5 ms·

An interesting, short read is the difference between Emergency Use Authorization (EUA) and the full FDA approval[0]. Basically it is manufacturing, funding and

by matt_s 5y ago

An interesting, short read is the difference between Emergency Use Authorization (EUA) and the full FDA approval[0]. Basically it is manufacturing, funding and red tape being the difference, nothing about safety or clinical trials differs. In software terms, EUA is parallel tracked sprints for clinical trials and manufacturing at same time vs. regular approval is Waterfall where manufacturing occurs after approval. [0] https://healthtalk.unchealthcare.org/whats-the-difference-between-fda-emergency-use-authorization-and-fda-approval/ https://healthtalk.unchealthcare.org/whats-the-difference-be...

vlovich123 5y ago
Why isn’t the EUA process the default then? It sounds like manufacturing being after approval would just be a cost thing producers could figure out without needing the FDA involved…? Edit: also why is there such a large lag between EUA and full FDA approval? That flow chart seems misleading.
- ceejayoz 5y ago
  Vaccines are pretty low margin. Jumping straight to production for a vaccine that winds up not approved would prove pretty expensive, and most of them aren't an emergency scenario that would justify that risk.
  - vlovich123 5y ago
    You've answered why the government guaranteed purchases of the vaccine & why production was parallelized. That doesn't answer the question why this changes the FDA authorization flow because in the flow chart EUA & full approval happen at roughly the same time & the claim is they have the same safety requirements profile (i.e. I am free to burn money & produce something someone doesn't buy - why would the FDA be involved). Said another way, what was the extra steps that needed to happen between EUA & full approval?
- icegreentea2 5y ago
  EUA can be applied to many different product categories including diagnostics (basically every single PCR and antigen test in the US up to very recently was initially released under EUA), therapeutics (for example the FDA granted an EUA on chloroquine for threatment of COVID), other medical devices (for example PPE) and vaccines. The EUA rules for each category is different in how they differ from the categories baseline. For vaccines the gulf between EUA and full process was relatively small - the clinical dataset was basically equivalent. I found this article to be a better summary of the differences between EUA and BLA (https://blog.petrieflom.law.harvard.edu/2021/06/15/whats-the-difference-between-vaccine-approval-bla-and-authorization-eua/ https://blog.petrieflom.law.harvard.edu/2021/06/15/whats-the...). I think you are right - the diagram from the OP is somewhat misleading. There is absolutely nothing stopping a company from manufacturing whatever they want before they get a BLA - they just can't market it. In real terms, it looks like the two big time savers was reducing long-term effects follow up from 6 months to 2 months, and well as probably an abbreviated review of manufacturing processes.
  - vlovich123 5y ago
    > In real terms, it looks like the two big time savers was reducing long-term effects follow up from 6 months to 2 months, and well as probably an abbreviated review of manufacturing processes. That's plausible. Thanks!
colinmorelli 5y ago
This flow chart is not quite accurate, or at least is misleading. There is more to a distinction between EUA and full FDA approval than where manufacturing happens. The FDA's own website[0] says: > The EUA process is different than an FDA approval or clearance. Under an EUA, in an emergency, the FDA makes a product available to the public based on the best available evidence, without waiting for all the evidence that would be needed for FDA approval or clearance. I don't post this to spread doubt about the EUA and am fully confident in the safety and efficacy of these vaccines. But as written, this website would seem to suggest that the only difference is when production happens - which is not accurate. [0] https://www.fda.gov/consumers/consumer-updates/understanding-regulatory-terminology-potential-preventions-and-treatments-covid-19 https://www.fda.gov/consumers/consumer-updates/understanding...
- matt_s 5y ago
  I'm sure there are more and very detailed differences, like if the evidence leads to an unsafe vaccine that there are different processes. I think the major talking point is covered by this info, which is meant for the general public. I'll make an assumption that the general public is also less educated on average than the users on HN on average. A flowchart that would satisfy a bunch of nerdy engineers (us HN users) with all possible paths would confuse the heck out of everyone else.
ericcholis 5y ago
One of the anti-vaxx or vaxx hesitant arguments is that Pharma can't be sued for damages under EUA. I'm honestly not sure how true that is precisely.
- gambler 5y ago
  https://www.phe.gov/Preparedness/legal/prepact/Pages/default.aspx https://www.phe.gov/Preparedness/legal/prepact/Pages/default... https://www.federalregister.gov/documents/2020/03/17/2020-05484/declaration-under-the-public-readiness-and-emergency-preparedness-act-for-medical-countermeasures https://www.federalregister.gov/documents/2020/03/17/2020-05... The Secretary must also state that liability protections available under the PREP Act are in effect with respect to the Recommended Activities. These liability protections provide that, “[s]ubject to other provisions of [the PREP Act], a covered person shall be immune from suit and liability under federal and state law with respect to all claims for loss caused by, arising out of, relating to, or resulting from the administration to or use by an individual of a covered countermeasure if a Declaration has been issued with respect to such countermeasure.” ... The PREP Act states that a “Covered Countermeasure” must be a “qualified pandemic or epidemic product,” or a “security countermeasure,” as described immediately below; or a drug, biological product or device authorized for emergency use in accordance with Sections 564, 564A, or 564B of the FD&C Act.
- cies 5y ago
  FDA approved or not, they cannot be sued for vaccine drama. https://www.cnbc.com/2020/12/16/covid-vaccine-side-effects-compensation-lawsuit.html https://www.cnbc.com/2020/12/16/covid-vaccine-side-effects-c... Claims can only go by "vaccine court" (yes that's a thing according to Wikipedia)... https://en.wikipedia.org/wiki/National_Vaccine_Injury_Compensation_Program https://en.wikipedia.org/wiki/National_Vaccine_Injury_Compen...
  - nextaccountic 5y ago
    From that Wikipedia article, pharma companies paid a total of 2.5 billions in damages from 2006 to 2020. Seems hard to say that they can't be sued, it's just a different court system.

