[waiseristy]

I haven't yet seen anyone mention this, but will BioNTech's / Modernas mRNA vaccine need to go through phase 1-3 trials when encoding for other proteins?

The greatest advancement with mRNA is that you can have a vaccine in under a month. But that doesn't help if for each new mRNA encoding you need 9 months worth of health & safety trials.

[jounker]

Of course they will. The issue is with the things the mRNA codes for, and not with the mRNA.

[pg_bot]

Yes, they will have to go through health and safety trials for each additional vaccine developed using this technology. No one gets special treatment when it comes to FDA approval, and this is the way it should be.

You can get fast tracked if you show superior effectiveness, meet an unmet medical need, or get rid of serious side effects of an existing therapy. We should look at ways to speed up this process, (in the grand scheme of things 9 months isn't that long to wait to cure a disease) not eliminate it altogether. If we approved something that actually does harm, it will further undermine efforts to widely vaccinate the public. We already have issues with people trusting vaccines when there is no evidence of negative effects, I can't imagine how hard it would be if we had another thalidomide on our hands.

[a-dub]

> Yes, they will have to go through health and safety trials for each additional vaccine developed using this technology. No one gets special treatment when it comes to FDA approval, and this is the way it should be.

true, but there are loopholes. the 510(k) loophole for medical devices where any device that is "substantially equivalent" to an existing approved device can get fast track approval has proved problematic. this has been publicly documented both in the press and in independent documentaries for some time.

https://www.fda.gov/medical-devices/premarket-submissions/pr...

[usrusr]

How are the flu vaccines doing this? Nature forces them to have an update cycle reminiscent of the fashion industry.

[dr_faustus]

The have to go through an approval process on every update but AFAICR only with a study including 300 adults, so substantially less then the tens of thousands that were included in the Biontec/Moderna trails.

[usrusr]

Thanks. So they only test for lack of side effects, not for effectivity (outside of leech dish experiments), because with just 300 it would take decades to see a meaningful delta? (unless they do challenge tests?)

[waiseristy]

You think the mRNA vaccines with minimal changes be treated similarly? e.g one years flu cocktail, vs the next?

[pg_bot]

Planning, prediction, and coordination.

https://www.cdc.gov/flu/prevent/vaccine-selection.htm#:~:tex....

[usrusr]

That's talking about selection for production, not about development. How is development not part of three scope at all? Are they only selecting amongst a pre-developed library? Do they have a reusable process that goes from strain to vaccine and "just works"? The latter would be very similar to a liberal approach like "we got delivery mechanism for mRNA blueprint of spike protein X approved, we can use the same approval for spike protein Y".

[pg_bot]

Here are some links that provide more information on how we make and regulate the flu vaccine.

https://www.cdc.gov/flu/prevent/how-fluvaccine-made.htm

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4947948/#irv123...

[okl]

As I've understood, (correct me if I'm wrong) one of the main concerns is that you end up with a protein that interferes with other functions of the body in unexpected ways. So I guess it would be prudent to go through phase 1-3 trials again.

[ghc]

Yes. BioNTech are already into phase 1s and phase 2s with several others. My wife works on one of the programs targeting cancer, which has years of development and trials behind it.

[okr]

Good luck. A relative of mine also goes through immune therapy instead of chemo.