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How is it safe when the fda has not approved these vaccines nor has there been any studies on the permanent adverse effects some have experienced as a result of

by stevev 5y ago

How is it safe when the fda has not approved these vaccines nor has there been any studies on the permanent adverse effects some have experienced as a result of taking this vaccine?

jbd28 5y ago
Every side effect this vaccine has caused is also caused in far greater numbers by Covid itself. No vaccine has ever had a new side effect after 9 weeks of administration in the history of medicine. And the mandate for the military is timed to be after full FDA approval which is a formality at this point.
- vaidhy 5y ago
  Any data to support this? This seems incredible.
- deleted 5y ago
  [deleted]
ceejayoz 5y ago
Approval is fully expected by pretty much everyone. No vaccine in the approval process has ever had so much data to base the decision on, and that data remains very positive.
- stevev 5y ago
  If that is the case, why are big pharma exempt from liabilities when people are damaged from getting the vaccines?
  - ceejayoz 5y ago
    Because anti-vaccine FUD like this previously threatened our ability to produce them, leading to a specific system for evaluating claims and paying out damages. https://en.wikipedia.org/wiki/National_Vaccine_Injury_Compensation_Program https://en.wikipedia.org/wiki/National_Vaccine_Injury_Compen... Be honest: Would FDA approval and extra safety studies actually move the needle for you as implied, or would you consider it all a part of Big Pharma's conspiracies?
    - jdhn 5y ago
      >Be honest: Would FDA approval and extra safety studies actually move the needle for you as implied, or would you consider it all a part of Big Pharma's conspiracies? If it had the same review time as all other vaccines (even if I think the term "vaccine" is wrong in this case), absolutely.
      - ceejayoz 5y ago
        > If it had the same review time as all other vaccines Good news - it has! Approval is expected this month, delayed largely by the fact that the actual wait is one of the few bits of red tape they can’t speed through.
  - vmception 5y ago
    Because the vaccine was released almost a year prior and it didn't have approval but governments and individuals wanted it so bad. If that's what validates your reality, then call your senators about removing the exemption from liability after the FDA approval. Advocate for that. One thing I've been having fun with is imagining how people will move the goalpost after the FDA decision. I wonder how many people upon approval will say "ah the FDA is controlled by big pharma and other shadow masters!" If not approved "ha I knew it!" I wonder how many others will read the clinical trial studies the the FDA is evaluating (which are already available now) and reach a conclusion that agrees with the FDA.
    - stevev 5y ago
      Would you buy a vehicle that skips third party quality control? I think most people would not. Especially if it’s something going into their bodies. I’m for science, but hearing vaccinated people able to get infected with the delta variant tells me these vaccines aren’t as effective. We’ve had people survive covid when no vaccines existed. Were they just lucky?
      - davidcbc 5y ago
        The vaccines have not skipped quality control. They've done all the testing required by the FDA. Vaccines are not 100% effective. The vast vast majority of people who have been vaccinated have not been infected with covid, delta variant or not. A very small number have been infected, an extremely small number of those have been hospitalized and an infinitesimal percentage of people who have been vaccinated have died compared to the millions of unvaccinated people who have died from it. We've had millions of unvaccinated people die from covid and almost nobody vaccinated die from covid. So yes, the people who survived without vaccines were comparatively lucky. But now that there are vaccines dying from covid isn't unlucky, it's an unfortunate choice made by people who listen to people such as yourself spread lies about the vaccines. By spreading misinformation you are contributing to the deaths of thousands.
      - chapium 5y ago
        How many millions of human trials will satisfy you without an FDA rubber stamp? Will FDA approval matter, or will you move on to your next talking point?
  - vermarish 5y ago
    If I worked at a pharma company and the government expected me to develop a vaccine in record time, I would probably bargain for zero-liabilities in advance.
halfmatthalfcat 5y ago
Let's query the 1.2B people on Earth who have already gotten it. I think that's a large enough sample size to extract safety (spoiler: it's incredibly safe).
- HKH2 5y ago
  Does that rule out the possibility of long-term side effects?
  - ceejayoz 5y ago
    Largely, yes. Historically, vaccine adverse effects have occurred in the first six weeks. There’s little reason to believe otherwise this time around.
davidcbc 5y ago
The technology behind the mRNA vaccines has been studied for 30+ years and there's absolutely 0 evidence of permanent adverse effects that wouldn't be known by now. At what point will you be satisfied?
- deleted 5y ago
  [deleted]
- mikem170 5y ago
  It seems that the lipid delivery was trickier than the mRNA payload: > Over more than 3 decades, promising lipids studied in the lab often failed to live up to their potential when tested in animals or humans. Positively charged lipids are inherently toxic, and companies struggled for years before landing on formulations that were safe and effective. [0] Lots of other details in this article of the problems they had over several decades finding lipids that worked and weren't toxic, wouldn't accumulate in the liver, etc. The lipids used in the covid vaccines don't go back that far: > The first time the FDA approved the use of lipid nanoparticles as a drug delivery system was in 2018, when the agency approved the first siRNA drug, Onpattro.[56] Encapsulating the mRNA molecule in lipid nanoparticles was a critical breakthrough for producing viable mRNA vaccines, solving a number of key technical barriers in delivering the mRNA molecule into the host cell. [1] So they had something approved in 2018 for shorter siRNA payloads, but had to scramble since then to figure out something that would handle an mRNA payload. [0] https://cen.acs.org/pharmaceuticals/drug-delivery/Without-lipid-shells-mRNA-vaccines/99/i8?PageSpeed=noscript https://cen.acs.org/pharmaceuticals/drug-delivery/Without-li... [1] https://en.wikipedia.org/wiki/RNA_vaccine https://en.wikipedia.org/wiki/RNA_vaccine
gdulli 5y ago
I got the vaccine, and I would hate to think that the people protecting us are less willing or able to face minor or imagined danger than I am.
everybodyknows 5y ago
“Safe” is the wrong criterion. The right criterion: “Less dangerous than the disease itself”.
- xfitm3 5y ago
  What about those who've been ill, recovered, and have natural antibodies?
  - DoktorDelta 5y ago
    The vaccine provides better protection than natural antibodies: https://www.cdc.gov/media/releases/2021/s0806-vaccination-protection.html#:~:text=These%20data%20further%20indicate%20that,CDC%20Director%20Dr.%20Rochelle%20Walensky https://www.cdc.gov/media/releases/2021/s0806-vaccination-pr....
    - reducesuffering 5y ago
      Isn’t that the n=234 study that’s not an RCT? https://news.ycombinator.com/item?id=28108657 https://news.ycombinator.com/item?id=28108657 https://www.medrxiv.org/content/10.1101/2021.06.01.21258176v3.full.pdf https://www.medrxiv.org/content/10.1101/2021.06.01.21258176v...
      - jenkstom 5y ago
        You say that like 234 is supposed to be a low number?
    - xfitm3 5y ago
      What about if the person cannot receive the vaccine due to a known and accepted risk? Are antibodies a suitable alternative?

