There are also more agencies than just the FDA that approved these vaccines, if you don't trust them specifically.
Publication bias is a real issue, and I'm annoyed that all efforts to reduce it seem to be rather ineffective. The ideas behind requiring registration of trials is good, but it doesn't do much if you don't actually police the rules. But the COVID vaccines got such enormous amounts of attention that it really doesn't matter in this specific case.
But is the science being done "good" considering that the political and social pressures around reporting of negative results/adverse effects still exists? How do you get good data on adverse events if vaccine recipients don't even think to correlate strange symptoms x weeks or months post vaccination with the vaccine? How would you detect an autoimmune disorder with vague and nonspecific symptoms, for example, when doctors also are unwilling or unable to collect relevant data out of a combination of bias and ignorance?
It's a double whammy, because of the novelty we don't know exactly what we're looking for, and because of stigma/political pressure we are arguably not looking hard enough. Being labeled an anti-vaxxer is effectively career and social suicide, how many researchers are willing to stick out their necks, especially when rigorous proof would take years of research and funding to aggregate?
To me this is pretty good evidence that the existing mechanisms for detecting rare side effects work in general. One can argue about the details in this case on how exactly the authorities responded, and I think also reasonably disagree on how to weigh the risk/benefit in this particular case for specific age groups. But those are much more difficult questions based on inherently fuzzy data due to the low frequency of this serious side effect. But the detection itself worked well, and also produced very quick reactions.
What is also demonstrably true is that the death rate from COVID is now negligible for those vaccinated. Might there be some super rare interaction we don't know about? For sure, but there's also as likely to be super rare interactions with COVID itself, or whatever crank treatment of choice replaces a vaccine.
The mandates only came in once enough of the population had been inoculated to make a requirement possible. At that point the initial trials are a footnote compared to the results from mass vaccinations. IMHO it's just not reasonable for that objection to carry any weight. There may be other reasons, of course.
There's a major caveat here, sudden and obvious adverse effects are rare. The subtle and possibly long term ones are still unknown. It took some 5-10 years before Thalidomide was found to cause severe birth defects, for example.
So just say you won't take it and be done, because there is no mechanism that can satisfy you.
The vast majority of people objecting to covid vaccines have no history of vaccine denial, and no good reason to suspect the covid vaccines are particularly dangerous compared to the many vaccines they have accepted previously without a thought or any interest in their history, testing or method of action. It’s politically motivated from start to finish and has nothing to do with the medical facts.
Just to name one small issue, our only measurements of vaccine efficacy are case counts, covid hospitalizations and covid deaths. Each one of these measurements is confounded by population-level differences in testing rate, testing polices (ie routine testing on entrance to hospital), PCR cycle count, and many other factors. There is no longer a monitored control group, so we can't ever account for any group-level differences or confounds. I've seen no attempt to address these issues.
We also have no access to reliable data about confirmed adverse effects. A year later, it is still very hard for a person to quantitatively assess his/her own age-stratified risk/benefit tradeoff, even with the confounded efficacy measures.
So, given all that, why isn't skepticism reasonable anymore?
Have you always felt this way about the medical profession? Have you any specific reasons to doubt the medical profession and it’s institutions, across many nations and accreditation agencies, now in particular?
Because mRNA is a novel technology and that people obliviously make this argument is a testament to the effectiveness of the "safe and effective" propaganda.
>Have you always felt this way about the medical profession? Have you any specific reasons to doubt the medical profession and it’s institutions, across many nations and accreditation agencies, now in particular?
There were numerous reasons to be skeptical before covid - regulatory capture and the replication crisis in particular. Suddenly bringing these up gets you branded an anti-vaxxer. Wr shouldn't be blindly trusting our modern institution, it has strayed increasingly far from clean science over the years, now you have influences from industry and unrelated politics, in addition to the pressures that come with sticking close enough to orthodoxy to maintain a career and receive funding for grants.
When I was younger I also had much more trust in our institutions, but with age and experience I have grown to recognize how imperfect they are, and none of those imperfections disappeared when the president decided he wanted a new vaccine yesterday; in fact many of those problems were enormously amplified.
