1-dose J&J is ok for a while, but needs a 2nd dose of vaccine (any) by 6 months. Anytime after 2 months is fine. A short thread on the recent J&J data to the FDA . 🧵
fda.gov/advisory-commi…
J&J 1-dose clinical trial efficacy.
These data, from a placebo controlled clinical trial for efficacy + safety, are robust. They are also consistent w/ multiple "real world" studies. Efficacy v. cases, hospitalizations, and deaths isn't as good as mRNA vaccines, across 6 months.
Or graphically:
Hence, a 2nd dose is needed.
The J&J 2-dose clinical trial (being termed a booster).
Definitely gives a boost in antibody responses. (Waiting for T cell data) medrxiv.org/content/10.110…
And gives a boost in vaccine efficacy.
(COV3001= 1-dose. COV3009= 2-dose)
Overall efficacy 75%.
If you just look at USA, 94%, with overlap
Clinical trial shortcomings:
* Quite short term follow up after J&J 2-doses so far (36 day average).
* not many COVID-19 cases, so the efficacy calculations are not particularly tight.
Overall, it is REALLY good to see these data! It clearly took a lot of work to get this far for the 2-dose J&J COVID-19 vaccine clinical trial!

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More from @profshanecrotty

25 Oct
What should I get as the 2nd dose? That's a question I get a lot.

If it were me, and I had only gotten 1-dose of vaccine & was soon to get my 2nd dose, here's what I would do:
1st dose + 2nd dose
J&J + Mod
Pfizer + Mod
Mod + Mod
See a pattern? 🙂 Moderna 2nd gives the most robust immune response with any of the others. But Pfizer is pretty close! (and I'd get 100mcg Moderna if I could)
Both in the Atmar/Lyke et al. work, and multiple published studies of AZ vax + RNA 2nd, getting RNA vaccine as the 2nd dose after an adeno vector has resulted in better antibody and T cell responses, compared to 2 doses of adeno.
Read 6 tweets
25 Oct
Is it good to mix COVID vaccines?

This is a really great clinical study by Lyke et al., reported at the recent FDA meeting.

Mix-and-match COVID vaccines

fda.gov/advisory-commi…
Mix-and-match COVID vaccines
Key findings:
🔵   mRNA + mRNA combinations are similar
🔵   J&J + mRNA gives much higher antibodies than J&J + J&J
🔵   No T cell data (sigh)
All the key data:
Read 11 tweets
19 Oct
Why isn't there a Delta variant vaccine?

I hear this a lot. 🧵 Three reasons:
1. The regular vaccines give great booster responses against Delta and other variants.
2. “Original recipe’ vaccine is better suited for other variants
3. It is faster to proceed with original vaccines
1/ The regular vaccines give great booster responses against Delta and other variants
This was first shown by Moderna, with 'original recipe' vaccine booster, compare to Beta booster.
nature.com/articles/s4159…
And for T cells, the T cell epitopes between variants are highly conserved, so the 'original recipe' vaccine should be a good booster. Though no T cell booster data are published.
doi.org/10.1016/j.xcrm…
Read 6 tweets
19 Oct
FDA panel greenlighted Moderna booster vaccines. CDC will consider it this week. My thoughts 🧵:
🔵   Moderna booster definitely enhances immunity
🔵   Moderna boosters for people > 65 at 6+ months is reasonable, and healthcare workers
🔵   Moderna booster needed less than Pfizer
🔵   The Moderna booster definitely enhances immunity
Over the Moderna booster data and FDA filing look good. The data are more limited than desired, but it all makes sense.
The FDA probably struggled with the idea of making a Moderna booster recommendation different than the Pfizer booster recommendation they recently made.
Read 18 tweets
24 Sep
CDC Director Dr. Walensky made the right decision last night on boosters. 🧵
Boosters now available (not required) for Pfizer vaxxed after 6 months:
🔵  65 and older
🔵  healthcare workers
🔵  nursing home residents
🔵  50 and older with health problems
apnews.com/article/corona…
This was in line with the FDA decision last week. It also matches my suggestions two weeks ago on TWIV and VOSD. And earlier on UCSF Grand Rounds. It makes sense to have vaccine boosters available to these people, who received the Pfizer vaccine.
Again, the Pfizer vaccine booster shot is *available*. It is not *required* to count as fully vaxxed. That is because without the booster shot, the vaccine is still doing an outstanding job at preventing serious COVID-19.
Read 21 tweets
20 Sep
Good news! Pfizer data today indicate they have a safe and effective COVID-19 vaccine for kids ages 5 to 11. Kids vaxxed by Halloween? 🧵
🔵  Antibody titers as high as adults
🔵  "Favorable safety profile" with 10 microgram dose used
🔵  Filing with FDA

pfizer.com/news/press-rel…
🔵  Antibody titers were as high as adults

The fact that the peak antibody titers are equal between the kids 5 to 11 years old and young adults indicates the COVID vaccine will be protective in the kids.
🔵  "Favorable safety profile" with the 10 microgram dose used

Pfizer used a dose of 10 in the kids instead if the 30 used in adults. That was a reasonable decision, and they see fewer side effects with the lower kid dose (fevers, chills, etc). Other doses were tested early on.
Read 10 tweets

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