Bivalent Omicron Covid Booster - Info For Making Your Decision

Humans need not apply for trials... decisions made on just 8 mice.......

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?

Before We Push the New Omicron Vaccine, Let’s See The Data — Dr. Marty Makary (Aug 23)

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)

Friday Roundtable: New Booster Rollout With No Human Testing With Meryl Nass, MD, Toby Rogers, Ph.D. + Brian Hooker, Ph.D. (Sept 2)

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

COVID Booster Approved Despite ZERO Human Testing — Jimmy Dore

Twitter

Marty Makary MD, MPH @MartyMakary

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?

sensiblemed.substack.comBefore We Push the New Omicron Vaccine, Let’s See The DataThe White House is pushing Americans hard to take a novel Covid vaccine before the studies are complete.

Wittgenstein @backtolife_2024

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 youtube.com/watch?v=S4DnG5…

Vinay Prasad, MD MPH 🎙️📷 @VPrasadMDMPH

The sequence inside mRNA vax has everything to do with myocarditis 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

Vinay Prasad, MD MPH 🎙️📷 @VPrasadMDMPH

Pfizer slides from ACIP nicely show to whom the data is relevant I would have zero hesitation if I fell into this demographic category Right over here...............................................................👇👇👇👇

Vinay Prasad, MD MPH 🎙️📷 @VPrasadMDMPH

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 20 yr old man s/p 3 doses and ba 5 breakthrough is now 'recommended' to get booster. Madness

Jessica Adams @RxRegA

@SarahKarlin by oversimplifying the situation the only clean messages that come across 1) we'll reframe the data to suit our agenda, 2) we think you don't know anything about it and wouldn't understand complexity and 3) we assume you'll do whatever we say.

Mahesh Shenai, MD @mahesh_shenai

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. Defies basic principles of medicine. But, this rec. based on hypotheticals will be misconstrued to support MANDATES for the young & healthy.

Jay Bhattacharya @DrJBhattacharya

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.

Genève CampbeII @bergerbell

How… how are we still thinking like this?! https://t.co/Rh4q6pppj3

Vinay Prasad, MD MPH 🎙️📷 @VPrasadMDMPH

This is embarrassing answer. 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.

Scott Morefield @SKMorefield

Watch CDC Director Dr. Rochelle Walenski completely dodge a question about Dr. Paul Offit saying not everyone would benefit from another booster, then try to tell me these people should be taken seriously. 🤡 https://t.co/wHj5PVnNZi

Afshine Emrani MD FACC @afshineemrani

Dear #MedicalTwitter. Is there any scientific evidence that: 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?

Vinay Prasad, MD MPH 🎙️📷 @VPrasadMDMPH

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.

Jay Bhattacharya @DrJBhattacharya

I don't know what the right covid booster schedule is, nor does anyone else, even @AshishKJha46, Tony Fauci, or @cdcgov. That is because there is effectively no scientifically valid evidence base on which to make such a judgment. As usual, @AndrewNoymer is an honest broker. https://t.co/J5sdOeYLBJ

Vinay Prasad, MD MPH 🎙️📷 @VPrasadMDMPH

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

Medscape @Medscape

Barring any "pandemic curveballs," the newly authorized combination vaccines against COVID-19 will move most eligible Americans closer to just getting a 𝘊𝘖𝘝𝘐𝘋-19 𝘴𝘩𝘰𝘵 𝘰𝘯𝘤𝘦 𝘢 𝘺𝘦𝘢𝘳 — the way routine flu vaccinations are done. https://t.co/jjgIVJ8PZU

Marty Makary MD, MPH @MartyMakary

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

wsj.comU.S. Plans Shift to Annual Covid Shots as New Boosters Roll OutHealth authorities expect to recommend that people get boosters once a year, starting with the new shots now rolling out, a shift from their current practice of issuing new advice every several months.

Remnant | MD @RemnantMd

The bivalent booster was only tested on handful of K18 hACE2 mice. 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... 🧵

Vinay Prasad, MD MPH 🎙️📷 @VPrasadMDMPH

Remember that the EUA booster is Wuhan + BA4/5. BA1 clinical data is a different product Here is the most relevant hard hitting data supporting the authorized product (Moderna) Gulp! https://t.co/DmAomaDVQp

Vinay Prasad, MD MPH 🎙️📷 @VPrasadMDMPH

Our new paper is now out 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 dangerous papers.ssrn.com/sol3/papers.cf…

History

The End of Covid-19 Vaccine Safety Science in America — June 29, Toby Rogers (Utobian)