On trial

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. https://www.medpagetoday.com/special-reports/exclusives/93035?xid=nl_mpt_DHE_2021-06-11&eun=g1700464d0r&utm_source=Sailthru&utm_medium=email&utm_campaign=Daily%20Headlines%20Top%20Cat%20HeC%20%202021-06-11&utm_term=NL_Daily_DHE_dual-gmail-definition