A Booster Shoot For Presidential Administration

President Biden assures people booster shots will be widely available. And his CDC director overrules her agency's narrow recommendations.

A quarter century ago, then-Professor Kagan published her most influential work of scholarship, Presidential Administration. She explained "that President Clinton, building on a foundation President Reagan laid, increasingly made the regulatory activity of the executive branch agencies into an extension of his own policy and political agenda." Recently, President Biden gave presidential administration a booster shot.

Earlier this week, President Biden predicted that booster shots would become available "across the board." However, the CDC Advisory Committee on Immunization Practices only recommended boosters for older Americans, as well as people at higher risk of the disease. The Committee did not recommend boosters for health care workers, teachers, and others in high-risk positions. Yet, that same day, CDC Director Rochelle Walensky overruled her committee. The New York Times reported that the reversal was somewhat chaotic:

The C.D.C.'s statement arrived well past midnight, a sign of the complicated and confusing decision-making surrounding the boosters. The C.D.C. advisers similarly spent two days debating who should get boosters and when, and could not agree on whether occupational risk should qualify as a criterion. . . .

Minutes before Dr. Walensky's statement, Dr. Amanda Cohn, who oversaw the two-day meeting of the panel, tried to prepare the advisers for the director's decision.

"Dr. Walensky is reversing the decision to not recommend use of a booster dose in persons at high risk for occupational or institutional exposure," Dr. Cohn wrote in the email. "I am hoping to share this news with you before you see it in the press."

Dr. Walensky's decision to go against her own agency's advisers came as a surprise to at least some of her staff members: The C.D.C. director's endorsement of the advisory committee's recommendations is typically just a formality. Hours before her statement, agency insiders predicted she would stick with the usual protocol because doing otherwise would undermine the process and upset the advisers as well as her own staff.

Indeed, the Times suggests that Biden's comment may have put "pressure" on #FollowTheScience.

But Mr. Biden's public embrace of booster shots has rankled many in the public health sector, including those working inside the government, who say it could have the effect of putting undue pressure on scientists to make a recommendation they do not believe is supported by the evidence.

Some public health officials and doctors say they fear Mr. Biden — who has staked his presidency on successfully managing the pandemic — is pushing for boosters because they are politically popular.

…

The president's Friday remarks were the second time in two months that he had suggested boosters would be available to everyone. And they were issued on the same day that Dr. Rochelle P. Walensky, the C.D.C. director and one of the president's political appointees, came under fire for allowing boosters for a broader group of people than her agency's own immunization panel recommended.

Taken together, the announcements by Mr. Biden and Dr. Walensky did not sit well with all of the scientists who advise them, raising questions about the president's pledge to always "follow the science" as he fought the pandemic. While some of them credited the C.D.C. director for charting a course through uncertain waters, others warned that politics had intruded on scientific decisions — something that Mr. Biden had promised to avoid after the blatant pressures seen during the Trump administration.

"Everybody uses this statement 'follow the science' very glibly, and I think that the science here did not warrant picking out a group of people and saying that you may be at more risk for acquiring an infection," said Dr. Sarah S. Long, a member of the C.D.C.'s advisory committee, referring to the groups of workers who were made eligible for booster shots.

Dr. Long, who is a professor of pediatrics at Drexel University College of Medicine, said that a president telegraphing his opinion before the formal public health process undermined the expert advisers, calling it a violation of the "checks and balances" built into the system. She also criticized Dr. Walensky for expanding the number of people eligible for the boosters.

Checks and Balances! More like Presidential Administration. The accountable President is in charge. Not an obscure panel of scientists.

Comments

[Chernobog]

This entire argument falls apart when you acknowledge that the FDA recommended boosters.

[Michael P]

Does the FDA have some Borg-like hive mind, or just a political appointee at the top?

[Chernobog]

The FDA panel that assessed the vaccine recommend boosters for high-risk workers. So this isn't a case where the weight of science was against boosters and a political appointee ignored that for political reasons, which is what Josh is implying.

