The safety and efficacy have been established. — Fooloso4
600,000 thousand and counting dead in the U.S. from the virus or complications. How many deaths from the vaccine? What long term deleterious effects are you rationally contemplating that could make the vaccine the less good choice?Long term safety certainly has not been established. That said, I have no doubt many therapeutics are approved prior to long term safety being established. — Janus
What long term deleterious effects are you rationally contemplating that could make the vaccine the less good choice? — prothero
Required studies must, at a minimum, address these concerns: i. Coagulopathy issues, including blood clots, hemorrhage, thrombocytopenia, heart attack, and strokes. According to the VAERS, as of May 21, 2021, there have been a total of 1,222 reports of thrombocytopenia/low platelets; and 6,494 (112 in 0-24 year-olds) reports of blood clots/strokes. ii. Reproductive issues, including menstrual irregularities, reduced fertility, miscarriages, and preterm births. According to VAERS, as of May 21, 2021, there were 511 reports of miscarriage and 522 reports of uterine hemorrhage (including 88 in women older than 50 years). The vaccines induce the generation of antibodies to attack spike protein, which are genetically similar to proteins produced by the placenta.30 To date, no vaccine sponsors have conducted immunologic studies of spike protein involvement with proteins involved in placental development. iii. Carcinogenesis. There is preliminary and theoretical evidence that the spike protein may promote cancer.31,32 Considering the potential for annual booster vaccinations, COVID-19 vaccines should be treated similarly to medication taken for chronic conditions on a long term basis. Carcinogenic potential is important to characterize. iv. Transmission of spike protein (or its fragments) from vaccinated individuals, such as through breast milk and associated risk in neonates and infants. According to the UK Medicines & Healthcare products Regulatory Agency, there are 921 reports of exposure via breast milk following AstraZeneca’s vaccine and 215 reports following Pfizer’s v.vi.vii.viii.Neurological disorders, including Guillain-Barré syndrome, acute disseminated encephalomyelitis, transverse myelitis, encephalitis, myelitis, encephalomyelitis, meningoencephalitis, meningitis, encephalopathy, demyelinating diseases, and multiple sclerosis. Cardiac issues, including myocardial infarction, myocarditis and pericarditis, among others. According to the VAERS, as of May 21, 2021, there have been a total of 1,598 reports of heart attacks (24 reported in 0-24 year-olds; 501 resulted in death). Autoimmune diseases, including thyroiditis and diabetes mellitus, immune thrombocytopenia, autoimmune hepatitis, primary biliary cholangitis, systemic sclerosis, autoimmune disease for skeletal muscles (myasthenia gravis, myositis such as polymyositis, dermatomyositis, or other inflammatory myopathies) Studies should be conducted in individuals of both sexes 33 and all ages. We cannot assume that the effects of spike protein are the same across populations of all ages, sex, and across pre-existing conditions.
practically nothing is yet known over any long-term adverse effects in adolescents
Very often, it's the fact that we have that placebo controlled follow-up over time, that gives us the ability to say that the vaccine didn't cause something at a longer period of time after vaccination Continuation of placebo controlled follow-up after EUA will be important and may actually be critical to ensure that additional safety and effectiveness data are accrued to support submission of a licensure application as soon as possible following an EUA. Once a decision is made to unblind an ongoing placebo controlled trial, that decision cannot be walked back. And that controlled follow-up is lost forever.
For adults, the benefits of COVID-19 vaccination are enormous, while for children, they are relatively minor. Rare side effects from adult COVID-19 vaccination are unlikely to lead to future vaccine hesitancy whose public health impact could be comparable to the benefits of the adult COVID-19 vaccination program itself. But accelerated mass child vaccination under EUA — perhaps even spurred by school mandates and “vaccine passports” — presents a different balance of risks and benefits. Rare adverse events really could prove to be the most durable public health legacy of an EUA for child COVID-19 vaccines.
