FDA Approves Fourth Booster for Adults >50 Using a Tiny, Single Non-Randomized, Non-Peer Reviewed Study With Zero Safety Data
I've been stunned a few times before. This one takes the cake.
The US FDA approved a fourth COVID-19 vaccine dose (aka “second booster” using a single, small study from Israel.
A few shocking facts about the study:
It was not peer-reviewed. It was published on an NIH pre-print server (something called “Research Square”.
It was not a small study. It was an itsy, bitsy, teeny-weeny study (154 patients) that lasted only 40 days.
It was a retrospective study, not a prospective randomized clinical trial.
It is a single, non-replicated study.
The authors adjusted for risk factors associated with COVID-19 deaths. This is like adjusting for risk factors of dying from cancer in a chemotherapy trial.
The study itself nevertheless generalizes to “the elderly population” and the “older adult population” after adjusting for risk covariates, a logical flaw called translational failure. Their study results are restricted to people without risk of death of COVID-19.
The authors of the study warned that their study had a serious limitation, specifically that the study did not examine the safety of the fourth dose. They wrote:
“An important drawback of this study is the absence of safety data, as it was out of the scope of this short-term study. Future studies will be needed to assess the safety of the second booster administration.”
I have other technical concerns over the authors’ use of censoring data, for adjusting for coexisting illnesses, and other issues that I’ll save for another time.
All of this information is published on the preprint server. The FDA’s inexplicable position on reliance on such a huge recommendation of hundreds of millions of additional medical procedures on such paltry data is indefensible.
Dr. Peter Marks and everyone who rubber-stamped a fourth dose of COVID-19 for people over 50 should resign.
With each "pass" they become more and more bold. It's gotta stop!
I read through the study. It's amazing that the authors want it published with only a 40 day duration and no safety data! Where does it list the 154 patients? The authors looked at the Israeli 2nd booster rollout to 328,597 people out of 563,465 eligible.