No, a healthy 20 year old man who had COVID19 should NOT GET a bivalent booster
The Unknown Benefits Can't Outweigh the Known Harms & Why Medicine Has to take Absolute Risk into Account
This week I saw a 20 year old man in clinic. He had normal BP and a healthy BMI. His LDL was 85. He runs 30 miles a week, eats well, and lifts weights. He had 3 covid shots, as mandated by his university, and, despite that, he still contracted and recovered from COVID (presumably Omicron) over the summer. What did I do?
I started Atorva 80mg qday.
Reading this, you just threw your coffee cup against the wall. You cursed me. You shouted, “why” and “what a ..…..” What word did you use? I texted a group of cardiologists this hypothetical, and they said many words I can’t repeat here. The kindest was… “that's aggressive.”
What if instead of the statin, I offered the same patient a bivalent booster?
Turns out this would be an even worse decision!
The risk to the patient from the booster is not zero. Very likely it will be comparable to what Katie Sharff (KP) found from the original booster (1 in 10k clinical myocarditis), and probably much more subclinical myocarditis. Meanwhile, the upper bound absolute risk reduction of the intervention is as close to zero as it gets. Why? Because the risk to such a young man is practically nil.
Turns out there are several doctors just this reckless. They are: Ashish Jha and Peter Marks and Rochelle Walensky and Bob Califf and the entire White House’s COVID-19 team. They have made a strong recommendation that this 20 year old man OUGHT to get a bivalent booster. As a result, some colleges have mandated it.
These ‘experts’ have no credible evidence that this decision is in the net benefit of this young man. And, they know for sure it won't help others. Why? Because no vaccine has been able to halt transmission. This gentleman, will transmit yet again. Without a compelling societal benefit, nor an individual health benefit, the White House is playing bad doctor.
It's like prescribing a statin to the hypothetical 20-year-old, but it's worse.
Because statins don't cause myocarditis. And no one mandates a statin.
America has always had a fundamentalist streak. Fundamentalism can lead to doggedly pursuing one goal even if it comes at your destruction. When it comes to vaccines the dialog is dominated by fundamentalists.
Of course there's fundamentalism on the antivax side. Some people honestly think an 80-year-old person who never had Covid should never have gotten the first dose back in Jan 2021. That's a deranged point of view. There was a reduction in severe disease in RCT. The absolute benefit was massive.
There's also fundamentalism on the vax side. The idea that we should boost young men in perpetuity is a fundamentalism that's unproven by evidence. The difference is that these fundamentalists are not on the dark corners of the internet, they are actually setting bad national policy!
This week three pieces of data undermined bivalent boosters further. First, the New England Journal Medicine published antibody titer data that shows the bivalent booster does not generate more Omicron antibodies than the OG booster. Expert speculate this is due to imprinting. Whoops!
Second, data from Israel shows the risk of hospitalization from Covid for someone who didn't get a bivalent booster is abysmally low (prob = 0.0005), and this came from an elderly population. (I'm setting aside the causal claims of the study which are entirely unreliable). I'm just looking at absolute risk in the control arm. Now consider, the risk is far lower in a younger population, and lower still in someone who had COVID.
Third, the FDA advisory committee is upset that the company and the White House withheld information that suggested that Moderna's bivalent booster may actually be associated with increased infections. Eric Rubin, NEJM editor says, “It’s not a group of children. We understand how to interpret these results.” This is a scathing article worth your time.
Fourth, at the end of last year, Pfizer was required to complete the post-marketing commitment to report subclinical myocarditis. That means how many kids have troponin rise without symptoms. That should have been submitted to the FDA. Those results are not yet transparent. This is a failure of government.
Ultimately, the people who made this decision chose to debut bivalent boosters in all populations, including young men and children, without evidence that that was a wise decision.
They did not demand appropriate randomized trials from Pfizer. They did not distinguish an 85 year old from a 5 year old. They do not appear to be knowledgeable in the principles of evidence-based medicine, or even basic common sense.
I worry they may be aspiring for future jobs at Pfizer. There is precedent for it. The recent FDA commish Scott Gottlieb is now on the Pfizer Board of Directors.
More than anything, these people are practicing like bad doctors. They are indifferent to absolute risks, and they continue to trivializing harms to healthy young men.
Fundamentalism is always wrong, and it's hard to make a healthy person better off. These are lessons that any wise doctor knows. Sadly, none of them seem to be employed by this White House.