Yesterday, Ed Morrissey discussed the rather awkward decision-making process that went into the FDA’s plan to skip their normal advisory panel process and grant immediate, emergency authorization for all adults to receive booster shots of either Pfizer or Moderna vaccines six months after receiving their initial vaccination. The CDC also appeared to be skipping over a few steps in the normal procedure and trying to catch up with the politicians at both the federal and state levels. These rapid changes in not only the decision-making process but how the boosters would be rolled out by age groups and other factors have rightly raised questions about how organized this process is and how much they are “following the science.” Perhaps all of this confusion became obvious to the FDA because later that same day they sent out vaccine chief Dr. Peter Marks to explain what this “simplified” system really means. (Associated Press)
The U.S. government’s booster campaign got a lot simpler Friday after Food and Drug Administration officials authorized the Pfizer and Moderna COVID-19 vaccines for all adults. It replaces a complicated system in which eligibility was based on age, health conditions and other factors.
“It’s simplified things, I think significantly over the situation that we had in place previously,” FDA’s vaccine chief Dr. Peter Marks told The Associated Press.
The FDA action comes after months of debate among experts over whether everyone 18 and older should get an extra shot for protection.
The helpful thing about this AP report is that it covers some of the recent history of this debate, not among members of the public, but inside of the CDC and the FDA. The White House has been pushing for boosters for a while now, but as recently as two months ago, the FDA’s own advisers “soundly rejected” the idea, saying there was no need and the testing of boosters was still underway. When they did get around to saying that boosters shots might be able to begin, they put forward the same cautious approach that was used with the original approval of the vaccines. They suggested that the oldest and those with underlying conditions should go first, followed later by those in lower-risk groups.
So how did all of that go out the window and get replaced by this “simplified” system so quickly? According to Dr. Marks, “I think we are at a point in this pandemic that everyone, including state governors, are getting a little bit desperate.”
So you’re saying that the “desperation” of state governors – a group of politicians, not one of whom is a virologist – outweighed your normal laboratory data evaluation process? Is that was passes for “following the science” these days?
The FDA also gave a nod to the fact that we are still seeing some (thankfully rare) cases of myocarditis. But they said that the risk of that was “outweighed” by the “extra protection” offered by the boosters. It’s worth noting that this FDA approval of “simplified” boosters for all includes both Moderna and Pfizer. But in the European Union, their scientists came to a different conclusion, authorizing only Pfizer boosters because the heart inflammation risks of Moderna were deemed to be too much. Both sides can’t be correct about this.
Getting back to one point that Ed made yesterday, these jokers at the FDA and CDC are simply creating even more layers of confusion. We were told for nearly the entire year that the vaccines were “safe, effective, and free.” But if they’re all that effective, why do we need boosters so soon? (As soon as two months if you opted for the J&J vaccine.) Has something in the formula for the boosters changed to make them last longer or are we going to be having the same damned debate yet again in April?
It’s sounding more and more as if this “simplified” system was born out of political necessity far more than any sort of scientific method. And it’s not as if the individual states were all waiting for a green light from the feds anyway. My wife and I went back to consult with our doctor more than three weeks ago and asked for more information about the boosters. She looked into it and not only suggested we get a Pfizer booster (we did Pfizer the first time) but offered to make an appointment for us the same day. That was well before any FDA approval had shown up. (We haven’t done it yet, by the way.)
If the White House was hoping to build confidence in these shots and expand public support for Biden’s vaccine mandates, this isn’t the way to do it. Also, their constant chatter about “following the science” is looking more and more like an empty political slogan than actual expertise in handling a public health challenge.
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