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?
It should be <9mo, as you can take a flu vaccine in January for one manufacturer and October from another.
But if there is a policy that a shot at 6mo is not in the "primary series" but acting more like an annual booster, then maybe the statute of limitations should be 6mo.
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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
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
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.
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.
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.
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)
You may recall on August 6 the SA trial announced 71% effectiveness against Delta hospitalization, but didn't say anything about effectiveness against disease, which is the default metric and the one used if you are gonig to report only one number.
Some surmised that effectiveness against Delta disease must be very unimpressive, or else it would have been reported alongside the hospitalization numbers on 8/6 (which were already unimpressive).