Please do not spread misinformation, especially misinformation about healthcare during a deadly and dangerous pandemic. Lives are at stake.
Moderna's FDA trial: https://clinicaltrials.gov/ct2/show/NCT04470427 Estimated Study Completion Date: October 27, 2022
Pfizer's FDA trial: https://clinicaltrials.gov/ct2/show/NCT04368728 Estimated Study Completion Date: May 2, 2023
JnJ's FDA trial: https://clinicaltrials.gov/ct2/show/NCT04505722 Estimated Study Completion Date: January 2, 2023
Study completion date does not mean phase 3 trial completion date.
“ However, these dates do not mean clinical trials will continue for this long, and instead reference continued safety monitoring after the vaccine has been approved and rolled out, which is standard practice within the industry”
https://www.pfizer.com/news/press-release/press-release-deta...
Get a clue. Lives are at stake. Vaccination will save them. The majority of people dying now are dying because they made the choice not to get vaccinated.
It is clear that I'm correct. The vaccines are still in phase 3 clinical trials, as reported by clinicaltrials.gov, the source of truth for such questions.
Estimated Study Completion Date literally means the date that the Phase 3 trial study is estimated to be completed, at which point FDA goes through the process of approving or not approving the treatment.
The vaccines have been released due to an EUA (Emergency Use Authorization). I'm guessing you're not aware of this, even though it's clearly elucidated even in your own link.
It seems you think that the actual, you know, "study" part of Phase 3 trials is just some unnecessary bureaucratic technicality thing? As someone well acquainted with the world of pharma, I assure you it is not. It seems you think they just jab the 40k or so participants, watch them a few minutes, and then the Phase 3 trial is completed save for some paperwork. I assure you, that is not the case.
Phase 3 serves a very specific, important purpose: Identifying any long-term safety issues with medical treatments prior to their authorization for widespread adoption in the USA. The reason Phase 3 exists is because it has very often been the case that promising treatments turned out to not be so promising after long-term study.
One of the foundational, bedrock principles of bioethics is "informed consent". That is, the people undergoing medical treatment, especially experimental medical treatment, must have full information about the risks and potential benefits of treatment. You are spreading misinformation which may lead others to misunderstand the current state of the covid vaccines. They are not through phase 3 trials. According to every other situation when treatments not approved through the normal FDA process are administered, they are called "experimental" (e.g., my grandma, prior to her death, was given the option to take drugs that were currently in phase 3 of FDA trials for treating her ailment, and she was told, accurately, that she could elect this experimental drug, which often is authorized for terminal patients--but they are given INFORMED consent--i.e., told they are experimental and the safety risks are not fully understood).
Please, please stop violating bedrock principles of bioethics. These vaccines are still not through phase 3 trials. This is just a plain fact and you shouldn't lie to people to increase their likelihood of taking these vaccines.
Regardless of whether you think the vaccines are safe, they are quite clearly effective.
Is that what you're implying?
To directly answer your question: I do not think the ethical calculations change one single iota based on any other outside calculation.
You should never misrepresent or elide any relevant information from people when they're about to make a decision about their health (or, hey, ever, in any situation).
It seems you're thinking if we were honest with people about the status of the vaccines, they'd be less likely to take them.
Like, here's the messaging I think is appropriate: Hey, we have some limited safety and efficacy data about these vaccines. The limited, phase 2 information shows that we think they're safe and effective, however, these vaccines have nowhere near the testing and trials that normal vaccines have prior to authorization. As well as lacking phase 3 long-term study, we eliminated animal studies and animal toxicity studies for some inexplicable reasons, so we're flying a bit blind. But we're in the midst of a deadly pandemic. The risk is yours to take.
I think the majority of people would still take the vaccines.
I think you think we should lie to the masses because they're too stupid to handle the truth.
I think that's evil.
The point of principles is to practice them when it's hard, not when it's easy. If you abandon them when it's convenient or during an emergency, you don't really have any principles.
You think you are smarter and more thoughtful about this than the experts who debated it in the open for hours upon hours to decide it was safe and should be available to everybody.
You said earlier you were safe because of your vitamin D levels. The science on the protective nature of vitamin D to COVID is not clear at all. But you claimed it as fact because you want it to be true. You want the vaccines not to be safe so you make up thresholds and then tell us you are being honest by saying the vaccine doesn’t cross them. Why do you trust all the other vaccines the FDA has approved, but not this one that the FDA says is safe and effective. Do you trust them or not? Or do they lie sometimes when you disagree and tell the truth when you agree?
