Fragmented and Poorly Executed- the Failed Potential of mRNA Vaccine Therapeutic Platform

It has taken Pfizer nearly 2 years to publish a paper showing any data regarding whether the mRNA is actually made into a protein product. Two years!!! This work should have been available before the emergency use authorization (EUA) was granted for the vaccines. Unfortunately, none of the basic bench-to-bedside work was submitted for these mRNA vaccines and surprisingly the FDA vaccine approval panel did not ask for any data to show that the fundamentals behind the mRNA platform, such as mRNA integrity and delivery to its proper subcellular localization was indeed happening and that the mRNA was being translated into a protein product. Over the past two years more than 12.7 billion doses of these mRNA products have been delivered to a largely otherwise healthy population worldwide. The first publication from Pfizer is long overdue- the paper is very telling and disturbing to say the least.

Tardy and Murky Data: Hallmark of Pfizer and Moderna mRNA Vaccine

In my scientific career of reviewing manuscripts for over 25 different journals and having served on the editorial boards of 3 Scientific Society Journals (The Endocrine Society, American Physiological Society, and FASEB) and other peer reviewed journals, I have seen manuscripts rejected for several reasons, but mainly poor quality of data and those that lack proper controls. Many manuscripts submitted these days report bare minimum methodology, making it impossible for their results to be replicated. The paper titled “Characterization of BNT162b2 mRNA to Evaluate Risk of Off-Target Antigen Translation” falls in the category of a poorly executed study, without proper controls, and inadequately executed methodology. I would rate the paper in the bottom 50% of those submitted. At any other time, I would have passed this off as just another poor-quality publication and data, but what is really scary and troublesome is the fact that this methodology and platform has already been administered to millions of healthy people- children, pregnant women, adults, elderly, and immunocompromised. The scientific community and the public should be up in arms, but the constantly moving goal post about vaccine effectiveness and safety that has been shamelessly amplified by…