Boosters studies from Israel that the US FDA relied upon were COMPLETELY WRONG
Our NEJM letter proves it, and the authors concede!
Out this week in the New England Journal of Medicine, our team —- Tracy Beth Hoeg, Ram Durseti, and I— investigate an Israeli study that the FDA used to justify their booster campaign.
Let me walk you through it, but tl;dr: it was completely flawed bc people who get boosters are different than those who don’t. The full correspondence is below.
First, the original Israeli authors claim that boosters lower the risk of COVID death (adjusted for confounders) by 90%, which is a huge number.
Later, and only in response to a Letter to the editor, the authors admit that they found a reduction in death from COVID AND deaths from reasons other than COVID.
Wait, how does a COVID shot lower the risk of death not due to COVID?
Good question— it probably doesn’t.
And, the precise number that the authors were now claiming is that COVID boosters nders lower non covid deaths by get this…. 94.8%! (Not adjusted for confounders, 77% when adjusted for confounders)
That number is INSANELY high, and basically the same as the effect on COVID death.
So which is it: Are COVID boosters are a magic shot that heals you like the long lost fountain of youth OR did the authors push a completely flawed analysis of groups that are fundamentally dissimilar, and worse withhold the information until a NEJM letter brought it into the open?
Of course, we think the answer is the latter, the authors admit as much!
In the reply, they write, “The policy in Israel prioritized the administration of boosters to persons in the community setting who were at the highest risk. However, boosters were generally not administered to hospitalized patients who were at high risk for death from any cause.”
In other words, they knew that they were not comparing groups that were similar for reasons besides the booster. Furthermore they concede, “However, the associations between vaccination and deaths not due to Covid-19 should be interpreted cautiously because numerous potential confounders exist.”
Yes, of course, but this also means that the association between vaccination and deaths DUE TO COVID should be interpreted cautiously— something that the authors and the FDA and the CDC did not do.
Ultimately, in order to show that boosters lower death from COVID— you need large randomized studies. These are costly, but interestingly Pfizer has 100 billion reasons that they can afford to conduct such studies.
The US FDA has the legal authority— actually, the mandate— to demand these studies as condition of use of boosters, but has repeatedly refused to make large, adequately powered (for hospitalization) trials the bar that the drug companies have to clear.
Instead, they use data from Israel— a country that has repeatedly and quickly used Pfizer vaccines. By comparing people who got the shot to those who did not, they have drawn inferences about the vaccine.
But the groups who rush to get the shot are fundamentally different. Proof of that is the difference in non-COVID death. Worse, some analyses show that the survival curves split to fast, a topic we wrote about for JAMA internal medicine.
Now, in the NEJM, we show that people who got boosters in Israel have huge reductions in non-covid death, on par with reductions in COVID death. This ensures that unmeasured confounding exists.
Some argue that adjusting for non COVID death is a way to correct the analysis (https://twitter.com/jsm2334/status/1682450942623469585?s=20), and this has been employed in some papers. Using this method the vaccine efficacy falls, but still is non-zero.
But— here is the key— this method is also unproven. It has not been validated. To do so would requiring comparing the new estimate from this method and comparing it against randomized trial’s estimate. That is validation 101, and has not been met.
As such we still don’t know the real effect of boosters, and how much they reduce mortality — particularly in young people who have the least to gain and most to lose.
Ultimately, the FDA failed the American people, and the initial NEJM paper on booster efficacy withheld vital information. Both of these are a scandal, worthy of correction.
Here is our full paper in the NEJM for those interested. Thanks for supporting this work.
And this is one of the reasons that, as a physician, I no longer trust anything put out by the CDC or the FDA. I first questioned when they denied natural immunity was effective and still pushed vaccination, especially in young healthy adults. Then they approve the vaccine for kids based only on the fact that they produced similar antibody response to what was considered protective in young adults. The disease was so mild in healthy children there was never a need to vaccinate, and despite many countries no longer recommending it, our incompetent and corrupt agencies continue to recommend for kids. Including boosters. With no longterm safety data.
You suggest Pfizer had a 100 billion reasons to do better studies. Some might argue they had 100 billion reasons to NOT do the studies. After all, RCTs showing a smaller effect (or even a net harm in some populations) may have made it harder to push and mandate these interventions the way they were.