AstraZeneca trial continuing at MUSC; doctors hopeful FDA approval could come soon

Updated: Jan. 22, 2021 at 4:16 AM EST
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CHARLESTON, S.C. (WCSC) - Approved COVID vaccines are in short supply but another option already approved in other countries is being tested in the Lowcountry.

The AstraZeneca trial is currently underway at MUSC. It’s a study that’s designed to last for two years but the more immediate goal is to get another vaccine out to the market so people can be protected against COVID-19.

“By the plan, the AstraZeneca study will then soon look at their interim data, specifically looking at those subjects who did suffer a COVID infection, to see if there’s a difference between those who got a vaccine and who got a placebo,” Dr. Patrick Flume, a professor of Medicine and Pediatrics at MUSC, says.

The AstraZeneca trial at MUSC has been ongoing since September. The overall study enrolled more than 30,000 people, nearly 650 of which are at MUSC.

“The only way you can have a vaccine is to have people testing first,” Donald Muglia, a Mount Pleasant resident who’s taking part in the MUSC trial, says.

Muglia started the trial last month.

“I’ve always wanted to become a trial person,” Muglia says. “It’s the only way that you can get new drugs on the market and new vaccines on the market.”

Muglia has already had his second dose, like all of the MUSC participants. And, while he isn’t sure if he got the actual vaccine or a placebo, he’s happy to be a part of history.

“It’s well worth it; you’re helping the entire world,” Muglia adds.

This trial has been interesting though because some people in the study were actually eligible to get the already approved Pfizer or Moderna vaccines.

“We were permitted to break the blind and identify if they had received placebo or actual vaccine, so that those who did get placebo were now able to go and get the Pfizer or Moderna vaccine,” Flume says.

Those people will stay in the study though so they can be monitored over time.

MUSC is also continuously sending the data, from the active participants in their trial, to AstraZeneca to be analyzed to see how effective the vaccine is.

“The FDA set the bar at 50% to try and get approval,” Flume says. “And, if they hit a good number and there’s sufficient safety, they’ll go for an EUA. That would substantially increase the ability of us to begin vaccinating the larger population.”

But the big question is – when could that happen? Flume likes to think it could be around the corner.

“On the one hand, the UK gave the authorization for its use based upon the data obtained from the study done in the UK and Brazil,” Flume says. “Ours is a much more global study. There’s little reason to suspect that we will get vastly different results than what they got.”

While Flume couldn’t give a specific date, he hopes that, any day, they’ll get the results from all of the data being collected. If those results are good, it shouldn’t take long to get an Emergency Usage Authorization from the FDA. Even when that happens, though, the MUSC study will still continue over the next couple of years.

While the AstraZeneca trial is ongoing, MUSC is also now involved in the Johnson and Johnson Jensen trial and the Novavax trial. They’re looking to enroll up to 500 participants each.

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