Well generally registration trials are not powered to safety endpoints, they are powered to clinical efficacy endpoints. From a safety perspective, the multi-phase clinical trial system is good at generating safety signals and detecting common adverse events, but is really not built to detect serious side effects that may not be as common or are clouded by background noise. I am speaking more generally than vax trials, but the same principles apply. Many people do not appreciate that there are actually four phases to drug development and approval. It does not stop at phase III with an initial approval. Phase IV is post-marketing research. It is not uncommon at all for the FDA to approval a drug conditional on certain post-marketing commitments. These commitments may involve observational studies, registries, or other studies intended to evaluate the relationship between drug exposure and very common events such as AMI or stroke, neoplasms, etc. or any variety of various serious but rare adverse events. These PMR studies can often take many years to complete after the drug is released to the market. Only then do we really have a comprehensive understanding of the safety profile. I am not as familiar with how things work on the vax side, but same general limitations of the registration process apply.
So with that general perspective, that's why I think that this is a bad setup for a safety issue. We are compressing a vax development process that typically takes 5, 10, 15+ years into 5, 10, 15+ months. Protocol are being rushed, some of the companies really do not have the expertise for this (looking at you MRNA), and there is overwhelming pressure to ramp production and roll out in mass. Layer in that we have some really neat, but novel mechanisms of action here using viral vectors to deliver viral material, DNA or RNA injections...things that are basically first in human vaccine types, and it puts me on alert.
It's a fucking pandemic, and a vax appears to be the only way out at the moment. I don't want to stoke a fire needlessly. The vax issue and vax safety is already a toxic topic, and this line of reasoning is not intended to and should not be used to feed into an antivax narrative. So we will do what we need to do, but let's be clear eyed about it, and ensure that we have the proper surveillance systems in place to be able to quickly detect safety events when we start lining up 300MM+ people for shots. This will be an unprecedented vaccination effort and should be treated as such. That's the bottom line for me.