5 ms·

> What are regulatory agencies going to to do? If you were to start doing this without regulatory approval, the most likely outcomes seems that you’d be arrest

by new299 7y ago

> What are regulatory agencies going to to do? If you were to start doing this without regulatory approval, the most likely outcomes seems that you’d be arrested [1]. Do you have anything that suggests otherwise? > 1. We would know it is safe in humans before we began. The regulatory requirements for “knowing it is safe in humans” are currently quite high. As things stand, I would expect trials to be required. Can you provide any evidence to suggest trials wouldn’t be required? You want to know how the vaccine effects individuals with pre-existing conditions etc. etc. And, as there’s always some risk, you want to be sure that the vaccine is effective. > 2. We would know what mutations make the virus less pathogenic. Large scale sequencing of the virus, in individuals and populations will be interesting. Being able to link this patient outcomes is also interesting. And might help in vaccine development. It would be interesting to have a large dataset of viral sequences from asymptomatic individuals. Can we see clear differences between asymptomatic and symptomatic individuals? This would be an interesting dataset, but I’m not sure that the results would be as clear as “look this deletion exists in a sub-population of asymptomatic individuals”. Would be a cool dataset and an interesting project though. There seems to be a lot of NGS data [2] available. This might be a suitable starting point for such a project. > 4. It will be work in poor countries that can’t afford or distribute a conventional vaccine. If a vaccine is available, then I suspect there will be sufficient international support to make it widely available. Having an active outbreak anywhere in the world would likely be deemed an unacceptable risk, given the potential for further mutation. [1] https://www.theverge.com/2020/3/26/21195236/fbi-doj-arrest-fake-coronavirus-vaccine-cure-covid-19-keith-middlebrook https://www.theverge.com/2020/3/26/21195236/fbi-doj-arrest-f... [2] https://www.ncbi.nlm.nih.gov/genbank/sars-cov-2-seqs/ https://www.ncbi.nlm.nih.gov/genbank/sars-cov-2-seqs/

danieltillett 7y ago
I am not going to be spreading the virus around so why would I be arrested? Actually once a “safe” strain was identified and could be tested for it would be impossible to stop it being spread by individuals on their own to those they know. As we have seen with the whole HCQ fiasco regulations have a habit of getting lowered once there is data, even poor data. If we contact trace everyone who has been infected with the attenuated strain we will get some good data on the safety of the strain. It might not be 100% safe, and we might have some questions, but that is a discussion we can have once we find the strain. We need to make some hard choices here between certainty and action. Waiting for certainty is a choice that carries a very high cost.
- new299 7y ago
  Perhaps I’ve missed something in your argument then. I’d need to understand exactly how you are planning to promote the spread of the attenuated form. If you’re talking about a “sequencing driven” Pox party [1] then I suspect you will run into issues. Particularly if you were to say that the Pox party will infect you with an attenuated form of the virus and vaccinate. Both the diagnostic (sequencing or otherwise) and claim that you are vaccinating individuals would seem like they’d require regulatory approval. But I’d be interested in evidence that suggests this is not the case in a modern context. Overall, it seems like the idea is as dangerous as deploying an untested mRNA vaccine. Because of this, I’d suspect that regulatory or other authorities would get involved. [1] https://en.m.wikipedia.org/wiki/Pox_party https://en.m.wikipedia.org/wiki/Pox_party
  - danieltillett 7y ago
    I am not planning on doing anything other than trying to look for the attenuated strain. How it is used is for others - what I am suggesting is once such a strain is found is it will be impossible to stop people spreading it around on their own.
    - new299 7y ago
      But you do seem to be suggesting that "people spreading it around on their own" is a "solution to Covid-19"? Otherwise, what is your plan for this attenuated strain? Don't get me wrong, I think large scale sequencing or COVID19 is interesting. But think that attempting to spread a attenuated strain without regulatory approval is probably a very bad idea.
      - danieltillett 7y ago
        Unregulated spread by individuals is a solution, just not the one I think would be implemented if such a strain were found. I think it much more likely that the regulatory agency would quickly approve the use of the strain on the basis of the epidemiological data gathered in the process of finding it.

by new299 7y ago

danieltillett 7y ago

I am not going to be spreading the virus around so why would I be arrested? Actually once a “safe” strain was identified and could be tested for it would be impossible to stop it being spread by individuals on their own to those they know. As we have seen with the whole HCQ fiasco regulations have a habit of getting lowered once there is data, even poor data. If we contact trace everyone who has been infected with the attenuated strain we will get some good data on the safety of the strain. It might not be 100% safe, and we might have some questions, but that is a discussion we can have once we find the strain. We need to make some hard choices here between certainty and action. Waiting for certainty is a choice that carries a very high cost.

new299 7y ago
Perhaps I’ve missed something in your argument then. I’d need to understand exactly how you are planning to promote the spread of the attenuated form. If you’re talking about a “sequencing driven” Pox party [1] then I suspect you will run into issues. Particularly if you were to say that the Pox party will infect you with an attenuated form of the virus and vaccinate. Both the diagnostic (sequencing or otherwise) and claim that you are vaccinating individuals would seem like they’d require regulatory approval. But I’d be interested in evidence that suggests this is not the case in a modern context. Overall, it seems like the idea is as dangerous as deploying an untested mRNA vaccine. Because of this, I’d suspect that regulatory or other authorities would get involved. [1] https://en.m.wikipedia.org/wiki/Pox_party https://en.m.wikipedia.org/wiki/Pox_party
- danieltillett 7y ago
  I am not planning on doing anything other than trying to look for the attenuated strain. How it is used is for others - what I am suggesting is once such a strain is found is it will be impossible to stop people spreading it around on their own.
  - new299 7y ago
    But you do seem to be suggesting that "people spreading it around on their own" is a "solution to Covid-19"? Otherwise, what is your plan for this attenuated strain? Don't get me wrong, I think large scale sequencing or COVID19 is interesting. But think that attempting to spread a attenuated strain without regulatory approval is probably a very bad idea.
    - danieltillett 7y ago
      Unregulated spread by individuals is a solution, just not the one I think would be implemented if such a strain were found. I think it much more likely that the regulatory agency would quickly approve the use of the strain on the basis of the epidemiological data gathered in the process of finding it.