ORLANDO, Fla. – A coronavirus vaccine trial has been paused in Orlando.
Johnson & Johnson announced the company has temporarily paused all dosing in the Janssen coronavirus vaccine candidate clinical trials due to a participant having an “unexplained illness.”
Johnson & Johnson has not released what the illness is yet or if the participant received the experimental vaccine or placebo. Orlando emergency physician Dr. Latha Ganti said pausing the vaccine trial can be seen as a good thing.
“As a physician and as a researcher, I am happy that they are pausing to see what is going on and whether this is related. That’s very crucial and it reinforces my confidence in the process. We are told a vaccine will be ready by the end of the year, now the beginning of next year... Understandably, people are skeptical but I will say that developing a good vaccine without taking the shortcuts is important, so in that way, I think this is good news," Ganti said.
More than 600,000 participants from across the globe are expected to be a part of the trials, some of them in Central Florida at the Orlando Immunology Center. Ganti said this protocol is normal for any vaccine trial.
“Whenever somebody has an adverse event, usually the trial will be paused and the data is referred to the Data Safety and Monitoring Board, who will then review the case and decide whether the adverse event is related to the vaccine or drug or not," Ganti said.
The same thing happened during AstraZeneca’s COVID-19 vaccine trial in September. The trial was put on hold when a participant reported a spinal injury. Within days an independent health regulatory organization determined the injury was not related to the vaccine and the trial resumed.
Unlike some other COVID-19 vaccines that are being tested, Johnson & Johnson’s COVID-19 vaccine requires only one dose and does not need to be refrigerated.
“Anytime you introduce a second dose or third dose, your likelihood of compliance with the vaccine is definitely going to go down. I really like that it’s a single-dose vaccine and that it doesn’t have to be refrigerated," Ganti said.
Johnson & Johnson said it is not uncommon for a participant to get ill during a vaccine trial.
Johnson & Johnson said it’s scaling up manufacturing capacity, and if all goes well during its trials, is expected to provide a billion doses in 2021.