SAN DIEGO (KGTV) — Two separate clinical trials for phase three COVID-19 vaccines will resume in San Diego next week after AstraZeneca and Johnson & Johnson paused their students to find out why some participants became ill.
“Pauses like this are absolutely common in large phase three trials so people should not be alarmed,” said Dr. Susan Little, the trial director for both studies that UC San Diego is set to take part in. “Studies will only resume when they are deemed safe for the study participants.”
Little said not only are pauses like this common, but they also prove that the safety review process is working as it should.
“Part of the reason we want people to understand that these are common is they will probably occur again, AstraZeneca with 30,000 people, Johnson & Johnson 60,000 people. It would be surprising if we don’t have another pause,” she explained.
Little said once a trial is paused, it is immediately investigated by the independent Data Safety and Monitoring Board (DSMB). The board reviews the issues and determines if they are related to the trial.
“In this case, the event and all other safety events were reviewed and deemed not related,” she said.
The AstraZeneca study is scheduled to start on Monday, and UCSD will be using a mobile vaccine clinic that will travel from Chula Vista, La Mesa, and Imperial Beach.
The Johnson & Johnson study is scheduled for Tuesday in National City, where trailers have been set up as a clinic at El Toyon Park.
“We are signing people up right now to have scheduled visits next week,” said Little. “Safety will always remain the number one priority for study participants.”
Those interested in participating in the study can sign up here.
Participants must be 18 years or older and in generally good health. People with underlying health conditions like heart disease or lung disease may participate.
“They just need to be relatively stable with their conditions,” said Little.