[Michael P]

I think you really need to elaborate on what panel and what recommendation you are pointing at. The only FDA panel decision I can find was a recommendation that people 65+ or at "high-risk of contracting severe COVID-19" get booster shots: https://www.ny1.com/nyc/all-boroughs/health/2021/09/17/fda-panel-meets-to-decide-on-pfizer-covid-19-booster-shots . The CDC/FDA decided the panel was underinclusive, but you write as if the agency merely followed the panel's recommendation.

[JJJSSS]

Read more closely: https://www.fda.gov/news-events/press-announcements/fda-authorizes-booster-dose-pfizer-biontech-covid-19-vaccine-certain-populations

The groups included were:
*Individuals 65 years of age and older;
*Individuals 18 through 64 years of age at high risk of severe COVID-19; and
*Individuals 18 through 64 years of age whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of COVID-19 including severe COVID-19.

[Michael P]

Right. That's what the political appointee at the head of the FDA approved. The vaccination science panel decided against including the last group, but that decision was overridden -- perhaps because otherwise it made Biden into too much of a liar.

[James Pollock]

Where do you go to get your revisionist history textbooks?

[James Pollock]

"Does the FDA have some Borg-like hive mind, or just a political appointee at the top?"

It's a bureaucracy, so the answer to your question is "yes".

[jimc5499]

The FDA panel that was looking at booster shots did NOT recommend them. The FDA brought in an OUTSIDE panel that recommended them. Two of the people on the FDA panel resigned over this.

[Rossami]

It's taken me a while but I think I finally figured it out. Chernobog's opening statement is wrong - not by much but enough.

The FDA did not "recommend" boosters. The FDA approved boosters - that is, they said that you are allowed to get a booster if you're in the approved categories (and their approved categories did include occupational exposure).

The CDC panel, on the other hand, did issue a report that specifically "recommended" boosters - that is, they said who should get boosters whether or not they are allowed. The CDC panel's report did not include a recommendation for those in the occupational exposure category.

Since the FDA decision was for a different purpose, it cannot be directly compared to the CDC panel's recommendation. Trying to do so is a red herring.

[Rossami]

To illustrate the difference with a silly example, the USDA will allow you to hang a raw pork chop around your neck. The US Forest Service will recommend that you not do so when sleeping in grizzly bear country.

[circleglider]

Biden promised boosters “across the board.” That means everyone. So arguing over which agency “approved” or “recommended” that vaccine boosters be administered to which narrow subset of the population is a straw man.

And unlike pork chops, the only way for an ordinary individual to obtain a COVID-19 vaccine without committing a federal felony is through a licensed healthcare provider. These providers risk legal sanction if they administer any prescription medicine to anyone contrary to the guidance of federal agencies—including the FDA, CDC and whatever other agency might claim such power. Which leaves no method for an individual outside of the various recommended or approved populations to obtain a booster, yielding straw man number two.

At the end of the day, who gets a vaccine paid for by taxpayer dollars is a political policy question involving the allocation of scarce resources. Science may inform the decision-making process, but it cannot by itself provide an ultimate resolution.

Unless, of course, the unelected bureaucrats aren’t doing “science” but instead are simply making political policy.

Which mean Professor Blackman was absolutely correct.

[Rossami]

No disagreement. My point was only that the FDA and CDC panel were answering different questions so the argument at the top of this thread that one agency said X while the other said Y is a red herring.

[James Pollock]

"Biden promised boosters 'across the board.' That means everyone."

Check the tape. Biden was always careful to specify "per CDC guidelines" or some variant.

We're still a few steps shy of hunting down the vaccine-defiant, and holding them down while they get a shot they didn't want.

[circleglider]

Yep, “check the tape.”

