In case you missed it, the CDC’s Immunization Safety Office Director, Dr. Tom Shimabukuro, recently admitted at an FDA Vaccines and Related Biological Products Advisory Committee (VRBAC) meeting that – yes – people have in fact, suffered “debilitating illness” and “lasting health problems” following COVID-19 “vaccination.”1
Held on January 26, 2023, the VRBAC meeting convened to discuss COVID-19 booster “vaccination” safety and future regimens. Near the end of the meeting, Shimabukuro, an MD who also holds an MPH and MBA, was asked a poignant question by one participant.
The participant asked Shimabukuro to explain how the CDC is handling vaccine impacts to the population, which are not amenable to,2 (and therefore ostensibly not being captured by), the CDC’s current monitoring system, Vaccine Safety Datalink (VDS).3
Giving autoimmune disease as an example, the crux of her question implied that longer-lasting vaccine injuries were simply not amenable to capture by the Vaccine Safety Datalink (VDS) system, which uses electronic health records from selected provider sites around the US and relies on a specific protocol known as Rapid Cycle Analysis to look for danger signals.4
In other words, certain adverse impacts could be falling through the cracks of a safety monitoring system just not designed to find or look for them.
Shimabukuro’s answer was startling: he admitted what many who have experienced devastating COVID-19 “vaccination” injuries have waited far too long to hear from the CDC:
With respect to reports of people experiencing debilitating illnesses, we are aware of these reports of, of people experiencing long-lasting health problems following COVID vaccination.
He then pivoted – deflecting medical causation while promising to “continue” safety monitoring:
In some cases, the clinical presentation of people suffering these health problems is variable, and no specific medical cause for the symptoms have been found. We understand that illness is disruptive and stressful, especially under those circumstances, and we acknowledge these health problems have substantially impacted the quality of life for people, and have also affected those around them, and we hope for improvement and recovery, and we will continue to monitor the safety of these vaccines and work with partners to try to better understand these types of adverse events.5
Words Without Action – Is the CDC Gaslighting?
While the CDC’s open acknowledgment of the “vaccine” damage may be a step in the right direction, words without accountability and action are meaningless. Psychology experts suggest that, when dealing with someone who is gaslighting, it is advised to pay close attention to what the person does beyond what they say.6 These words ring true here. Despite what was acknowledged publicly in the VRBPAC meeting on Jan 26, 2023, the CDC’s pattern of obfuscation and inaction tells a different story.
The CDC has downplayed or even ignored reports of “vaccine” injuries contained within its own safety databases. One example is the CDC’s failure to adequately monitor safety signals contained in its Vaccine Adverse Event Reporting System (VAERS) – ignoring what has been termed the “death signal” triggered by its very own operating procedures.7 To this day, the CDC refuses to be fully transparent regarding data it has collected in safety monitoring sites put in place to monitor adverse reactions taking place after COVID-19 “vaccines.” After a lawsuit was filed to obtain V-safe “vaccine” safety data, a court ordered the CDC to release some of the data it had collected, and the results were deeply troubling: of the 10 million plus patients who participated in V-safe, 7.7% of those patients were forced to seek professional medical care for adverse events after COVID-19 “vaccination,” and another 25% missed school or work or had bad adverse reactions to the “vaccine.”8
Equally disturbing is that the CDC has downplayed and even ignored its own VAERS safety warning signals for COVID-19 injections administered in pregnancy; yet, this is the most vulnerable and dangerous group to experiment on with novel therapies. Just why the CDC is ignoring and dismissing the VAERS data is unclear (and will be the topic of another article) – but it’s not a good look for the CDC, which is tasked with protecting public health. Why bother to collect safety data at all, if it is cherry-picked, hidden, dismissed or simply ignored?
