Bivalent Omicron Covid Booster – Info For Making Your Decision
Did you know the new Covid boosters were ONLY tested on mice? Evidently, no humans needed….. Many doctors and scientists have weighed in.
This article is a compilation of resources to help you make your decision about taking this booster. If we missed some great resources, please drop them in the comments and we’ll update the article.
What Happened Last Week?
- Wednesday, August 31 — FDA issued emergency use authorization for new Covid boosters from Pfizer & Moderna. Normally we’d have a recording of the VRBPAC expert panel meeting. But… the FDA chose to skip convening these experts who normally review the data and make recommendations.
- Thursday, Sept 1 — CDC approves immediate rollout of vaccines based on ACIP (CDC advisory committee) recommendation. ACIP held an all day meeting to review and discuss the boosters. Watch the ACIP meeting and read Dr. Nass’s live blog alongside the meeting.
ACIP Meeting: Recommendations to COVID-19 Booster Framework — Liveblog by Dr. Meryl Nass
Slides from ACIP meeting — note from Dr. Battacharya — See p. 21/22 for the report on what happened to the 8 mice (from a paper “under preparation” not even available as a preprint afaik) - Booster is a bivalent vaccine — Wuhan spike + Omicron BA.5 spike
What Are the Experts Saying?
Bivalent Booster’s “8-Mice Trial” Actually FAILED — Igor Chudov (Aug 31)
From Safe and Effective to “Uncomfortably Scant.” — Dr. David McCune (Aug 31)
All “Bivalent Boosted” Mice Got Covid When Challenged — Igor Chudov (Sept 1)
CDC recommends the booster WIDELY after ACIP meeting | A Professor Reflects on this action (Video, Dr. Vinay Prasad, Sept 2)
The High-Speed, Bivalent COVID Boosters are Here (Dr. Meryl Nass, Sept 6) — Thanks to James Lyons-Weiler from Popular Rationalism who featured Dr. Nass’s article. I had missed it! Also reprinted as a guest post in the RESCUE with Michael Capuzzo substack on Sept 8.
FDA, BA 6 Vaccine — Video, Dr. John Campbell, Sept 7
If you have a WSJ account, check out this article Look Who’s Rushing Covid Vaccines Now. The FDA authorized the new ‘bivalent’ mRNA shots without any trials of their efficacy or analysis of their risk. (WSJ Opinion, Allysia Finley, Sept 4)
The New COVID Boosters — What You Should Know With Meryl Nass, M.D — Video, Dr Meryl Nass, Sept 8 (she walks through and comments on many of the CDC/FDA slides)
Humor
FDA will likely authorize the Omicron vaccine later today/tomorrow based on data from 8 mice and no human clinical data avail to the public. Americans deserve to see the data. Why is the White House/Dr. Jha pushing it so hard & universally w/o public data? https://t.co/mfgyJnHOiv
— Marty Makary MD, MPH (@MartyMakary) August 31, 2022
Dr. Paul Offit, Children’s Hospital of Philadelphia renowned vaccine expert and FDA Vaccine Advisory Committee member, says only animal data is available right now on the new vaccine booster shots. Source: NBC10 Philadelphia https://t.co/Wtb6fE7s7R
— Wittgenstein (@backtolife_2024) September 3, 2022
The sequence inside mRNA vax has everything to do with myocarditis
— Vinay Prasad MD MPH (@VPrasadMDMPH) August 31, 2022
Make a new seq (bivalent) & shove it in a vax
You might lower myocarditis
You might raise it
If you only give it to mice, and/or 65+, you have no idea about young men
You are flying blind
Total incompetence
Pfizer slides from ACIP nicely show to whom the data is relevant
— Vinay Prasad MD MPH (@VPrasadMDMPH) September 1, 2022
I would have zero hesitation if I fell into this demographic category
Right over here...............................................................👇👇👇👇 pic.twitter.com/f8fySVXu8v
Yes. CDC ACIP was painful. No thoughtful scientist or doctor I have ever met oversimplifies to the point of recommending things (and mandating then) to people that offer no value
— Vinay Prasad MD MPH (@VPrasadMDMPH) September 1, 2022
20 yr old man s/p 3 doses and ba 5 breakthrough is now 'recommended' to get booster. Madness https://t.co/2k3C33BkMW
We should all be VERY skeptical that the CDC/ACIP wants to recommend an updated booster to the MASSES, w/o ANY CLINICAL OUTCOME DATA.
— 〽️ahesh Shenai, 〽️D (@mahesh_shenai) September 2, 2022
Defies basic principles of medicine.
But, this rec. based on hypotheticals will be misconstrued to support MANDATES for the young & healthy.
In 2021, the Biden administration, Fauci, and the CDC made a bet on the basis of incomplete randomized trial data that the vax would stop covid transmission. Vax mandates and discrimination followed. For the new booster, some are making the same bet, based on data from 8 mice. https://t.co/yyIZM5b9x7
— Jay Bhattacharya (@DrJBhattacharya) September 5, 2022
This is embarrassing answer.
— Vinay Prasad MD MPH (@VPrasadMDMPH) September 8, 2022
I've never heard of medical practice that treats people who don't need something to simplify the message for those who do.
The fact that Pfizer makes billions from this choice should be noted. Let's see who they go consult for in a few years. https://t.co/y5OIN9hxBa
Dear #MedicalTwitter. Is there any scientific evidence that:
— Afshine Emrani MD FACC (@afshineemrani) September 6, 2022
1- A 5th booster is needed (saves lives/ hospitalizations) in young, healthy people?
2- The booster has any efficacy after 8 weeks?
3- The booster is SAFE in people- or are you happy with a trial on 8 mice? pic.twitter.com/OYeJCUvlBh
To me what is most scary is that from the point of view of the White House, Ashish is doing a good job as he pushes misleading messages, false statements and allows Pfizer to basically run the FDA. Approval based on 8 mice for 18 yo men is crazy. Pushing it hard. Even crazier. https://t.co/o2U0OLt20a
— Vinay Prasad MD MPH (@VPrasadMDMPH) September 7, 2022
I went ahead and pulled together all the data that shows a healthy person needs a COVID19 booster "once a year" in perpetuity to lower risk of severe disease or any other endpoint https://t.co/mK4FLw9jBC pic.twitter.com/O3rB2Q1sVU
— Vinay Prasad MD MPH (@VPrasadMDMPH) September 7, 2022
I'm concerned the White House annual Covid vax announcement is not data-driven and ignores nat imm & concerns of immune imprinting from a multi-dose vax strategy. Omicron vax authoriz was based on 8mice, non-public data & bypassed the usual FDA expert vote https://t.co/kcnG7LGAPr
— Marty Makary MD, MPH (@MartyMakary) September 6, 2022
The bivalent booster was only tested on handful of K18 hACE2 mice.
— Remnant | MD (@RemnantMd) September 2, 2022
These mice are made by the Jackson Laboratory, and designed to be specifically vulnerable to ACE binding viruses.
But there's more to it than that...
🧵 https://t.co/m3UswGQqId
Our new paper is now out
— Vinay Prasad MD MPH (@VPrasadMDMPH) September 6, 2022
Led by @KevinBardosh @KrugAlli @ID_ethics @TrudoLemmens @s_keshavjee @MartyMakary @sdbaral @TracyBethHoeg
5 ethical arguments against booster mandates & an empirical analysis
Policy is 10 steps ahead of data and that's dangeroushttps://t.co/sCv3PlFh4H pic.twitter.com/YbOEqNLqGG
