You may have heard @washingtonpost published an op-ed by @WF_Parker and I over the weekend

We argued ACIP was wrong to extend the pause on J&J vaccine in the middle of a pandemic

Thread for those who were enjoying a weekend off Twitter, incl. answers to some objections

1/12
COVID-19 remains a pandemic that causes serious, widespread, not fully understood harms

Universally stopping an efficacious COVID-19 vaccine should only be done after seriously weighing the harms of stopped access against side effects of the vaccine

ACIP didn’t do this

2/12
ACIP justified not rigorously weighing harms/benefits b/c other vaccines “are available”

“Availability” doesn’t mean equally easy access & uptake, equally quick protection, identical acceptance

Not every J&J vaccine appt became a Pfizer/Moderna one

3/12
Can people “protect themselves for 2 weeks” or switch to mRNA vax?

WFHers like ACIP (& me!) probably can. Not as easy for everyone

One-size-fits-all J&J pause meant delayed vaccine for homebound seniors on oxygen. Homeless people. Michiganders

washingtoncitypaper.com/article/514485…

4/12
We’ll hear soon about any cases of CVST from J&J

We’ll probably never hear from ACIP about any COVID cases, hospitalizations, & deaths that J&J access could've prevented—not to mention transmission

Harder to trace. Less likely to happen to WFHers. But no less important.

5/12
Why did ACIP make this mistake?

Voting members uncomfortable w/tradeoffs & uncertainty. (One would’ve withheld early COVID vaccine from long-term care patients b/c not enough data! statnews.com/2020/12/03/cdc…)

Needed broader expertise—comparative effectiveness, health econ

6/12
FDA hasn’t withdrawn J&J EUA

States can diverge from ACIP (as many did for vax eligibility), CDC could reject their rec

The public can push for this & ask for a permanent FDA director who'd have gotten this right. Can send public comments to ACIP: cdc.gov/vaccines/acip/…

7/12
Common objection #1: J&J side effects are “commission”, COVID harms are “omissions”

Disagree. Pause is commission—it’s not letting someone stuck on train tracks use a ladder to climb out, because that ladder has a few more side effects than others

nytimes.com/2021/03/19/wor…

8/12
Objection #2: “J&J pause protects public confidence”

Guidance should follow evidence while acknowledging unknowns. Idea that extended pause improves confidence is speculative (& isn’t officials’ stated rationale); must be weighed vs. reduced access



9/12
Objection #3: "J&J CVSTs would've harmed people with less access to doctors"

Remember core point: have to compare to likely harms of COVID.

Unlikely homebound seniors-maybe anyone-face more risk from J&J than COVID. Need to go w/Bayesian priors.



10/12
Objection #4: "Unknowns of J&J vitiate informed consent"

If true then we couldn’t use J&J even if no mRNA vaccine available. Not even ACIP thinks that.

Unknowns of COVID infection worse & more extensive than of J&J

Vaccine is efficacious & approved. Let patients choose

11/12
Objection 5: "We paused rotavirus vaccine in '99"

Yes: no deadly rotavirus pandemic in the US. Risks of non-vaccination matter.

And as @jasonlschwartz noted, ncbi.nlm.nih.gov/pmc/articles/P… even that pause had global harms. Similar now: nytimes.com/2021/04/14/wor…

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More from @GovindPersad

15 Apr
A lot of praise for #ACIP's transparency

But de facto pausing for 7-10 days got the *substance* wrong, as @ashishkjha et al. observe

Understanding the expertise of ACIP members (deep but too narrow) can help understand why these decisions need diverse experts, not just MDs

1/6
For vaccine allocation, CDC/NIH called on @NASEM_Health committee: nationalacademies.org/our-work/a-fra…

Not just MDs but:
- health econ (@healthecon_dan)
- behavioral health (@abuttenheim)
- literally wrote the book on "nonmaleficence" (Jim Childress)
- tribal health (@echohawkd3)
et al

2/6
In contrast, every #ACIP voting member (exc 1 community member) is a MD/DO/RN. Couple w/a MPH. But no health econ. No ethicists. No behavioral sci. No tribal health experts.

