Moderna: Covid vaccine booster produced ‘robust’ immune response against delta
cnbc.com
cnbc.com
Why did the mRNA technology remain unapproved for a long time since its inception?
What exactly was relaxed in the approval process that lead to its EUA?
Since the vaccine has been used population wide, will the missed studies or what ever due process eventually be done? Or will they be skipped, citing the real world usage (which was not controlled or followed up in a systematic manner)?
Also, I don't agree that I am spamming, because I only post the question in the relevant threads.
The short - and hopefully simple - answer to your question, which I hope is simple enough while not abstracting away too much of the more complex reality underneath it is that the mRNA tech was for a long time believed to be non-essential, and besides that there were some licensing issues and other claims. The pandemic provided the right circumstances (read: funding) to try to see if the advantages of mRNA would allow for either a faster development track or for a vaccine that could be changed more rapidly if the virus targeted would mutate.
Both of these turned out to be true - after the fact - and given that a vaccine is better than no vaccine the approval was then fast-tracked enough to allow the vaccine to come to market. There was a lot of testing to ensure that it was safe to administer of the various components in the past, the only part that was new was considered safe based on an abbreviated trial (that still had a surprisingly large 'N' for something done in such a short time).
>mRNA tech was for a long time believed to be non-essential
Please correct me if I am wrong, but this is is hard to believe. The mRNA tech provide obvious advantages in terms of production and quality control of the vaccines and reduced overall cost, because you no longer have to maintain this library of attenuated viruses..
Also you say
>advantages of mRNA would allow for either a faster development track or for a vaccine that could be changed more rapidly if the virus targeted would mutate.
So you agree that there is obvious advantages to mRNA tech, and we knew it is valuable because the mutation of viruses was not a new discovery that COVID provided.
Also, it seems unlikely that a Company like Moderna would invest in a tech that is currently considered as non-essential.
>The pandemic provided the right circumstances (read: funding)
Yes, this is the crux of my questions. What exactly did the funding enabled? What breakthrough did it yielded?
We already knew that advantages of mRNA would allow for either a faster development track or for a vaccine that could be changed more rapidly. So research funding did not disclose it, we already knew it.
So the questions still stands, sadly.
Also, I came across this article, which kind of says that
>In fact, right before winning federal funding for COVID vaccine development in March 2020, only 3 of Moderna's projects had made it past Phase 1 testing, and only one of these was a vaccine (a cytomegalovirus vaccine codenamed mRNA-1647).
And that kind of refute the claim that it was being blocked because it was seen as non-essential. Or do you think that results of clinical trials are rejected on the basis of how essential the technology is?
https://anthonycolpo.com/the-disturbing-truth-about-moderna-...
>only 3 of Moderna's projects had made it past Phase 1 testing, and only one of these was a vaccine
Is it too much if one wonder how these vaccines got past of the trials that were blocking it, by additional funding. Your answer does not make sense because clinical trials are not evaluated based on whether the technology is essential or not.
I don't think I am being unfair when I say your answer is not very convincing. On the other hand it is not really fair that I ll have to accept what ever that is supposed to be an answer. It might work in television debates, but not in an online forum.
https://anthonycolpo.com/the-junk-science-behind-the-moderna...
It says, among other things..
>Using reasoning that could only make sense to a government bureaucrat or drug company-sponsored researcher, it was decided no Phase 2 trials were necessary for a drug that had just been shown to cause local and systemic side effects in the vast majority of healthy subjects who took it.
Just read the bit you quote and try to wrap your head around it: according to him the vast majority of the recipients of the mRNA vaccine had local and systemic side effects, except of course that that never happened...
I'll say this again: there is no evidence that will convince you, but every bit of evidence that confirms your preferred position, no matter how far fetched is taken as gospel.
Can you show me conclusive evidence that phase 2 trials for these vaccines have NOT been skipped?
I have looked and couldn't find it.
Look at it this way: whatever size a phase 2 trial would have been it would have delayed the deployment and that would have cost 100's of thousands, quite possibly millions more dead and many tens of millions if not hundreds of millions more people infected. The chance that something major would not surface in the vaccinated population so far that would have surfaced in a phase 2 trial is nil, because the number of people that have now been vaccinated is orders of magnitude larger than the largest ever phase 2 trial.
You do a phase 2 trial when:
(1) you have serious concerns about possible side effects
(2) you have serious concerns about efficiacy
(3) there is no pandemic going on
(4) you want to market your product
The people that made the call to skip the phase 2 trial were experts in their field and apparently decided that (1) was a possibility so they decided to monitor the first couple of million vaccinations closely to see if there would be side effects and whenever those occurred they halted vaccinations until they found out what was up and whether or not there was a way to proceed or to call the whole thing off. AZ in particular ended up being banned for several applications due to an abundance of caution leading to the destruction of a large number of otherwise viable vaccines (and some got donated to countries with less stringent criteria).
(2) never was in doubt, though the exact numbers would only come out after a while and some of the longer term effects in terms of protection and protection against mutations we are only finding out now because some time had to pass for those effects to become apparent.
(3) is obvious, there was a pandemic going on and so every day counted because an exponential process only yields to one thing: fast and mostly accurate decision making, slow and perfect decision making gets you killed every time.
(4) was not much of a problem, regulators and governments alike were begging the companies producing the vaccine to get on with it, because they realized that they had botched their strategy so completely that their only hope was to have a vaccine developed and shipped as fast as possible. Under normal circumstances regulators would have been slower to ensure that all the i's were dotted and all the t's were crossed but in this case they were more than willing to take the -small- risk that a phase 2 trial would have uncovered something really bad that would not come out in the first batch of vaccinations to the general public.
Note that before the general roll-out there had already been a substantial number of people that volunteered to receive the various vaccines and they more than anybody else deserve a lot of credit because they allowed the pharmaceutical companies to compile a mostly complete list of side effects and things to watch for.
> (1) you have serious concerns about possible side effects > (2) you have serious concerns about efficiacy > (3) there is no pandemic going on > (4) you want to market your product
Please provide citation for this claim for the list of pre-conditions for phase 2 trials.
>so they decided to monitor the first couple of million vaccinations closely
Where is this data? Is it publicly available, and was it based on voluntary reporting?
>because the number of people that have now been vaccinated is orders of magnitude larger than the largest ever phase 2 trial.
I see this flawed logic getting thrown around, again, and again, and again. I don't think that "number of people vaccinated" does not without a control group where no one is following up and based on voluntary reporting is substitute of a clinical trial.
Why do you think such observational data is sufficient, when all the health agencies have rejected such observational results when it comes to things like Ivermectin?
So again, two questions. Citations for the pre-conditions and data from the initial couple of million vaccinations?
Because they were falsified. Ok, I'm done with you, you are in the position of having walked into the hard science department looking for confirmation for your pet conspiracy theories, it isn't going to happen so please stop dumping your junk on HN, thank you.