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Pfizer submits Covid vaccine to FDA for approval, to distribute in December

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Re: Pfizer submits Covid vaccine to FDA for approval, to distribute in December

#101
post #52
post #37

This will save lives. However I imagine most people will end up getting the Oxford vaccine, that doesn't have the storage requirements or need a second dose and is a fraction of the cost.

Well, I wouldn't be so happy. Think about it. Out of million people only small percentage would become infected with covid and of that, only small percentage would die. On the other hand, vaccine must be distributed to everybody. Alternatively to people who, by occupation, have to contact many other people, daily. We don't know yet if there are complications from the vaccine. It is not possible to judge long term eff…

> We don't know yet if there are complications from the vaccine. It is not possible to judge long term effects of anything based on very short exposure

...

> Looking at this selfishly and from PoV of game theory, the best decision is to let vaccinate everybody else but don't take vaccine yourself. Obviously, not everybody can make same decision

There are two different ways a medicine might have long term unintended and currently unknown effects.

1. It does some kind of permanent damage to you fairly immediately after taking it that takes a long time to show noticeable effects, or

2. It does some some kind of damage that is not permanent and won't lead to any long term noticeable effects as long as the original damage is allowed to heal or at least not made worse.

Category two is what you have to worry about with things you have to take regularly, because they can accumulate the damage or risk and it can take many years before it accumulates to the point that we might notice.

Because this is a not a "take every year" kind of vaccine, I don't think there is much need to worry about category two.

With "take it once" types of medicine (yes, I know some vaccines require more than one dose over a week or two, which counts as taking it once when considering long term effects), with wide deployment, I'd expect any unintended and unknown long term side effects to start being found within maybe a year of wide deployment.

Re: Pfizer submits Covid vaccine to FDA for approval, to distribute in December

#102

Earlier quoted context omitted.

Well a one second google search says chickenpox is 98% effective, so already that's not unheard of. I would think extremely low p values are not just normative, but required for a vaccine to reach public acceptance. This vaccine is noteworthy for the speed at which it was developed, but its not the first really good vaccine. edit: and because I'm getting a lot of downvotes for some reason, Anthrax, Measles, Rubella,…

> required for a vaccine to reach public acceptance. This leads to frightening considerations. The reason FDA testing is so stringent is that trying to explain statistics along with a myriad of other fields, that are at this point likely too complex and exhaustive for any one human to fully comprehend even if they spent their entire lifetime learning, to the "public" for them to truly make an informed decision is a f…

> If by some very low chance this introduces an inheritable change, and if by an even lower chance that inheritable change leads to genetic collapse in 10-20 generations - just to be very clear, this is extremely unlikely - we have opened the window to humanity's end.

That's such a vague, unqualified (in the "lacking specificity" sense) concern, that you could apply that to practically any new technology or medical treatment.

10-20 generations is 250-500 years, if somehow this particular vaccine did cause inheritable damage, I'm sure that medical technology would be advanced enough at that point to find a solution.

And on that timescale there's also much more tangible and evidential existential crises, like climate change and nuclear war.

Re: Pfizer submits Covid vaccine to FDA for approval, to distribute in December

#103
post #29

Well just like I don't immediately update to the latest OS I think I'll wait for the beta testing to happen :)

Few key facts:

• In the entire history of vaccines, only one has been recalled because the vaccine itself caused long term side effects (a rotavirus vaccine that had rare complications and no deaths for those under 1yr). If you can't find any papers about it, that's why. It's like finding a paper on death by lava lamp explosions. It's happened (https://www.latimes.com/archives/la-xpm-2004-dec-01-na-brief....), but not enough to study it.

• Much of the speed was gained by relaxing enrollment rules, which are for study participant safety. The majority of normal study participants join in the last year or two anyways.

• These studies were larger than usual to make up for the decreased time. 30,000 people is a lot, and plenty to check for rare side effects.

• Then compare the odds that there's a common reaction that didn't show up in 30,000 participants against the ~5-10% chance of serious health complications from COVID. It's a no-brainer.

