On trial

Commenter and blogger, Professor Joel Eissenberg, Department of Biochemistry and Molecular Biology, Saint Louis University.

Introduction: “A group of clinicians and researchers is petitioning the FDA to delay fully approval of any COVID-19 vaccines before clinical trials have been completed, calling the notion of approval to stimulate vaccination rates ‘backward logic.’

The group, led by Linda Wastila, BSPharm, MSPH, PhD, professor of pharmaceutical health services research at the University of Maryland School of Pharmacy, includes 27 petitioners, including 16 experts outside the U.S., primarily based in Europe.

The message of our petition is ‘slow down and get the science right. There is no legitimate reason to hurry to grant a license to a coronavirus vaccine.’ We believe the existing evidence base, both pre- and post-authorization, is simply not mature enough at this point.”

Taken from a blog post published in The BMJ.

If the FDA listens to us, they won’t give serious consideration to approving a COVID-19 vaccine until 2022.” 


I enrolled in the Moderna phase III COVID-19 vaccine trial last August. The trial lasts two years. Initially, it was a double-blind trial, although I knew I was in the vaccine arm 12 h after the booster and unblinded myself with the spike antibody test a month later. In January, all subjects were offered unblinding and the placebos were offered the vaccine.

Meanwhile, the Moderna vaccine has emergency use approval for everyone over age 12, so the number of people vaccinated outside the trial dwarfs the number in the trial.

So the issue is whether the FDA should relent and give full approval to this (and the Pfizer, J&J and AstraZenica) vaccine before the phase III trial is done. Trial participants like me are subject to a much higher degree of surveillance than the rest of the vaccinated public (weekly phone log, monthly wellness calls, six month clinical visits and blood samples) for research purposes. I can understand why the FDA would want the trials to be completed, but what if granting full FDA approval would convince more folks to get vaccinated?

A bunch of physicians just weighed in on the side of withholding full approval pending completion of the trial. As a scientist, I get the importance of data-driven decision making, but the horse is already out of the barn and way down the road on COVID-19 spike protein vaccines. Here’s an article. You decide.

Docs, Scientists Call on FDA to Delay Approval of COVID Vaccines, MedPage Today, June 10, 2021