Self-Congratulatory CDC-Contracted NASEM Report Misses the Signals We Had to Publish – At Risk

There is little point in polishing pig iron. But NASEM tries.

NASEM points to the government agency work but ignores those who worked in the public interest at risk. The old guard guarding the old guard, but to no avail. We have their numbers– and they are not welcome to persist.

A CDC-funded National Academies review declares ISO’s pandemic surveillance “timely” and “high-quality,” then quietly concedes that ISO lacks independence and needs to publish protocols, open methods, and separate itself from vaccination-promotion units. The public did not imagine the problem. The structure caused it (National Academies Press, 2025).

The Setup: A Flattering Premise with a Buried Confession

On October 7, 2025, the National Academies of Sciences, Engineering, and Medicine released Vaccine Risk Monitoring and Evaluation at the Centers for Disease Control and Prevention, a CDC-requested review of the Immunization Safety Office’s (ISO) COVID-era performance. The landing page sells a familiar storyline—ISO produced “an impressive quantity of timely, important, and high-quality” work—while the official Conclusions & Recommendations sheet concedes the core defect: ISO “currently lacks the organizational independence and resources to directly disseminate its information” and should be kept administratively separated from units that promote vaccination. You cannot fix a “perception” problem with independence language that reads like an indictment.

---

Sponsorship Is Not a Footnote: It’s a Design Flaw

The sponsor sets the scope. Here, CDC asked NASEM to evaluate CDC/ISO’s methods and communications. The committee delivered praise up front and placed its structural remedies (publish protocols, allow prompt publication, separate risk from promotion) in the back matter. The order matters. If independence were already real, you would not need to recommend it. (National Academies Press, 2025)

---

MISSED SIGNALS: External Teams (Including Ours) Had to Publish on Risk - AT RISK

“Proactive identification” implies ISO detected and publicly quantified safety risks before outside researchers did. The record does not support that implication. A series of peer-reviewed analyses from outside CDC established the effect sizes that still anchor policy discussions.

Myocarditis After mRNA Vaccination

Israeli teams published the first high-resolution, age- and sex-stratified risk estimates in NEJM, quantifying a marked elevation after dose two in young males (Mevorach et al., 2021). A separate NEJM analysis from a large Israeli health system corroborated and refined those estimates (Witberg et al., 2021). A multinational Nordic cohort (23.1 million residents) in JAMA Cardiology (Karlstad et al., 2022) mapped product- and dose-specific risks across four countries. These peer-reviewed studies defined the magnitude. Meanwhile, VRBPAC heard from Tom Shimabukuro’s VSD analysis “no signal” on myocarditis—one month before FDA threw a flag on—yes—myocarditis risk. CDC’s ACIP then documented myocarditis in an MMWR update (Gargano et al., 2021) and maintained a benefit-risk stance—an appropriate policy call, but nowhere near the first quantitative detection.

VITT/TTS with Adenoviral-Vector Vaccines

Mechanism and phenotype—anti-PF4 antibodies, cerebral venous sinus thrombosis patterns, treatment implications—were elucidated by European investigators in NEJM (Greinacher et al., 2021; Schultz et al., 2021). The U.S. pause of Ad26.COV2.S (Janssen) on April 13, 2021, followed with ACIP deliberations and MacNeil et al., (2021) that absorbed those clinical insights. Again, definitive characterization led from the outside; U.S. policy caught up.

Menstrual Cycle Changes

Low-cost, massively independent studies first documented menstrual cycle changes (See Peters et al., 2024). The BMJ Medicine global cohort quantified a small, largely transient increase in cycle length using prospectively logged data and transparent methods (Edelman et al., 2022). ISO did not originate that quantification. Public trust improves when inconvenient signals get measured cleanly and published, not when they get reframed as “communication” questions.

Mortality Analytics (The Analysis ISO Never Pre-Registered in Public)

If a safety office claims “comprehensive monitoring,” it should pre-register time-since-dose, all-cause mortality analyses with code and a fixed update cadence. The NASEM materials do not point to a public, reproducible mortality pipeline; instead, they recommend making protocols public, documenting protocol changes, and permitting prompt publication. That recommendation acknowledges the gap without naming it. (National Academies Press, 2025)

It is unacceptable that NASEM is silent on CDC’s silence on death signals we published.