Read Biden’s 8/18/21 speech, beginning at 11:04. He repeatedly makes unqualified, categorical statements, including “booster shots to every fully vaccinated American, adult American,” “The plan is for every adult to get a booster shot eight months after you’ve got your second shot,” and “anyone vaccinated on or before January 20 will be eligible to get a booster shot…”

He closes by reiterating, “It will be easy. Just show your vaccination card and you’ll get a booster. No other ID, no insurance, no state residency requirement.”

https://www.rev.com/blog/transcripts/joe-biden-covid-vaccine-booster-shots-speech-briefing-transcript

[James Pollock]

So, you couldn't be bothered to do what I asked, and look for the disclaimer.

[James Pollock]

"To illustrate the difference with a silly example, the USDA will allow you to hang a raw pork chop around your neck. The US Forest Service will recommend that you not do so when sleeping in grizzly bear country."

At least when you choose to be stupid in this exact manner, you are the one who will get the claw marks. The bears mostly choose to keep distant from people, unlike coronaviruses, which are only too happy to invade your personal spaces.

It's like the virus doesn't even care.

[James Pollock]

"This entire argument falls apart when you acknowledge that the FDA recommended boosters."

The political argument is this:

Premise 1: Biden (and other Democrats) want us to get vaccinated.
Premise 2: We want whatever the opposite of what Biden wants.
Conclusion: Therefore, we don' want no vaccine, dammit! QED.

[Life of Brian]

Given that Moderna had to abandon its original VC-funded dream of mRNA-based therapeutics and switch to vaccines because they couldn't come up with an mRNA dose that was both effective and could be repeatedly administered without blowing up the immune system, liver, etc., it is astounding to me how many people are rabidly jumping onto the booster hamster wheel.

(The fact that the CDC/FDA are blessing the widespread use of boosters in the face of an overwhelming vote to the contrary by the FDA's advisory panel is sadly predictable, but far less astounding.)

[Chernobog]

The FDA voted in favor of boosters for high-risk workers, people at high risk due to health conditions, and people over 65. Which is exactly what CDC authorized.

[Life of Brian]

The FDA voted in favor of boosters for high-risk workers, people at high risk due to health conditions, and people over 65. Which is exactly what CDC authorized.

Negative. The committee voted against high-risk workers.

Totally coincidentally, the category where the FDA broke ranks with the committee happens to be an exceptionally squishy one that basically will provide cover for anyone at any age to get a booster (and for many to get pressured to do so), per the administration's desire.

[Chernobog]

You just linked to the CDC panel's recommendation to refute that the FDA voted to approve it.

[Chernobog]

Oh, you thought I was arguing that the CDC panel voted to authorize it. My point was that CDC authorized it through the director's override—which is consistent with FDA.

[Life of Brian]

My point was that CDC authorized it through the director’s override—which is consistent with FDA.

My original comment said that the FDA and CDC were both contravening the panel's advice, so apparently we're on the same page despite appearances to the contrary.

[Chernobog]

We're not at all on the same page. There are two panels at issue: the FDA panel, which approved boosters for high-risk workers, and the CDC panel, which—in a narrow vote—did not. The CDC director's override is consistent with the FDA panel's recommendation, but not with the CDC panel's recommendation.

[Chernobog]

Note that the FDA recommendation preceded the CDC recommendation, so if anything the CDC panel "contravened" the FDA panel.

[Life of Brian]

the FDA panel, which approved boosters for high-risk workers

That's not correct either. The FDA panel voted 18-2 against boosters for the general adult population, and then voted to approve them for "people 65 and older or at high risk of severe COVID-19." The FDA's final amendment to the EUA included those two categories, and added "individuals 18 through 64 years of age whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of COVID-19 including severe COVID-19." And the CDC's rendition of that last category is even looser.

It's really not clear at this point what sort of academic pinhead you're trying to dance on here, unless it's to distract from the simple fact that apparently we "follow the science" only when politically convenient.

[Dick King]

I strongly suspect that the recommendation was rewritten because somebody noticed that not enough BIPOC would be eligible under the FDA recommendation.

Remember that in the early days [fall-winter 2020] there was that matrix of saving lives, social equity, or reducing transmission, versus three possible prioritization's, and they decided to recommend prioritizing certain occupation categories, which they judged likely to lead to about 6% more deaths but to be more equitable.

