Yes . . . but you need to be cautious about the above, and it is far to blanket a statement.
I have personally seen how what are expectedly "small" changes to a genetic sequence can cause some very un-expected consequences. It is proper, and nothing less should be expected, that EVERY new sequence change to mRNA vaccines be thoroughly tested through clinical trials until there is a far longer established track record than we have currently, like the changes we use for the annual flu vaccine. This is a very new technology, and I 100% guarantee you that we don't know everything about it that we think we do.
mRNA is actually relatively simple. You have code for a protein and code that tells the cell machinery to transport it to the edge of the cell. Every sequence change we're talking about here is a change in the structure of the protein. So if you don't change the structure of the protein to match what's circulating, you're creating a vaccine that won't be as effective. If there were something interesting about the protein itself, you'd be hearing about new and interesting side effects from the virus itself. If you aren't, you can't possibly have new surprises from the vaccine, realistically.
No one here could have predicted that the relatively minor (sometimes single point mutations) that occurred would have changed SARS-CoV-2 from a deadly lower-respiratory pathogen (pneumonia) with high blood-clotting potential to what we see now in Omicron - a pretty mild-by-comparison upper-respiratory infection with an IFR that is rapidly approaching that of seasonal influenza.
Literally nothing in that sentence is correct.
First, every zoonotic virus that sticks around long-term eventually adapts itself to human physiology, and that almost always means getting less serious and more contagious. So pretty much anyone who knows anything about immunology could have predicted that those changes would happen, and did. Could they have predicted which specific mutations would cause that to happen? Maybe not. But the point above still holds — the vaccine produces part of the virus, and if the virus isn't doing something bad, then the vaccine won't, either. And the rest of the vaccine (the delivery part) is very well understood, so further testing is a waste.
Second, there's not really any indication that the blood clotting potential of COVID-19 has diminished. It likely produces fewer clots in the lungs, which means the clots are maybe less likely to be fatal, but that's a very different question.
Third, literally anyone even without a solid understanding of immunology could have told you that when almost everybody in the world has either gotten COVID or been vaccinated, the mortality rate would fall off a cliff. This is not the same thing as saying the virus is less deadly. To COVID-naïve individuals, the risk is likely not significantly less than it was in the delta wave.
Decades ago people building vaccines had some un-justified hubris and thought they could cure about anything with a vaccine. There are some very notable vaccine trials that resulted in many un-necessary deaths and live-long disability, and that happened simply because biological systems are FAR FAR more complex and have unforeseen interplay (biology LOVES to reuse components in seemingly bewildering ways) than any of those researchers could have predicted.
And again, the vaccine produces part of the virus. It would be very nearly impossible for the vaccine to have any effect that the virus doesn't. So from a safety perspective, further testing is useless at this point. The
only reason people are pushing for human testing is to determine whether a vaccine against BA.4/BA.5 is more effective than a vaccine against BA.1 or the prime strain. If they were talking about eliminating the primary series, that might make sense, but as a booster, it's pretty silly.
No, the FDA is spot on in proceeding with caution here.
There's caution, and then there's paranoia. We should be on at least the third or fourth vaccine formulation by now. If they had done that (as very nearly ALL the immunology experts said they should), omicron likely wouldn't even exist now. Instead, their excessive caution led to a dramatically worse outcome for the entire world. So no, the FDA is most certainly NOT "spot on".
