More vaccine drama
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So two weeks ago it seems like the administrations plan was to give pre-eleciton approval to the Oxford/AZ vaccine. It seems like a reasonable contender for safety, since it's using a well proven approach (not to mention the Russians stole it and are dosing lots of people with it).
The problem is they didn't even register a P3 trial in the US until late August.
So now the administration is looking at two other vaccines for pre-election approval. Moderna and Pfizer. Both are messenger RNA vaccines, a technology that's never been used before.
Note that a pre-election approval date seems to be the constant here, only the vaccines they're looking at have changed.
There's a committee that approves vaccines, called the Vaccines and Related Biological Products Advisory Committee, or VRBPAC. They have a meeting scheduled for the 22nd of October, but no applications for approval are on the agenda.
I looked at the membership of that committee, the newest members all started 2/1/20, so we can assume they're actual scientists, not political sycophants. I doubt they share the Whitehouse's imperative of late October approval when safety considerations would demand another month or two of time.
Dr Peter Marks runs the biologics division of the FDA, which is where vaccines are approved (a different division than the 'drug' approval side of the FDA). He has said he'll resign if the politics trumps the science in this. (He's a serious guy, my foundation has dealt with him directly since our main treatment is a plasma based product.)
Nevertheless, Trump's appointee at the FDA can overrule him and the committee, and the political head of HHS can overrule the FDA completely.
Its worth noting that literally everybody is in favor of early approval. The actual P3 trials for Moderna don't conclude until late 2022. Not a typo. The study protocol continues for 2 years.
But earlier in the summer, or maybe late spring, the FDA came out with minimum guidelines for covid vaccine approval. They defined a relatively low bar on efficacy (50%, with lower bound on the confidence interval being 30%) in order to speed up the trial. (it takes time for the control group to get enough infections to establish robust efficacy statistics).
On the safety side, there was less of a compromise. I think none at all. They require the companies to monitor 'serious and medically attended adverse effects' for 6 months past dosing. Potentially more if it's a novel vaccine platform, say messenger RNA which has never been tried before
It is on this basis that Fauci and others have said early 2021 for emergency approval. The P3 trials of the major contenders got up and running in July or so.
Note that you can speed up efficacy testing by increasing the number of people dosed. If you dosed enough people, you could have efficacy results in a month.
But you can't throw bodies at safety results, any more than 3 pregnant women can produce a baby in 3 months. It might simply take time for adverse reactions to appear.
So, will Trump force a pre-election approval before the safety data are in?
And what if he does? We've already seen polling data about wariness towards the vaccine. How would this effect it?
In previous surveys, people on the left were more open to the vaccine than people on the right. Surely Trump overruling scientists who then resign would cause a rethink on the left. Would people on the right who are more skeptical become less so?
If you zoom out far enough, true vaccine efficacy - creating herd immunity - is really the product of two numbers: the technical efficacy of the vaccine and people's confidence in it - i.e. the percentage of people who are willing to take it.
How much damage is he willing to do to that confidence number for a pre-election 'victory'? Will he even take the time to understand the tradeoff?
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@jon-nyc said in More vaccine drama:
Trump overruling scientists who then resign
I can't quite believe this is even open as a possibility.
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Given all the attempts to undo and dislodge Trump by Schiff and the daily MSM attacks it is hard to know if delays are part of that strategy. What was done to Trump is unprecedented in my lifetime. There is no paper of record anymore and no more objective news.
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@Loki said in More vaccine drama:
Given all the attempts to undo and dislodge Trump by Schiff and the daily MSM attacks it is hard to know if delays are part of that strategy. What was done to Trump is unprecedented in my lifetime. There is no paper of record anymore and no more objective news.
I don't imagine the fact that nobody reputable in the world has finished testing a vaccine is an attempt to undermine Donald Trump. Other countries actually have more important things to worry about.
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@Doctor-Phibes said in More vaccine drama:
@Loki said in More vaccine drama:
Given all the attempts to undo and dislodge Trump by Schiff and the daily MSM attacks it is hard to know if delays are part of that strategy. What was done to Trump is unprecedented in my lifetime. There is no paper of record anymore and no more objective news.
I don't imagine the fact that nobody reputable in the world has finished testing a vaccine is an attempt to undermine Donald Trump. Other countries actually have more important things to worry about.
If other countries weren’t releasing a vaccine I would say your point is dead on.
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From a planning purpose at this moment it seems like the vaccines are moving faster rather than slower. I suspect a bad finding not contemplated will be the thing that has it delay post election.
Those who privately want a delay for election reasons should be prepared for that eventuality.
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If, for example, the UK releases a vaccine, and it takes the US another few months, then it's going to look pretty bad.
Releasing it after Russia doesn't look bad. They stole it from the UK, anyway, and didn't test.
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If you are old you would want a vaccine ASAP. Think of all the potential spared lives in nursing homes. It’s not like the vaccine is going to hurt them years later.
I know I would get one today just to safely get on a plane and get on with my life. I’m quite sure I am not alone.
He’ll make it optional at your own risk until whatever hoop you want to go through.
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The phrase 'What could possibly go wrong?' springs to mind.
I'd kind of like somebody semi-reputable to have tested it, other than Vladimir Putin's daughter and Donald Trump's hairdresser. It wouldn't have to be the FDA.
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@Doctor-Phibes said in More vaccine drama:
The phrase 'What could possibly go wrong?' springs to mind.
I'd kind of like somebody semi-reputable to have tested it, other than Vladimir Putin's daughter and Donald Trump's hairdresser. It wouldn't have to be the FDA.
I’m sincerely not worried, more worried it would be ineffective. Nothing is more scary than an economy where no one goes to work. We will be paying for this for a generation.
Watch the narrative change after the election. Vaccine right away!! I can’t wait truth to come out.
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And what if in 9 months time a bunch of kids are born with serious birth defects?
That could never happen, right?
Proud supporter of Plan 2525. Everything you think, do and say will be in the pill you took today.
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@Doctor-Phibes said in More vaccine drama:
And what if in 9 months time a bunch of kids are born with serious birth defects?
That could never happen, right?
If the roll-out is done with the highest risk people, I don't think a lot of birth defects would be a primary concern.
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@jon-nyc said in More vaccine drama:
Loki you are sidestepping the obvious problem that will occur if he is seen overruling the scientists for some marginal political gain. That will destroy a great deal of confidence in the vaccine and set herd immunity and recovery back significantly.
It could also give a huge boost to the rest of the anti-vax brigade, which is the last thing we need.
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Just think of it as the largest P3 trial ever!
Winning!
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Yeah if we approve before safety data AND it turns out to be unsafe then there will be lasting damage well beyond Covid.
Heretofore I’ve been talking about the damage arising just from having the safety timelines shortened for an election, even assuming it ends up safe.
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It all comes down to the number and type of nanobots Gates uses.