See (Rose, 2021).

See also (Skidmore, 2023).

---

The Marketing Language (“Layered and Comprehensive”) Collapses under Methods

A comprehensive surveillance pipeline integrates sources with shared denominators, pre-declared signal rules, and cross-validation. The current stack does not do that.

VAERS: passive, open-reporting system with variable verification latency; useful for hypothesis generation, not for rate estimation.

VSD: The Vaccine Safety Datalink offers high-quality linked EHR cohorts within integrated health systems (McNeil et al., 2014). However, its reach is limited compared to the overall U.S. population. Historically, the VSD’s own papers describe a network built for sequential signal evaluation, not for public, real-time dashboards.

v-safe: opt-in smartphone check-ins; valuable for reactogenicity and pregnancy registries but not designed for population-level incidence rates. Representative outputs appear in JAMA (Chapin-Bardales et al., 2021) and NEJM (T. T. Shimabukuro et al., 2021), not as open, continuously updated tables with code.

CDC was not the first to note poor tracking ability. In fact, they only much later admitted they biased reports—or failed to run them altogether—to prevent public fear of COVID-19 mRNA injections. Then-Director Walensky said: “CDC performed PRR analysis between March 25, 2022, through July 31, 2022,” and clarified, “CDC also recently addressed a previous statement made to The Epoch Times to clarify PRR were not run between February 26, 2021, to September 30, 2021.” (Walensky, 2022)

Even as they tried to track, as unbalanced0 as they were, it required truly independent, peer-reviewed analysts to expose their reporting bias—a fact ignored by NASEM (Ealy et al., 2020).

If these systems truly functioned as a single, auditable pipeline, NASEM would not need to instruct CDC to publish protocols, standardize risk reporting, make data available to external researchers, and separate risk monitoring from promotional units. Those are first-principle requirements, not cosmetic upgrades.

---

Chronology, not Spin: What Actually Shaped Decisions

Myocarditis: External quantification in NEJM (Israel) and JAMA Cardiology (Nordic) set the baseline (age, sex, dose, product). ACIP’s June 2021 MMWR followed. Detection and quantification came first outside; U.S. policy responded.

VITT/TTS: NEJM case series and mechanistic work from Europe preceded the U.S. Janssen pause and informed diagnostic guidance (Greinacher et al., 2021; Schultz et al., 2021).

Menstrual Changes: Edelman et al., (2022) quantified cycle-length shifts transparently—the model regulators should have followed.

---

Independence and Transparency: The Report Quietly Says the Quiet Part, Quietly

NASEM’s one-page summary does the real work. It states that ISO “currently lacks the organizational independence and resources to directly disseminate its information” and instructs CDC to keep risk monitoring “organizationally and administratively separated” from units that carry out policymaking or promotion. It also directs CDC to “permit and encourage prompt publication of risk data” and to make protocols public, including change logs and justifications. Those directives validate the critique: the barrier isn’t perception; it’s structure and opacity. (National Academies Press, 2025)

---

What Honest Oversight Demands Now (It’s Not Pablum)

Statutory firewall and budget autonomy. Put the risk-monitoring office outside promotional and policy lines; publish a legal org chart and a firewalled P&L. (National Academies Press, 2025)

Pre-registration of surveillance analyses. For each endpoint—myocarditis by age/sex/dose/product; VITT by platform; all-cause mortality by time-since-dose—pre-register code, windows, comparators, and stopping rules. Post a change log when you adapt. (National Academies Press, 2025)

Cross-database integration with auditable logic. Define how VAERS hypotheses trigger VSD adjudication and how v-safe feeds follow-up cohorts. Publish thresholds and validation steps (McNeil et al., 2014).

Researcher-usable data access. Provide de-identified extracts with documentation and a governance policy; measure and report access latency. (National Academies Press, 2025)

Publication autonomy and cadence. Post (at least!) quarterly updates—even if results are null—so policy and public can track stability or change. (National Academies Press, 2025)

---

Bottom Line

The National Academies deliver a CDC-funded review declaring ISO’s pandemic-era surveillance “timely” and “high-quality,” then prescribe remedies—independence, public protocols, prompt publication—that only make sense if those elements were missing when it counted. The decisive risk quantifications for myocarditis, VITT/TTS, and menstrual changes came from external teams with DOI-anchored methods; ACIP and CDC followed with policy. If CDC wants trust restored, it must retool surveillance as public science: register the analyses, separate risk from promotion, open the code and data, and publish on schedule—with or without applause.

