It's a moving target, so it's hard to say. Phase 3 trials depend entirely on the number of infected in the control group. Current estimates seem to indicate we may start seeing preliminary results in early Q4 with vaccines on target for an early 2021 date for implementation. These are the most aggressive schedules of course. Few are giving conservatives estimates right now, but I've seen June floated for more reasonable timelines.
The virus is pretty bad, right? Ought we be making a cost-benefit analysis where we compare the risks of side effects from the vaccine to the risks of the spread of the virus? In comparison to a vaccine like Gardisil, which surely prevents far fewer deaths than a covid-19 vaccine will, wouldn’t such an analysis actually indicate that the trials be rushed to some extent?
I’m feeling anxious that the current political milieu has a few factors pushing against deployment of a vaccine:
1. Republicans have been downplaying the virus the whole time, so they don’t take the need for a vaccine seriously.
2. Democrats are justifiably afraid of Trump pushing out a vaccine to get a pre-election “win”.
What I’m worried about:
1. Huge numbers of people dying every day from covid-19, with so many people out of work and struggling, with no end in sight other than a vaccine.
What’s the worst-case scenario for undiscovered side-effects on a treatment that has already been tested on thousands of people for months, and how probable is that risk?
Covid isn't that bad when compared to the potential harm that a dangerous vaccine could cause when injected into billions of people. Particularly because deploying the vaccine would not immediately stop all the covid19 damage. Further, deploying a dangerous or innefective vaccine would also cause significant long term damage to public health by fueling doubt in healthcare; particuarly since antivaccers are already a growing public health concern.
If we want to rush the process safely, the way forward is a challenge trial; where we deliberatly expose vaccinated people to the virus to see if they get infected. If you cannot get that experiment passed an ethics review board, you should not be able to get widespread deployment of an untested vaccine passed.
No point shipping a vaccine early if it doesn't actually work. That could do more damage, people thinking it's safe to be around others maskless, when in fact the world population instead received an ineffective vaccine.
This concern can be addressed other ways. I run two subreddits aimed at helping people establish an online income (as part of the goal).
In a post-covid world, I think we will do more good if we focus more on adapting to a new reality where increased germ control is a permanent expectation rather than expecting a vaccine to fix everything and allow us to return to "business as usual."
My impression is that this was done to specifically counter Donald Trump rushing a vaccine prior to the election. I don't think it was really made to give any security beyond that
I wouldn't have thought the companies involved are primarily thinking of that. The risk to the companies is that Trump going on about skipping trials will hurt public confidence in any vaccine that is finally released, even if such skipping never happens. This announcement may serve to reassure some people that the manufacturers are going to behave themselves even if the government is negligent.
Also, probably, reassure some shareholders. The reputational risks involved in this trial-skipping stuff are horrific.
According to FDA, phase III trials typically take 1-4 years.
It's worth noting that, if there are any adverse effects that take a while to become apparent, the trial will need at least that long to be able to detect them. To my knowledge, severe vaccine reactions usually happen fairly soon, but a year before onset isn't necessarily unheard of for some vaccines. Also, that's just for vaccines that got approved; there may be some selection effects there.
The bigger one I'm worried about is whether or not the vaccine will confer lasting immunity. If we rush a vaccine to market in six months, everybody gets it, and returns to their pre-pandemic lifestyles, then we'll be in for a nasty surprise on down the road if it turns out that it only confers immunity for a year. It seems to me like we need to consider the possibility that an imperfect vaccine is worse than no vaccine at all.
If the vaccine only confers a few months of immunity, like the yearly flu vaccine, how long does it take to develop, produce and distribute the update?
You can look up those details on clinicaltrials.gov. They will list the timeline for the primary endpoint. That doesn't include recruitment delays though.
Here are the details for the Oxford/Astrazeneca vaccine.[1] It's a 1 year trial. From what I've seen, they vary in length, but have interim analyses scheduled on a regular basis (3-6 months). If they see a strong signal, they can seek approval based off that interim data.
I heard somewhere that we should be prepared for middle of next year. They don't want politics to influence the safety of it. Releasing a vaccine that would cause damage would be devastating for the company.
I'm wondering how do they test it, do they inject volunteers with the vacine, and they tell them to go infect themselves with a virus that 1 time out of 100 will kill them and an unknown percentage disable them?
> I'm wondering how do they test it, do they inject volunteers with the vacine, and they tell them to go infect themselves with a virus that 1 time out of 100 will kill them and an unknown percentage disable them?
No, and this is why Phase III trials take a long time, potentially a very long time if we actually get a handle on the virus with measures like masking and social distancing.
Here's the protocol:
1. Volunteers get the vaccine (experimental arm) or a placebo (control arm).
2. They go about their lives.
3. Both study arms report any cases of COVID they develop. Also, any deleterious symptom (potential side effects).
4. If the vaccine arm has a statistically significant reduction in infection rates, and/or severity, everyone wins and the study is concluded.
This process can take years if the background rate of infection is low enough.
> I'm wondering how do they test it, do they inject volunteers with the vacine, and they tell them to go infect themselves with a virus that 1 time out of 100 will kill them and an unknown percentage disable them?
Obviously no
They get a large set of people (tens of thousands), half placebo, and then check rates afterwards.
No one will be told to go intentionally infect themselves. There will be no human virus challenge trials in the US as that would obviously never pass a review board. Instead they will vaccinate a study group and then compare infections, symptoms, and deaths versus a control group.
