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You make this statement: "The most important thing to note is that such a virus would not be a vaccine from a regulatory perspective." Can you provide any evid

by new299 7y ago

You make this statement: "The most important thing to note is that such a virus would not be a vaccine from a regulatory perspective." Can you provide any evidence to back up this statement? If you were to start intentionally infecting people with a (naturally) attenuated strain claiming that it will confer immunity I suspect authorities would request you get regulatory approval. If you're approach does require regulatory approval. What advantage does your approach have over those currently in developement? Some of them are just bits of the virus (mRNA that codes for the spike protein) packaged with a delivery mechanism [1]. It's a plausible approach, that has been tested in animal studies. There are a number of other, similarly plausible vaccines entering human trials. It is however deemed to be too high risk to just start giving the vaccine to large numbers of people. So the vaccine will have to go through (an accelerated) trial process. It will then likely be given to at risk groups (health care professionals), before becoming widely available. Most experts expect this to take at least 16 months (which would be a world record). Your approach would have the same issues as are present with any other vaccine. If regulatory authorities are willing to skip trials for your approach, then the same should apply to other vaccines under development. [1] https://www.modernatx.com/modernas-work-potential-vaccine-against-covid-19 https://www.modernatx.com/modernas-work-potential-vaccine-ag...

danieltillett 7y ago
You are looking at this from the wrong perspective. If people start spreading this attenuated strain around on their own what are the regulatory agencies going to do? Even if you wanted to go down the regulatory pathway for some reason it still has a number of advantages over other approaches. 1. We would know it is safe in humans before we began. 2. We would know what mutations make the virus less pathogenic. 3. Once used it would drive the pathogenic strains to extinction. 4. It will be work in poor countries that can’t afford or distribute a conventional vaccine. 5. It will infect and protect those that are not deliberately infected through contact with others.
- 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.

by new299 7y ago

danieltillett 7y ago

You are looking at this from the wrong perspective. If people start spreading this attenuated strain around on their own what are the regulatory agencies going to do? Even if you wanted to go down the regulatory pathway for some reason it still has a number of advantages over other approaches. 1. We would know it is safe in humans before we began. 2. We would know what mutations make the virus less pathogenic. 3. Once used it would drive the pathogenic strains to extinction. 4. It will be work in poor countries that can’t afford or distribute a conventional vaccine. 5. It will infect and protect those that are not deliberately infected through contact with others.

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.