Why are FDA and CDC so hesitant to vaccinate young children?
This is a thread on the regulatory dysfunction that has abandoned children under age 5 without access to safe covid vaccines. It’s longer than a CVS receipt, so I also made a Medium post for easier reading. I’ll do a second one on what we might do about it. #immunizeunder5s
Why are CDC and FDA so invested in this idea that dragging out kids’ vaccine authorizations and banning off label access is necessary to preserve confidence in all childhood vaccines? They assert it frequently but seem to have no evidentiary basis. https://twitter.com/sophiacbess/status/1516104628588400649?s=20&t=7WcTrDte9jrjd1vnyex5Qg
For instance, the quotes in these articles. It’s so self-evident to them that it doesn’t require proof. https://www.propublica.org/article/whats-holding-up-the-covid-vaccines-for-children-under-5 https://www.npr.org/2022/03/10/1085670147/many-are-frustrated-that-kids-under-5-still-dont-have-a-covid-19-vaccine
In this, FDA and CDC fall into the “epistemic trespass” they condemn in others. Social and behavioral scientists have been shut out of this and many other aspects of the pandemic response. https://www.who.int/news-room/commentaries/detail/behavioural-and-social-sciences-are-critical-for-pandemic-prevention-preparedness-and-response
There are researchers who study vaccine hesitancy! But they’re evidently not in the room when decisions about vaccine trials and authorizations are being made instead on the basis of internal agency folk wisdom. https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0250123
The delay in vaccines for kids is not about The Science, either. There’s no research value in delay to add trial participants when the larger n is still underpowered to find the rare effects in question and we already know serious effects of covid are worse.
Nor is science served by demanding trials be extended for followup periods far longer than any vaccine side effect has ever taken to appear. We now have data from tens of millions of doses in slightly older kids — no safety issue. https://www.cdc.gov/mmwr/volumes/70/wr/mm705152a1.htm
(Please just report/block trolls who show up to argue that we shouldn’t vaccinate children against a leading cause of pediatric death. Let’s not engage them to amplify their message.)
So why the urge to treat the pediatric emergency authorization (of a lifesaving vaccine in a pandemic) like full licensing? Why the compulsion to anticipate every rare effect? Why the blackout of info to the public?
Agencies have adopted defensive techniques that hobble their mission:
I don’t have any insider knowledge of CDC or FDA, but I have had a lot of interactions with various regulatory agencies. Members of the public tend to think of these regulators as powerful, whether they agree with their aims or not.
But people working inside these agencies often see themselves besieged, on the defensive. When they try to enforce a rule or set a new one, industry jams up the process and sues to that the tiniest change takes decades.
Agency budgets have been starved for so long they don’t have the in-house resources or expertise to do anything without relying on the corporations they ostensibly regulate.
EPA relies on the chemical manufacturers to do their own safety testing. FDA does too, and the drug approval process is funded by drug companies, not public money. https://today.uconn.edu/2021/05/why-is-the-fda-funded-in-part-by-the-companies-it-regulates-2/#:~:text=The%20Food%20and%20Drug%20Administration%20has%20moved%20from%20an%20entirely,a%20medical%20device%20or%20drug.
Many of the most experienced and qualified people have been sucked out through the revolving door or pushed out for speaking up instead of toeing the institutional line.
Agencies like USDA and OSHA don’t have even one percent of the inspectors they would need to regularly inspect sites. Even when there’s a blatant violation, agencies usually just ask nicely for compliance, sometimes over and over for decades.
Enforcement on the honor system:
OSHA https://www.nelp.org/news-releases/number-federal-workplace-safety-inspectors-falls-45-year-low/
USDA https://thecounter.org/federal-meat-inspectors-overload-burnout-fsis/
EPA https://ceh.org/latest/press-releases/chemours_cape_fear/
State Enviro agencies https://www.mlive.com/news/2020/01/state-vows-to-be-more-aggressive-with-polluters-after-green-ooze-spills-onto-i-696.html
IRS https://www.propublica.org/article/has-the-irs-hit-bottom
SEC https://www8.gsb.columbia.edu/researcharchive/articles/13981
So a big part of the regulatory process has to be building consent among stakeholders. But, although they make a show of taking public comment, “stakeholders” doesn’t mean the people whose lives are at stake. It means industries whose profits are at stake, and sometimes a few advocacy groups.
