Some people are reporting that the failed Pfizer trial kids 6mo -4yo will show a reduction in symptomatic infections even though the antibody titers failed

Here is why even that data will be problematic 🧵
The first question will be how many of these infections occurred when Omicron was the dominant strain.

Any infection from the prior strain will not be that interesting or pertinent.
The next question will be: how symptomatic were the kids.

The second dose of their vaccine was perfectly timed so that the transient immunity would occur during the Omicron Wave. This also coincided with widespread asymptomatic testing for the holidays
It is possible that this endpoint is being driven solely by positive tests done for holiday travel, and not symptom driven testing.
It is also possible that the transient vaccine effect for Omicron, which fades with time happened to coincide with the December peak and so you will have a spurious short-term benefit. That will be washed out with longer follow-up
The real question is how many severe diseases were averted. It's hard to believe this study will be able to show that endpoint is improved because it has no power for it.
Let's not forget that we're not even talking about the primary endpoint. We're talking about a cherry picked secondary endpoint that occurred due to a lot of overlap of the moon and sun, in an environment where the administration is desperate for a win
Meanwhile, no one is talking about whether or not the risks to kids these age warrant lowering vaccine standards.
It's hard to look at this figure and believe that lower in the standards below. EUA is even appropriate.

If anything, the better argument is whether BLA is needed

Finally, if you believe these results, despite these caveats, you should be actively trying to lower the dose in 5-year-olds who may be getting too much dose: why not run a trial of dose de-escalation in that cohort as the titer is not predictive?

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More from @VPrasadMDMPH

Feb 3
Lots of talk of wearing masks.
The policy question is: what happens when you advise people to:
Wear cloth masks
Wear surgical
Wear n95s

You have to combine mask properties with real world compliance

Ans:
No benefit
11% benefit in setting w no immunity & high bias rct
No trial
The 11% benefit should have an* because there is a serious risk of concealment being revealed in the study due to imbalance and study population by arm
If you pair this imbalance with the idea that people will be slightly less likely to report symptoms if they were enrolled on the margin. You have a big problem
Read 6 tweets
Feb 2
This administration's COVID-19 policy is best summarized by n95 for kids, while nursing home patients are unboosted

We do controversial things on the lowest risk that will make no difference, but poison public sentiment

And we don't do simple things that would save lives

🧵
Here are some controversies:
White House pushes boosters so FDA officials resign
We push boosters down to 12 years old without all appropriate advisory committees
We use Pfizer data so Moderna can be given booster at 5 months
We mandate millions of 20-year-olds get boosted in college or for certain employers even though they are at negligible risk after vaccine, and there is no evidence, booster will further lower their risk of severe outcomes
Read 20 tweets
Feb 1
Last I saw the RCTs in kids at this age failed to meet the modest benchmark of non-inferior antibody titers from 2 doses of 3 micrograms of vax. Pfizer had extended the trial to add a 3rd dose, but the trial is ongoing. What changed? Do we realize how low a bar this is? 🧵
We are going to approve mass vaccination in the USA based on antibody levels-- not fewer severe cases of COVID19. The trial has absolutely no power to ascertain this rare outcome in kids.

But, even that low bar was not met. the trial added a 3rd dose as Ab levels low
So has the trial met the endpoint?
Is this really the evidence we want? Or should we demand more

Our failure was not demanding kids RCT powered for clinical endpoints.
Read 4 tweets
Feb 1
Few thoughts on Rogan/ Spotify 👇👇

1. If Rogan is pushed off Spotify, his influence will actually rapidly grow

Spotify makes it slightly harder to listen to the show. Being independent means he will reach more peopel Clever analysis of this

🧵
theverge.com/22632213/joe-r…
2. The "bad"/ "deadly" claims made on the show are actually far more complex.

I listened to both episodes twice and dissect what was right and wrong for Unherd Magazine 👇👇

It cannot be reduced to simple soundbites
unherd.com/2022/01/we-nee…
3. Many passionate commenters have not listened to the episodes/ have not explained what they view as correct or incorrect.

We increasingly enter a culture where it is acceptable to criticize something without providing examples or reasoning. Not good.
Read 12 tweets
Jan 31
Not only am I a progressive, Bernie Sanders fan, but I wrote 2 books about how to reform drug regulation & medicine to improve health & save society $$

So it has been heartbreaking to watch the left on the wrong side of many COVID19 issues: masking, kids, school, mandates, etc
Everything done to keep kids "safe" has been delusional, unproven, harmful mitigation that is not proportionate to the risks they face, harmful to their language and development, and has hurt a generation more than any other insult this century.

The left failed kids
End of story
Here are some links:
I can't believe they never ran a single, cluster RCT in kids
tabletmag.com/sections/scien…
Read 5 tweets
Jan 30
Wes' argument is that misinformation thrives in a vacuum where experts/ institutions have lost trust through repeatedly lying or pushing flawed or distorted science...
Is True!

A few e.g.
The Nobel Lies: slate.com/technology/202…
🧵
That was just the start on many issues...
city-journal.org/public-healths…
It even applies to people outside of anointed circles.

What am I to think when someone offers this paper as evidence that masks keep daycares open?

Just read the issues with it. It is astonishing.

vinayprasadmdmph.substack.com/p/a-new-paper-…
Read 7 tweets

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