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.
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.
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.
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.
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.
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.
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.
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.
> 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.
Have you had experience with dealing with said regulatory agencies?
Unfortunately yes and they normally move at a glacial pace and demand 100% certainty about everything. I do have faith that they are capable of moving faster when the need is as urgent as the need right now.
Daniel, can you please elaborate on this: "Unregulated spread by individuals is a solution" ? How do you envision it ? Virus is not an open source software, you cannot just "make your own copy" without a physical contact. :)
It is ‘a’ solution, but in my opinion not a good one. There are a number of ways this could happen, the easiest is just to send people to the area where it was first found and look for people infected. It is technically very easy to test any sample to make sure it is the right strain.
Even if you can’t get the strain it would not be technically very complex to recreate the virus from scratch once you know what deletion you need.
A modification of the standard RT-PCR tests can be used to identify if someone has the correct strain. This really is just a matter of making a different set of primers.
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-ag...