7 COVID 19 shots: 5 Wuhan, 2 Bi-valent
Is this evidence based medicine? or Peter Marks & White House making things up?
Someone in the FDA or the White House is leaking to the press that the agency may grant EUA to the second bivalent booster soon to people over the age of 65.
For a moment, let’s just set aside that leaking possible drug or vaccine approvals and then gauging how excited/ angry the public is— is not exactly a good way to regulate medical products.
This announcement would mean that an 65 year old person may soon be able to get at least 7 shots of COVID vax per this FDA. 5 regular old wuhan shots, and then 2 bivalent boosters. They may also have had COVID once, twice or three times!
This raises the question: Why 7?
Antivaxxers might prefer 5 or fewer, and anti-anti-vaxxers might want 9 or more! Who decided 7 was optimal? Is it based on good science?
The correct answer is that no one has any clue what they are doing. The FDA has so profoundly failed the American people.
The first 2 doses have the strongest evidence. There was a clear reduction in symptomatic sars-cov-2 and a strong signal of a reduction in severe disease. The third dose was plausibly beneficial. It was supported by some (limited) observational data. Doses 4-5 had weaker observational data from Israel. Dose 6 was basically a gamble. Dose 7 is FDA approved based on hope, and one other factor:
They want to clean out the refrigerator.
I should not have to say this: but it is profoundly stupid to approve drug products because you are worried about wasting supply. You approved products for favorable benefit> harms. Therefore this makes zero sense medically.
Here is the part of the article where I say (as I always do): we need RCTs, and the FDA is failing the American people by not compelling the manufacturer— who has made 100 billion dollars and has so much cash they have to buy SeaGen just to put it somewhere— to run them. But you may fire back: look, these people are old and frail, we don’t need randomized trials.
But that logic is flawed. Even if you think, multiple doses might benefit older people: why not 9 doses? why not 6? You need RCTs to know if 7 is optimal. If 9 were better, wouldn’t you want 9? We should randomize people to no more doses, yearly, bi-yearly, tri-year, and quarterly doses— why let people die unecessarily without this study?
If you think that additional doses likely have some diminishing effects— as sensible doctors would think— or that doses post infection might also have diminishing effect— then why enrich a company who is selling essentially a costly medical product that does not add benefit. Here too, RCTs needed.
Either way, shouldn’t everyone agree that some studies are needed?
Evidence based medicine is misunderstood, but one thing it means is advocating for better evidence. 7 doses has been pulled directly from Peter Marks’ ass. It has no sound evidence base. Worse, leaking FDA decisions and gauging public opinions is the politicization of vaccine science. The top two FDA vaccine regulators resigned over the betrayal of regulatory principles long ago, and this betrayal deepens with time. Finally, wasting doses you foolishly purchased is not the basis to approve more doses.
Simply put: what the hell are we doing?
Finally, I just want everyone to know. I always said it was 7 dose series!