I am the biggest advocate of adult vaccination, and took the first opportunity I could get to get mRNA, but I am stunned that so many smart people are so eager to embrace EUA for 12 to 15 without closer scrutiny of the data.

There are 7 issues, as I see it
[thread] Image
1. Issue 1
Does the avg. recipient benefit?

The avg. recipient of the vaccine was not going to die of covid, nor going to have a rare AE from vaccine, so the first Q I have is does the avg. person benefit?
The answer to this question is to consider the adverse event profile against the typical case of covid in this age group

The typical AEs are worth noting.. Image
You have a 2% of severe chills, headache, muscle pain, and fatigue

And the average person lowers their risk of covid by ~2% in this time period (as covid had higher spread in USA back then)

That second 2% will be lower today, and it is unclear how severe these cases were
So does the avg kid benefit from this vaccine?

I dunno for sure; but I have some questions

Hopefully ACIP tells us how severe the 16 infections were
2 Do the rare events favor vaccination?

The mortality of COVID19 among an infected kid is very very low in this group; the study's sample size is too small to prove a mortality reduction, though I am willing to infer it.

The size also can't exclude rare AEs

Which is bigger?
What were the 0.3% SAEs seen on vaccine arm?
We will need to know that.

As far as I can tell, one should not be convinced that the balance of rare events favors vaccination with these data.

That is uncertain.
3 Do we vaccinate kids because of adults who refuse to be vaccinated?

Many on twitter cite adults, particularly those over 50, who refuse to be vaccinated as a reason to vaccinate kids... is this correct?
First, what is the added protection to such an adult in the next few weeks, as rates of covid19 decline from vaccinating kids? v. low

Second, are we incentivizing these adults from not getting vaccinated by offering kids in their stead?
Concerning

This is novel territory
4. What concerns me the most about this debate is that we are confusing a rational appraisal of a vaccine with classic virtue signaling.

Doctors have already offered their kids to the vaccine... but we have yet to have the ACIP!
5. I continue to believe that this is truly unprecedented to use the EUA authority to push this vaccine through, there are grave risks to doing this

detailed here
blogs.bmj.com/bmj/2021/05/07…
If an un-anticipated safety signal emerges (perhaps like the still under investigation myocarditis/ israeli data) you will have an existential crisis in the USA

People are too divided on this issue; we need to be sure of net benefit to kids.
6. Some say Kids need this to 'return to normal'

I would humbly suggest that is because adults have deprived them of normalcy irrationally, and beyond the risk posed to them by the virus.

The solution to that issue is not expedited authorization

statnews.com/2021/02/03/kid…
7. Many people refuse to comment on this issue because of the daily insults and epithets that they are anti-vax

I am a cancer doc, who takes care of post BMT pts, I promise, I have given more vaccines than you.

I also have 2 books on drug regulation & policy
So spare me
Was this interesting?
My answer is who are we decreasing transmission to?

If the answer is adults who are choosing not to vaccinate, I am not sure that justifies EUA

If the answer is younger kids, I am not sure they need it

& what will covid rates be in 1 mo? (ala Israel)

Some argue that the 16 cases in the control arm will grow and grow and grow were not for vaccination.

To some degree yes, but problem is the base rate is already lower than 16. The other problem is the aforementioned problem which is are these cases as severe as the AEs?
Over a long time horizon, with good adult vaccination what will the percent of kids suffering from covid (with symptoms) be. And Will it be bigger, and worse than the upfront AEs? The answer is these are uncertain questions not slam dunks
Others argue that you need to do this to reopen schools "safely"

Unfortunately that is not and was not ever a prerequisite to opening schools with very safe outcomes

Now the teachers are vaccinated, Not opening is unforgivable
Some argue that all kids will eventually get the virus were it not for vaccination. But that is an argument for a safe and effective vaccine at some point, and not an argument for a relaxation of approval standards and an EUA now with the remaining uncertainty
A way to split the difference would be to roll out the vaccine in the safe group slowly. Let's not do 5 million in one week, let's spread that over time, and couple it with a surveillance system that is capable of adjudicating AEs
This thread should not be misconstrued to mean that under no conditions is a vaccine acceptable but rather under the current conditions there are residual questions that are non-trivial
And here is H. Cody Meissner from Tufts saying the same thing
One difference btw this age group and the adult age group is that the adult data shows a reduction in severe infections, but here it cannot be shown as these occur too infrequently in this population, and the sample size is smaller Image

• • •

Missing some Tweet in this thread? You can try to force a refresh
 

Keep Current with Vinay Prasad, MD MPH 🎙️📷

Vinay Prasad, MD MPH 🎙️📷 Profile picture

Stay in touch and get notified when new unrolls are available from this author!