-dk

[James Pollock]

"Remember that in the early days [fall-winter 2020] there was that matrix of saving lives, social equity, or reducing transmission, versus three possible prioritization’s, and they decided to recommend prioritizing certain occupation categories, which they judged likely to lead to about 6% more deaths but to be more equitable."

There are several ways to fight the spread of infectious disease. One path is permanent exile of the infected. This helps limit the spread of the disease, except wherever the exiled people are sent. Another is isolation. What you do, see, is you take all the players and coaches and put them in a resort hotel somewhere, and don't let them out. If any of them DO slip out for whatever reason, you don't let them back in, and the games go on without them. Whether or not this works depends on how good the food provided by the resort hotel is.
Another approach is, you could develop a vaccine and make it available to all the people who are smart enough to get it, and then also let them know which people weren't smart enough to get vaxed up so they can be avoided.

[fafalone]

You are incorrect. The FDA panel voted unanimously to include 18-64 with underlying health issues and working in high risk jobs. Those were *not* added without votes. They voted, it was unanimous in favor. The FDA did not add it without consulting them, stop lying.

[James Pollock]

"That’s not correct either. The FDA panel voted 18-2 against boosters for the general adult population, and then voted to approve them for “people 65 and older or at high risk of severe COVID-19.” The FDA’s final amendment to the EUA included those two categories, and added “individuals 18 through 64 years of age whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of COVID-19 including severe COVID-19.” And the CDC’s rendition of that last category is even looser."

You've conflated the Emergency Use Authorization, which had no boosters for anybody, with the later application to add boosters to the actual, FDA approval for the Pfizer/Biontech vaccine.

[James Pollock]

"My original comment said that the FDA and CDC were both contravening the panel’s advice, so apparently we’re on the same page despite appearances to the contrary."

It appears that you are stupid. The FDA did nothing (of any kind) in contravention of the CDC's advisory panel. FDA did their thing even before CDC assembled their panel.

[James Pollock]

"Given that Moderna had to abandon its original VC-funded dream of mRNA-based therapeutics and switch to vaccines because they couldn’t come up with an mRNA dose that was both effective and could be repeatedly administered without blowing up the immune system, liver, etc., it is astounding to me how many people are rabidly jumping onto the booster hamster wheel."

LOLWUT? The discussion at hand is regarding Pfizer vaccines, which HAVE FDA approval for adult use (including boosters for some adults) and Moderna's vaccine hasn't even gotten final FDA approval yet, much less had an addendum filed requesting authorization for boosters.

[starlord1988]

A "booster shoot"!

[Longtobefree]

The CDC is a political action committee, ignore anything it says.

[DaivdBehar]

Correct. The FDA and the CDC are composed by partisan, Democrat attack dogs. Their advice is not based on science. It is to promote the election of Democrats. For example, the FDA falsely delayed approval and the rollout of the vaccines so that Trump could not get credit during the election.

[Nisiiko]

This was clear after they reversed their original change that vaccinated people no longer needed to wear masks. The Democrats couldn't have that, as masks are now part of their identity.

[James Pollock]

You are both equally loony.

[AtR]

Clearly, there is not sufficient science to support any of the decisions on boosters. These are all just shots in the dark - massive, population-level experiments whose results we will only learn in the many upcoming years.

The FDA lost any sense of independence when it disregarded its own advisory committee's strong recommendation on Aduhelm ... the CDC never had any expectation of independence.

[Don Nico]

"massive, population-level experiments "
That is your typical nonsensical and divisive rhetoric.
Pubic health policy is not an experiment. It is not a operations manual for a physics experiment. Rather is is a set of prudential decisions about which one can never be 100% certain.
Has the ruling elite done its due diligence? It hardly seems like it.
Should you and I be skeptical? Yes.
But there is no gain in promoting a political cold war.