A Retrospective VAERS Investigational Study Flashes “Danger”
Questions like these prompted seven authors, including ObGyn and Maternal Fetal Medicine physician James A. Thorp, MD, to conduct their own investigational safety study of the “vaccines,” and their study is currently in preprint.9 Lead author Thorp (who holds nearly 44 years of clinical obstetrical practice) and his co-authors demonstrated in the study that the VAERS database contains multiple concerning safety signals indicating that COVID-19 injections are unsafe and dangerous in pregnancy.
The retrospective study investigated adverse events following both COVID-19 “vaccination” and Influenza vaccination. Using the Influenza vaccine as control group, the authors compared 18 adverse events which occurred post-COVID-19 “vaccination” with those occurring after the Influenza vaccine. Influenza vaccine was chosen as a comparison group in the study because the CDC and FDA specifically authorized the Influenza vaccine for use in pregnant women, but only after the vaccines were in general population use for 60 years. Influenza vaccine thus represents the best available control group; ethical questions now preclude a randomized, placebo-controlled trial of the mRNA injections in pregnancy (which would mean giving one group a substance that could potentially harm them).
The results of this VAERS investigational retrospective study are catastrophic. For example, the FDA and CDC use a 2-fold increase as a breach in the safety signal, yet the study led by Thorp found a 57-fold increase in miscarriage, and a 38-fold increase in fetal death (stillbirth). A total of 18 separate adverse events, including abnormal menses and 17 other major pregnancy complications, all exceeded the CDC and FDA safety signal.
The study’s conclusions are corroborated by over 30 other independent sources, including Pfizer’s own internal documents10 (which Pfizer also attempted unsuccessfully to suppress for 75 years). These independent corroborating sources, which we wrote about here, also include four separate geographic locations in highly COVID-19 “vaccinated” locations within California and Canada, in which whistleblowers document surges in fetal death (stillbirth) rates exceeding 40 standard deviations (sigma) from that of the national average.11
The CDC Must Back Its Words with Action: Halt Dangerous mRNA Shots in Pregnancy
Shimabukuro’s admission on behalf of the CDC that “debilitating injuries” and “long-lasting health problems” have occurred in people following COVID-19 “vaccination” comes too little, too late, for too many. While perhaps a step in the right direction, the admission raises valid questions about the propriety of continuing to push these novel and experimental therapies to all ages and all peoples. This rings particularly true in pregnancy – yet these novel and dangerous therapies are still being pushed by the CDC, American Board of Obstetricians and Gynecologists (ABOG), American College of Obstetricians and Gynecologists (ACOG), and the Society of Maternal-Fetal Medicine (SMFM).
Pushing novel and experimental therapies in pregnancy is unprecedented in the history of medicine, and is an abomination of the golden rule of pregnancy that – until now – has never been globally disregarded. Yet today, an estimated 13.26 billion of the experimental “vaccinations” have already been given worldwide, with 1.22 million still being administered daily12 – and they are still being recommended in pregnancy.
If the CDC does, in fact, take “vaccine safety very seriously” – as Shimabukuro contended at the meeting – words must be backed up by actions.
The CDC’s actions must include recommending a universal moratorium on the use of experimental gene therapy in pregnancy. Halting COVID-19 “vaccinations” in this highly vulnerable group will allow more time for all parties, including government, “vaccine” manufacturers, and independent research groups, to make fully transparent all of the safety data. While future double-blinded, randomized controlled prospective trials would clearly be unethical at this time given the clear and present dangers of the COVID-19 “vaccines,” unbiased and independent investigations must be conducted regarding a number of medical and legal issues of concern.
Flawed NEJM Data Undermines CDC’s Recommendation of mRNA Shots in Pregnancy
It is now imperative for Shimabukuro, on behalf of the CDC, to initiate this moratorium on the use of the experimental gene therapy in pregnancy and call for investigation. In addition to his CDC role, Shimabukuro was the lead author on a highly influential but statistically flawed study published during the height of pandemic fear-mongering. Published April 21, 2021, in the New England Medical Journal (NEJM),the Shimabukuro study, which utilized the CDC’s V-Safe data, concluded there were no obvious safety concerns with use of the COVID-19 “vaccines” in pregnancy.13 But the original study contained serious flaws in its statistical analysis, which cast doubt on its conclusion.