by matt_s 5y ago

vlovich123 5y ago

Why isn’t the EUA process the default then? It sounds like manufacturing being after approval would just be a cost thing producers could figure out without needing the FDA involved…? Edit: also why is there such a large lag between EUA and full FDA approval? That flow chart seems misleading.

ceejayoz 5y ago
Vaccines are pretty low margin. Jumping straight to production for a vaccine that winds up not approved would prove pretty expensive, and most of them aren't an emergency scenario that would justify that risk.
- vlovich123 5y ago
  You've answered why the government guaranteed purchases of the vaccine & why production was parallelized. That doesn't answer the question why this changes the FDA authorization flow because in the flow chart EUA & full approval happen at roughly the same time & the claim is they have the same safety requirements profile (i.e. I am free to burn money & produce something someone doesn't buy - why would the FDA be involved). Said another way, what was the extra steps that needed to happen between EUA & full approval?
icegreentea2 5y ago
EUA can be applied to many different product categories including diagnostics (basically every single PCR and antigen test in the US up to very recently was initially released under EUA), therapeutics (for example the FDA granted an EUA on chloroquine for threatment of COVID), other medical devices (for example PPE) and vaccines. The EUA rules for each category is different in how they differ from the categories baseline. For vaccines the gulf between EUA and full process was relatively small - the clinical dataset was basically equivalent. I found this article to be a better summary of the differences between EUA and BLA (https://blog.petrieflom.law.harvard.edu/2021/06/15/whats-the-difference-between-vaccine-approval-bla-and-authorization-eua/ https://blog.petrieflom.law.harvard.edu/2021/06/15/whats-the...). I think you are right - the diagram from the OP is somewhat misleading. There is absolutely nothing stopping a company from manufacturing whatever they want before they get a BLA - they just can't market it. In real terms, it looks like the two big time savers was reducing long-term effects follow up from 6 months to 2 months, and well as probably an abbreviated review of manufacturing processes.
- vlovich123 5y ago
  > In real terms, it looks like the two big time savers was reducing long-term effects follow up from 6 months to 2 months, and well as probably an abbreviated review of manufacturing processes. That's plausible. Thanks!

colinmorelli 5y ago

This flow chart is not quite accurate, or at least is misleading. There is more to a distinction between EUA and full FDA approval than where manufacturing happens. The FDA's own website[0] says: > The EUA process is different than an FDA approval or clearance. Under an EUA, in an emergency, the FDA makes a product available to the public based on the best available evidence, without waiting for all the evidence that would be needed for FDA approval or clearance. I don't post this to spread doubt about the EUA and am fully confident in the safety and efficacy of these vaccines. But as written, this website would seem to suggest that the only difference is when production happens - which is not accurate. [0] https://www.fda.gov/consumers/consumer-updates/understanding-regulatory-terminology-potential-preventions-and-treatments-covid-19 https://www.fda.gov/consumers/consumer-updates/understanding...

matt_s 5y ago
I'm sure there are more and very detailed differences, like if the evidence leads to an unsafe vaccine that there are different processes. I think the major talking point is covered by this info, which is meant for the general public. I'll make an assumption that the general public is also less educated on average than the users on HN on average. A flowchart that would satisfy a bunch of nerdy engineers (us HN users) with all possible paths would confuse the heck out of everyone else.

ericcholis 5y ago

One of the anti-vaxx or vaxx hesitant arguments is that Pharma can't be sued for damages under EUA. I'm honestly not sure how true that is precisely.

gambler 5y ago
https://www.phe.gov/Preparedness/legal/prepact/Pages/default.aspx https://www.phe.gov/Preparedness/legal/prepact/Pages/default... https://www.federalregister.gov/documents/2020/03/17/2020-05484/declaration-under-the-public-readiness-and-emergency-preparedness-act-for-medical-countermeasures https://www.federalregister.gov/documents/2020/03/17/2020-05... The Secretary must also state that liability protections available under the PREP Act are in effect with respect to the Recommended Activities. These liability protections provide that, “[s]ubject to other provisions of [the PREP Act], a covered person shall be immune from suit and liability under federal and state law with respect to all claims for loss caused by, arising out of, relating to, or resulting from the administration to or use by an individual of a covered countermeasure if a Declaration has been issued with respect to such countermeasure.” ... The PREP Act states that a “Covered Countermeasure” must be a “qualified pandemic or epidemic product,” or a “security countermeasure,” as described immediately below; or a drug, biological product or device authorized for emergency use in accordance with Sections 564, 564A, or 564B of the FD&C Act.
cies 5y ago
FDA approved or not, they cannot be sued for vaccine drama. https://www.cnbc.com/2020/12/16/covid-vaccine-side-effects-compensation-lawsuit.html https://www.cnbc.com/2020/12/16/covid-vaccine-side-effects-c... Claims can only go by "vaccine court" (yes that's a thing according to Wikipedia)... https://en.wikipedia.org/wiki/National_Vaccine_Injury_Compensation_Program https://en.wikipedia.org/wiki/National_Vaccine_Injury_Compen...
- nextaccountic 5y ago
  From that Wikipedia article, pharma companies paid a total of 2.5 billions in damages from 2006 to 2020. Seems hard to say that they can't be sued, it's just a different court system.