As a Canadian who emigrated to the US, the attitude you so proudly display--ostracizing people who aren't convinced of a novel vaccine with zero long-term safety information--makes me so happy I live here.
It's not novel, this technology has been trialed and used for a decade, 3 years in vaccines.
We do already have long-term data. You would see side effects for a vaccine within six months, and we have been administering it for much longer than that.
I used to be a close follower of the pharma industry, and you're making it seem like FDA trials happen on molecules and formulations somewhat related to the proposed formulation and then are, like, transitively approved on that hand-wavey basis. This is totally wrong.
For reasons that should be obvious to any engineer that's worked on any kind of even moderately complex system, the molecule that is tested and trialed is the molecule that goes to production.
You don't test "the technology" and then some unrelated other vaccine and then say, there we go, this one's safe.
You test the actual formulation that will go to production. This can't have happened for this yet. The trials are still underway. Unknown risk.
I dunno if you're misinformed or a troll, but that's dangerous stuff to be putting out there.
Vaccines are amazing life-saving tech, and they're safe because of our cultural technologies (FDA trials for e.g.) that make them safe. You can't take all the safety gear out and still get the same safety rating. Doesn't make sense, lol.
The flu shot that's available each year doesn't undergo long term trials - it actually usually goes through about nine months to a year of trials due to predictions on what the flu outbreak will look like - but even then the substance is a reconfiguration of technology with new details being integrated.
In some areas of medicine we can afford to move slowly and we absolutely should - but when it comes to the flu we don't have that luxury.
And outside of some specific professions, the yearly flu shot is entirely optional. We don't have people running around screaming that you're a murderer or that you should be excluded from society if you choose not to get it. It's a personal medical decision, and that's the end of it.
Even if true, this novel molecule is not floating around in a body for an entire year waiting to have some side effect. They've been shooting it into people for a year and a half now. If there was something to worry about, it would have been seen.
But there are many parts of this vaccine that is shared with previous ones and the mechanics have been tested thoroughly. The science is the same. There's just no credible reason for those with normal immune systems to delay.
"This can't have happened for this yet. The trials are still underway. Unknown risk."
That's just simply untrue. The trials completed. Read the link.
Not sure why everyone keeps saying the trials completed, or which link you mean, because we can go right to the primary source (clinicaltrials.gov) and see that all the vaccines are still in Phase 3 of FDA trials. Here are the links.
Please stop spreading misinformation during a deadly pandemic.
One of the foundational, bedrock principles of bioethics is "informed consent". It is extremely, practically diabolically, unethical to lie to people about medical treatments prior to gaining their consent. This is literally bioethics 101.
You are saying that I am putting people, or society, at risk simply by stating the simple, 100% true fact that these vaccines are not through FDA Phase 3 trials.
The implication of this is you believe it is best if people are NOT given informed consent, that they are kept in the dark, and told lies about the status of these vaccines, because doing so will encourage more people to take them.
I'm sorry, man, but that is just awful, terrible stuff.
Coursera has a course on bioethics, you may want to inform yourself before you engage in discussions about medicine, because you are totally operating in an evil way.
> Even if true, this novel molecule is not floating around in a body for an entire year waiting to have some side effect. They've been shooting it into people for a year and a half now. If there was something to worry about, it would have been seen.
There are lots of things we do see and we should worry about. The problem is that we can't tell right away if it's just noise, if it's a potentially rare side-effect. Then you have the problems like Myocarditis, which are clearly caused by the vaccine, which we hand-wave away with speculative "the benefits still outweigh the risk" scenarios:
Right, anything not yet discovered is going to be a pretty rare side effect. We're still learning about what covid does to the body, tell me about the side effects of getting sick.
> You would see side effects for a vaccine within six months, and we have been administering it for much longer than that.
We have now had two separate rare-but-serious side effects of different Covid vaccines: the CVT issue with J&J, and the myocarditis issue with the mRNA vaccines in children. It's disingenuous to suggest that the vaccines are "safe" merely because they've been widely administered; even the question of what "safe" means is a far more nuanced question than you're presenting. For children, in particular, two-dose vaccination with the mRNA vaccines is probably a poor risk/benefit profile. We didn't know that until we started dosing enough kids to see the rare side effects.
The phase 3 trials were not powered to detect rare side effects, which is part of the reason that they're still classified as emergency use, and not fully approved.
I am an advocate for vaccination, but it's not right to ignore these issues.
I don't think anyone is ignoring these issues - on the contrary, even in these very rare cases of side effects vaccination efforts were halted immediately.
Safe is always relative. If you don't think the vaccines are safe enough, then please also be consistent and don't engage in equally unsafe activities, e.g. don't drive a car, exercise regularly, eat healthily, don't encourage your girlfriend/wife/daughter/friend to take the contraceptive pill or, even worse, get pregnant, also do not take a large number of other drugs etc.
Again, from what we know today, it is safer to vaccinate your kids then driving them around in a car. Even when the risk/benefit profile is even/negative, absolute risk is super low.
Not ignoring but these are very rare side effects. It's something for doctors to know about in order to help treat the unlucky. But I think we have different meanings of the word safe.
These vaccines are very, very unlikely to give anyone a hard time. Nothing's without risk, but even for the unlucky that doesn't even sound that bad.
As soon as my son is eligible, he's getting it, too.
> Not ignoring but these are very rare side effects. It's something for doctors to know about in order to help treat the unlucky. But I think we have different meanings of the word safe.
The chances that a child will experience anything other than extremely minor illness from Covid is also very rare. The current numbers are teetering on the edge of implying that children are at more risk from the vaccine than from the virus.
