGill on Friday November 20, 2020 @10:18AM (#25161232)
N is not 1. N is 14: all of my or my wife's siblings and their spouses. If you run the statistics based on what we know about COVID my anecdotes are well within the expected range (though higher than average, not high enough to be outside of the normal standard deviation). A large portion of the world has a similar set of personal statistics.
Re:Pfizer submits Covid vaccine to FDA for approval, to dist... by dsjoerg on Friday November 20, 2020 @09:45AM (#25160869)
You should balance that against your chance of contracting COVID-19, and the unknown long term effects of COVID-19.

For me, the long-term consequences of the vaccine seem to be better understood (theoretically, not empirically) than the long-term consequences of a COVID-19 infection.

Re:Pfizer submits Covid vaccine to FDA for approval, to dist... by TuringNYC on Friday November 20, 2020 @10:10AM (#25161145)
I think "we" -- as a society -- should balance those two sides. Vaccinations do not always make sense at an individual level, but make a lot of sense at a societal level. If everyone was making a personal trade-off we would not reach the global maxima.
Re:Pfizer submits Covid vaccine to FDA for approval, to dist... by abfan1127 on Friday November 20, 2020 @10:11AM (#25161161)
how can the long term consequences of the vaccine be better understood than the virus? The vaccine is younger than the virus, and orders of magnitude of more people have had the virus.
Re:Pfizer submits Covid vaccine to FDA for approval, to dist... by floatingatoll on Friday November 20, 2020 @10:16AM (#25161216)
mRNA vaccines were understood and studied prior to Covid. Covid infections (still) are not understood.
Re:Pfizer submits Covid vaccine to FDA for approval, to dist... by mrosett on Friday November 20, 2020 @10:56AM (#25161611)
This isn't entirely true; the technology is still very new.
Re:Pfizer submits Covid vaccine to FDA for approval, to dist... by floatingatoll on Friday November 20, 2020 @11:01AM (#25161659)
A five second search finds papers on mRNA vaccines from 2018. I see no papers on Covid prior to 2019. In relative terms, as the parent comment was using, we have been studying them longer.

I am not arguing that they are well understood, but I imagine most people are filling in that word when they read the comment.

Re:Pfizer submits Covid vaccine to FDA for approval, to dist... by abfan1127 on Friday November 20, 2020 @01:59PM (#25163653)
We've researched coronaviruses since the 1960s, had MERS and SARS most recently (less recent the 2018). I don't understand why we worry about long term effects of Covid, but not long term effects of mRNA vaccines? Both seem to have things to worry about, with both having different scales.

https://www.cdc.gov/coronavirus/types.html

Re:Pfizer submits Covid vaccine to FDA for approval, to dist... by tzs on Friday November 20, 2020 @10:48AM (#25161525)
Are there any prior mRNA vaccines that have been approved for human use? Wikipedia (currently...) says this and the Moderna ones would be the first.
Re:Pfizer submits Covid vaccine to FDA for approval, to dist... by bluGill on Friday November 20, 2020 @02:18PM (#25163846)
There have been a few phase-1 trials in humans. But mostly it is research.
Re:Pfizer submits Covid vaccine to FDA for approval, to dist... by abfan1127 on Friday November 20, 2020 @01:56PM (#25163618)
why do we get to generalize mRNA vaccines, but not SARS-Cov-2? We've known about coronaviruses since the 1960s, we've had MERS, SARS, and other more recent ones.

https://www.cdc.gov/coronavirus/types.html

I don't think we have long term information on either SARS-Cov-2 or the vaccine...

Re:Pfizer submits Covid vaccine to FDA for approval, to dist... by just-juan-post on Friday November 20, 2020 @11:06AM (#25161704)
100% incorrect.

These are the very first mRNA vaccines. Here is Wikiepdia to confirm. [1]

You. Are. An. Alpha. Tester. And so is the rest of the world. We all are.

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

"Up until November 2020, no mRNA vaccine, drug, or technology platform, had ever been approved for use in humans, and before 2020, mRNA was only considered a theoretical possibility for effective use in human"

Re:Pfizer submits Covid vaccine to FDA for approval, to dist... by davewritescode on Friday November 20, 2020 @09:49AM (#25160908)
From what I've read ~20% of COVID cases end up with some long term affect, some of which are quite bad and could be permanent. While the vaccine also probably has risks, I personally would rather take my chances with the vaccine instead of infection.

At the very least, the vaccine seems less likely to kill me in the very short term.

Re:Pfizer submits Covid vaccine to FDA for approval, to dist... by nradov on Friday November 20, 2020 @09:49AM (#25160915)
Where have you read that?
Re:Pfizer submits Covid vaccine to FDA for approval, to dist... by floatingatoll on Friday November 20, 2020 @10:04AM (#25161069)