also there's the issue of Myocarditis https://www.sciencedirect.com/science/article/pii/S0264410X21006824 in young people which significantly outweighs their risk from Covid-19. — Isaac
I think it's a bit of a leap from that to your conclusion that the risk of myocarditis from vaccination outweighs the risks from Covid. — Janus
I'm disagreeing with the proposition that the FDA work does not relate to safety and efficacy. — Isaac
The role of the FDA is to verify that products are safe and effective. — Fooloso4
I don't see the justification for saying that the additional work of exactly the same form to meet the higher threshold is 'just bureaucracy'. — Isaac
The FDA will approve the vaccine. At this point it is a matter of bureaucracy rather than safety or efficacy, which have been amply demonstrated. — Fooloso4
No one is denying it's safe and effective. — Isaac
At this point it is a matter of bureaucracy rather than safety or efficacy, which have been amply demonstrated. — Fooloso4
The role of the FDA is to verify that products are safe and effective. — Fooloso4
I'm not disagreeing with the proposition that the vaccine has been shown to be safe and effective. I'm disagreeing with the proposition that the FDA work does not relate to safety and efficacy. — Isaac
You are arguing for marginal safety on principle. — Cheshire
And then claim that their main job is some other work rather than safety and efficacy work. — Isaac
At this point it is a matter of bureaucracy rather than safety or efficacy, which have been amply demonstrated. — Fooloso4
But then, the person that might end up paying the price for that might be someone they infect. So perhaps the compromise is, anyone has a right to refuse to be vaccinated, but by so doing they forfeit the right to move freely in society. — Wayfarer
So perhaps the compromise is, anyone has a right to refuse to be vaccinated, but by so doing they forfeit the right to move freely in society.
I get a lot if insights from your posts on maths. — Wayfarer
It is a matter of where they are in the process of approval. — Fooloso4
I understand that the regulatory process is complicated, but right now, it feels like a black box. And I think this is what I and other public health experts are calling for the FDA to not make this process so opaque. I mean, it would be really important, I think, for public credibility and understanding for them to say, for example, here are the 50 steps that we need in order for full approval to occur. We already have these 30 taken care of, 10 are in process, 10 are still to be determined. — Leana Wen, Public Health Professor at George Washington University
As you admit the vaccine has been shown to be safe and effective, so why hasn't it been approved yet? — Fooloso4
Safety in regards to the threshold for public disbursement was met; safety beyond this threshold is literally increased incrementally following further results, studies, aggregate data expositions, etc. — Cheshire
I am surprised to hear that you are waiting. The FDA will approve the vaccine. At this point it is a matter of bureaucracy rather than safety or efficacy, which have been amply demonstrated. — Fooloso4
In view of that, shouldn't the vaccinated be prohibited from free movement as well? — fishfry
I think this only holds if you can somehow quantify each of the safety levels (unless I've misunderstood what you mean by 'marginal', I took it to mean 'small'). The EUA threshold is one level of safety, the BLA approval is another, higher, level. To know that the difference between the two is 'marginal' we'd need some way of quantifying each. I don't think such a way exists, which is why - going right back to the beginning of this whole shambles of an argument - which was... — Isaac
If we truly want our lives to return to normal, the fastest way to do so is simple — get vaccinated right now.
Secondly, you've still not given any detail on exactly what it is you think the FDA are doing over the next stage in their work (this mysterious 'bureaucracy' which is apparently unrelated to either safety or efficacy). — Isaac
You repeatedly conflate the question of whether the vaccine has been shown to be safe and effective enough to get vaccinated now with the issue of full approval. — Fooloso4
What they are doing is exactly what I said they are doing, reviewing and evaluating the data. — Fooloso4
Speculating, I would suppose you are waiting for reductions of uncertainty concerning the last 5% which simply comes with time.
— Cheshire
We can all speculate, that's the point of each individual being left to decide for themselves (on proper scientific advice, of course). — Isaac
Proving the capacity for inquiry doesn't speak to the state of affairs. Because I was speculating I selected the number that errored against my position. The assumption of a .05 Alpha isn't exactly what I would call grabbing numbers out of the sky. — Cheshire
...data relating to safety and efficacy, hence you are wrong to say the the work they're doing is other than safety and efficacy work, which is the sole point of disagreement. — Isaac
The role of the FDA is to verify that products are safe and effective. There is ample evidence that the vaccine is safe and effective. They are still required to do a thorough review of the data ... — Fooloso4
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