My definition of the word "safe" includes the rational weighing of risks vs. benefit for a target population. Is it worth it to put kids at risk from myocarditis that exceeds their risk from Covid, just to reduce population-level Covid stats and reduce the marginal risk to the elderly? I don't know, but it's not a question to simply ignore.
Child deaths from Covid-19 in the US as of 6/24 [1]: 336
Child deaths attributed to vaccines [2]: 0. We can break this down further: 3 deaths from blood clots attributed to adenovirus vector vaccine, none in children. 616 reports of myocarditis[3], 393 confirmed, none fatal.
If you think you can reduce this to the singular axis of "deaths", you're making a straw-man argument: we should absolutely vaccinate the children who are at risk of death, and fortunately, we can easily identify them, because it's not random. Essentially all child deaths from Covid have occurred in kids with serious pre-existing conditions.
Moreover, you're implicitly using a biased selection of data to make this argument. Want more children to die of myocarditis? Keep doing the same thing we're doing now. It will happen. We've been vaccinating kids for a fraction of the time they've been getting Covid.
I will say this for the benefit of others: regarding the CDCs numbers, in particular, they've used the incorrect counter-factual (no doses vs. two doses), and substantially mis-represented the rates of myocarditis in children.
This is true by medicinal standards, but it's also a sleight-of-hand. The AstraZeneca vaccine had a rare side-effect that was right on track to kill more young women in Europe than the virus itself. That's why it was banned. By that standard, I could argue the viral infection is also safe - for young women at least.
Just to clarify - that is false. It is generally advisable to get Moderna/Pfizer if they're available and you're a young woman but the chance of mortal thrombosis is around 5 per one million. The EU recommends getting AZ over not receiving a vaccine if that is the only option available to you[1] - though at this point there should be a sufficient supply of alternatives.
> It is generally advisable to get Moderna/Pfizer if they're available and you're a young woman but the chance of mortal thrombosis is around 5 per one million.
No, the risk for anyone to develop a lethal thrombosis is roughly 5 per million. The chances are much higher for younger women, to the point where it exceeds the risk to die of COVID.
It's not even close, for women age 20-29 the risk of fatal thrombosis is 1:250k, while Covid is somewhere around 1:25k [1]. That's a whole order of magnitude.
The risk/benefit ratio of AZ vaccine is only poor when the risk of exposure is very low [2].
> It's not even close, for women age 20-29 the risk of fatal thrombosis is 1:250k
I have yet to find a source that gives the risk for that cohort.
> ...while Covid is somewhere around 1:25k
Even if it's an order of magnitude higher, the risk of a actually getting a PCR-confirmed infection is an order of magnitude lower.
Again, Germany: 28 deaths of women in that age group over the course of the pandemic[1], including all potential co-morbidities that may tilt the risk in favor of vaccination.
> The risk/benefit ratio of AZ vaccine is only poor when the risk of exposure is very low.
This is comparing "ICU admissions" against "Serious harms due to the vaccine". Utter nonsense. Why not compare mortality? Probably because it wouldn't look too good...
That was caught and the shots stopped. Millions of people have had the other vaccines with no similar bad news. If there was any kind of wide-spread problem, it would have been loudly seen by now and those vaccines would have also been pulled. There has not been.
> If there was any kind of wide-spread problem, it would have been loudly seen by now and those vaccines would have also been pulled. There has not been.
Yes, if it was a wide-spread problem. The side-effect that killed AstraZeneca wasn't widespread, it was extremely rare, and it was caught because it was such an unlikely combination of symptoms. Yet, this extremely rare side-effect was enough to make the vaccine more dangerous than the virus - to young women at least.
In a year, when all the facts are collected and processed, we'll see how much trouble the Pfizer vaccine really caused in terms of Myocarditis. Then we'll scramble to make up numbers on how many infections must've been prevented by the vaccine to make it all worthwhile.
> In most cases it goes away on it's own or people don't even know they got it.. That doesn't seem all that scary.
...like COVID in young people?
It's true that Myocarditis often goes unnoticed and undiagnosed. That's what makes it dangerous. It's a leading cause of cardiac arrest in young people. If you actually do get diagnosed with Myocarditis, it's not necessarily a mild case. That's what makes me suspect the cases being reported now are just the tip of the ice berg.
Oh, not very sure at all. However, I may have already have it, so that cat's out of the bag (and invalidates any reason to get the vaccine anyways). Or I may never get it. Taking the vaccine, which includes three brand new medical technologies and has not completed phase3 trial, guarantees me taking that risk.
I am extremely healthy, have a great diet, and as a farmer, I get plenty of time soaking up vitamin D, a potent inhibitor of covid. The vaccine doesn't make any sense for me to take.
Normal disclaimer, I am a huge, huge believer in vaccines, and am probably more vaccinated (due to travel and other circumstances) than nearly everyone reading this comment. I believe bar none vaccines are the medical technology that has saved the most lives in our history as a species. Big fan of vaccines.
But, vaccines are made safe via clinical trials and long-term studies. These vaccines are wholly new in type, were rushed to market, have liability waivers for those pushing them, and to make things even worse, the manufacturers aren't collecting followup data about adverse events in any kind of systematic way (as they would during a normal phase4). So it seems to me the playbook that gave us generations of safe vaccines that saved billions of lives has been thrown out the window.
You have no clue what you are talking about and have spouted multiple falsehoods in your comment, especially in regards to phase 3 trials not being completed (they are) and that they are not conducting follow ups for an extended period of time (again, they are).
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.
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”
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.
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.
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.
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.
We do already have long-term data. You would see side effects for a vaccine within six months, and we have been administering it for much longer than that.
The vaccines are safe.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7956899/