As millions of Americans continue to get vaccinated every day, the process of how we got here is nothing short of a big step in innovation in the eyes of health experts.
“The very thought that we could possibly have a vaccine that's effective in a year is scientifically miraculous,” said Dr. Richard Zane, chief innovation officer at UCHealth.
So, how did we get here? A few processes made the COVID-19 vaccine trials different than others.
“Clinical trials often happen serially,” said Dr. Zane, who is referring to how, for normal trials, we move from phase to phase after completion.
However, in this case, Dr. Zane says everything happened in parallel.
“We didn't wait for phase one to be fully completed before beginning phase two and phase three,” Dr. Thomas Campbell, chief clinical research officer at UCHealth, said. “Mass production of the vaccine was actually beginning before we even had the phase three results.”
Dr. Campbell has spent almost two decades in clinical research.
“With COVID, there was clearly a global health emergency and we needed to get to the vaccine as soon as possible,” he said.
A large number of people continue to show interest in volunteering in vaccine trials, and the internet is playing a big role in helping researchers keep up with all of those volunteers and all of their data.
“These vaccine trials have included other measures like electronic diaries where participants are reporting in real-time what symptoms they are having or not having via an app they install on their smartphone,” Dr. Campbell said.
“This concept of being able to do virtual decentralized clinical trials had been evolving for years. Not many years but two or three years,” Dr. Zane said.
Michael Rouse experienced it firsthand.
“We used an app that could instantly feed our data into NIH,” Rouse said.
He is a phase 3 vaccine trial participant. He uses the app for weekly follow-ups with researchers.
“This is the first clinical trial I’ve volunteered for. Because this was a global pandemic, I just felt I wanted to do something,” he said. “On August 20, when I got my first vaccine, I didn't know if I actually had the vaccine or if I had a placebo.”
In January of this year, he was told he did get the vaccine and will be monitored for the next two years for long-term effects. Every three months, he goes in to get his blood taken, but otherwise, being a participant is a remote experience.
Moving forward, Dr. Campbell and Dr. Zane believe there are some lessons we can take from how these trials are being handled, but it won’t make sense in every scenario.
“We have a COVID vaccine, which clearly had a business case. The entire globe is going to need this vaccine,” Dr. Zane said. “Who is going to buy 100 million doses of these vaccines before you even put a needle in an arm? So, they had 100 million doses guaranteed purchase, whether it worked or not. They had a lot to gain and very little to lose.”
“These type of lessons we've learned with COVID, even if they’re not going to change the way we do clinical trials for less pressing medical illnesses, we’ll at least have this experience that can be used for future global emergencies,” Dr. Campbell said.