The paused trial involves a vaccine which uses a modified adenovirus.
The Moderna and Pfizer trials use mRNA vaccines. These are in phase 3 trials and might have sufficient data by late October to submit for an EUA approval. The FDA has set an October 22 meeting to discuss vaccine progress.
There are several other vaccines in development too.
It depends what the issue is, and no details have been released. Maybe this vaccine trial will start up again after an investigation. Maybe it’s antibody enhanced problems. (I forget the real name) and it bodes badly for any vaccine. This could really mean almost anything.
I wonder whether singers (and other people who have been trained to project their voices) are more likely to spread particles than most people? I know Tom Scud and I, who are both choir geeks of long standing, don’t seem to have a problem making ourselves heard through masks, but my mom seems not to know how to speak up so we can actually hear her, even just a few feet away. Does that phenomenon extend to projecting other things from our lungs?
I wonder whether corticosteroids are part of the reason that my dad, in spite of being a 79-year-old asthmatic, never had any symptoms although prior infection was confirmed by antibody testing? He has been on daily asthma medication basically forever (I’m not sure exactly what drug). In any case, I’m glad he is alive!
From the BBC article:
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My despair is approaching a limit where I am considering prayer.
“To Whom it may concern…”?
Isn’t this part of the reason why expecting a properly tested vaccine before November is implausible?
Doing the testing properly, on a large enough population to check for relavely uncommon negative results, is going to take significant time partly because of the need for such pauses. Even when the illnesses turn out to not be related, or possibly to be so rare that the vaccine’s still worth using, it still takes time to investigate.
I’m not sure how these trials work. Are we still in a phase where only a small number of subjects have been immunized, and this will delay an upcoming phase where a much larger number of subjects are to be immunized?
Because if a large number of subjects have already been immunized for the current phase, this “pause” doesn’t imply any ultimate delay. It means no new immunizations until we know what happened, but we will still get the same data in the same timeframe from all the subjects who have already been immunized.
Well, that’s from the article, not from me personally; but yes, one of the reasons it would seem. I’m not familiar with the detail of how Phase III vaccine trials are run, but for a regular medicine (that you give to someone who’s sick) I wouldn’t expect a trial to be paused for a single serious adverse reaction. But vaccine trials are different - you’re giving a drug to someone who’s well (to prevent them from getting sick, which they might or might not so) - so that’s one thing. Also (I’m oversimplifying here) generally in a trial of a regular medicine, there’s a major issue about stopping someone’s treatment (to pause a trial); if you’ve already had the vaccine, no such issue. For a vaccine trial, “pause” means pause in recruitment of subjects, I presume.
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Los Angeles has cancelled Halloween.
One thing I don’t understand about these trials.
It seems to me only healthy people will volunteer for the trials. Not people who aren’t. But it’s the unhealthy people who might experience the most severe complications from the vaccine. Should people the people most at risk for COVID19 mortality wait a while before taking a vaccine? That would seem prudent, but I don’t know if that’s the strategy. I keep hearing how at-risk populations will be prioritized for the vaccine once it hits the market.
Apparently it isn’t just that “only healthy people will volunteer for the trials” - apparently only healthy people are accepted. Astra Zeneca’s information, for example:
(Bolding mine.)
But still the trade off may be worthwhile for the highest risk: less direct evidence of efficacy and safety but greater potential benefit.
Of course. But if we get a vaccine, the messaging will have to be a tad more convincing than that if we expect the general population (many of whom have “significant diseases, disorders, or findings”) to get on board.
Jesus himself could vouch for the COVID vaccine, and I don’t think someone like my mother would trust it. So I know she’s not going to trust it if it comes with a big disclaimer. I’m not afraid to lecture her when I think she’s being hyper paranoid, but I wouldn’t know what to say to her about this.
When you’re doing a clinical trial, you want subject with the fewest variables. This gets you cleaner results, but also accounts for why “efficacy” (in the trial) is typically better than “effectiveness” (in the community).
You want matched populations in both arms. That doesn’t necessarily mean fewer variables. Testing only in white males 18 to 40 would be few variables … but of not great value.
Not including those who should be targeted for use of the vaccine first and foremost in the trials? Instead testing it in the population most likely to have a stronger response and one suspects lower risk of adverse events? It gets cleaner data but not as useful of data, for either efficacy or side effect rates in those who need the vaccine the most.
Wouldn’t including people who aren’t healthy be a matter for later trials?
First, you try it on a few healthy adult volunteers, to make sure it doesn’t do outright serious damage to most people.
Then, you try it on a lot more healthy adult volunteers, to find out whether it does any good, and whether it causes significant amounts of less frequent side effects in healthy people.
After that, you try it on children, pregnant women, and people who aren’t healthy. Why do that before you find out whether it damages even the healthy? And children can’t really volunteer; but it’s a good idea to do trials with them eventually, instead of just giving it to all children as soon as you give it to any.
I have the uneasy feeling that they’re going to skip step 3; in addition to possibly rushing step 2.
Nope.
This is the phase 3 trial. 20,000 in the vaccine arm and 10,000 in the control arm. The phase three that might not be completed before approval.
They don’t do any more adult trials after this. They do “post marketing surveillance”.
So… if this is already phase 3, and they have already inoculated the 30,000 subjects, what does a “pause” mean? What are they pausing, and how will this slow anything down?
Phase 3 completed will have inoculated 30,000 subjects. No idea how many they have inoculated to date but it was just launched September 1. “Pause” means no more added right now. Maybe not too many yet … at least not in the U.S.
Are you saying that they are going to have no trials done on children, elderly, diabetics, etc. before they start supplying it to the general public?