The vaccine trials are being run by vaccine manufacturers, not researchers on the public payroll. And childhood vaccines aren’t a big moneymaker — the government subsidizes manufacturers and doctors to provide them. They aren’t Pharma’s priority. https://academic.oup.com/cid/article/38/10/1440/346900
Agencies deliberately limit info to the public because they are trying to avoid “giving critics ammunition” and because their clients, the manufacturers, don’t want to share information that could affect stock prices or help competitors.
The CDC’s provider agreements ban off-label use of the covid vaccines. Off-label prescription is very common in pediatrics because children are usually excluded from trials. https://publications.aap.org/pediatrics/article/149/2/e2021054578/183457/Off-Label-Prescription-of-COVID-19-Vaccines-in
This unusual off-label ban either came at the request of the manufacturers, or it’s not important enough to them to object. Because it wouldn’t be there otherwise.
People don’t go into public service to provide cover for industry — they want to work through these agencies for the public good in a way individuals alone can’t. But the institutional culture of learned helplessness is strong. https://www.propublica.org/article/shes-supposed-to-protect-americans-from-toxic-chemicals-first-she-just-has-to-fix-trumps-mess-and-decades-of-neglect
Agencies rely on process so to justify their actions when challenged in the press or in court. Following the process is a defense even when the outcome is wrong.
Requiring a set process prevents rules from being put in place by political fiat. E.g. the DC federal circuit struck down the Trump administration’s gutting of Clean Power Plan as arbitrary and capricious. Processes hadn’t been followed. https://www.washingtonpost.com/climate-environment/2021/01/19/federal-circuit-court-scraps-trump-administration-power-plant-rules/
This defensive reaction gets in the way of vaccinating our kids:
How does this relate to the failure to #immunizeunder5s ? CDC and FDA are under pressure, so they are doubling down on process. It’s an emergency; kids are dying every day because they can’t get vaccinated. https://data.cdc.gov/NCHS/Provisional-COVID-19-Deaths-Focus-on-Ages-0-18-Yea/nr4s-juj3
But treating it like the emergency it is, even to the stringent standards of the EUA, seems very risky to people who view any deviation from normal procedures as a threat to legitimacy.
In order to do their jobs, they are trained to focus narrowly on the limited question before them. They aren’t supposed to consider the wider context, like the fact that mask mandates have been trashed and kids forced into daycare as unemployment assistance was ended for caregivers.
And it’s considered inappropriate to point out the real-world consequences of agency actions or inaction. Professional decorum requires detachment; it’s rude to mention dead or disabled kids.
As regulators/public health agencies face attacks from monied interests, antivaxers, and politicians, the defenders claim the high ground as rational, apolitical, and scientific. But public health is always already political. https://www.theguardian.com/commentisfree/2022/apr/03/peoples-cdc-covid-guidelines
It’s the job of policymakers to look at the big picture, demand that agencies adjust their internal policies/procedures as needed to serve their public purposes. But the White House, Sec. Becerra, and Congressional oversight have all been MIA.
