Thread by @Theresa_Chapple

I cleared my schedule to watch ACIP discuss the J&J vaccine.
I'll try to live tweet important portions for those who didn't take the day off.
ustream.tv/channel/VWBXKB…

Interesting comparison slide between AZ and J&J clot epidemiology and symptoms

Good question about age difference between AZ and J&J clots.
Could the difference in mean age be related to the timing and rollout of J&J vaccine and not be a function of age. Older ppl got mRNA vaccines bc the came out first.
Answer- more to come on that later today.

I kept asking people to stop saying "only 6 cases" we all knew more were coming.
More cases are under review. Some of those under review are cases in males.
Data source- VAERS (which is subject to underreporting)

Cases in Females broken down by age (N=15).
0 were pregnant/post partum
2 on oral contraception
7 obese

All heparin treatment was before the notice went out to Healthcare providers.
None of the 3 deaths recieved heparin.

10 under review as potential cases using the restrictive case definition.

Well expand case def and they expect more cases that need to be underreview.

I don't like verbal public comment periods!

Risk benefit of J&J present by Janssen researchers.
Supports a warning on label

Proposed warning

More on proposed warning

J&J wants awareness, enhanced labeling, and education, and wants the paused lifted because of variants and impacts that a pause in America could have on global vaccine uptake, hesitancy, and goal of herd immunity.

I'm excited about this current talk. Here's what she plans to address

7 day average of Covid cases, just in case you haven't seen data in a while

Epi of Covid-19 since March 1
Faster growing covid rates in adults, females 18-29
Mortality 3 per 100,000

26 cases of TTS will occur but 2200 hospitalizations and 1400 deaths prevented if J&J resumed for all adults.

Lost confidence in J&J over the last month, but this doesn't extend to the mRNA vaccines

Populations most likely to be impacted by pulling J&J vaccine

listening to the 4 policy options. Here's the 2 I prefer.
either restrict access to those 50 and over, or provide really detail education to females under 50.

My problem with education for females under 50 is the implementation of this.

This is the option currently being discussed. (4th option, educate women under 50)
If it was a warning, how would it be implemented?
Response- we'll educate providers and general public through infographics.

Q's from members
Q- why not just give J&J to males only?
Q- why would it be challenging for sites to carry two vaccines? Lots are doing this already?
Q- BIPOC communities feel targeted & don't like that bc of J&J lower efficacy and now safety concerns. Any look into this?

Here's all 4 options

Better picture of the 4 options. Male only is not an option mainly bc there was 1 case in phase 3 trials in a male and there's some males being examined in the potential case data.

Member questions
Q- Is it harder to keep multiple types of vaccines on site or educators all providers and the public on the risks of TTS?

Q- could sites publicize which vaccines they have so the public could decide where to go to get the vaccine that's best for them?

I should have been keeping track, but so far, most are leaning towards option 4, a couple has expressed interest in option 3. Options 1 and 2 aren't being discussed at this time.

Discussion, is there a differences between #2 and 4?
And how will the "may choose another vaccine" be implemented if sites only have 1 vaccine available?
A- ACIP would reinforce that a certain group has a small risk of a serious adverse event.

2nd for #2, keep it simple.

Here's my concern...
people are pushing for J&J for ease of vaccinating incarcerated, homeless, transient population.
But, how well will we be able to identify TTS in these groups? Healthcare access will be an issue, How well will we intervene in these groups when TTS occurs?

I'm getting tired, but I want to hang in to see the final vote. Send energy my way.

Options 1 and 3 have been taken off the table. Voting will be for options 2 or 4.

Proposed language that will be made into a fact sheet and infographics if ACIP moves forward with option 2 or 4.
I hope they change the word "remote". That wouldn't resonate with all people.

Great discussion going on
Q- Will J&J let people know that there are other vaccine options?
A- very vague response
Q- Will people recieve the fact sheet right before their appointment? like after they already traveled there and are awaiting their vaccination?
A- vague response

Vote occurring on this

10 in favor, 4 oppose, 1 abstained

JJ so continue to be offered for those 18 in over.

There's no informed consent requirement.

A person who voted yes said it will be up to local health departments to ensure people understand risk.

I'll have my job cut out for me.