When I moved to New York, I put in a request to be transferred from one study site (in Chapel Hill) to another (in Manhattan). I was told that this was a pretty straightforward process, but after weeks of checking in with UNC about my transfer, they just said they still were waiting for Novavax/ICON (who was managing the study) to do the transfer. It got to the point where I felt like it was unethical, because I didn't know whether I was vaccinated (only 2/3 of those vaccinated in January 2021 actually got the vaccine, the rest got the placebo), and we were at the crossover point (which I believe Fauci came up with, which was a point where everyone in the control got the vaccine and everyone in the treatment got the control, that way everyone was vaccinated but nobody knew when they got vaccinated and comparisons could still be made between the two groups while maintaining the ethics of letting people get a vaccine during a roaring pandemic). read more
So, I decided to write an email to speed things up. After waiting 2.5 months, this email kicked things into gear and I was scheduled to get my crossover shot a couple days later. I do want to say: it turns out Cornell wasn't at fault either, they were concerned about some process issues that Novavax/ICON had with regard to transfers and they didn't want to transfer me until those were fixed.
From: Joe Puccio Sent: Thursday, April 22, 2021 7:35 PM To: Roy M Gulick; Kristen Marks; Andrew J Crawford; steve.cutler@iconplc.com Cc: cctucovid; Kerrine Carter; Ciaran.Murray@iconplc.com; Mary.Pendergast@iconplc.com Subject: [EXTERNAL] Novavax phase 3 trial; immediate transfer needed Dear Dr. Marks, Dr. Cutler, Dr. Gulick, and Dr. Fins, I'm Joe Puccio, one of the volunteers in the Novavax phase 3 trial. I'm writing to request that you please complete my transfer to the CCTU site from the UNC site immediately. I moved to New York more than 2 months ago and requested a transfer two weeks prior to my move. I wanted to ensure my participation in the trial was without interruption so that the data collected from me would be most beneficial to the greater good. However, despite the best efforts of myself and the great team at UNC, my transfer has been delayed time and time again, in part by ICON, in part by the CCTU. Because my transfer still hasn't been completed, I have now missed both my day 35 and day 90 blood draws and check-ups. The last time I was seen by study members was February 10th for my second injection, when I still lived in North Carolina. I understand and am forgiving of normal administrative delays, but 2.5 months is not acceptable. Despite all this, because I know how important this research is, I've continued to stay in the trial and blinded even though I've been eligible for an EUA approved vaccine for the past 3 weeks. Now that the blinded crossover is beginning, I believe this administrative delay is progressing from careless to unethical. Please, complete my transfer. Best, Joe