Many, many blue-check health experts defending the FDA and CDC when on Tuesday they announced out of the blue with no warning whatsoever that they were recommending a pause in the use of the J&J COVID-19 vaccine over fears of rare blood clots.
For example, is Brown professor Dr. Ashish K. Jha say “this is how it works” it’s it’s good news that we have a “vigorous system that takes adverse events seriously”:
I know lots of folks think this will cause more vaccine hesitancy — and more harm than good.
I'm honestly not so sure
My sense is confidence comes from people believing that we have a vigorous system that takes adverse events seriously.
We do.
This is how it works.
— Ashish K. Jha, MD, MPH (@ashishkjha) April 13, 2021
This editor questioned him at the time over this Pollyannaish view of the world:
honest question: have you met any real people? https://t.co/CT8r8H7rja
— Greg Pollowitz (@GPollowitz) April 13, 2021
And we were right to question him as he’s now flip-flopped, accusing the FDA and CDC of punting and calling this lake of advisement a “mistake”:
CDC's vaccine advisory committee ACIP met today to advise on J&J pause
After thoughtfully discussing what we know & don't know about rare clotting events, they punted
The advisory committee decided not to advise
This was a mistake. J&J should be un-paused soon
Thread
— Ashish K. Jha, MD, MPH (@ashishkjha) April 15, 2021
He’s referring to the decision on Wednesday that delayed re-authorization of the vaccine for “another 7-10, at least”:
Recommended
Health authorities decided to keep the J&J vaccine out of circulation for another 7-10 days, at least.
Almost 7 million people have received the single-dose vaccine. One person died from a blood clot that *might* have been related. https://t.co/fPBm9daAnR
— Graeme Wood (@gcaw) April 14, 2021
“The risk-benefit here is all wrong,” you say?
Initial pause by FDA on Tuesday was a close call
But I supported it
A few days to alert people, begin process of collecting more data, advise physicians — all made sense
Now advisory panel wants to return in 7 – 10 days to discuss further
The risk-benefit here is all wrong
— Ashish K. Jha, MD, MPH (@ashishkjha) April 15, 2021
Maybe blue-checks owe Nate Silver an apology then?
Nate Silver spars with CNN medical analyst over the FDA-CDC decision to pause the J&J vaccine https://t.co/nMs9qG72sR
— Twitchy Team (@TwitchyTeam) April 14, 2021
Anyway, the thread continues here but the damage has already been done:
Nearly all the adverse events are in women 18-49 years old
Cerebral Venous Sinus Thrombosis (CVST), the clot seen with J&J, is known to be more common in young women
Suggests that young women probably the group at high risk
This actually gave ACIP a smart way forward
2/7
— Ashish K. Jha, MD, MPH (@ashishkjha) April 15, 2021
Given that most cases of vaccine-related CVST appears in women
ACIP should have recommended continuing pause for women 18-49 but resuming for everyone else
Keeping vaccine paused for everyone makes little sense
Risk-benefit keeping vaccine paused for everyone WAY off
3/7
— Ashish K. Jha, MD, MPH (@ashishkjha) April 15, 2021
But what about the fact that we have Moderna/Pfizer?
They are great. But not easy for everyone.
For many, J&J is a life-saver
Imagine 54 yo male migrant farm worker with diabetes who can't return for a 2nd shot?
Based on what we know today,
Would you give him J&J?
4/7
— Ashish K. Jha, MD, MPH (@ashishkjha) April 15, 2021
His risk of getting COVID may be as high as 1 in 1000 per day
His chances of dying of COVID may be 1 in 100
So each unvaccinated day, his risk of death is 1 in 100,000
His life-time risk of CVST from J&J?
WAY less than 1 in million
May be zero
No-brainer. Give him J&J
5/7
— Ashish K. Jha, MD, MPH (@ashishkjha) April 15, 2021
ACIP's decision to wait would be fine if there was no pandemic going on
But there is
And waiting 7-10 days won't do much. Not sure what data they will get in that time
But we'll have done real harm to a terrific vaccine particularly well-suited for vulnerable populations
6/7
— Ashish K. Jha, MD, MPH (@ashishkjha) April 15, 2021
Good news is that ACIP is just advisory
So FDA/CDC can still move forward and recommend resuming vaccinations for everyone except women 18-49
And for all groups, continue to vigorously, proactively collect data and make changes later if needed
7/8
— Ashish K. Jha, MD, MPH (@ashishkjha) April 15, 2021
We’re in a pandemic
Short pause to alert folks is reasonable
Waiting when its unlikely to change what we know is not
J&J highly-effective, safe vaccine with rare side-effects
I'd make it available soon, particularly for those for whom alternatives are not good choices
Fin
— Ashish K. Jha, MD, MPH (@ashishkjha) April 15, 2021
***
Related:
'Great work, folks': The NYT reports on how the FDA and CDC's pause of the J&J vaccine will kill people internationally https://t.co/7k6R2SxQah
— Twitchy Team (@TwitchyTeam) April 15, 2021
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