ORLANDO, Fla. – A COVID-19 vaccine trial has been paused in Orlando after a study participant at another site developed unexpected complications.
The Orlando Immunology Center is participating in the coronavirus vaccine study sponsored by Oxford University and AstraZeneca.
OIC officials said a study participant at another site who received the same vaccine under going trials in Orlando has developed a serious unexpected adverse event.
There is no word at this time if the vaccine was the cause of the event, according to OIC.
Officials said an independent committee is going to review the situation.
“The basic science for this study is very robust. It’s very solid,” said OIC Medical Director Dr. Edwin DeJesus.
DeJesus said they have recruited about 50 people to participate in the study since Aug. 31.
He said all 50 people have received injections. Two-thirds of them received the experimental vaccine, and one third received a placebo.
The vaccine trial is on hold pending the results of the investigation, according to OIC. Researchers said this is routine action when an unexplained illness takes part in a clinical trial.
“Those participants will continue to be monitored until the date that they are due for their second vaccine,” DeJesus said. “The second vaccine -- which is the last, there’s two vaccines total -- is 30 days from the first one.”
Officials said none of the Orlando participants have developed any adverse events.
The trial involves 30,000 participants across the world, officials said for every two random participants to receive the vaccine, one gets a placebo.