Medications and vaccines never stop being tested. Drugs have been pulled from the market after full approval because extremely rare but serious complications appeared once you get the drug into hundreds of thousands of people.
It’s a best odds scenario, balancing risk/reward-full testing is going to identify the vast majority of issues, and is worth doing when there is no emergent and critical need. It’s the most risk averse.
EUA approval and compassionate use approval accepts slightly more risk because the need is so great and dire.
Experimental use accepts the most risk because the need is desperate or no other options exist. Use of these drugs require the highest level of informed consent and monitoring.
The issue is transparency, so the consumer knows what the level of approval is. FYI, I served over a decade on a trial board for cancer and psychiatric meds for a large hospital, approving research trials.
The rules for full authorisation are in place for every new medicine (meaning new chemical entity, new biological - there are different rules for generics and biosimilars). There isn’t any need (or case) for a general changing of the rules. As we have seen, there are systems in place which work fine for this sort of situation - EUA in the States, similar systems elsewhere.
In general, two adequately sized well-controlled clinical studies giving similar results* are required for authorisation (reproducibility of research and all that). So far as I am aware the EUAs were all granted on the basis of one study. I assume that the second study is the biggest issue holding up full authorisations (AZ may have additional issues).
Yes we now have the experience of millions of IRL doses being delivered, involving far more subjects than will ever be included in a clinical study; and this is fantastic confirmatory safety data. But it is not good efficacy data, because there isn’t a defined, appropriate control group. You still need that second study.
I would have assumed that there were also quite a few other areas where data were missing/incomplete at the time of EUA. This certainly was the case in Europe, and these were all essentially marked To Be Provided ASAP for those approvals (they were full approvals on an expedited basis in the EU). So there are likely other, less important gaps to be filled as well.
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* - interesting aside in this case: because of the rapid emergence of variants, what is the meaning of a “a second adequately sized well-controlled clinical studies giving similar results” in this case? It behoves an agency to be pragmatic right now. But I’ll be interested to see how it’s dealt with.
What do you think is going to suddenly change when it gets full approval in a couple of months? The reality is that we will have increased testing time by a few months, but nothing else. We’ve been watching this like a hawk since the middle of last year. There are now more people who have been given this drug than any almost any other drug ever invented and a lot of them have had it in their system for months and months with no ill effects, but wonderful positive impact.
So again, what would change if suddenly tomorrow it had full authorization? I can tell you right now that the anti-vaxxers aren’t going to suddenly go “Finally, it’s auhorized, give me my shot tomorrow.”
Of course. From that perspective, testing never stops. But even so, there is a point at which which they say, “Okay, we have now done enough testing to approve this for general use.”
And we have not yet reached that point for these vaccines. There is some lingering need – however slight – for additional testing.
Well, good news for you then, as it is going to reach that status very shortly! Me, I’m far more excited that I received a safe, effective vaccine that I rightfully had little concern about taking, while fully understanding just how intensive the testing process has been.
What do you need to hear to help with your questions?
You’ve been given many answers for why the vaccine is deemed safe despite full testing is incomplete, and why full testing is still necessary even when EUA authorization is apparently good enough.
You still have doubts, which I suspect people repeating these answers won’t satisfy.
So what answers, or types of answers, to your questions would be satisfactory?
AZ and J&J are mRNA vaccines. The method they deliver it is different, viral vector for them (and SputnikV and CanSino) versus being encased in lipids for BionTech (not Pfizer) and Morderna.
Thank you. What I’d like to hear is the difference between the requirements for emergency approval, and the requirements for general approval.
For example, perhaps general approval requires a larger number of tests, or over a longer length of time, or over more test patients. Or maybe a drug can get emergency approval even if a tiny number of deaths (or other bad side effects) have occurred, but general approval requires an even tinier number. Or maybe general approval has nothing to do with safety, but with efficacy.
That sort of thing. I understand that “safe” is a relative term, and nothing is totally safe. I’m just interested in the difference between “safe/effective enough for emergency use” and “safe/effective enough for general use”.
Yes, that sounds like what I want. If I’m reading it right, emergency use must have passed phase 1 and phase 2, and although phase 3 isn’t complete, a group of “well over 3,000 vaccine recipients, representing a high proportion of participants” must have been followed for at least one month, and half of them need a followup at two months.
Do you have a cite for that? The only vaccines I see being referred to in any literature, include Johnson and Johnson’s, as mRNA vaccines are the Pfizer and Moderna ones. The J&J and Oxford-Aztra-Zeneca vaccine is DNA-based, from what I’ve read.
Short answer, process. The FDA rules say six months of testing. Then you need to get all your data together in exactly the format the FDA requires. Then you apply. Then there is a lengthy bureaucratic process of review. Then they approve. It normally takes years to get through the process. The emergency authorization allowed them to bypass much of that.
They haven’t changed the process, they’ve just bypassed some of the steps and shortened others of them via emergency authorization. To get real approval, the process, including many stupid steps that don’t seem to have much purpose, still need to be followed.
Because of the scope of the vaccinations, there is the opportunity for a hell of a lot of followup. They have millions of people checking in daily for two weeks, weekly for four, and monthly for I think six months - maybe longer. Almost everyone given the vaccine was given a chance to opt in.
Yes, my understanding is that the critical thing the current EUA vaccines lack for ordinary approval is 6 months of data, neatly collected and collated. We are fast approaching that point, however, so unless something unexpected pops up, I expect full FDA authorization fairly soon.
I don’t think so. I believe they are DNA vaccines (the DNA having been inserted into a viral vector) and that is why they are so much more shelf-stable than the mRNA vaccines. Because DNA is intended to store data, and is fairly robust, whereas mRNA is intended to do its thing and be rapidly destroyed by the cell, so it’s quite fragile.
Thirding the disagreement here. Everything I’ve seen - even doing a quick search just now - tells me that AZ and J&J are not mRNA vaccines. Would love to see a cite to the contrary.
The vaccines are not completely safe. They do nothing to mitigate the risk that you’ll be struck by lightning, or run over by a bus, or blown up by terrorists. Every time you walk out your door, you’re risking those things.
But the thing is, safety is relative. You don’t need to prove that the vaccine is 100.000% safe. You only need to prove that it’s safer than not getting it. But that depends on how safe it is to not get it.
Right now, the pandemic is still pretty prevalent. An unvaccinated person right now has a certain chance of catching the disease, and if they do, a certain chance of suffering various afflictions, possibly including death. We now know, with a very high degree of confidence, that the risk from getting the vaccine is less than that level of risk from the virus. And so, in this emergency when the risk from the disease is relatively high, the vaccines have emergency approval.
But now consider another world, a few years from now. In that other world, COVID hasn’t been completely eradicated, but it’s been reduced to a very rare thing. In that world, being unvaccinated has a much lower risk. Is the risk of the vaccine lower than that reduced disease risk? Probably, but we’re not as confident about that as we are that it’s better than the current risk. Once we’re sufficiently confident of that, then it’ll be approved for general use.