by stevev 5y ago

How is it safe when the fda has not approved these vaccines nor has there been any studies on the permanent adverse effects some have experienced as a result of taking this vaccine?

jbd28 5y ago

Every side effect this vaccine has caused is also caused in far greater numbers by Covid itself. No vaccine has ever had a new side effect after 9 weeks of administration in the history of medicine. And the mandate for the military is timed to be after full FDA approval which is a formality at this point.

vaidhy 5y ago
Any data to support this? This seems incredible.
deleted 5y ago
[deleted]

ceejayoz 5y ago

Approval is fully expected by pretty much everyone. No vaccine in the approval process has ever had so much data to base the decision on, and that data remains very positive.

stevev 5y ago
If that is the case, why are big pharma exempt from liabilities when people are damaged from getting the vaccines?
- ceejayoz 5y ago
  Because anti-vaccine FUD like this previously threatened our ability to produce them, leading to a specific system for evaluating claims and paying out damages. https://en.wikipedia.org/wiki/National_Vaccine_Injury_Compensation_Program https://en.wikipedia.org/wiki/National_Vaccine_Injury_Compen... Be honest: Would FDA approval and extra safety studies actually move the needle for you as implied, or would you consider it all a part of Big Pharma's conspiracies?
  - jdhn 5y ago
    >Be honest: Would FDA approval and extra safety studies actually move the needle for you as implied, or would you consider it all a part of Big Pharma's conspiracies? If it had the same review time as all other vaccines (even if I think the term "vaccine" is wrong in this case), absolutely.
    - ceejayoz 5y ago
      > If it had the same review time as all other vaccines Good news - it has! Approval is expected this month, delayed largely by the fact that the actual wait is one of the few bits of red tape they can’t speed through.
- vmception 5y ago
  Because the vaccine was released almost a year prior and it didn't have approval but governments and individuals wanted it so bad. If that's what validates your reality, then call your senators about removing the exemption from liability after the FDA approval. Advocate for that. One thing I've been having fun with is imagining how people will move the goalpost after the FDA decision. I wonder how many people upon approval will say "ah the FDA is controlled by big pharma and other shadow masters!" If not approved "ha I knew it!" I wonder how many others will read the clinical trial studies the the FDA is evaluating (which are already available now) and reach a conclusion that agrees with the FDA.
  - stevev 5y ago
    Would you buy a vehicle that skips third party quality control? I think most people would not. Especially if it’s something going into their bodies. I’m for science, but hearing vaccinated people able to get infected with the delta variant tells me these vaccines aren’t as effective. We’ve had people survive covid when no vaccines existed. Were they just lucky?
    - davidcbc 5y ago
      The vaccines have not skipped quality control. They've done all the testing required by the FDA. Vaccines are not 100% effective. The vast vast majority of people who have been vaccinated have not been infected with covid, delta variant or not. A very small number have been infected, an extremely small number of those have been hospitalized and an infinitesimal percentage of people who have been vaccinated have died compared to the millions of unvaccinated people who have died from it. We've had millions of unvaccinated people die from covid and almost nobody vaccinated die from covid. So yes, the people who survived without vaccines were comparatively lucky. But now that there are vaccines dying from covid isn't unlucky, it's an unfortunate choice made by people who listen to people such as yourself spread lies about the vaccines. By spreading misinformation you are contributing to the deaths of thousands.
    - chapium 5y ago
      How many millions of human trials will satisfy you without an FDA rubber stamp? Will FDA approval matter, or will you move on to your next talking point?
- vermarish 5y ago
  If I worked at a pharma company and the government expected me to develop a vaccine in record time, I would probably bargain for zero-liabilities in advance.

