AstraZeneca COVID-19 vaccine authorized for emergency use in U.K., trials underway at IU School of Medicine

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INDIANAPOLIS — On Wednesday, the U.K. became the first to approve the COVID-19 vaccine developed by AstraZeneca Plc and Oxford. 

After the announcement, U.S. Health and Human Services and Defense Department leaders held a briefing on Operation Warp Speed, saying that the AstraZeneca COVID-19 vaccine will ‘likely’ be authorized for emergency use in the United States in April.

Right now, clinical trials for the AstraZeneca vaccine are being conducted at various sites, including at the Indiana University (IU) School of Medicine.

Experts said they expect the AstraZeneca vaccine to be relied on in many countries because of its low cost to manufacture, availability, and ease of use.

Gregory Zimet, professor of pediatrics and clinical psychology at the IU School of Medicine, specializes in vaccine research. He said, “We are truly in an unusual situation to have so many vaccines coming forward in such a short time span.”

“The upside of all of this is the more vaccines that are available that have good efficacy and good safety, the more people that can potentially be vaccinated,” he said.

“What we’re faced with now in the United States is that the rollout has been okay, but the actual delivery of the vaccines has been somewhat slower than expected and desired,” he said. “So, the more vaccines available, the more production of vaccines, presumably the more that can be administered.”

Zimet believes the AstraZeneca vaccine holds promise for more countries based on numerous factors.

“The Pfizer vaccine has to be kept at a very cold temperature,” he said, “and there are not many places that can store that, particularly as you get into rural areas.”

“The Moderna vaccine has to be stored at a cold temperature, but not nearly as cold, so there’s less logistical problems,” said Zimet.

However, with the AstraZeneca vaccine he said, it “doesn’t have to be kept at ultra-cold conditions, so particularly as we’re looking worldwide, the AstraZeneca vaccine holds greater promise for delivery to low income and low-middle income countries that may not have the infrastructure to keep, you know, what they call the cold chain.”

Another key factor that differentiates the AstraZeneca vaccine from the two already approved for emergency use in the United States is the lower cost to manufacture it.

“It is cheaper to manufacture, which means that’s good in terms of being able to produce and deliver more vaccines,” said Zimet, “particularly for poorer countries where vaccination efforts are often subsidized, but not always adequately subsidized.” 

Operation Warp Speed chief adviser Dr. Moncef Slaoui said Wednesday that recruitment in AstraZeneca’s late-stage U.S. trial is almost complete, with more than 29,000 participants already enrolled.

At IU School of Medicine, nearly 525 Hoosiers have participated in the trial and IU says it plans to enroll more than 1,000. 

More than 3,000 Hoosiers applied within days of the local study site being announced, officials said.

“IU has really been at the center of several different vaccine development efforts,” said Zimet. 

“The Indiana University researchers on the clinical trials have done a great job and we have a good history, so it’s nice to see that history continuing.”

Joe Morris, a 79-year-old retiree and trial participant, said applying for the vaccine trial was an easy decision. “I’m in high-risk category. I got kids and grandkids,” he said.

Morris said, “To be honest with you, one of the most selfish things, is I wanted to start traveling again. I’m tired of staying home. I’m tired of being restricted on what I can do even around home. I don’t have that many years left to take advantage of things I could do.”

He has received both doses of the vaccine and said, so far, he has not experienced any side effects. 

“I’ve actually had no reactions to anything. No redness, no headaches, no temperature, anything. Matter of fact, it was even less than getting a flu shot,” said Morris.

In the study, two-thirds of participants will receive the AstraZeneca vaccine, while the remaining one-third will receive a saline shot as the placebo. Neither participants nor the researchers know who is getting the vaccine and who is getting the placebo.

Morris said if he received the placebo and not the vaccine, he is looking forward to being one of the first in line after to get his vaccination.

“You know, it’s just like getting a measles shot or getting a polio shot,” said Morris. “You have to do it to protect yourself and others.”

Participants will attend follow-up visits for two years and will be compensated for their time.

In November, the IU School of Medicine said results from early-stage trials show a strong immune response, producing both T cells and antibodies, which can find and attack virus cells.

According to AstraZeneca, average efficacy of its COVID-19 vaccine, based on a pooled analysis, is 70 percent, compared to that of Moderna and Pfizer’s vaccines, which both show around a 95-percent efficacy rate.

“If the only vaccine I could get was the AstraZeneca vaccine, I would get the AstraZeneca vaccine without hesitation,” said Zimet.

“The analogy I use for that is if you’re on an airplane and you have to jump because it’s going to crash and there’s one parachute, it’s damaged, so there’s a 30 percent chance it’s gonna work, do you jump without the parachute or with the parachute? I’ll take my chance with the parachute because it’s a 30 percent chance, it’s gonna protect me. No parachute is zero,” he said.

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