---

References

Chapin-Bardales, J., Gee, J., & Myers, T. (2021). Reactogenicity Following Receipt of mRNA-Based COVID-19 Vaccines. JAMA, 325(21), 2201. https://doi.org/10.1001/jama.2021.5374

Ealy, H., McEvoy, M., Chong, D., Nowicki, J., Sava, M., Gupta, S., White, D., Jordan, J., Simon, D., & Anderson, P. (2020, October 12). COVID-19 data collection, comorbidity & federal law: A historical retrospective. Science, Public Health Policy and the Law. https://publichealthpolicyjournal.com/covid-19-data-collection-comorbidity-federallaw-a-historical-retrospective/

Edelman, A., Boniface, E. R., Male, V., Cameron, S. T., Benhar, E., Han, L., Matteson, K. A., Van Lamsweerde, A., Pearson, J. T., & Darney, B. G. (2022). Association between menstrual cycle length and covid-19 vaccination: Global, retrospective cohort study of prospectively collected data. BMJ Medicine, 1(1), e000297. https://doi.org/10.1136/bmjmed-2022-000297

Gargano, J. W., Wallace, M., Hadler, S. C., Langley, G., Su, J. R., Oster, M. E., Broder, K. R., Gee, J., Weintraub, E., Shimabukuro, T., Scobie, H. M., Moulia, D., Markowitz, L. E., Wharton, M., McNally, V. V., Romero, J. R., Talbot, H. K., Lee, G. M., Daley, M. F., & Oliver, S. E. (2021). Use of mRNA COVID-19 Vaccine After Reports of Myocarditis Among Vaccine Recipients: Update from the Advisory Committee on Immunization Practices — United States, June 2021. MMWR. Morbidity and Mortality Weekly Report, 70(27), 977–982. https://doi.org/10.15585/mmwr.mm7027e2

Greinacher, A., Thiele, T., Warkentin, T. E., Weisser, K., Kyrle, P. A., & Eichinger, S. (2021). Thrombotic Thrombocytopenia after ChAdOx1 nCov-19 Vaccination. New England Journal of Medicine, 384(22), 2092–2101. https://doi.org/10.1056/nejmoa2104840

Karlstad, Ø., Hovi, P., Husby, A., Härkänen, T., Selmer, R. M., Pihlström, N., Hansen, J. V., Nohynek, H., Gunnes, N., Sundström, A., Wohlfahrt, J., Nieminen, T. A., Grünewald, M., Gulseth, H. L., Hviid, A., & Ljung, R. (2022). SARS-CoV-2 vaccination and myocarditis in a nordic cohort study of 23 million residents. JAMA Cardiology, 7(6), 600. https://doi.org/10.1001/jamacardio.2022.0583

MacNeil, J. R., Su, J. R., Broder, K. R., Guh, A. Y., Gargano, J. W., Wallace, M., Hadler, S. C., Scobie, H. M., Blain, A. E., Moulia, D., Daley, M. F., McNally, V. V., Romero, J. R., Talbot, H. K., Lee, G. M., Bell, B. P., & Oliver, S. E. (2021). Updated recommendations from the advisory committee on immunization practices for use of the janssen (johnson & johnson) COVID-19 vaccine after reports of thrombosis with thrombocytopenia syndrome among vaccine recipients — united states, april 2021. MMWR. Morbidity and Mortality Weekly Report, 70(17), 651–656. https://doi.org/10.15585/mmwr.mm7017e4

McNeil, M. M., Gee, J., Weintraub, E. S., Belongia, E. A., Lee, G. M., Glanz, J. M., Nordin, J. D., Klein, N. P., Baxter, R., Naleway, A. L., Jackson, L. A., Omer, S. B., Jacobsen, S. J., & DeStefano, F. (2014). The Vaccine Safety Datalink: Successes and challenges monitoring vaccine safety. Vaccine, 32(42), 5390–5398. https://doi.org/10.1016/j.vaccine.2014.07.073

