4:13 PM, Feb 27, 2020


Infectious Disease doctors explain FDA approval process ahead of meeting Thursday

Posted at 7:00 AM, Dec 10, 2020

GRAND RAPIDS, Mich — Canada joined the United Kindom Wednesday, in giving their stamp of approval for Pfizer’s COVID-19 vaccine. Now, it could be the U.S’s turn when the FDA holds their own public approval hearings on Thursday.

Infectious disease doctors in West Michigan say so far, this vaccine approval process has been the most transparent one they’ve ever seen.

You can watch the public hearings on the FDA’s website, Youtube, and other platforms.

“The scrutiny on this thing is intense,” said Liam Sulivan, DO, and infectious disease specialist at Spectrum Health.

Dr. Sullivan, along with Andrew Jameson, MD, the Division Chief of Infectious Disease at Mercy Health tell FOX 17 that they have been looking at the data themselves as it comes out and believe the microscope on a potential COVID-19 vaccine couldn’t be bigger.

Dr. Jameson said, “From someone who looks at the basic science and the data, I’ve been super optimistic.

Dr. Sullivan explains that during the hearings, the FDA will be consulting with and asking questions to an independent advisory panel.

He said, “They are going to do their best not to make a mistake on this, because they know if they screw this up it’s a disaster, it’s a complete catastrophe.”

That advisory panel, Dr. Sullivan said is just another example of the trust and transparency people should have in the FDA approval process.

“They are independent, they don’t work for the government, they work for academic institutions and other institutions across the country, so they are going to be less susceptible to other pressures so to speak, political pressures if you want to put it that way,” Dr. Sullivan said.

Both Pfizer and Moderna turned their data and applied for Emergency Authorization of their respective vaccines weeks ago, so they’ve already had time to review it. Dr. Jameson added that the FDA will be looking much deeper than what the companies provide them.

Dr. Jameson said, “They get all the notes from the doctors, they get all the patient encounter visits from the sites that are doing the vaccine, so they actually get all of the raw data and re-interpret it and re-analyze it themselves for efficacy. So they don’t just believe what the drug manufacturers tell them.”

Both doctors said that this meeting could truly represent a turning point in the pandemic.

“There has probably been no class of drugs more important to the history of medicine than vaccinations,” said Dr. Sullivan.

Doctors said that they hopes the amount of oversight involved in the FDA approval process reassures people that any approved vaccine, will be safe.

Dr. Sullivan said, “They are well aware of the scrutiny of this vaccine and I can pretty much guarantee they are not going to say ‘yes’ to this vaccine, unless they all feel very comfortable with it, and feel ‘yes this is ready to go, yes this is safe, yes it has met all of the rigorous standards for safety and efficacy that we should have in vaccine trails.’”

If Pfizers vaccine is approved Thursday, officials with Operation Warp Speed have said that they expect to start distribution within 24 hours of that approval.

The FDA will hold another hearing discussing Moderna's version of the vaccine on Dec. 17th.

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