INDIANAPOLIS (Network Indiana) — A potential coronavirus vaccine will go through clinical trials at I-U-P-U-I.
The vaccine developed by AstraZeneca is of four potential COVID vaccines in their final phase of testing before federal approval. The I-U School of Medicine will be one of 81 sites nationwide testing the vaccine on 30-thousand volunteers.
I-U will inject its first test subject next week. Researchers are looking for 15-hundred adult volunteers who haven’t had the virus already, and who work in places like schools, stores and warehouses, placing them at higher risk for exposure to the virus.
I-U clinical medicine professor Cynthia Brown says the AstraZeneca vaccine is actually a one-two punch of two vaccines, with patients returning for a second shot four weeks after the first. That means patients won’t start getting the second dose till mid-October. The Centers for Disease Control have advised states to be ready to distribute a vaccine by November.
Brown says other trial sites have already started administering the AstraZeneca vaccine, and two other companies are more than a month into trials on their own versions. The companies’ data review committees will assess when there’s enough information to say with confidence whether the vaccine is both effective and safe. It’s then the Food and Drug Administration’s job to decide when there’s enough data showing a meaningful response to approve the vaccine.
“I just want to say I’m glad I’m not at the F-D-A having to make those decisions,” Brown says.
Followup with participants will continue even past approval of the vaccine, for up to two years. Brown says researchers need a full picture of any potential side effects, and are trying to establish how long patients remain immune after receiving the vaccine
