Wow! π
secondary endpoint
potential for infinite looks at data
yet still, scant events (50?) of dubious clinical value (some asx?)
Plus other issues, including durability discussed in video
But postponing/ flip flopping is going to poison vax confidence
White house should not have pressured FDA on boosters
Gruber and Kraus should still be there
Politics cannot dictate vaccine approval
This is a total fiasco
This administration is doing serious, serious damage to vaccine confidence
The backlash will hurt a lot of people
States will get rid of good programs to encourage routine childhood immunization
Vaccines become even more political
This administration does not have a plan here
They should have awknowledged natural immunity
and tried for just 1 dose in people with no prior NI
Instead they overrode advisory panel to boost 20 year olds and 12 year olds. Totally illogical
And they tried to push through a failed trial, only to back off later.
What are they thinking? These actions have serious consequences
I don't want to live in a world with greater vaccine hesitancy
I also don't want to live in a world where politicians approve vaccines and push out regulators with decades of experience
I don't want to live in a world where Paul Offit disagrees with vax mandates
thats bad
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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
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 π§΅
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
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
π§΅
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
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? π§΅
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.
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.