The best estimate of infection fatality rate is 0.65%, not 1%.
>>I don’t feel reassured that those won’t be rushed.
actually I am. Vaccine makers don't gain much by doing something risky (considering the negatives) so they'll check the ones seeking election at all costs.
Well, this is a case of high risks and high rewards. I don't know a lot about business, but I don't find it hard to imagine that there's some companies out there that are willing to take the risk, especially if they have some kind of government agreement that can alleviate their liability.
There is already employer liability protection in the Senate stimulus bill, I wouldn't be surprised to see some sort limited liability clause added for vaccine makers as well.
Also with only 38.9 approval rating of Trumps covid response, and him trailing in the polls I wouldn't be shocked to see him trying to pressure some sort of deliverable around the end of Oct, which is when some of the 3rd phase ends.
EDIT:
From Trump
> "We’re gonna have a vaccine very soon. Maybe even before a special date. You know what date I’m talking about."
deelowe|5 years ago
shajznnckfke|5 years ago
I’m feeling anxious that the current political milieu has a few factors pushing against deployment of a vaccine:
1. Republicans have been downplaying the virus the whole time, so they don’t take the need for a vaccine seriously.
2. Democrats are justifiably afraid of Trump pushing out a vaccine to get a pre-election “win”.
What I’m worried about:
1. Huge numbers of people dying every day from covid-19, with so many people out of work and struggling, with no end in sight other than a vaccine.
What’s the worst-case scenario for undiscovered side-effects on a treatment that has already been tested on thousands of people for months, and how probable is that risk?
gizmo686|5 years ago
If we want to rush the process safely, the way forward is a challenge trial; where we deliberatly expose vaccinated people to the virus to see if they get infected. If you cannot get that experiment passed an ethics review board, you should not be able to get widespread deployment of an untested vaccine passed.
spamizbad|5 years ago
It was rushed by the Ford administration for political reasons and got a lot of people very sick.
JMTQp8lwXL|5 years ago
DoreenMichele|5 years ago
This concern can be addressed other ways. I run two subreddits aimed at helping people establish an online income (as part of the goal).
In a post-covid world, I think we will do more good if we focus more on adapting to a new reality where increased germ control is a permanent expectation rather than expecting a vaccine to fix everything and allow us to return to "business as usual."
marcosdumay|5 years ago
dmarchand90|5 years ago
rsynnott|5 years ago
Also, probably, reassure some shareholders. The reputational risks involved in this trial-skipping stuff are horrific.
saiya-jin|5 years ago
calvinmorrison|5 years ago
mumblemumble|5 years ago
It's worth noting that, if there are any adverse effects that take a while to become apparent, the trial will need at least that long to be able to detect them. To my knowledge, severe vaccine reactions usually happen fairly soon, but a year before onset isn't necessarily unheard of for some vaccines. Also, that's just for vaccines that got approved; there may be some selection effects there.
The bigger one I'm worried about is whether or not the vaccine will confer lasting immunity. If we rush a vaccine to market in six months, everybody gets it, and returns to their pre-pandemic lifestyles, then we'll be in for a nasty surprise on down the road if it turns out that it only confers immunity for a year. It seems to me like we need to consider the possibility that an imperfect vaccine is worse than no vaccine at all.
RangerScience|5 years ago
refurb|5 years ago
Here are the details for the Oxford/Astrazeneca vaccine.[1] It's a 1 year trial. From what I've seen, they vary in length, but have interim analyses scheduled on a regular basis (3-6 months). If they see a strong signal, they can seek approval based off that interim data.
[1]https://clinicaltrials.gov/ct2/show/NCT04536051?term=ChAdOx1...
takeda|5 years ago
I'm wondering how do they test it, do they inject volunteers with the vacine, and they tell them to go infect themselves with a virus that 1 time out of 100 will kill them and an unknown percentage disable them?
loeg|5 years ago
No, and this is why Phase III trials take a long time, potentially a very long time if we actually get a handle on the virus with measures like masking and social distancing.
Here's the protocol:
1. Volunteers get the vaccine (experimental arm) or a placebo (control arm).
2. They go about their lives.
3. Both study arms report any cases of COVID they develop. Also, any deleterious symptom (potential side effects).
4. If the vaccine arm has a statistically significant reduction in infection rates, and/or severity, everyone wins and the study is concluded.
This process can take years if the background rate of infection is low enough.
dmoy|5 years ago
Obviously no
They get a large set of people (tens of thousands), half placebo, and then check rates afterwards.
nradov|5 years ago
The best estimate of infection fatality rate is 0.65%, not 1%.
https://www.cdc.gov/coronavirus/2019-ncov/hcp/planning-scena...
unknown|5 years ago
[deleted]
darkerside|5 years ago
onetimemanytime|5 years ago
actually I am. Vaccine makers don't gain much by doing something risky (considering the negatives) so they'll check the ones seeking election at all costs.
farias0|5 years ago
Jaepa|5 years ago
There is already employer liability protection in the Senate stimulus bill, I wouldn't be surprised to see some sort limited liability clause added for vaccine makers as well.
Also with only 38.9 approval rating of Trumps covid response, and him trailing in the polls I wouldn't be shocked to see him trying to pressure some sort of deliverable around the end of Oct, which is when some of the 3rd phase ends.
EDIT:
From Trump
> "We’re gonna have a vaccine very soon. Maybe even before a special date. You know what date I’m talking about."
Tarq0n|5 years ago
takeda|5 years ago
loeg|5 years ago