Why are you particularly concerned about these ones? Are there any others of the many, many new medical technologies coming out for which you have the same concern, or is it all of them?
I'm particularly concerned about this one because the critical safety evaluation process was accelerated by a factor of 5-10 and the clinical safety data is not available for third party review, however it was used to justify propaganda that has influenced (biased) all subsequent research. Just like software, the marginal gains of throwing money at a problem eventually approach zero, some things just take time, especially when you're evaluating biological side effects which may develop slowly.
I'm particularly concerned about this one because it hijacks your cellular machinery to manufacture a sudden megadose of an inflammatory protein (not a complete virus) which results in short term (at least) autoimmune behavior.
I'm particularly concerned about this one because it was effectively mandated for hundreds of millions of people with an obviously incomplete cost/benefit analysis and anyone who asks if maybe the benefit is overestimated and the cost is underestimated is immediately branded an anti-vaxxer/right wing conspiracy nut.
>Novel medical technologies are developed all the time. Every year new life saving treatments and drugs come out that transform the lives of people all over the world.
And how many of the candidates that make it to clinical trials never make it to market, or worse, are withdrawn after measurable harm? Now throw in the accelerated (rushed) safety analysis and systemic pro covid vaccine bias and it would be foolish not to be at least a little skeptical.
>and development and testing methodologies have been improved and refined over many decades of experience, in many countries around the world working together to develop best practices and cross-check each other's work.
And those testing methodologies still take time because of the nature of biology, you can't just snap your fingers and make adverse events happen more quickly. All those best practices and cross checking go out the window once a rigid sociopolitical orthodoxy solidifies around certain subjects, and suddenly few researchers are willing to risk careers for simply asking the wrong questions.
Nothing about the mRNA vaccine development process has been "normal", and these are emphatically not typical vaccines, this technology is unprecedented and its effects on the body are complex and difficult to study.
That’s best practice, due to the problem that access to data from past trials can bias the planning and design of new trials. It’s SOP from hard win practical experience over many decades.
The effect of the vaccines is so huge that you only have to look at a Kaplan-Meier plot and will immediately see the huge difference. And we don't have a single study here, we have a lot of different ones that all indicate that the vaccines are very effective and safe.
In some proportion of hospitals, when someone who is not vaccinated goes to hospital for any reason, they are tested for COVID-19. If found positive this is counted as a COVID-19 hospitalization. We have no access to the precise rate of these incidental hospitalizations. In some of these hospitals, it is the policy that vaccinated people who go to the hospital are NOT routinely tested unless they have symptoms. If this is the policy at a substantial number of hospitals, it could dramatically change the "effect size" of the measurements that we are talking about. The same issues essentially applies to COVID-19 deaths and cases.
Large effect size alone generally isn't convincing when you're using such fundamentally confounded sampling procedures, merged age-groups with wildly different risk profiles, and data aggregated across long time-windows with different population sizes.
It's not a conspiracy, people just tend to look away from things that could endanger their livelihoods. An emergent property of socioeconomic systems. A failure mode, so to speak.
It might seem shady if you don’t know the reasons for it (what are they hiding?). I understand that, but the fact is this is standard practice and releasing the raw data would be reckless and irresponsible.
reality is, that we can't have policy/public sentiment that is nuanced. (I heard it breaks the timecontinuum)
Find the silver lining and move on. I'm just glad that, a lot of people are in pro-vaccine side overall. While in your case it is a bit of mob mentality (mostly appeal to authority + optimism + jugde_dissagreeing_side), in the long run "pro vaccines" is (even if only on average) leaps and bounds and couple of parsecs better than "no vaccines".
Not to derail the thread but this nicely encapsulates my reservations toward the COVID vaccines, and why I think mandates are egregiously unethical. The raw clinical trial data is still effectively a secret between pharma and the FDA, and both are under immense financial/political pressure to release a "safe and effective" product, not to mention the incestuous relationship between the ostensibly independent FDA and big pharma.