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by djsumdog 2004 days ago
There were human trials, but they skipped Longitudinal trials (long term effects) and they also didn't do challenge responses (exposing those people with the vaccine to COVID in a controlled manner), correct?
2 comments

Challenge trials aren't something that is normally done since they are considered high risk and of questionable morality
I find it fascinating how we submit batteries of tests to code as software engineers. Yet when it comes to our own health as a species, the rigor suddenly falls.
I regularly test programs by feeding them garbage to see if they'll die but I don't think that would pass by the ethics board in medicine
It'd be fine back when Jenner created the first vaccine over 185 years ago. There were no ethics boards back then. A lot of people died from snake oil treatments too.
It's not lack of rigor, it's ethics. We don't want to intentionally expose people to something that might kill them. Instead, we perform a trial on a large group and allow them to naturally avoid or be exposed to the virus as they will. Then, with full mathematical and statistical rigor (the best kind of rigor) we determine whether the vaccine has a demonstrated benefit.
We test code. We don't do destructive code tests in production.

Normal vaccine trials is like normal software testing. Challenge testing is like running dangerous tests in production. Its faster at detecting a problem than normal tests, but ultimately not needed and can blow up badly. The argument for doing it during covid is that time was of the essence and its faster than normal testing procedures. Instead we opted for the safer slower normal testing procedure.

They didn't just decide to "skip" long term effect studies. Long term effects can be studied only over a long term. No one wants to wait five or more years with the world in disarray.
So, they intentionally decided not to do longitudinal studies before releasing the drug. You can dress it up, but it's still skipping them.
Do longitudinal studies ever happen before a vaccine is released? Every longitudinal study I can find uses data from after a vaccine has been released to the general public. Stage 4 studies happen after the vaccine is in use by the general public.

“Even after the vaccine is approved and licensed, regulatory agencies stay involved, continuing to monitor production; inspecting manufacturing facilities; and testing vaccines for potency, safety and purity.

The FDA also monitors adverse events that may occur related to receiving the vaccine, including through its Vaccine Adverse Event Reporting System and Phase 4 clinical trials—optional studies pharmaceutical companies may be required to perform after a vaccine is licensed to continue to monitor safety and effectiveness.” [0]

[0] https://www.jnj.com/innovation/the-5-stages-of-covid-19-vacc...