Read on Twitter
Once again, Silver reveals that he has no idea what he's talking about. The J&J / Janssen vaccine uses a technology (adenoviral vector) that is entirely different from Moderna & Pfizer's (mRNA).
Let's talk for a second about what the FDA is doing and why.
/1 https://twitter.com/NateSilver538/status/1357520287634518017
Let's talk for a second about what the FDA is doing and why.
/1 https://twitter.com/NateSilver538/status/1357520287634518017
First, Silver's (and Yglesias's) whole argument is premised on FDA review of J&J's vaccine delaying distribution. That's questionable. J&J keeps a lot of this stuff confidential, but we know they've had delays and are not ready to distribute yet.
/2 https://twitter.com/HelenBranswell/status/1357744283177136130
/2 https://twitter.com/HelenBranswell/status/1357744283177136130
At this very moment, the Biden admin is working to speed up J&J's production line. @aslavitt46 is on it. There is no benefit whatsoever in yelling at the FDA for doing its job to ensure the safety and efficacy of the vaccine.
/3 https://www.reuters.com/article/health-coronavirus-whitehouse/white-house-says-it-is-working-to-speed-early-production-of-jj-covid-19-vaccine-idINKBN2A603K
/3 https://www.reuters.com/article/health-coronavirus-whitehouse/white-house-says-it-is-working-to-speed-early-production-of-jj-covid-19-vaccine-idINKBN2A603K
One thing FDA has to do is see if "zero deaths" is correct. J&J could've had deaths with symptoms of COVID, but not PCR-confirmed. FDA also must sort out that 15% for which it was ineffective at preventing severe COVID. And much more.
/4
https://twitter.com/mattyglesias/status/1357636028689956864
/4
https://twitter.com/mattyglesias/status/1357636028689956864
Second, "approval" isn't a simple yes. The odds of J&J's vaccine being approved in some form are high. The odds of it being approved exactly as J&J applied are low. There will be changes to manufacturing & labeling, with potentially huge ramifications.
/5 https://twitter.com/NateSilver538/status/1357704988152201217
/5 https://twitter.com/NateSilver538/status/1357704988152201217
Adenoviral vector vaccines are cool new tech, but what does "consistent" mean here? Janssen recently published a paper saying they hadn't done a statistical review of Ad26 adverse effects: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7532807/
I don't trust J&J's PR, but I trust David Kessler's review.
/6
I don't trust J&J's PR, but I trust David Kessler's review.
/6
The cost of error in a rapid drug deployment is quite high. Poor efficacy or serious side effects would have massive ramifications.
To get Vioxx approved, Merck claimed 0.4% of clinical trial users had myocardial infarctions, when it was 0.494%. This was the impact:
/7
To get Vioxx approved, Merck claimed 0.4% of clinical trial users had myocardial infarctions, when it was 0.494%. This was the impact:
/7
If J&J's vaccine has efficacy or adverse effects that differs compared to Moderna/Pfizer, we need to know the specifics.
Put another way: let's give your grandmother the one better for her and I'll take the other—but it's not obvious which is which. Let the FDA do its job.
/end
Put another way: let's give your grandmother the one better for her and I'll take the other—but it's not obvious which is which. Let the FDA do its job.
/end