Read all threads

This Thread may be Removed Anytime!

PDF

Twitter may remove this content at anytime! Save it as PDF for later use!

Try unrolling a thread yourself!

how to unroll video
  1. Follow @ThreadReaderApp to mention us!

  2. From a Twitter thread mention us with a keyword "unroll"
@threadreaderapp unroll

Practice here first or read more on our help page!

More from @VPrasadMDMPH

3 Aug
I listened and its true
He says parents of unvaccinated kids should wear masks at home
Probably the worst policy idea I have heard the entire pandemic.
How can anyone have confidence in leaders so out of touch with humanity?
Parents of unvaccinated children should not wear masks at home

They should allow children to see their entire face

And NIH leadership should turn over every 5 years or so; for fresh ideas
Americans are so delusional about masking children. Our CDC recommends we mask kids under the age of five, although there's no data that supports this, and it's contrary to the world Health organization recommendation and ignores any downside such as language acquisition
Read 4 tweets
1 Aug
So after we throw unvaccinated people out of school and college, ban them from restaurants & bars, fire them from private and federal employment, the next step is to round them up and put them in prison?

Hmmm what would that do for viral spread?

washingtonpost.com/opinions/2021/…
I would love it if someone who offers strong arm tactics walks me through their thinking about what happens next in a volatile nation with 300 million guns
This time the fat tail risk is what the response will be.
Read 7 tweets
1 Aug
Crossed the 300 peer review publication mark recently #nomedicalwriters

Here is what I learned over 12 years of publishing

1. Don't include too many authors...
You have to type their name, affiliation AND email into those damn submission portals
God help 30+ collaborators!
2. Well, if someone is willing to submit the paper, maybe they do deserve to be a co-author after all
#letsnotbehasty
3. If the journal asks you to suggest reviewers, you will probably suggest people you think will like the paper or people who like you
#nohaters
Read 28 tweets
31 Jul
The idea that Delta somehow changes the risk benefit for kids attending school is literally the dumbest idea I've heard

Unless a new variant has an IFR 10-fold higher in that age group, the net benefit is to continue school in person

School has mental and physical benefits
It has benefits on upward mobility, socioeconomic status, equality, civics, society.
It was always a bad idea to close schools. It was a forgivable bad idea in the spring of 2020. By the fall of 2020, the data were clear and it was no longer a forgivable mistake. By 2021 It's criminal to keep it closed any longer
Read 7 tweets
29 Jul
I hope real experts in EBM know that the idea cloth masks "work" on vaccinated people with >50/100k cases SUMMED over 7 days with delta, but not pre-delta, & not at lower case rates, is actually....

100% MADE UP
Like, I hope that masks have not been so politicized and so linked to virtue that the last intelligent person in biomedicine actually thinks this is evidence based anything
Instead, what it is is the APPEARANCE of doing something, as we wait for the inevitable break in the pandemic trajectory
Read 7 tweets
29 Jul
I appreciate this thread by @SarahKarlin an excellent biotech/ regulatory reporter

Some thoughts on Pazdur's comments [thread]
First, all this fiasco is due to Rick himself!
STAT reports that he advised FDA to approve aduhelm by AA, which drew attention to the pathway

The pathway had been abused for years in cancer, but few cared; now all eyes on it.

He has only himself to blame for the attention!!
Next, as background. FDA lets cancer drugs come to market that improve survival AND some that shrink tumors (RR) or slow their growth past arbitrary thresholds (PFS)

The ratio is what, would you guess?
5:1?
4:1?
....
Read 15 tweets

Did Thread Reader help you today?

Support us! We are indie developers!


This site is made by just two indie developers on a laptop doing marketing, support and development! Read more about the story.

Become a Premium Member ($3/month or $30/year) and get exclusive features!

Become Premium

Too expensive? Make a small donation by buying us coffee ($5) or help with server cost ($10)

Donate via Paypal Become our Patreon

Thank you for your support!

Follow Us on Twitter!

:(