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Here Neil DeGrasse Tyson says there was testing and a system in place assuring the safe production of the new vaccines. He addresses people who have claimed there was no testing. That got me curious about the process so I did some research. Looking to fill in some gaps.

Could the new mRNA vaccines have come to market without any testing? I keep hearing claims that the new Covid vaccines weren't tested before being brought to market, and that there's a law eliminating all liability, both criminal and civil, in the emergency situation. Lacking legal incentives to test, Pfizer, Moderna, and the rest did not, so it is claimed. My own research suggests otherwise, perhaps on a technicality, but I'm no lawyer.

Best I can tell, limited liability for vaccine manufacturers comes from the 2005 law PREPA. It still allows for prosecuting "willful misconduct". Am I right to take that to mean criminal liability is still on the table? From what I can tell, an effort is made to rein in what qualifies as "willful misconduct" which could potentially reduce even criminal liability to nothing.

It's also been said that those potentially hurt by an emergency vaccine have no recourse when injured. From what I can tell, they may have no legal recourse but VICP and CICP of The Healthcare Systems Bureau will compensate people. This happens rarely and with a pittance, so arguably doesn't exist.

If there are no legal consequences, what reason would pharmaceutical companies have to conduct clinical trials before going to market? A gesture of good faith?

I can't tell if companies are legally required to test before going to market. Is there a specific law about that?

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    – Dale M
    Commented Jul 8, 2023 at 6:26

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Could the new mRNA vaccines have come to market without any testing?

No.

The FDA still has to approve emergency limited approvals of new vaccines. At least as a practical matter, the FDA requires some testing to grant this approval, although not the full testing regime of a non-emergency application for a new vaccine or drug approval.

FDA approval is the limiting principle that prevents emergency drug approval from being used recklessly despite a lack of civil liability.

I know this from news reports about the COVID vaccine approval process and can't cite chapter and verse of the relevant statutes.

If there are no legal consequences, what reason would pharmaceutical companies have to conduct clinical trials before going to market?

Drug companies have to get FDA approval for every single product they make. If they act in bad faith to get emergency approval, the FDA will not treat them well in the future and could even revoke their authority to manufacture any drugs going forward.

Also, keep in mind that vaccines are not particularly high profit margin products for drug companies.

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    The caveat is that when testing something like a vaccine, you kind of need people exposed to that disease to verify whether it works or not. Nothing creates more test subjects than a global pandemic. The fact that it was highly infectious and everywhere means that you can get the completed clinical trials MUCH faster. I actually doubt COVID vaccines got less testing. Nobody ever talks about the quantity tested; they all just focus on time, and somehow conclude that just because it was so fast, then it must be untested.
    – Nelson
    Commented Jul 7, 2023 at 7:28
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    @Nelson: May have gotten more of some testing and none of others. For example, having a larger population of test subjects doesn't magically enable testing long-term side effects in a short time.
    – Ben Voigt
    Commented Jul 7, 2023 at 14:56
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    @Nelson they could've actually completed the testing in ~3 weeks if they've used a vaccine challenge trial. Unfortunately so-called "bioethicists" shot down that idea, costing tens of thousands of lives worldwide due to slower vaccine rollout. So if anything, it was over-tested rather than under-tested. Commented Jul 7, 2023 at 19:40
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    @BenVoigt: Mind you, AFAICT, no vaccine in history has ever shown evidence of "long term effects"; if you don't have a side-effect within the first two months, and the vaccine has been proven effective against the disease in question (so no amplifying effect on exposure to the actual disease like dengue vaccines potentially have), you're in the clear. These aren't drugs taken regularly where the levels build up over time; you get a handful of shots and the actual vaccine components themselves are eliminated in days, there's simply nothing that can trigger new effects on a meaningful delay. Commented Jul 8, 2023 at 0:24
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    The only reason it can even take two months for side-effects is that's roughly how long it can take for the maximum immune response to build, so a side-effect to the long eliminated vaccine could be some autoimmune condition that was built along with the immunity. The trials took long enough that any common delayed side-effects would definitely be identified, and only the rarest of side-effects (e.g. J&J's clotting) could potentially get missed. Commented Jul 8, 2023 at 0:27
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No. If you plan to sell any pharmaceutical products in the US, you have three choices.

  1. Go through the FDA's New Drug application process.
  2. Sell it without FDA approval, which is a felony. You risk going to jail for a long time and paying a hefty fine.
  3. Give up on the US market altogether. But most significant markets have an equally onerous process.

BTW, the FDA aren't stupid, or willfully obstructive, whatever snake-oil merchants might claim. If urgency is justified, there are mechanisms such as the Orphan Drug Program to expedite development and approval.

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