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by tremon 1660 days ago
The regulator is only tasked with approving the manufacturer's end results, I don't think they audit the production facilities or the design process. If the production process were fully transparent and the manufacturer could prove it didn't change anything except for "this one input tweak here", the approval process could likely be further streamlined -- but I don't think the authority of the regulator stretches that far, and manufacturers will likely claim trade secrets on their internal processes.

Besides, I don't expect the anti-vax crowd to be very forgiving about mistakes or unforeseen consequences of an updated vaccine. I'm perfectly happy with the regulator having very strict controls for what gets approved for rapid rollout to the entire population.

2 comments

FDA absolutely reviews stated design processes and audits against these. See 21CFR211 - The perspective here is that even if we are actually pretty confident that it is just "one little tweak here", a one-letter change could have wide ranging affects when interacting with the human body.
If all you want is transparency, most governments are perfectly capable of demanding it.