Vaccine trial participants starting to find out if they got the real shot in unblinding

Medical Watch

The Moderna trial was randomized and double-blinded, which meant some people got the actual COVID-19 vaccine and others received a placebo. No one knew.

Today, trial participants are finding out. Moderna made the decision to unblind the trial because it was simply unethical to keep people in the dark and not able to get the protection so many want and need.

Study participants, like Eduardo Rollox, were happy to sign up for UIC’s Moderna COVID-19 trial. On Thursday, he was even happier as he awaited the call from study leaders beckoning him back to UIC.

“At that visit they are unblinded. If they received placebo, they are getting vaccinated at that visit,” UIC Chief of Infectious Diseases Dr. Richard Novak said.

Bonnie Blue, 68, the first study participant to roll up her sleeve, always thought she got the real deal. It turned out she received the placebo.

But thanks to the unblinding, now she received the vaccine.

“I was excited because I was putting my future, as much as anyone possibly can, I was putting my future and my health in my hands,” Blue said. “This gives us an opportunity to try to protect ourselves so we can fight back, so we can be here for our family and for other people.”

The decision came from Moderna to fully inform study participants as it considered the cost to people who were willing to help advance science in the development of a vaccine to fight to novel coronavirus.

Once the shot was rapidly discovered, the very people who helped make it possible, might not be able to get the inoculation that has proven to prevent people from getting sick.

“It wouldn’t be ethical to keep people blinded and on placebo knowing that there is an effective vaccine available,” Dr. Novak said.

But in putting study participant’s best interests first, trial data will be compromised.

“It’s a little bit frustrating but we have to temper that with the fact that it’s so exciting we actually have an effective vaccine in such a short time,” Dr. Novak said.

By vaccinating all participants, the study focus will shift to immunity and the duration of efficacy.

“As we’re unblinding people now we are bringing everybody back whether they got placebo or vaccine, and collecting blood samples on them at the time of unblinding because those blood samples will question that question,” Dr. Novak said.

There were 300 Moderna study volunteers at UIC with another 125 at the University of Chicago. By next week, they should all be informed and vaccinated pending supply. Pfizer is expected to unblind its study participants and vaccinate by March.

Listen to the Bair Facts on Health

Get the real facts on everything from diet trends to cutting-edge treatments, brought to you by Dina Bair and actual experts, so you can ignore the noise on social media and make informed decisions about your health.

Subscribe to the podcast

Apple Podcasts

Pocket Casts

Spotify

Stitcher

Popular

Latest News

More News