I'm tempted to disagree. There are two major problems with the experimental vax:
It must be kept at sub-zero (C) temperatures until just before use. AFAIK there's no way to tell whether this procedure has been followed and it's certain that in some cases the "vax" has been injected after it has started to break down.
The injection should be "aspirated". In other words, you stick the needle in and withdraw the plunger to see if blood appears. If so, you must withdraw the needle and try a different injection site, otherwise you are injecting directly into a vein and the result will be very bad.
In regards to “subzero” temperatures, that is entirely dependent upon the stability of the IND. you usually don’t freeze attenuated viruses anyways, because you’d fucking kill it. Sauce For mRNA, you’re gonna have to rely on the manufacturers’ stability and validation protocols.
They’re shipped cryo temps. They’re refrigerated for up to 30 or so prior/during use or so.
I’ve done vaccine transfer for a small clinical start up before and this was the industry norm
I'm tempted to disagree. There are two major problems with the experimental vax:
It must be kept at sub-zero (C) temperatures until just before use. AFAIK there's no way to tell whether this procedure has been followed and it's certain that in some cases the "vax" has been injected after it has started to break down.
The injection should be "aspirated". In other words, you stick the needle in and withdraw the plunger to see if blood appears. If so, you must withdraw the needle and try a different injection site, otherwise you are injecting directly into a vein and the result will be very bad.
In case you’re disagreeing; https://clinicaltrials.gov/ct2/show/NCT04848584
In regards to “subzero” temperatures, that is entirely dependent upon the stability of the IND. you usually don’t freeze attenuated viruses anyways, because you’d fucking kill it. Sauce For mRNA, you’re gonna have to rely on the manufacturers’ stability and validation protocols.
Also sauce for vax handling: https://www.modernatx.com/covid19vaccine-eua/providers/storage-handling
https://www.cdc.gov/vaccines/covid-19/info-by-product/pfizer/downloads/storage-summary.pdf
They’re shipped cryo temps. They’re refrigerated for up to 30 or so prior/during use or so. I’ve done vaccine transfer for a small clinical start up before and this was the industry norm
You’re disagreeing that the overwhelming majority of RCT’s submitted for FDA review by pharmaceutical companies use placebos? Bold strategy, Cotton.
Your points about aspiration and subzero temps are non-sequitur to placebos being used.