Great group for indiv patient care & virology expertise

Not for managing trade-offs in a pandemic

3/6
Read 9 tweets
13 Apr
I agree that a pause isn't permanent & the FDA should track safety concerns

But forced "pausing" (AKA cancelling people's J&J appointments) isn't the right move

People should be given the info & allowed to choose

Deaths from Covid b/c you weren't vaccinated are permanent

1/3
This feels like Germany's mistakes on AZ's vaccine

I thought the "precautionary principle" popular there might be why nytimes.com/2021/03/19/wor…

But it seems telling people stuck on the trolley tracks they can't use a ladder to get out isn't confined to that side of the pond

2/3
Imagine if we'd had a J&J vaccine that was 10% less *effective* than our current one, but didn't potentially have any rare side effects

That vaccine would lead to more deaths than the one we have

Yet I'd guess FDA would have no problem letting people choose to use it

3/3
Read 4 tweets
10 Apr
This mechanistically backs up the evidence of vaccine benefits 10 days after *first* dose from the original Pfizer trial

Underscores the extremely strong precautionary and benefit maximizing case for surging vaccines to Michigan
We have the luxury of two very good options

We have enough supply that we could send MI more vaccines. Only Jeff Zients’ bizarre burden-insensitive conception of “fairness” prevents this

Or we could let MI extend dosing intervals by 2 weeks to get first doses to more people
But apparently sticking w/an ethically ungrounded Trump Admin holdover policy of giving vaccines only proportional to population (which many states aren’t doing intra-state), & an arbitrarily selected dosing interval, is more important than letting people in MI protect themselves
Read 4 tweets
20 Dec 20
For those following #ACIP vaccine prioritization debate - proposal to have 75+ alongside frontline workers in phase 1B is interesting, and different from prior discussion. But there are still pitfalls with any age cutoff, whether 75 or 65, as I explained in a comment to ACIP /1
Down Syndrome deaths are disparately high and happen before 75. 54%, 61%, and 69% of Black, Hispanic, and AI/AN deaths (respectively) happen before 75. I haven't seen US data on income x age at death, but a similar gradient is plausible, and may help explain the race data. /2
So I continue to think #ACIP should encourage states & localities to look at overlapping risk factors like housing+age as LTCF priority did and @CDCDirector suggested, rather than using age cutoffs that sweep in ppl at very different risk & exclude some /3
Read 6 tweets
20 Dec 20
Last (grumpy) thread about #ACIP vax prioritization before bed. Sure, there are some hard tradeoffs, though looking for overlapping risk should make it easier, & ACIP could have had better framing. But critics have been a real mess. Exhibit A, dishonest quoting (aka lying): 1/6
Redfield: need to"demonstrate that we as a Nation also prioritize the elderly (>70 yo) who reside in multi-generation households. Often our Hispanic, Black and Tribal Nations families care for their elderly in multigenerational households and they are also at significant risk."2/
Here, current @CDCDirector Redfield (hardly "Mr. Woke"), after endorsing long term care priority, is sensibly arguing for another multi-factor (age+housing risk) priority similar to LTCF, which would also address disparities for "Hispanic, Black, and Tribal Nations families" 3/6
Read 7 tweets
19 Dec 20
Thread on interconnected #bioethics problems in #COVID19 vaccine allocation: (1) the Stanford med center allocation debacle, (2) Rupert Murdoch, and (3) high-profile calls for age-only (“oldest first”) allocation policies. If you like (3), unfortunately you get (1) and (2). 1/7
People are right to be upset w/Stanford: see @CarolineYLChen excellent piece . But it’s not “algorithms”, it’s inputs. If your inputs are too simplistic (age-only, ignore exposure or medical risk), you get bad outcomes, e.g. no residents, senior WFH 1st 2/7
Same w/ Murdoch: . People are right to be upset. But age-only priority like the UK (start w/85+ or 90+), ends up prioritizing Murdoch over a 60 yo bus driver. Who lives to 90? We know the answer: more often, wealthier people. Need to consider other risk 3/7
Read 9 tweets

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