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Biden's Bivalent Booster Blunder (substack.com)
For Dems to survive, they need to fire all their COVID advisors
The Biden administration has made a fool of themselves with their bivalent vaccine roll out. Pretty much all decisions were errors, and very likely these will hurt them politically. The only way for Biden to save himself from his terrible Covid policy is to fire all his advisors and rehire good ones. Let's review the facts:
The Biden administration granted emergency use authorization to Pfizer and Moderna for a bivalent booster that targeted Wuhan and BA45. That vaccine received EUA based on mouse data (8-10 mice). There were no human data at the time of approval. (Please don't confuse the BA4/5 with BA1 bivalent)
Since then, both companies have press released results, but do not specify the numeric values of antibodies generated in people. No one has clinical data-- i.e. is there a reduction in hospitalization? Severe disease? And if so, we don't know which people (how old) have a further reduction in severe disease or hospitalization from this vaccine.
We also know breakthrough can occur. Rochelle Walensky herself received the vaccine and then had COVID one month later. Ironically, this is probably the peak vaccine efficacy (peak Ab). I don't know what the vaccine effectiveness is, and neither does she, but my guess is it isn't terrific.
The Biden administration said that we didn't have time to wait for clinical trials in people. But each passing day reveals that is a lie. The uptake of this vaccine is abysmal. No one wants it. If no one was going to get it then why not take the time to run the proper studies?
A recent pre-print has shown that the bivalent booster is not better at generating BA45 antibodies than getting the old booster one more time. This is the failure of not generating human trial data.
You could have sorted this out pre-market. *Let’s be clear, these are not clinical data (living longer/better) but without better antibodies, clinical endpoints seem unlikely to be met*
Many universities are now requiring this vaccine for 20-year-old college students who have had three prior doses and Omicron. I think you have to be dropped on your head to actually believe a 20-year-old man in good health who's gotten three doses and just had Omicron will derive any benefit from this bivalent booster. I have never met even one doctor who thinks that that is true. And yet that is the position of the Biden administration.
They are so hellbent on earning Pfizer money-- I mean vaccinating people who just had covid —that they are willing to ignore the mountain of data that suggests that's not what you should be spending your energy on.
More than a year ago, Marion Gruber and Philip Krause the number one and number two at the US FDA vaccine branch resigned, citing White House pressure to approve boosters for all ages. Their published remarks suggest that they wanted to do it only for the elderly and vulnerable. Their message was repeatedly ignored as the Biden administration rammed booster after booster through the US food and drug administration for ultra low risk populations.
The have actually said a 5-year-old who has had three doses and had covid should get this booster. It's insane.
Their entire vaccine policy seems to be interested in giving Pfizer and Moderna a perpetual market share for a yearly vaccine. But seems to have no interest in generating credible randomized control trial evidence to inform the public. As such, they fail the American people.
I am concerned that after this White House stint: Ashish Jha, Rochelle Walensky, Vivek Murthy, and Peter Marks (post FDA) will work for or consult for Pfizer and Moderna. That would be devastating.
American people obviously do not want to receive a vaccine every year with non-trivial adverse events without knowing that it gives them some benefit. Benefit to third parties cannot be had because it cannot stop transmission.
Some misguided policy makers argue that even a small reduction in transmission is meaningful. That's nonsense. The problem is that you can get COVID every single day of your life from now until the end of your life. Even changing the probability modestly won't change the outcome. Because the probability you will get COVID is one over time. Think of it this way:
You can play Russian roulette with one bullet or three bullets. I would much rather play with one bullet, if I had to. But if you have to play a thousand times in a row, we all know how that game ends.
That's COVID 19. It's not going anywhere. You're going to have to play over and over and over again. And that means you're all going to get COVID. So the only question is how many doses minimize severe disease? And who needs that to be minimized?
Today in the governor's debate of New York state, only the Republican candidate was stage the opposed to children's mandates. It's amazing that the Democrats are clinging to a failed vaccine policy. Their covid-19 policy is going to lead to catastrophic losses.
They need to fire all their advisors and start new. That's the only way to fix the situation.
