Rebuttal: Pregnancy, COVID-19 Vaccines, and the Erosion of Medical Ethics when Pregnant Women Are Studied
A "Medpage Today" "expert" makes claims not supported by data, underscoring why we need Robert F. Kennedy, Jr. at the helm at HHS more than ever.
What We Owe Pregnant Women
On June 6, 2025, MedPage Today published an article titled “Infectious Disease Docs Slam New COVID Vaccine Recommendations.” It paints a picture of chaos: pharmacies refusing pregnant women COVID vaccines, infectious disease specialists decrying federal reversals, and professional societies urging clinicians to ignore updated HHS guidance.
The core assertion? That the evidence supporting COVID-19 vaccination in pregnancy is “abundantly clear.”
It is not. And pretending that it is undermines both science and trust.
What’s at Stake: Are We Treating Pregnant Women as a Protected Class or a Policy Convenience?
Pregnancy is not just another medical variable—it is a biologically complex, ethically sensitive state that demands special protection in research and clinical care. This is codified in:
45 CFR 46 Subpart B: U.S. regulations requiring extra safeguards for pregnant research subjects. John B. Lynch, MD, a fellow of the IDSA and medical director of Harborview Medical Center in Seattle, the expert quoted by MedPage Today, should be required to study the US Code of Federal Regulations. To demote the study of safety of vaccines of any type in pregnant women and children to retrospective studies rather than gold-standard long-term randomized clinical trials is to deny them the special protections required by the US Code of Federal Regulations.
The Declaration of Helsinki and Nuremberg Code: Global ethical standards mandating informed consent and rigorous safety data before exposing vulnerable populations to experimental interventions.
Yet, despite these clear legal and ethical frameworks, mRNA COVID-19 vaccines were recommended for pregnant women without direct safety testing in pregnant women pre-authorization. That should alarm every scientist, physician, and policymaker.
What Does the Evidence Really Say?
Let’s compare the evidence across maternal vaccines:
Table 1: Evidence Comparison for Maternal Vaccination
Conclusion: COVID-19 vaccine recommendations for pregnancy rest on weaker evidence than even Tdap or flu shots, and those were not gold standard either.
The Tdap Precedent: A Case Study in Misleading Science
A 2018 study by Becerra-Culqui et al. claimed no link between prenatal Tdap vaccination and autism. It is often cited as a precedent for recommending vaccines in pregnancy.
But in 2021, I published a detailed peer-reviewed critique (Lyons-Weiler, Fujito & Pajer, IJVTPR) outlining major flaws:
Selection Bias: The cohort was drawn from Kaiser Permanente Southern California—non-representative of national diversity and a proprietary data set not accessible to independent scrutiny and verification.
Exclusion Criteria: Genetically at-risk populations were removed, biasing outcomes; no such genetic screening is conducted in clinical application.
Outcome Bias: Autism diagnosis depended on electronic records; true prevalence was underreported compared to California’s known 3.8% rate at the time.
Overfitting and Arbitrary Statistical Adjustments: Data transformations lacked clear justification.
Lesson: Even heavily cited maternal vaccine studies like this often fail to meet robust scientific standards. Using them as justification for newer, less-tested interventions is indefensible.
COVID-19 Vaccines in Pregnancy: The Truth About the Trials
❌ No pre-licensure studies in pregnant humans.
Women who were pregnant were excluded from all pivotal Phase III mRNA vaccine trials.
❌ No long-term outcome tracking in infants.
We do not know what happens to children of vaccinated mothers over time. There is no tracking of developmental, neurological, or immunological outcomes.
❌ Shimabukuro et al. (2021), often cited for safety, had no control group and was based on self-reported data from V-Safe and VAERS—both of which are acknowledged to suffer from severe underreporting and self-selection bias.
What About Maternal Antibodies and “Protection” to Baby?
Yes, maternal IgG crosses the placenta. But:
The antibodies wane rapidly, within weeks.
They are strain-specific, and by the time of birth, the virus may have drifted.
No clinical trial has demonstrated reduced infant morbidity or mortality due to maternal COVID-19 vaccination.
Hypothetical benefit cannot outweigh uncertain risk. That is especially true in pregnancy.
Pathogenic Priming and Autoimmune Risk: The Missing Mechanism
In 2020, we published the first paper on pathogenic priming in COVID-19 vaccine development. Using sequence homology analysis, I showed that:
Many spike protein epitopes mimic human proteins, including those involved in immune regulation and placental development (Lyons-Weiler, 2020).
Vaccination could train the immune system to recognize and attack self-proteins, a well-known autoimmune trigger mechanism (ibid).
