INDIANAPOLIS — This week, Germany and Canada became the latest countries to restrict the use of the AstraZeneca COVID-19 vaccine over concerns of serious side effects including blood clots.
While not yet approved in the United States, the company has released trial results.
Nationwide there were 88 trials. One happening at the IU School of Medicine with 530 participants.
The study is a double-blind trial where two-thirds of participants got the vaccine and the other third, a saline shot. Dr. Cynthia Brown leads the study.
“It takes a lot to bring a size of this trial through the finish line at Indiana University,” Brown said.
Brown said side effects like blood clotting have not been reflected in the IU study.
“As you go from tens of thousands to hundreds of thousands or even millions of people receiving the vaccine it is possible a rare but serious side effect could show up,” Brown said.
While the lead researcher for IU School of Medicine’s AstraZeneca vaccine trial said these are valid safety concerns, she hopes people will give the scientific community time to do more research before jumping to conclusions.
“It’s important also that we let the scientific community try to determine what this might be before we say 'Ok this is not something that should be used worldwide,'” Brown said.
Back in November, WRTV spoke with Brown and participants about this same trial. It was then Brown spoke about trying to recruit a diverse group of participants.
On Tuesday, she said the study recruited “strongly” in the Latinx and 65 and older age groups.
However, the Black and African American community she said was under-recruited. Brown said her team could have been more “upfront” to connect with community leaders and committees to help with enrollment.
She added there was a disconnect and loss of connection with this community between the first point of contact and follow-up.
“We’ve had multiple meetings about this because I think it’s really important as the flagship university and medical school here in this state, that as a research community we understand the potential barriers to enrollment as well as how to make those connections,” Brown said.
The doctor said on a personal note, she has learned through recruitment in this study to not rely on past practices to get the word out about what they are trying to accomplish.
Joe Morris and Mia McLendon both participated in IU’s trial. On a Zoom call Tuesday afternoon, both said they did not experience any side effects.
Morris is a 79-year-old retiree who loves to travel and lives in Bloomington. McLendon is a 44-year-old IT professional and mother living in Carmel.
“I just want us to go back to normal," McLendon said. "I just felt like I needed to do something and this was the way to do it and I don’t regret anything."
The two already received both shots. Unique to this study is the opportunity for participants to know if they received the vaccine or placebo once their age group becomes eligible to get vaccinated in the state of Indiana.
“I was quite fortunate I was one of the two-thirds that got the good vaccine,” Morris said.
As for McLendon, “I have an appointment scheduled for myself and my husband on April 17th and as far as I know, two days prior I will be unblinded.”
All three agreed if the AstraZeneca vaccine does become authorized, do not pass it up.
“If you do not have a history of a clotting disorder in the past, I would not have a hesitancy to take it myself,” Brown said.
McLendon said, “If it’s available I would recommend it.”
“I’m 100% with Miia on that," Morris said. "It’s another option we need as many options to get as many people vaccinated.”
For up to two years, more than 500 plus in the IU trial will be monitored. As for possible Emergency Use Authorization in the U.S., a timeline is unknown at this point.