Roy Exum: Wary Of Booster Shots

Monday, September 27, 2021 - by Roy Exum
Roy Exum
Roy Exum

The Hamilton County Health Dept. has announced they’ll start administering the COVID-19 booster shot today but after former FDA Commissioner Dr. Scott Gottlieb appeared on “Face the Nation” yesterday, I am not as sold on the Pfizer booster as I had hoped I would be. Not only do I think the process has been too hurried, the CDC is purposely vague and I’m looking at this as “wait-and-see.”

Understand, I’m as pro-vaccine as they come. I’ve not only taken two Moderna doses but recently was given a third because I’m autoimmune compromised. There are 2,319 active COVID cases right now in the county with 239 in the hospital. Hamilton County’s death toll was 613 as of Friday and the infectious disease is still raging here.

We have 143 new cases a day right now.

But because the CDC and the FDA have yet to agree on the best usage of the boosters, who should get it and when, right now there isn’t a solid plan. Commentator Margaret Brennan noted CDC director Dr. Rochelle Walensky has admitted a lot of confusion over who should get the Pfizer booster and asked Dr. Gottlieb, “Well, the CDC director said, ’I recognize confusion.' So, she's acknowledging that there is some confusion on who falls into that frontline worker category of someone who should self-select to go get a booster shot. In your view, should all of us eventually go get a booster?”

The renowned doctor said that’s an open question. “I think the data is still to be determined on that question. I mean, very clearly- look, they authorize it for anyone 65 and above and in a long-term care facility. I think that you can make an argument that the data suggests that people above the age of 60 and maybe even above the age of 50 should get a booster based on just a … a ‘risk benefit analysis’.

What’s this: the health department rolls out a Pfizer booster and neither the FDA nor the CDC can agree who should take it? Oh please. (Note: The boosters for the Moderna and the Johnson & Johnson boosters have not yet been introduced and medical minds say don’t mix the brands. Those with Moderna or Johnson & Johnson should wait for corresponding boosters.)

"And that's where the FDA ultimately was heading in the discussion that they had. But people below the age of 50 who are otherwise healthy, I think it's an open question right now. The data isn't strong to support the question either way. But those who have medical risk factors, I think, certainly need to take that- take that into consideration and people who have occupational exposures. And that's exactly where the CDC came out. They left a lot of flexibility—for people to make judgments on their own risks and for doctors to guide their patients.”

Commentator Brennan  noted the CDC director Walensky didn't take it off the table that it would open up. In fact, what the president said is that we will eventually open it up. And she did seem to say no, not yet, leaving room to do so. Is that a political judgment?

DR. GOTTLIEB: Look, I think they created a set of criteria, the CDC did, where they ultimately came out that are very sort of accommodating, and it's going to allow a lot of people to self-select into boosters if they want to and a lot of doctors to make recommendations for patients to get boosters. I think that was intentional, the- the language they ultimately used. I think they want a frictionless process. That's what I've been told by pharmacies who've been advised by the CDC. And I think the director's comments today reflected that, where she didn't want to really articulate very clear divides on who should and shouldn't be opted into getting a booster. She left it very general in terms of her own advice and, you know, left it to patients to make judgments with their doctors and with themselves.

MARGARET BRENNAN: Lastly, the CEO of Pfizer, the company you served on the board of, affirmed today that that data on vaccinations for 5 to 11 year olds will be going to the FDA within a matter of days. Is that confirming your schedule of vaccines by Halloween?

DR. GOTTLIEB: Yeah, I think that's still possible. FDA has said that the review is going to be a matter of weeks, not months. I- I interpret that to mean potentially a four-week review, maybe a six-week review. So, I think on the low end, it could take four weeks and that could give you a vaccine by Halloween. If it slips a little, it could be mid-November.”

That may be when the Centers for Disease Control and the Food & Drug Administration agree on booster shot, but until the two do, I think I’m going to stall.

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