[AtR]

No political cold war ... just bringing the corruption to light, because so few others seem interested. See https://www.cnn.com/2021/09/26/politics/alzheimers-drug-aduhelm-fda-approval/index.html

[Don Nico]

I agree with you about that disgraceful decision.

[James Pollock]

Meh. The FDA either "approves" that the drug being examined is safe and effective, or it doesn't because either it's not safe or not effective. They don't recommend who should get it, the manufacturer does that.

[M L]

The bigger experiment isn't a biological one, it's a political one to see how far a totalitarian social control agenda can be advanced.

[James Pollock]

"The bigger experiment isn’t a biological one, it’s a political one to see how far a totalitarian social control agenda can be advanced."

So this is part of that PATRIOT ACT thing?

[Don Nico]

Dr. Walensky should learn to "follow the science." Her agency should also learn and follow evidence based medicine.
As for Old White Joe, he should learn that he confounds the public at every step in the pandemic

[James Pollock]

"As for Old White Joe, he should learn that he confounds the public at every step in the pandemic"

Only SOME of the public wants to use the "pretend it doesn't exist until it goes away" approach to dealing with the pandemic.

I propose a new triage protocol:
You present at the ER with symptoms of COVID, you get tested for COVID. If the test comes back positive, you get asked, "Is there a medical reason you didn't get vaccinated?" and if the answer is yes, then you get taken to ICU, and if the answer is "no" your gurney gets rolled directly into the parking lot. Eventually, someone can go out and round up the spares, like they do for grocery carts in the grocery store parking lot.

[Doug Huffman]

Fool me once and shame on you. Fool me twice and shame on me. There will not be a third fooling.

Perhaps the root of our problem is misunderstanding medicine as science. Medicine is not science but an art and technology depending on verification for validation.

Karl Popper taught well that falsification is the demarcation boundary of science from nonsense. The medical arts are in infinitely recursive ad hoc defense. Eschew ad-hockery.

[James Pollock]

"Fool me once and shame on you. Fool me twice and shame on me. There will not be a third fooling."

You'll be missed. By someone. I mean, statistically, there's gotta be someone.

What will you be using instead of scientifically-tested medicines?

[jimc5499]

Scientist: "I vote no on booster shots."
Bureaucrat: "Do you like your job?" Do you want to keep your job?"
Scientist: "Yes"
Bureaucrat: The President wants booster shots. That means that I want booster shots. I also decide your funding....."
Scientist: "Sorry I meant to say Yes. I support booster shots."

[James Pollock]

Your fanfiction isn't ready to publish yet.

[Flagrown]

"CDC Director Rochelle Walensky overruled her committee."

Not to get overly pedantic here, but Walensky did not overrule the advisory committee; rather, she did not accept its advice.

[M L]

SCIENCE! lol

[circleglider]

#FollowTheScience: also known as government by our unelected technocratic meritocracy, whether they are de facto life-tenured civil service bureaucratic employees or de jure life-tenured jurists.

“Democracy” has been a joke for over a century, to keep the plebes in their places. Which is also why the “deep state” must be an outlandish conspiracy theory.

[James Pollock]

"Which is also why the 'deep state' must be an outlandish conspiracy theory."

Damn those deep state bureaucrats at the CDC and their ridiculous clutching at the notion of protecting people from infectious disease, like it's their job or something.

[circleglider]

“Damn those deep state bureaucrats at the CDC and their ridiculous clutching at the notion of protecting people from infectious disease…”

Sure, it’s the CDC’s job to develop ways to protect Americans from infectious diseases—although it seems that’s not been a high priority for them for some time.

But in America, no single person or institution has the power to pass, execute and adjudicate laws—least of all unelected civil service burecratic employees. Not even if everyone accepts that their motives are as pure as the driven snow.

At least in Australia, it’s been the elected politicians who have locked down the entire country.

