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Alarm as FDA willing to issue Covid-19 vaccine before stringent safety testing

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Re: Alarm as FDA willing to issue Covid-19 vaccine before stringent safety testing

#31
As highlight by many scientists, a badly working vaccine is much worse than no vaccine at all. There are two serious risks, the vaccine can have serious side affects for certain genetic population groups, or the vaccine doesn't provide the protection it claims it does. Both will be taken advantage of by anti vaxers.

Re: Alarm as FDA willing to issue Covid-19 vaccine before stringent safety testing

#32
I'm signing up for the Pfizer phase 3 trial today. I have every confidence in the world that the researchers involved know what they are doing and would never push something like this if it weren't safe. If I don't get the placebo (fingers crossed), I will be one of the first people in the world with an immunity against SARS-CoV-2. That's worth a slight risk in my opinion. I honestly don't think they can do this fast enough. The difference of having this vaccine by the end of the year versus waiting until next spring could mean hundreds of thousands of lives.

Re: Alarm as FDA willing to issue Covid-19 vaccine before stringent safety testing

#33
post #15

Every day vaccines are delayed costs thousands of lives. Bioethicists who have forbidden challenge trials in vaccine trials have firmly taken the no-action stance in the trolley problem. A normal phase 3 trial gives the vaccine to volunteers and waits for them to get sick (or not). A challenge trial is the same, but infects the volunteers intentionally, which significantly speeds up the trial and reduces the sample s…

>The trolley is running over thousands of people every day, and by flipping a switch you could reroute it to another rail where only a few people would be at risk.

The mathematical issue is that a vaccine is given to everybody, so even if it has a very small rate of harm, it can be greater than the illness it's meant to prevent, if the incidence of the illness is small enough.

I'm not against vaccines in general, but they have to be incredibly safe to be worthwhile, assuming all lives are equal. Much more so than regular medication that is only given to sick people. Inherently, there has to be a higher bar.

Re: Alarm as FDA willing to issue Covid-19 vaccine before stringent safety testing

#34
post #22

How dangerous are untested vaccines and what would be the worst case scenario?

This was probably the worst so far: https://en.wikipedia.org/wiki/Dengvaxia_controversy

Note that the worst long-term outcome of this was probably decline in trust of vaccines. Government regulators are in a position of significant trust on this stuff, and the consequences if that was damaged would be disastrous.

Re: Alarm as FDA willing to issue Covid-19 vaccine before stringent safety testing

#35

Earlier quoted context omitted.

If you're below 40 your risk of dying of the regular influenza is higher than the risk of dying of covid-19. If your fear of the flu doesn't motivate you to take the flu vaccine every year, rationally, you shouldn't want to take the covid-19 vaccine either.

> If you're below 40 your risk of dying of the regular influenza is higher than the risk of dying of covid-19. Do you have a source for that? As far as I'm aware they're both pretty low, but we haven't had a study that concluded what you're saying.

https://www.nature.com/articles/d41586-020-02483-2

Re: Alarm as FDA willing to issue Covid-19 vaccine before stringent safety testing

#36

Earlier quoted context omitted.

Really? The risks of COVID are pretty well known at this point, and for the vast majority of people they seem quite low.

I think the most important thing to remember is that the risk profile of covid-19 is vastly different for different people. I'm sure as fuck not getting an untested vaccine, because I'm not in a risk group. If I catch the virus, my risk of death is in lightning strike territory. For my 70+ dad, he's in a bunch of risk groups, which means the risk equation looks very different for him, and for him it might be worth th…

> If I catch the virus, my risk of death is in lightning strike territory.

there's two wrong concepts here - you don't know how the virus will affect you medically. May be you will only suffer minor symptoms, or may be you will almost die with fluids in your lungs.

But that's not important. The most important aspect of you catching the virus is you become a transmission vector. And you cause infection in other people who _do_ suffer from the symptoms. And you cause economic damage because people will need to lock down, or reduce economic activity.

Therefore, it's not a matter of just risk to themselves that is important in the calculus of vaccines. It's the over-all health risk of the society.

Re: Alarm as FDA willing to issue Covid-19 vaccine before stringent safety testing

#37
post #15

Every day vaccines are delayed costs thousands of lives. Bioethicists who have forbidden challenge trials in vaccine trials have firmly taken the no-action stance in the trolley problem. A normal phase 3 trial gives the vaccine to volunteers and waits for them to get sick (or not). A challenge trial is the same, but infects the volunteers intentionally, which significantly speeds up the trial and reduces the sample s…

I don't have much of an opinion here, but the situation is a bit different than the classic trolley problem. With the vaccines, you don't know how many people are on the rails. Yes, a not finished vaccine might safe thousands of people. But what if it causes other damage and the vaccinated people die a year later, even though the would've survived covid?

Re: Alarm as FDA willing to issue Covid-19 vaccine before stringent safety testing

#38
post #22

How dangerous are untested vaccines and what would be the worst case scenario?

Unlikely worst case: there are rare side-effects that get only discovered very late. For example: 70% of those who get the vaccine develops liver complications within 3 years and 60% die a horrible death with no way to cure. Or every women who gets the vaccine becomes infertile within a decade. This is super unlikely, and moreover could only partially detected in a Phase 3. But the longer you give people to look for such complications, the more likely that they're discovered before mass-application.

Realistic worst case: there are some minor complications, and some people will get hurt. This has happened before: https://www.cdc.gov/vaccinesafety/concerns/concerns-history.... , which is why we have such strict guidelines for vaccine development today.

Realistic bad case: the vaccine is not at all effective and does absolutely not protect from (re-)infection, but gives everyone post-covid19-fatigue. It will also be giving anti-vaxxers actual arguments and getting Trump re-elected.

Re: Alarm as FDA willing to issue Covid-19 vaccine before stringent safety testing

#39

I'm signing up for the Pfizer phase 3 trial today. I have every confidence in the world that the researchers involved know what they are doing and would never push something like this if it weren't safe. If I don't get the placebo (fingers crossed), I will be one of the first people in the world with an immunity against SARS-CoV-2. That's worth a slight risk in my opinion. I honestly don't think they can do this fast…

Good luck, but you should consider that this isn’t a ”researcher is good/bad” issue, this is a ”global pharma race for billions in profits” issue with all kinds of interference from management, finance, etc.

Re: Alarm as FDA willing to issue Covid-19 vaccine before stringent safety testing

#40
Sounds like a cheap shot at politics and manipulating the narrative

If it works, praise the POTUS for being "brave", if it fails, blame the company.

Sure, the vaccine looks safe, and we might discuss if the protocol of Phase 3 testing can be modified and/or what are the reasons for it, but ignoring testing is stupid (and it's not only a matter of safe/not safe, but of dosage, booster shots required, etc)

Wear a mask and protect yourself while the vaccine gets ready, it's not hard. Or not, if you believe the recent misinformation news about "only 6% of healthy people die" then please join the queue for your Darwin Award.

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