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Michael Lin, PhD-MD 🧬 Profile picture
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7 Oct, 8 tweets, 3 min read
This Lancet study has Pfizer VE vs Delta infections trending to ≤50% at 6 mo. VE drop seems to accelerate between 3 and 6 mo

Thus shouldn't wait beyond 6mo past your last shot to get boosted if you or household members are at risk

thelancet.com/journals/lance…
Earlier wasn't clear if VE decay was linear, exponential, or sigmoidal. Now it's looking sigmoidal.

The Israel data also looked sigmoidal but many worried about sampling bias (not sure if MOH ever shared if VE was calculated vs matched demographics)

The earlier Oxford study didn't go past 3 mo, so we didn't get a good idea of what might happen at 6 mo. Error bars widened in both directions so it looked pretty straight in the 0-3mo time window.

In summary the latest results look like Israel was fairly representative of the US, and that the WH was actually conservative setting a 9mo booster target.

And a recent story said everyone at the top agreed on the boosters for reducing spread.

politico.com/news/2021/10/0…
In contrast it was the lower-level staff and outside advisors who pushed back citing LoD. They're usually asked to vet data for robustness, so not surprising they may have a forest-vs-trees problem.

So maybe this Lancet paper is good enough for them now?
I remember when the opposition to boosters was based on questioning Israel's waning VE for infections as wrongly calculated or a fluke.

When the same effect was seen in UK and finally US, the major argument changed to VE being important only vs death/hospitalization not cases
Changing scientific arguments for a position may suggest the position wasn't based on a scientific consideration to begin with (when occurring within the same people — must be careful not to transfer an argument from one set of people to another)
I should add this is a study of 3M (yes million) patients followed for 6 months in the Kaiser Permanente Southern California records.

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More from @michaelzlin

Michael Lin, PhD-MD 🧬 Profile picture
4 Oct
Did @nytimes just bury the scoop?

"A study by NIH suggests that Moderna’s vaccine works better as a booster than a second shot of J&J."

This appears to be the first mention of results from the NIH J&J+Moderna trial that Fauci said just finished.

nytimes.com/2021/10/04/us/…
Another interesting mention: if boosters for J&J are authorized only after 6mo, J&J can continue to market the vaccine as 1-shot.

Not sure where that policy came from (maybe related to some guidance regarding vaccine durability for EUA application?)
But I've been wondering what the proper "statute of limitations" is for vaccines. That is, how long until you don't have to consider which other vaccines you are getting for that antigen?
Read 4 tweets
Michael Lin, PhD-MD 🧬 Profile picture
4 Oct
Gottlieb on CDC:
"Couldn't mount the logistical response we needed"
"It just wasn't in the capacity or ethos"
"Backward looking mindset"
"Uncomfortable surfacing information that's partially predictive"
"Uses their own bespoke datasets"
Listen from 1:00

finance.yahoo.com/video/wsj-opin…
I usually take a pass on anything labelled WSJ editorial, but this discussion avoids politics and is just about how to better respond to new pandemics.
Essentially Gottlieb confirms my impression of CDC: a plodding nontransparent organization that prefers to tabulate their own data over more abundant information in the public sphere, and doesn't have the will or ability to rapidly formulate preventive policy
Read 7 tweets
Michael Lin, PhD-MD 🧬 Profile picture
21 Sep
Finally, ENSEMBLE2 results (2-dose J&J vaccine) have arrived. The results?

Good, in a preliminary way

A disappointment, in the inexplicably tiny sample sizes and large uncertainties

Also some questionable real-world analyses

I'll discuss

#JnJers

jnj.com/johnson-johnso…
I'm sure we'll be hearing a lot about the top-line results: Protection of 75% worldwide for ≥moderate COVID-19 and 100 percent for severe COVID-19. Some news are reporting 94% protection for ≥moderate COVID-19 in the US.

These results are seen in the press release below
I like to start with the good news first before diving into issues with the data, so that means we can talk about the 75% protection against ≥moderate COVID19 worldwide and what it means.
Read 34 tweets
Michael Lin, PhD-MD 🧬 Profile picture
18 Sep
The VRBPAC meeting shows how FDA okays *indications*: a drug must prove efficacy for a defined health condition. But this is defined for individual patients. For vaccines the fxn of stopping infection chains is ignored.

Thus FDA is ill suited for the booster question.
CDC could have solved this problem by simply issuing guidance about who can get a Pfizer booster via the off-label pathway.

Sure, if they wanted, they could ask ACIP first. If CDC were to present the right data, ACIP would approve.

But asking FDA means PH was not considered.
Put another way FDA and CDC may demand different burdens of proof due to their different missions, with FDA requiring incontrovertible evidence of efficacy and safety (unless you're Biogen), while CDC should promote anything easy that can promote public health.
Read 10 tweets
Michael Lin, PhD-MD 🧬 Profile picture
15 Sep
1) The news has been reporting on this "expert" editorial opposing boosters.

Just read it. Shocked that anyone would use pre-Delta studies to argue against boosters now.

Plus blatant data destruction that I'll try to explain.

A complete Lancet fail.

thelancet.com/journals/lance…
2) The editorial takes the form of a metaanalysis of vaccine efficacy, but it's the worst statistical malpractice I've ever seen. Fortunately it's short (one figure of 4 panels), so hopefully we can get through it quickly and point out the major issues.
Panel A: What is this??? Studies are grouped by efficacy ranges of 50-80, 80-90, and 90-100 for disease, then their average efficacy for all disease and severe disease are plotted. Why??? I'll try to be polite but I'm upset by this. It's an insult to human intelligence.
Read 19 tweets
Michael Lin, PhD-MD 🧬 Profile picture
10 Sep
And there you go

New CDC stuy shows best estimate of J&J efficacy vs Delta hospitalization is 60%

This is worse than 80% for Pfizer and 95% for Moderna

cdc.gov/mmwr/volumes/7… Image
And before anyone complains the CIs are overlapping, that's a sophomoric complaint. Remember that's the 95% CI, and 95% is an arbitrary bar. Also there are other data that show J&J's lower effectiveness on hospitalization, such as below (pre-Delta)

Or the finding that J&J is only 71% effective vs hospitalization due to Delta, from South Africa

Read 15 tweets

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