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Doctors say AstraZeneca data setback should bring confidence in the oversight process

Posted at 5:48 PM, Mar 23, 2021
and last updated 2021-03-23 19:38:20-04

GRAND RAPIDS, Mich — An independent advisory panel is asking for more updated information for AstraZeneca’s version of the COVID-19 vaccine.

The drugmaker has 48 hours to release that data, but in the meantime health experts in West Michigan say this request is the perfect example of the approval and safety process working like it’s supposed to.

“There’s been some concerned that AstraZeneca may have used some outdated information,” said Dr. Ronald Grifka, chief medical officer for Metro Health University of Michigan.

The company’s latest data is the biggest concern for the Data and Safety Monitoring Board, also known as the DSMB.

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Dr. Grifka said even with the information available, the vaccine looks promising.

“AstraZeneca says it’s 79% effective against symptomatic disease and 100% effective against the severe or critical disease in hospitalization, which is fantastic results,” he said.

This setback comes right on the heels of the vaccine’s suspension in a few European countries after reports of blood clots in some vaccine recipients.

However, Dr. Liam Sullivan, an infectious disease specialist with Spectrum Health, said there hasn’t been.

“At this time, Europe’s FDA equivalent and the World Health Organization have both deemed that this vaccine does not indeed cause blood clots. The interesting part about this is that they have not had this problem in the United Kingdom, where they’ve probably administered more AstraZeneca vaccine than anywhere else in the world,” he said.

Dr. Sullivan added this latest setback for the company is actually a really good thing for the community.

“That’s what the Data Safety and Monitoring Board’s job is: is to be that independent advisory board to say, ‘Hey, wait a minute, this isn’t quite right; you need more data here; you have a safety problem here.’ That is their job, and it’s good to see this process is working like it's supposed to be working,” said Dr. Sullivan.

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While the latest news may have people feeling concerned, Dr. Sullivan hopes it’ll increase trust in the system.

He said, “It should make people feel ‘Okay, at least someone is looking at this, and it isn’t just coming out of the vacuum from somewhere.’”

Both doctors are eager to see the new data from AstraZeneca in the coming days and know that while the vaccine appears to be safe, it’ll be under a bigger microscope.

Dr. Sullivan said, “They had to halt their clinical trial in the United States, and then they came out and said they had a dosing error in their clinical trial, so they’ve had to battle some public relations issues throughout their clinical trials with her vaccine, so I think the FDA is going to be especially scrutinizing of them when they go through their data.”

Dr. Grifka added, “Rest assured, the FDA has done the due diligence with the three vaccines that they have approved, and they’ll do the same thing with the AstraZeneca, and they are in the process of analyzing that now, hopefully will find out very soon.”

AstraZeneca is expected to officially apply for Emergency Use Authorization to the FDA within the first two weeks of April.

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