You can read the list of recalled vaccines and why they were recalled straight from the FDA (https://www.cdc.gov/vaccinesafety/concerns/concerns-history....).

Re: Pfizer submits Covid vaccine to FDA for approval, to distribute in December

#104
post #85
post #81

Earlier quoted context omitted.

Being a coder and not a biologist, I asked a friend who regularly works with drug companies on FDA approval. I asked what the risks could be of a vaccine that was “rushed” through. In his opinion, there was virtually no risk of the vaccine actively causing harm. The biggest risk is giving people a vaccine they think is effective but isn’t and they contract the virus.

What was rushed through? The messaging from my government (not US) has been that approval process rules have not been changed.

From the article:

> for Emergency Use Authorization

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

> authorizes FDA to facilitate availability of an unapproved product, or an unapproved use of an approved product, during a declared state of emergency from one of several agencies or of a "material threat" by the Secretary of Homeland Security

Rushed, yes, but via an existing set of rules for this sort of scenario. It's an appropriate use of this sort of process, but it does come with some risks.

Re: Pfizer submits Covid vaccine to FDA for approval, to distribute in December

#106

Earlier quoted context omitted.

Is there an example of a vaccine in history that produced no initial side effects but only very long term side effects (ie. several years later)?

2009-2010 GSK H1N1 - settled by the gov of multiple EU countries https://www.cdc.gov/vaccinesafety/concerns/history/narcoleps...

> In 2018, a study team including CDC scientists analyzed and published vaccine safety data on adjuvanted pH1N1 vaccines (arenaprix-AS03, Focetria-MF59, and Pandemrix-AS03) from 10 global study sites. Researchers did not detect any associations between the vaccines and narcolepsy.

Re: Pfizer submits Covid vaccine to FDA for approval, to distribute in December

#107

Earlier quoted context omitted.

Same. I'm not an anti-vaxxer or anything like that. But I think "don't use version 1.0" advice applies here just like it does for software. Especially given the possibility that things have been "hurried" in the name of expediency in terms of getting the vaccine(s) developed, tested, and approved. The good news, in a sort of perverse sense, is that some delay to see what happens with "early adopters" is kinda inevita…

If the enemy is charging my base and someone offers me armor I'm not going to wait for all my fellow soldiers to try it out and see what happens.

Sounds like a reasonable position, until you extend the analogy: there is a slight, but nonetheless real chance that said armor has seriously adverse health effects on you. Maybe it spontaneously grows spikes and punctures your insides.

Additionally, you also have, as an individual, the option to just stand further back in the line. You don't have to get in immediate contact with the enemy, you can just go to the back of the army and wait for some time until the experimental armor is battle tested.

What sounds like the more rational choice (from an individual standpoint) now?

EDIT: not sure why this is getting downvotes. I do agree that the risk equation does seem leaning towards taking the vaccine. Tests have been conducted with >30.000 people, and so far it seems safe. There still exists of course a probability of that not being the case, but compared to the (known, and very real) side effects of covid, taking the vaccine asap even if it's version 1.0 seems like the sensible choice.

Still, parents analogy seemed flawed so I tried to extend it.

Re: Pfizer submits Covid vaccine to FDA for approval, to distribute in December

#108
post #56

I wonder how long it'll be before third world countries get the vaccine

WHO has a fund specifically for vaccines for developing countries, I can't find the latest total, but it's in the hundreds of millions.

A good portion of the WHO is funded by the Bill & Melinda Gates foundation. Imagine contributing billions towards world health and then somehow you are painted as the villain by insane people like Q, Russian propaganda and anti-Vaxx organizations.

Re: Pfizer submits Covid vaccine to FDA for approval, to distribute in December

#110
post #78
post #37

This will save lives. However I imagine most people will end up getting the Oxford vaccine, that doesn't have the storage requirements or need a second dose and is a fraction of the cost.

I believe the Oxford vaccine does require a booster. It’s the J&J that is single shot.

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