Yea, that would help! I heard somewhere that the things they’re evaluating now are technical things like how well the vaccine can be transported and stored, etc, not like how safe or effective it is. Wonder if that’s true. Certainly seems strange that they haven’t lit a fire under the formal approval process, since so many people are using the emergency approval as an excuse. But I guess if they hurry it, maybe it won’t seem credible to those people? Idk. I feel like there are always going to be people saying “this was approved in a year, which is four times faster than any other vaccine approval, and is therefore suspicious”, nevermind the fact that we’ve never had the urgency of a global pandemic behind vaccine authorizations.First FDA needs to approve covid vaccines. Not just emergency use, but formal approval. It is pretty ridiculous that this hasn't happen yet.
my friend this is a very logical, measured approach.I am sure there are many "good" reasons, but surely transportation, storage, production have been sorted out at this point, given how many vaccines have been delivered. The approval will help a lot and not having it casts a weird light on the issue. There will still be people that will refuse to vaccinate, but at least there will be less reason for them to do so. At the moment it is difficult to argue for the safety of the vaccine when FDA doesn't have it approved. Not to mention that it is not easy to require people to vaccinate with something not having full FDA approval. General public doesn't care about the technicalities of the FDA approval process. For decades we've been fed the "fact" that if it is not FDA approved it is not safe and should not be used. Most know this is not technically true, but under the circumstances not having FDA approval is a very good argument against the vaccines.
I disagree, most of the people I've talked to that haven't vaccinated yet bring up lack of full FDA approval as the main reason. All are rational, educated and smart people. So I'd say exactly 73.93421% of the still unvaccinated population of educated and rational actors are affected.There's exactly .0001125% of the population that is objectively looking at the FDA emergency authorization vs. approval process and making decisions based on scientific concerns about the safety of vaccines.
From a non-scientific standpoint, I haven't talked to or observed anyone expressing vaccine reservations based on anything other than "freedom" or regurgitation of amorphous talking points.
People can and will make their own choices, but I don't think that the admittedly muddy narratives that the FDA and CDV have caused are impacting a lot of rational actors.
I don't find it that difficult, really. I'm happy saying that there are various hoops and such that the FDA has to jump through that haven't been done yet, but that the basically unanimous consensus of the FDA, the CDC, and the overall scientific community is that these vaccines are safe, effective, and essential to combating the pandemic, unless we all want to shelter in place for the next however many years. That's not to say that they'll believe this argument, but I don't find it hard to say.Jokes aside it is very difficult to argue with people not wanting to vaccinate when the government agencies that we supposed to listen to send mixed messages.
This is wishful thinking. You're saying that having more doses administered speeds up the passage of time somehow?It is ridiculous that FDA has not granted full approval for the COVID vaccine yet. Given how many doses have been administered they have safety data worth decades of normal clinical trials.
As true as that might be. Not having full approval is a solid reason not to trust the vaccine or FDA message. Yes some people will find another reason not to get vaccinated, but some will just get vaccinated, I personally know a few. We can argue percentages and all that, but the message would be clearer. Right now to a lay person like myself that doesn't know all the intricacies of FDA approval process it just seems like they are not sure of long term effects, so they don't give full approval. This might not be true, but in this situation perception is more important than reality. There is absolutely no reasonable downside for them giving full approval at this point. If down the road it turns out that there are long term effects FDA will be blamed regardless, since they are pushing the vaccines hard.This is wishful thinking. You're saying that having more doses administered speeds up the passage of time somehow?
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AT5760 has it right.. the distinction between only matters to people looking for an excuse to refuse the vaccines. It's a moving target, and granting full approval won't lead to widespread vaccination. They'll just find another complaint to latch onto.
This is wishful thinking. You're saying that having more doses administered speeds up the passage of time somehow?
Not really. What I am saying is that FDA has a lot more data that with a normal compound to evaluate safety. If you are looking for rare side effects, they would been recorded, given how many people got the vaccine already. Very large sample size a huge advantage when you evaluate safety.
It still does not tell you about long-term side effects, thats correct, but there are few or no cases of long term side effects with any vaccine so it is highly unlikely to see that with these ones. mRNA also stays in the organism for a day or less before it is degraded, which again puts long-term side effects in the improbable category. AT this point the benefit of a real approval vastly outweighs the risks.
Nice piece. It’s also nice to be reminded that I have no idea what goes into FDA approval, so I probably shouldn’t comment on whether it’s too fast or too slow. Presumably there’s a reason it’s taking this long.The problem IMO lies in the mindset of blaming someone to begin with, I don't know who will be blaming FDA and for what but everyone can make their own decision...to get informed, to get vaccinated, or not.
BTW: point folks to this, Opinion: Don't wait for full FDA approval to get your Covid shot. Here's why
I have no horse in this race... the FDA only indirectly affects me. The conversation interested me so I wanted to know what the fuss was about. I did 15 minutes of reading and found some logical sounding answers. There are plenty of articles written by credible sources. The FDA offers a lot of information. I am not going to pretend 15 minutes of reading will make anybody an expert on the approval process but finding some credible high-level explanations is possible! The probable answer is: "it is taking exactly as long as it needs to"I have no idea what goes into FDA approval, so I probably shouldn’t comment on whether it’s too fast or too slow.
Priority review was only granted two weeks ago!! A lot of this has to do with the manufacturers assembling all the correct data and applying. After an application checks all the boxes, the FDA needs to review all the submitted material to ensure the safety and efficacy of the vaccines. The FDA also has to validate that the vaccine can be manufactured safely and consistency at scale. Their process has a lot of checks, at multiple levels. This is purposely done to catch mistakes but it does put the brake on speed. I doubt full approval will take the 6 month period. But even with FDA employees working weekends and overtime, it is not going to happen in two weeks!Priority Review designation is given to drugs that offer major advances in treatment, or provide a treatment where none existed. The goal for completing a Priority Review is six months.
Yes/no... clinical trials are done in phases. You might not know it, but the last phase is done after market release. It can be really hard to catch the 1 in 100,000 events, even with large scale pre-market trials.Given how many doses have been administered they have safety data worth decades of normal clinical trials