Mevorach, D., Anis, E., Cedar, N., Bromberg, M., Haas, E. J., Nadir, E., Olsha-Castell, S., Arad, D., Hasin, T., Levi, N., Asleh, R., Amir, O., Meir, K., Cohen, D., Dichtiar, R., Novick, D., Hershkovitz, Y., Dagan, R., Leitersdorf, I., … Alroy-Preis, S. (2021). Myocarditis after BNT162b2 mRNA Vaccine against Covid-19 in Israel. New England Journal of Medicine, 385(23), 2140–2149. https://doi.org/10.1056/nejmoa2109730

National Academies Press. (2025). Vaccine risk monitoring and evaluation at the centers for disease control and prevention. National Academies of Sciences, Engineering, and Medicine. https://doi.org/10.17226/29240

Peters, S. E., Newman, J., Ray, H., Thorp, J. A., Parotto, T., Hooker, B., McDyer, D., Murphy, L., Stricker, R. B., McDonnell, M., Mills, P. J., Gieck, W., Northrup, C., & contributed equally., †The two lead authors. (2024). Menstrual abnormalities strongly associated with proximity to COVID-19 vaccinated individuals. International Journal of Vaccine Theory, Practice, and Research, 3(2), 1435–1461. https://doi.org/10.56098/tp99wn15

Rose, J. (2021, October 1). Critical appraisal of VAERS pharmacovigilance: Is the U.S. vaccine adverse events reporting system (VAERS) a functioning pharmacovigilance system? Science, Public Health Policy and the Law. https://publichealthpolicyjournal.com/critical-appraisal-of-vaers-pharmacovigilance-is-the-u-s-vaccine-adverse-events-reporting-system-vaers-a-functioning-pharmacovigilance-system/

Schultz, N. H., Sørvoll, I. H., Michelsen, A. E., Munthe, L. A., Lund-Johansen, F., Ahlen, M. T., Wiedmann, M., Aamodt, A.-H., Skattør, T. H., Tjønnfjord, G. E., & Holme, P. A. (2021). Thrombosis and Thrombocytopenia after ChAdOx1 nCoV-19 Vaccination. New England Journal of Medicine, 384(22), 2124–2130. https://doi.org/10.1056/nejmoa2104882

Sen. Johnson to CDC: Did health agencies perform sufficient surveillance of COVID-19 vaccine adverse events? (2022, June 27). Ron Johnson Senator from Wisconsin. https://www.ronjohnson.senate.gov/2022/6/sen-johnson-to-cdc-did-health-agencies-perform-sufficient-surveillance-of-covid-19-vaccine-adverse-events

Shimabukuro, T. (2021, February 26). COVID-19 vaccine safety update: Vaccines and Related Biological Products Advisory Committee (VRBPAC) (pp. 1–29). https://www.fda.gov/media/146269/download?

Shimabukuro, T. T., Kim, S. Y., Myers, T. R., Moro, P. L., Oduyebo, T., Panagiotakopoulos, L., Marquez, P. L., Olson, C. K., Liu, R., Chang, K. T., Ellington, S. R., Burkel, V. K., Smoots, A. N., Green, C. J., Licata, C., Zhang, B. C., Alimchandani, M., Mba-Jonas, A., Martin, S. W., … Meaney-Delman, D. M. (2021). Preliminary Findings of mRNA Covid-19 Vaccine Safety in Pregnant Persons. New England Journal of Medicine, 384(24), 2273–2282. https://doi.org/10.1056/nejmoa2104983

Skidmore, M. (2023, October 2). COVID-19 illness and vaccination experiences in social circles affect COVID-19 vaccination decisions*. Science, Public Health Policy and the Law. https://publichealthpolicyjournal.com/covid-19-illness-and-vaccination-experiences-in-social-circles-affect-covid-19-vaccination-decisions/

Walensky, R. P. (2022, September 2). Walensky letter to Hon Ron Johnson. In DocumentCloud. https://www.documentcloud.org/documents/22309653-walensky-letter/

Witberg, G., Barda, N., Hoss, S., Richter, I., Wiessman, M., Aviv, Y., Grinberg, T., Auster, O., Dagan, N., Balicer, R. D., & Kornowski, R. (2021). Myocarditis after covid-19 vaccination in a large health care organization. New England Journal of Medicine, 385(23), 2132–2139. https://doi.org/10.1056/nejmoa2110737