INDIANAPOLIS — Late-stage studies of a COVID-19 vaccine trial are on hold after a participant got sick.
Part of the AstraZeneca COVID-19 vaccine trials were planned for Indianapolis.
IU School of Medicine was one of the locations selected to host this clinical trial, but it’s now on hold.
“Whenever anybody signs up for the trial, they understand there are some risks associated with it,” Purdue University Virology Professor Suresh Mittal said.
AstraZeneca is putting its vaccine trial on hold “to review the safety data of a single event of an unexplained illness that occurred in the UK phase III trial.”
Mittal says it’s believed one of the vaccine’s recipients had a “potentially unexplained” illness.
He said illnesses don’t usually happen in a phase 3 trial.
“Those risks are usually minimal because that’s why we do the testing on healthy people. We usually don’t test a vaccine on people who have underlying health issues,” Mittal explained.
Now an independent committee will review the recipient’s symptoms to find out if they were caused by the vaccine.
Mittal thinks if the results show AstraZeneca’s vaccine wasn’t the issue the trial should resume in a few weeks.
All other companies’ trials are continuing.
“In the United States 9 companies have signed an agreement that they are not going to approach the FDA until they’re sure their vaccine is safe to use and also accurate,” Mittal said.
He says the FDA currently isn’t looking at any applications for a vaccine to be released to the general public.
When it is, Mittal thinks Hoosiers should really consider getting it even though he knows some people will refuse it.
“There may be some percentage of individuals who will refuse it. I people get it we will be able to defeat the pandemic and we can get back to our life the way we used to have it,” Mittal explained.
IU School of Medicine wants to ensure the public no one has even signed up for this clinical trial here locally.
President Donald Trump has told reporters he would like to see a vaccine by October.
Mittal thinks we may see one available by December, but scientific data is showing him it may be closer to the beginning of 2021.