halfmatthalfcat 5y ago

Let's query the 1.2B people on Earth who have already gotten it. I think that's a large enough sample size to extract safety (spoiler: it's incredibly safe).

HKH2 5y ago
Does that rule out the possibility of long-term side effects?
- ceejayoz 5y ago
  Largely, yes. Historically, vaccine adverse effects have occurred in the first six weeks. There’s little reason to believe otherwise this time around.

davidcbc 5y ago

The technology behind the mRNA vaccines has been studied for 30+ years and there's absolutely 0 evidence of permanent adverse effects that wouldn't be known by now. At what point will you be satisfied?

deleted 5y ago
[deleted]
mikem170 5y ago
It seems that the lipid delivery was trickier than the mRNA payload: > Over more than 3 decades, promising lipids studied in the lab often failed to live up to their potential when tested in animals or humans. Positively charged lipids are inherently toxic, and companies struggled for years before landing on formulations that were safe and effective. [0] Lots of other details in this article of the problems they had over several decades finding lipids that worked and weren't toxic, wouldn't accumulate in the liver, etc. The lipids used in the covid vaccines don't go back that far: > The first time the FDA approved the use of lipid nanoparticles as a drug delivery system was in 2018, when the agency approved the first siRNA drug, Onpattro.[56] Encapsulating the mRNA molecule in lipid nanoparticles was a critical breakthrough for producing viable mRNA vaccines, solving a number of key technical barriers in delivering the mRNA molecule into the host cell. [1] So they had something approved in 2018 for shorter siRNA payloads, but had to scramble since then to figure out something that would handle an mRNA payload. [0] https://cen.acs.org/pharmaceuticals/drug-delivery/Without-lipid-shells-mRNA-vaccines/99/i8?PageSpeed=noscript https://cen.acs.org/pharmaceuticals/drug-delivery/Without-li... [1] https://en.wikipedia.org/wiki/RNA_vaccine https://en.wikipedia.org/wiki/RNA_vaccine

gdulli 5y ago

I got the vaccine, and I would hate to think that the people protecting us are less willing or able to face minor or imagined danger than I am.

everybodyknows 5y ago

“Safe” is the wrong criterion. The right criterion: “Less dangerous than the disease itself”.

xfitm3 5y ago
What about those who've been ill, recovered, and have natural antibodies?
- DoktorDelta 5y ago
  The vaccine provides better protection than natural antibodies: https://www.cdc.gov/media/releases/2021/s0806-vaccination-protection.html#:~:text=These%20data%20further%20indicate%20that,CDC%20Director%20Dr.%20Rochelle%20Walensky https://www.cdc.gov/media/releases/2021/s0806-vaccination-pr....
  - reducesuffering 5y ago
    Isn’t that the n=234 study that’s not an RCT? https://news.ycombinator.com/item?id=28108657 https://news.ycombinator.com/item?id=28108657 https://www.medrxiv.org/content/10.1101/2021.06.01.21258176v3.full.pdf https://www.medrxiv.org/content/10.1101/2021.06.01.21258176v...
    - jenkstom 5y ago
      You say that like 234 is supposed to be a low number?
  - xfitm3 5y ago
    What about if the person cannot receive the vaccine due to a known and accepted risk? Are antibodies a suitable alternative?