Go USA! What is the current standard of review for these authorizations since complete clinical trials are not possible, and a convenient point of contention for people that opt-out of taking the vaccine (most of them would move the goal post to something else even with successful clinical trials with a relatable list of side effects, but I was wondering about this process)
The clinical trials are actually the same (statistical power) as previous vaccine trials. They've simply enrolled more people faster and had a higher infection rate to evaluate safety and efficacy. It is likely in the next month that Pfizer will get a standard (non Emergency Use) Authorization.
The reason for EUA was that so many people were dying that some more limited (<1yr clinical safety) data was accepted. Now that many of the original subjects are falling past 1yr post inoculation (and variants have been evaluated) a full authorization in eminent. Previously, people worried that once one vaccine was authorized other EUA (NovaVax, AZ/ChadOx, etc) wouldn't happened, has also been resolved since the FDA realizes people want choice.
Yes, I think that at this point putting your own life at risk is acceptable. You'll probably have to wear a mask since you could make other people sick (who could then pass it on to someone immunocompromised). Of course you could face a civil suit, if someone get's sick or dies, and you can be shown as the proximate cause of illness. Your employer may choose not to take that risk.
If you're licensed in many states (e.g. medical, etc.) you're already required to be vaccinated against flu/TB. With EUA they've put this off, but with full authorization, why treat it differently?
One question, what long term effect of the vaccines are you concerned about, that wouldn't be far less severe than actually being infected?
For healthy, young people, I can see many of them making a not-irrational judgement that with the reports of blood-clot side effects above the population expectancy [from AZ’s vaccine], coupled with a lack of full authorization for any of them, to conclude that waiting is reasonable for them. I support what I believe is their right to make that choice particularly in advance of a full approval for use.
(I’m fully vaccinated as of today, just as context for what I said above. I came to a different [and I believe rational] calculation of my own risk-balance of complications from the vaccine versus fading the COVID risk unvaccinated for me and my family/colleagues and signed up for the very first shot I could get, a 75 minute drive away.)
I would love to be wrong, but I think the vast majority of people with vaccine hesitancy will feel no different once non-emergency authorization is granted
I also don't totally agree that it's rational to hold out on vaccination due to blood clot concerns. From the stats I've seen, (even for young people) death from post-vax blood clots seems to be rarer than death from COVID. Although I suppose there's an element of "if everyone else gets vaccinated, maybe I don't need to". It would be ironic if that attitude means that, instead of being eradicated, COVID will be floating around for decades until those now young people become at-risk due to age.
Age is a risk factor. Many European countries recommend AZ only above age 50 (Britain above 30) because of the risk/reward profile.
Also, the Pandemrix history teaches us that although adverse effects manifest within 2 months, it can take over a year to figure out problems (spoiler: pandemrix was touted as safe including by Fauci but was associated with 5X increase in Narcolepsy, a deveatatig life altering disease. There is a suspected mechanism but no certainty, so you can’t even say “we incorporated the lessons from that”)
The problem with this angle is that, if antibodies to the spike protein cause an immune response related disorder... what do you think the virus will do? It presents many more (and likely much less stable/useful) immune response targets any number of which might cause life altering diseases, even in young people! The H1N1 disease would have almost certainly had similar effects on autoimmune disorders (as Pandemris) since it looks like this was a genetic predisposition.
There is a fundamental problem with all of the hesitancy/risk issues, which is that the risk of not being vaccinated is much higher, unless you can personally count on never getting exposed to the virus, which at this point (for people alive now) seems highly unlikely. The classic example is the blood disorders for J&J, which are about as risky as driving 20-100mi (depending on where). It's not that driving is so dangerous (it's certainly not perfectly safe), but that the issues are so rare, and the alternative is worse.
That’s making an awful lot of assumptions, and is contradicted by a counter example with Pandemrix.
There is no equivalence between naturally getting it and artificially getting it. Almost everything is different about the process.
And everything you say had been said about pandemrix at the time, including the chance of getting the disease vs the vaccine - and historically was wrong.
Many people are wary of the newness of mRNA technology.
They think a long term affect has been overlooked or is unknown. Although some people make up long term effects, many other people are just acknowledging the absence of history to tell, and thats valid.
(Very few of the people opting out are distinguishing between any vaccine technology though. But some are.)
> Many people are wary of the newness of mRNA technology.
> They think a long term affect has been overlooked or is unknown.
To be a reasonable concern it has to be weighed against the alternatives. People have essentially four options assuming the virus does't just go away soon: get vaccinated using a new technology, wait for an older technology vaccine to be available, mask/isolate until the new vaccines have sufficient long-term data for their ill-defined concerns, get COVID.
Well COVID has high risk for long-term effects for all age-groups including death so any reasonable person will exclude that option. Older technology vaccines for many regions of the world may never be available or be sufficiently efficacious so that and masking/isolating indefinitely and maybe even getting COVID are the same option. Plus, there is no data showing any long-term effects for vaccines that don't become apparent in the first year or 100 million people receiving them.
COVID vaccine hesitancy is no longer a reasonable position to hold.
The Johnson & Johnson vaccine does not use mRNA and it is currently available in the United States.
There were adult women under the age of 50 who had some medical problems with it but, it is much better than getting COVID. If the mRNA vaccine are the obstacle in getting vaccinated I’d go with the J&J.
(Note: I am not a medical doctor and this is not medical advice)
It uses DNA delivered via a non-replicating adenovirus vector, it's the first vaccine of its kind to be given any form of approval in humans in the United States and maybe the fourth in the world all in the last year. It is still "new technology" in a similar fashion to the mRNA vaccines. For the new=scary=bad crowd it isn't much of an improvement.
Isn't "the mRNA technology" decades old at this point? Yes, this might be the first wide spread human deployment, but they've been researching the technique in animals for over thirty years.
What's the bar for when a technology is no longer "new"?
Come on, I did it last week but after weeks of hesitancy between mrna and the chinese deactivated alternative (I live in China).
Im a scientific, rational, atheist moderate person, I fight all day long against idiots spouting conspiracy theories, but still.
This vaccine is the first time I get an mrna vaccine, and I just have this one life. I understand why vaccination is important but in a world where people lie and cheat, I have only one shot. Be nice about it. This is new.
Scientists have been working on and reporting on dosing strategies, managing immune responses, monitoring long term effects on animals, etc. for a long time now.
Which part is parody? Just because something is new to you doesn't mean it's new.
I mean you literally typed “yeah it’s only been widely tested in animals and this is the first large scale human application of it, why are people thinking this is new?”
Sure, if you want to get into a semantic argument. The point is that the mechanism isn't complex, there is decades of research and multiple studies showing us it's likely safe, and still people are out here saying things like, "It's totally untested!"
Like, at some point we have to trust science and accept that studies and test groups will give us some reliable safety guesses. People generally have no idea how much research has already gone into this vaccine because they've been taken in by all the media coverage around the mRNA vaccines claiming the technology is new.
Let me try explaining via an analogy. It's like the folks who are really worried about 5G signals because they are new. On the one hand, yes, humankind has not had long term exposure to 5G signals. On the other hand science has a fairly complete understanding of various electromagnetic spectrums and is the phenomena of using electromagnetic phenomena is hardly new.
So yes, mRNA vaccines are 'new', but only in the way 5G is 'new'. We may not have deployed it widely before, but we're pretty dang sure we understand it.
In the absence of legitimate health concerns preventing one from safely receiving the vaccines, it's increasingly unreasonable and arguably unethical to opt-out of taking the vaccines.
Sure - but the parent didn't criticize the existence of the option. They criticized the decision making that many (not all) people use when exercising that option.