It seems like you're claiming anything that gets an EUA, regardless of FDA trial status or outcome, is "safe".
That would imply you believe FDA Phase 3 trials are irrelevant, and that safety, particularly long-term safety, is easy to assess without doing any long-term safety studies.
That's quite a strange position to take, but OK, you can take it.
I trust the FDA, however. It's strange to be arguing with somebody who doesn't trust the FDA, but here we are. I trust them, and they think long-term safety trials for pharmaceuticals are really important. You seem to disagree. That's fine.
I agree that the vaccines show good safety profiles for older patients in the short term. The younger the cohort it's administered to, the greater the number of adverse events occur, however, which is worrying, because it's the opposite for covid. But still, they look reasonably safe for the 18+ crowd, in the short term.
You seem to think they're perfectly safe in the long-term based on no studies. That's a cool, if strange, way of magical thinking. I think differently, and I seek data and trustworthy sources for my medical information.
For what it's worth my doctor also recommended I don't get the vaccine, for the same reasons I've laid out here.
The OP is throwing around giant misleading statements like "potent inhibitor", while chiding others for incorrectly stating tiny details.
The vaccine is a "potent inhibitor" of COVID, and we all have the data to prove it. There is no other substance, other than monoclonals, which would meet that standard.
The latest meta analysis indicates that ivermectin is also a fairly potent inhibitor, although the evidence is weaker.
There is one medium sized almost randomized trial that shows a strong result. I'm not interested in small retrospective studies. There are 50 retrospective studies that show HCQ is an amazing drug against covid.
Clearly since there is little downside to given vitamin D to people who have low levels, it can and probably should be done, but that is very far from proving that it is a "potent inhibitor" of covid. There also is a clear bias for the person who makes that site since they also want it to be true. Maybe they don't look as hard for studies which disprove what they want. It isn't an overwhelming case.
There is more than enough evidence for a big RCT to actually confirm, but given the safety considerations and low expense it probably makes more sense to just dose everybody and hope it works. But I don't see how you could make grand claims with this evidence.
Super, super strange that we'd take less-than-typical studies of novel vaccines, and then quibble the evidence on something created by nature that we know is easy to get, easy to dose, very safe, etc.
It's like someone wants to make some profit or something.
Do you believe the evidence for their effectiveness is equal?
The evidence about coronavirus is quite, quite clear. There may be long-term severe effects of covid, just like there may be severe deleterious long-term consequences of the vaccines. So you must calculate your risk-benefit ratio and use that to elect whether to take the vaccines or not. For those that are worried about experimental vaccines, I absolutely encourage them to get more fresh air and sunlight--in fact, almost everyone would benefit in many ways from getting outside in the sun, getting fitter, and avoiding prolonged "lock downs" in their houses. (To boot, covid has never been observed in the scientific literature to be transmissible outdoors.)
Here's a peer-reviewed study from the Lancet from this month that shows just how short-term irrelevant covid is to those under age 40 who are reasonably healthy: https://www.thelancet.com/journals/landia/article/PIIS2213-8...
For those under the age of 60, obesity is far and away the thing that makes covid dangerous, and if you're under age 40 and are not obese, the death rate is too low to be measured.
So from that, it seems clear to me: If you're under age 60, get fit (I already am, and getting fitter and fitter every day, which is oddly something never mentioned by the higher-ups at CDC or Pfizer or wherever, which is curious, wouldn't you say?). Get outside.
Effectiveness of the vaccine is irrelevant to me personally because for all people like me covid has thus far posed a risk profile similar to that of driving. Novel vaccine technology presents a totally unknown level of risk, and we've already observed plenty of healthy, young people get all sorts of negative outcomes from it. Plus, again, totally unknown long-term safety profile.
I'm curious why you're so against any kind of solution for covid that doesn't involve novel vaccines.
https://www.narcolepsy.org.uk/resources/pandemrix-narcolepsy
In fact, there are many, many vaccine-related long-term injuries that are well-studied and were totally not detected until well after the fact.
In fact, there's an entire medical school textbook about it, if you want to really know, published by Wiley, called Vacines and Autommunity: https://www.amazon.com/Vaccines-Autoimmunity-Yehuda-Shoenfel...
The corporate press does everything possible to make it seem to the common person that vaccines are the very single medical technology that has zero side-effects and zero long-term safety issues, but that couldn't be further from the truth.
(Wiley is not some crazy conspiracy theory crap, they make legitimate textbooks for colleges everywhere.)
Not to mention, the question itself is biased. You should really ask, Is there any example of an entirely new medical technology (really, three, if you consider the LNP) which post-deployment caused long-term safety issues?