[James Pollock]

"But in America, no single person or institution has the power to pass, execute and adjudicate laws"

You need to let go of your delusion. Turns out there are a number of institutions that have the power to pass, execute, and adjudicate law. The TSA had the power to decide that people aren't allowed to take liquids onto airplanes, then start confiscating all the liquids that people were trying to bring onto airplances. You should see the kinds of law the Bureau of Prisons can pass, execute, and adjudicate.

[James Pollock]

"SCIENCE! lol"

Are we just listing off things that you don't understand, and our response to your deficiency?

Everything! Pity...

[fafalone]

This narrative has some fatal flaws.

First, there has to be an acknowledgement that the advisory panel put Wallensky in a lose-lose situation. The FDA, pursuant to a unanimous vote by its expert advisory committee, had approved them for this group. Wallensky would either have to overrule a narrow 6-9 vote on the CDC panel, or overrule the FDA and the FDA advisory panel, who voted 18-0 to include to group.

The FDA panel, if you recall, soundly rejected Biden's call to allow them for everyone. So it's hard to argue their expert advisory panel was yielding to politics.

Similarly, it's entirely baseless to call Wallensky's decision politically motivated, because to overrule the FDA would be even more problematic, undermining public confidence in that agency. Of the experts consulted between the CDC and FDA, the overall vote combined was 24-9 to include that group. Defering to the combined expert opinion and syncing the decision with the FDA was the least bad of her two options, and framing that as political interference with science is utter crap.

[fafalone]

And beyond this, an important issue to consider what exactly was being voted on. The FDA/CDC technically had the question before them of need to protect against severe disease/hospitalization. That alone is what their vote was supposed to be on. Biden, Fauci, and other HHS people were thinking it would be worthwhile to prevent mild and moderate breakthroughs, for which there's a number of good reasons one might want to do it. And the science for that wasn't a close call or lacking at all; they're needed. That's not a political interference issue, it's a divided experts issue.

[James Pollock]

The other question they had was "what is the best use for existing doses of coronavirus vaccine? The choices are A) giving third doses to people in rich nations, or B) giving first and second doses to people in poor nations?
Before you jump straight to "help people in our country, first", recall that we keep getting variant strains that developed overseas, and the way to stop that is to vaccinate as many of those overseas people as possible.

[James Pollock]

"President Biden predicted that booster shots would become available 'across the board.'"

Not to get all Clinton-y or anything, but that depends on what he (and you) mean by "available".

Can you pop down to your local gas-station mini-mart and pick up a COVID booster with your gasoline purchase? Not quite yet. If you did get your hands on one, would you be expecting the FBI, DEA, and/or CDC to come bustin' through the door to haul you off to jail? Also not quite yet.
You want one provided to you for free by rich ol' Uncle Sammy? Be 65, and it's all your'n. If you're younger and healthier, all you gotta do is wait until you're 65 (assuming the vaccines stay cold for long enough.)
I supposed, you could always look for a veterinary supplier, and buy a horse vaccine.

[David Nieporent]

It might surprise you to learn, that Japan has dropped all vaccines and is, ahem, giving prescriptions for ivermectine for everyone with covid.

It would surprise me, because it is not in any way true.

Oh, and Norway is the latest European country to drop all COVID nonsense.

"Nonsense" is indeed the accurate description of what you said. They dropped social distancing requirements and capacity restrictions, not because those restrictions are "nonsense," but because they have virtually no covid spread.

Now, you wouldn’t know it, with the way the news is in the U.S.

You mean the news that Republicans are deliberately spreading covid? Yes, that would be a big difference between Norway and the U.S.

[James Pollock]

"It might surprise you to learn, that Japan has dropped all vaccines and is, ahem, giving prescriptions for ivermectine for everyone with covid."

It might surprise you to learn, that this claim is bullshit. Just because you're stupid enough to believe it, and pass it along, does not mean that anyone else is.

[James Pollock]

Those darn Democrats want us to beat the virus, and we want whatever is the opposite of what the Democrats want, so... of course we're pro-virus!!!!

--- Republicans, wondering why nobody will take their claims of losing elections because fraud, and not because they lost the election.