Two glaring problems undermined the NEJM study’s conclusion that the “vaccines” were safe in pregnancy. First, lead author Shimabukuro has deep ties to the CDC, which operates as a sub-agency of the HHS, thus raising valid questions of conflict of interest and bias, especially given the pro “vaccine” stance of the HHS and CDC prior to the study. In addition to serving as Director of the CDC’s Immunization Safety Office, over the course of the pandemic, Shimabukuro has been deeply entrenched in the CDC. He has reportedly served as VAERS “team lead” (raising valid questions about why the CDC seems to be ignoring the VAERS database) and “acting team lead” of the Vaccine Safety Datalink (VSD) team.14 He has also served on the CDC “COVID-19 Vaccine Coordination Unit.”15 His serving as lead author on a critically timed and highly influential study of these novel and experimental “vaccines” pushed by his own agency constitutes a flagrant conflict of interest and should never have been allowed.
Second, statistical analysis in the NEJM study utterly failed to show that the COVID-19 “vaccines” were safe in pregnancy, contrary to the study’s conclusions. In what was either a statistical sleight-of-hand or glaring calculation error which was missed by editors of the “renowned” NEJM (as well as multiple other doctor co-authors including three ObGyn physicians), the study pegged the overall miscarriage rate – otherwise known as spontaneous abortion rate – for “vaccinated” study participants at only 12.6%. Based on this flawed calculation, the study concluded the “vaccine” was safe, as the rate appeared – at first glance – to be in line with historical data for miscarriage.
However, the study’s authors arrived at this miscarriage rate by including 700 third-trimester “vaccinated” study participants in the denominator when calculating the miscarriage rate. By its medical definition, however, miscarriage can only occur before 20 weeks of pregnancy. As a result, the denominator was inflated because it included third-trimester “vaccinated” study participants in the miscarriage rate calculation – when, in fact, third-trimester “vaccinated” study participants could never have suffered a miscarriage. Not only were they “vaccinated” too late in their pregnancy to be statistically relevant for calculating miscarriage, but they also had past the point of pregnancy when a miscarriage could even occur. It was not medically possible for 700 of the “vaccinated” study participants to undergo a miscarriage, yet they were still included in the denominator when calculating the miscarriage rate, artificially padding the denominator with a statistically irrelevant group. One can state this in another more obvious manner: placing 700 study participants who received the “vaccine” after 28 weeks of pregnancy into the miscarriage denominator (prior to 20 weeks) effectively reduced the study’s miscarriage rate from 82% to 12.6%.
Critics further claim that even the study’s erroneously calculated miscarriage rate of 12.6% is unreasonably high, and therefore cause for concern, citing a study published in Nov. 2020 study by Naert et al.16 Looking at singleton pregnancy participants, the Naert study contends that the normal miscarriage rate should be only 5.4%, and at 13 weeks only 0.8%.
The Greatest Breach of Medical Ethics: Are We Playing with Fire?
The recommendation of experimental, novel, and untested gene therapy injections in pregnancy continues to be the greatest breach of medical ethics in the history of medicine. Some have argued that at the time these recommendations were made, they were based on a good faith desire to protect pregnant women, who were led to believe that they were at greater risk for serious illness from COVID-19. However, a study published in August of 2021 and conducted by Pineles et al.17 documents that pregnant women have less risk of death (0.8% vs. 3.5%) and admission to the intensive care unit (3.5% vs. 14.9%) compared to non-pregnant women.