And that would be a resounding yes.
And, please again note, even knowing all I do about all those things and the dangers of vaccines, I still am more vaccinated than you, having taken, e.g., rabies vaccine, even knowing the not-insignificant risks involved.
However, there was a risk I'd catch and be injured by rabies.
There's almost zero risk I'll be injured by covid, lol.
I mean, as well, look at the injuries being caused by the vaccines: They happen to people like me, young and healthy. Covid only hurts the fat people my age. Why would I take the side of the risk that hurts people like me?
I said show me one where the onset is hidden until after 6 months. The narcolepsy link above was concentrated in the first 6 months after the shot. At least try me with the dengue vaccine and ADE so I could explain why that is different.
Hundreds of millions of people have taken the vaccines and we know with huge amounts of power the side effects and their (incredibly tiny) probabilities. It is beyond uncommon for a hidden side effect to only appear later, especially with something like a vaccine. It produces an antibody response and goes away. If that antibody response is going to cause problems it generally happens sooner than later when there are the most antibodies.
I, like you, didn’t want to be the first person to take the vaccine. But at this point the safety record shows it is one of the safest, if not the safest, vaccine ever produced. Hopefully you don’t get COVID in the meantime of this point becoming clear to you.
Please stop fear mongering and repeating falsehoods that have been proven time and time again to be incorrect.
https://www.reuters.com/article/uk-factcheck-vaccine-monitor...
https://www.pfizer.com/science/coronavirus/vaccine/about-our...
“ This trial began July 27, 2020, and completed enrollment of 46,331 participants in January 2021. On November 18, Pfizer and BioNTech announced that, after conducting the primary efficacy analysis, their mRNA-based COVID-19 vaccine met all of the study’s primary efficacy endpoints. On December 2, 2020, the Medicines & Healthcare Products Regulatory Agency (MHRA) in the U.K. authorized the Pfizer-BioNTech COVID-19 vaccine for emergency use, marking the first Emergency Use Authorization following a worldwide Phase 3 trial of a vaccine to help fight the pandemic. Shortly after on December 11, 2020, the U.S. Food and Drug Administration (FDA) authorized the Pfizer-BioNTech COVID-19 vaccine for emergency use.”
Key words: met all of the studies efficacy endpoints, (Phase 3 is primarily designed to find EFFICACY), following a worldwide phase 3 trial
EUA does not equal still in Phase 3. Not even remotely correct.
https://www.pfizer.com/news/press-release/press-release-deta...
Key word: CONCLUDES
Your previous comments point to the long development of other vaccines as a mark against COVID-19 vaccines. Surprise surprise, a vaccine developed during a pandemic gets pushed to the front of the line and has full priority, no issues with funding, etc. The speed at which it was passed is not a slight against it, considering it was able to still make it through Phase 1, 2, and 3, and then ultimately gain EUA. Again, not because it was rushed, it still had to go through all other testing other vaccines had, if anything full approval was delayed so they could get 6 months of additional EFFICACY data.
https://www.mercurynews.com/2021/04/29/covid-19-vaccine-myth...
The current data we have shows the vaccines are very safe to a high degree of certainty. If you had created a bar beforehand, they’d have met it. But you can always keep moving the goalposts.
All the other vaccines I have been administered had at the minimum a decade of widespread use following their phase 3 trials (and as an aside, their phase 3 trials were much longer studies than these covid vaccines are projected to be).
I've never taken a drug released under EUA.
I investigated every vaccine I took and assessed the risk/benefit ratio and elected to take them. In general, I love vaccines, and I love the medical establishment that gave me the option to elect them! However, the medical establishment seems to have thrown away the playbook on these particular vaccines. The point is, I could examine the risks of those vaccines, and since their administration was not politicized, the data was totally trustworthy. And since most were out of patent, the financial incentive to manipulate data just wasn't there. I could be reasonably informed of the risk. Since these have not completed phase 3 trial, much less have decades of history in widespread use, I have basically no long-term safety data with which to inform my decision. So, precautionary principle tells me: No, thanks!
The risk to benefit ratio is the only thing that matters to me, as I believe it should to others. My likelihood of serious impairment from covid seems very low to me, just like it seems very low to children, for instance. Further, the ratio changes every single day: The more people who get vaccinated, the lower my risk gets, as does the risk for every other unvaccinated person, making the ratio, as more get vaccinated, skew towards not getting the vaccine.
https://www.reuters.com/article/factcheck-covid-vaccines-idU...
They have filed for full authorization for a reason. These vaccines have enough data backing their safety for full approval.