[sjwalter]

I don't know where you're getting your information from, but what I stated is very easy to validate and I'm completely correct. Here are the links to the actual FDA trials for the different major co vid vaccines on clinicaltrials.gov as well as their associated estimated completion dates. All are currently in Phase 3 trials. (Aside, it's not clear how they will complete reporting for these trials as the companies blew up the placebo arms of the study. I guess that's another role I can play in this pandemic, being the control arm of the experimental trials currently underway.)

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

[lame-robot-hoax]

You obviously didn’t read my link as it addresses exactly what you’re saying in your comment.

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.

[sjwalter]

I'm guessing you didn't read the link you pasted as well. Note the correction at the top of the page.

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.

[peter422]

How do the ethical calculations stack up when we account for the hundreds of thousands of lives saved?

Regardless of whether you think the vaccines are safe, they are quite clearly effective.

[sjwalter]

I'm having a hard time understanding your question because the only way I can interpret it seems to imply that you think it is better to lie to people about the status of a medical treatment than it is to be honest, in a gambit to ensure more people accept administration of the treatment.

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.

[peter422]

You are the one who is calling something that is obviously safe, not safe.

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?

[sjwalter]

I never said anything was safe or not safe. I claimed that the long-term safety profile of the vaccines is unknown. This is demonstrably true.

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.

[nradov]

The science on hypovitaminosis D being a serious risk factor for bad COVID-19 outcomes is now quite clear. This site has a fairly comprehensive index of the studies.

https://vitamin-d-covid.shotwell.ca/

[nradov]

Forcing people to undergo medical procedures against their will cannot be ethically justified by any number of hypothetical lives saved. Everyone who can safely get vaccinated should do so, but it can't be coerced.

[lame-robot-hoax]

It’s clear you are incorrect. Phase 3 trials have concluded as reported by all manufacturers. It’s literally that simple. Extended monitoring of those that were in Phase 3 does not mean Phase 3 is still ongoing. There is no debate to be had here, I am correct, and you are strangely insistent on misrepresenting anything I provide. The correction at the top of the previous article had nothing to do with what you claimed it did. Phase 3 met its endpoints for Moderna, Pfizer, and J&J full stop. They are over. You can write a bunch of irrelevant BS, but that’s all there is to it. I’m obviously fully aware what EUA is, do not talk down to me.

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...

[peter422]

Nothing is perfectly safe. All the vaccines you have taken have side effects. So does the food you eat and the Sun exposure you get.

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.

[sjwalter]

I agree nothing is perfectly safe. However, I have never once in my life taken a drug, vaccine, or other medical treatment that has not completed FDA phase 3 trials. I have no interest in doing so.

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.