A big part of this is that they are afraid of further politicizing public health. But they were willing to spend the political capital to do it when it came to adult boosters, despite the resignation of high-ranking FDA officials. https://www.cnn.com/2021/08/31/health/fda-vaccine-officials-step-down/index.html
This dynamic is echoed in the slew of news stories painting advocates of vaccination for young kids as irrational, impatient and hysterical. It is a very gendered narrative. You also see it in the complete dismissal of the expertise of (feminine-coded) social sciences. https://www.fda.gov/news-events/press-announcements/fda-will-follow-science-covid-19-vaccines-young-children
The more their authority is challenged, the less willing CDC and FDA are to incorporate input from other fields of relevant expertise — such as aerosol scientists, Bayesian statisticians or sociologists. It’s a groupthink death spiral. https://www.nytimes.com/2022/03/01/opinion/under-5-vaccine.html
The just world fallacy is an essential part of the technocratic worldview. If we do everything right, dot every “i”, then it will work out. Everyone will see how reasonable we are and be persuaded.
This kind of bargaining with reality is how you get arguments like “People will support mask mandates if we agree they aren’t needed outdoors” and “We’ll lift the protections while cases are low, so everyone will happily put them back on when needed.”
For kids’ vaccines it’s: “If we just show how diligent we are with trials and EUA criteria, people will trust us on vaccines. It will prove the anti-vaxers wrong.” The kids who die from the needless delay are just costly signaling in the cause of vaccine confidence.
They make up a reasonable opposition in their minds and imagine what would convince them. This fantasy would be punctured immediately on consultation with anthropologists, sociologists, etc. It’s about power and values, not preexisting facts.
It’s folly to assume everyone shares the same goal of ensuring safe vaccinations are available to children, and that they are just disagreeing in good faith about how to reach those goals.
There are folks whose professional reputations and egos are on the line, who are too invested in minimizing the impact of covid on children to recognize the need to vaccinate them.
There are influential “herd immunity” sociopaths who believe it will be better for the economy or their personal conveniences to infect children so that they will carry covid home regularly to boost their vaccinated parents or infect any remaining unvaccinated. This sounds mad but: https://www.bmj.com/content/375/bmj.n2718
There are politicians whose consultants are telling them that the only way to have a chance to enact their priorities is to cater to the fears of swing voters in marginal districts. Focus groups think allowing vaccines for kids is a slippery slope to the dreaded vaccine mandates.
There are anti-vaxxers who for ideological or financial reasons oppose vaccination. (Zealots, foreign agents, quack cure peddlers, opportunistic politicians and media darlings). Some of them are open eugenicists who fantasize about covid culling those they believe unfit.
But the process complaints of anti-vaxers are pretextual. They do not need real facts to hang their attacks on. (Microchips!) There is asymmetry when one side values playing by the rules and the other side only values winning. You can’t fix it by just getting better at following the rules on your own side.
At every step, agencies have chosen avoiding controversy over protecting children. They didn’t include kids in trials at the start, even though it was obvious they would need to be vaccinated. They allowed “skeptics” to demand more participants and longer followup at the last minute, more than once. https://www.cnbc.com/2021/07/26/covid-vaccine-moderna-says-it-plans-to-expand-trial-for-kids-5-to-11.html
They delayed vaccines for kids 5–11 until well into the school year. They delayed so long that the virus evolved away from the targeted strain, then allowed opponents to argue that this showed the vaccines weren’t effective in children. https://www.politico.com/news/2022/03/30/moderna-covid-vaccine-kids-00021492
All this delay reinforces the feeling that there must be something unsafe about the vaccines, or the government wouldn’t be choosing to allow children to be infected with a novel, deadly pathogen instead of vaccinating them.
Delay is victory for the opponents of childhood vaccination. Delaying vaccines at this point is an affirmative policy choice to infect and re-infect all children born after mid-2017 before they are vaccinated. By attempting to appease anti-vaxers, FDA and CDC have handed them control over vaccine policy.
It’s a problem that was decades in the making, with the rise of weaponized pseudoscience and the hollowing out of the administrative state. A long-term solution requires rebuilding public administrative capacity. Far too many of our babies have been drowned in Grover Norquist’s bathtub.
This thread is way too long, so I’m going to end here and blather another time about where I think the levers are for us to exert countervailing pressure against the forces that are standing between our children and safe vaccines to protect them from covid. #immunizeunder5s