This possibility was not ruled out in any preclinical or post-market trials for pregnant populations. Not in mice. Not in humans. Not even in cell lines.
Ethics Are Not Optional
Special protections for pregnant women were created precisely because of catastrophes like thalidomide and diethylstilbestrol. Today’s blanket statements of “safety” without evidence betray that legacy.
Where is the informed consent when patients are not told:
That they are part of a non-consented post-market experiment?
That long-term risks to their children are unknown?
That passive surveillance systems are not designed to detect long-latency effects?
Why Pulling CDC Recommendations Was the Right Move
The Medpage Today article frames the Kennedy administration’s decision as unilateral and unscientific. In truth, it was a long-overdue course correction. Here’s why:
Recommendations were made without gold-standard safety data.
Injury compensation is denied under PREP Act protections.
There is no proof of net benefit for mom or baby.
The precautionary principle demands restraint, not dogma.
Removing unjustified recommendations is not anti-science—it is science, finally applied.
Counterarguments Addressed
Call to Action: Five Steps Toward Medical Integrity
Publish all raw pregnancy outcome data, stratified by trimester.
Mandate inert, long-term placebo-controlled randomized trials for all future maternal vaccines.
Create an independent pregnancy vaccine safety board.
Remove liability shields under PREP Act for pregnancy-related claims.
Ensure all vaccine consent forms disclose the absence of pre-licensure pregnancy testing.
Conclusion: Science Is Not Consensus. It’s Courage
When we ignore foundational ethics to serve consensus or policy optics, we are no longer doing science.
Pregnancy is not a loophole in the system. It is the last place where errors can be tolerated.
Let this be the turning point where science reclaims its integrity—where mothers are not research subjects by default, and their children are not footnotes in retrospective analyses. This is Robert F. Kennedy, Jr. keeping his promise to the American public.
During his Senate confirmation hearings for Secretary of Health and Human Services, Robert F. Kennedy Jr. emphasized his commitment to evidence-based policymaking. He stated:
"I believe in evidence-based medicine and gold standard science."
Additionally, when questioned about his approach to revising CDC recommendations, Kennedy affirmed:
"Absolutely, Senator. I am not going to go into HHS and impose my preordained opinions on anybody at HHS. I'm going to empower the scientists at HHS to do their job and make sure that we have good science that's evidence-based, that's replicable, where the raw data is published."
These statements and the FDA’s actions underscore Kennedy's pledge to prioritize rigorous scientific standards and transparency in public health policy decisions.
Personal opinion is the lowest and cheapest form of “evidence”. HHS is not going to back down on someone’s mere opinion.
References
Shimabukuro TT et al. 2021. Preliminary Findings of mRNA Covid-19 Vaccine Safety in Pregnant Persons. New England Journal of Medicine. 384(24):2273–2282. DOI: 10.1056/NEJMoa2104983
Lyons-Weiler J, Fujito A, Pajer B. 2021. Maternal Gestational Tdap Vaccination and Autism: A Critique of Becerra-Culqui et al. (2018). Int. J. Vaccine Theory Pract Res. 2(1):46–58. https://ijvtpr.com/index.php/IJVTPR/article/view/39
Becerra-Culqui TA et al. 2018. Prenatal Tetanus, Diphtheria, Acellular Pertussis Vaccination and Autism Spectrum Disorder. Pediatrics. 142(3):e20180120. PMID: 30104424
Lyons-Weiler J. 2020. Pathogenic Priming Likely Contributes to Serious and Critical Illness and Mortality in COVID-19 via Autoimmunity. Science, Public Health Policy & the Law, 1:9–15. PMID: 32292901
45 CFR 46 Subpart B. Code of Federal Regulations for protections of pregnant women in research. https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-46
Meanwhile every other over-the-counter medication says, "Do not take while pregnant or nursing."
Thank you for addressing the overarching concern about use of any experimental substance in pregnancy.
You mention a Shimabukuro paper in 2021. There were two of this same paper with him as main author that year, one in April and one in September. There is a bit of controversy raging now as the footnotes in Table 4 changed to imply different numbers. But like unsolvable equations of too many variables, there is just enough data missing to prevent certainty of how to understand or to reconcile those papers. Hence, we have my warning after the April 2021 paper of a seeming 89 to 90% rate of pregnancy loss, with others taking into account the later Sept 2021 data and measuring between 82% and 89% pregnancy loss, ie from Pierre Kory, Naomi Wolf, James Thorp. Of course, even 82% pregnancy loss, or even much lower rate of loss, makes the COVID vaccines screamingly unsafe in pregnancy, and a black box warning on them has been warranted for all, with special urgency for pregnant women.