Johnson & Johnson’s COVID-19 vaccine trial is now on hold, after a participant became ill. Though pauses are not uncommon throughout the study or trial process of new medication, the pressure and demand of developing a vaccine to fight COVID-19 has cast a spotlight on those pauses.
Study pauses can vary, sometimes just last days. Little information has been given about the patient, but Johnson & Johnson’s researchers are studying the patient’s illness.
The same trial was set to begin recruiting participants in Northwest Indiana recently and has also been put on hold for the time being.
Dr. Robert Buynak is the owner of Buynak Clinical Research in Valparaiso, and facilitator of the vaccine study in the Region. He said the selection of northwest Indiana to find participants was based on COVID-19 cases, its geographic location and diverse minority populations.
“If a medication is studied in one group, but then it’s being used by another more diverse group, can you say the effects are the same in the study group, then the group actually using the drugs?” Buynak said.
Buynak said this is important since minority groups are primarily experiencing higher rates of mortality and infection when it comes to COVID-19.
Johnson & Johnson is conducting Phase 3 of their vaccine study with more than 60,000 participants enrolled.
A vaccine trial made by AstraZeneca and Oxford University, was put also on pause and is still being reviewed by U.S. officials.
Eli Lilly Pauses Antibody Study
Eli Lilly also reportedly paused its monoclonal COVID-19 antibody treatment study, ACTIV-3, Tuesday, due to safety concerns. However, Indianapolis-based Lilly has yet to release any more details about the safety concern.
The company had previously requested emergency use authorization (EUA) from the Food and Drug Administration, with plans to produce hundreds of thousands of doses of the drug before the end of the year.
Lilly also planned to request an EUA for their combination therapy, similar to what President Donald Trump was given after he was diagnosed with COVID-19.
This story has been updated with information about Lilly's COVID-19 antibody treatment study.