Moreover, early treatment of COVID-19, both in pregnancy and nonpregnant patients, has shown to be highly successfully with safe and effective therapeutics and medications, including hydroxychloroquine. Physicians of many specialties, including Obstetrics and Gynecology and Maternal Fetal Medicine, have all used hydroxychloroquine for over 40 years without significant adverse effects or teratogenicity noted. In contrast to experimental gene therapy rebranded as “vaccines,” at the proper dose, hydroxychloroquine has a history of safe usage, even in pregnancy, and enjoys a pre-pandemic safety endorsement from the CDC (which Google apparently forgot to scrub from the internet), and which we have written about here.18
Experimenting on pregnant women and their preborn babies is not only highly unethical, but it is also playing with fire. Pushing untested COVID-19 “vaccines” on women could potentially cause multigenerational harm – the extent of which was recently pondered by a Pfizer executive exposed by investigative news organization Project Veritas.19 Not only are pregnant mothers and their preborn babies one of the most vulnerable and dangerous groups to experiment on, but they are also the heartbeat of humanity’s future. Continuing to recommend the experimental COVID-19 “vaccines” in pregnancy in light of what we now know is not only unethical, but also unconscionable. Yet sadly, looking at the evolving timeline of the CDC’s recommendation of the “vaccine” in pregnancy over the last two years, (similar to what would become the recommendations for children), it was always a fait accompli placing profits over safety – there was simply no stopping it. This is a topic we will cover in a future piece.
References:
1 Food and Drug Administration (FDA). FDA Docket Number FDA-2022-N-2810. “178th Meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC)” (recorded live broadcast). Posted on YouTube, January 26, 2023. Accessed February 6, 2023 (cited material located at 6:56 – 7:00). https://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-january-26-2023-meeting-announcement.
2 Food and Drug Administration (FDA). FDA Docket Number FDA-2022-N-2810. “178th Meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC)” (recorded live broadcast). Posted on YouTube, January 26, 2023. Accessed February 6, 2023 (cited material located at 6:56 – 7:00). https://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-january-26-2023-meeting-announcement.
3 Centers for Disease Control and Prevention (CDC). 2023. “Vaccine Safety Datalink.” Accessed February 6, 2023. https://www.cdc.gov/vaccinesafety/ensuringsafety/monitoring/vsd/index.html.
4 Vaccine Safety Database (VSD). 2021. “Rapid Cycle Analysis (RCA) to Monitor the Safety of COVID-19 Vaccines in Near Real-Time with the Vaccine Safety Data Link,” Project #1342, Version 1.1, March 3, 2021, p. 7 (noting, “Rapid and accurate assessment of vaccine safety is needed to maintain public trust and to inform policy recommendations”). Accessed February 6, 2023. https://www.cdc.gov/vaccinesafety/pdf/VSD-1342-COVID19-RCA-Protocol_FinalV1.1_508.pdf.
5 Food and Drug Administration (FDA). FDA Docket Number FDA-2022-N-2810. “178th Meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC)” (recorded live broadcast). Posted on YouTube, January 26, 2023. Accessed February 6, 2023 (cited material located at 6:56 – 7:00). https://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-january-26-2023-meeting-announcement.
6 Thorp JA, Renz T, Northrup C, Lively C, Breggin P, Bartlett R, et al. Patient Betrayal: The Corruption of Healthcare, Informed Consent, and the Physician-Patient Relationship. G Med Sci. 2022; 3(1): 046- 069. https://www.doi.org/10.46766/thegms.medethics.22021403. https://www.thegms.co/medical-ethics/medethics-rw-22021403.pdf.
7 Kirsch, Steve. 2022. “Exclusive: Proof that the CDC is Deliberately Ignoring the Safety Signals from the COVID Vax.” Steve Kirsch’s Newsletter, October 3, 2022. Accessed February 6, 2023. https://stevekirsch.substack.com/p/unassailable-proof-of-incompetence.
8 Kirsch, Steve. 2022. “Why Didi the CDC Hide the V-safe Data from the American People for almost 2 Years?” Steve Kirsch’s Newsletter, October 5, 2022. Accessed February 6, 2023. https://stevekirsch.substack.com/p/why-did-the-cdc-hide-the-v-safe-data.
9 Thorp, J.A.; Rogers, C.; Deskevich, M.P.; Tankersley, S.; Benavides, A.; Redshaw, M.D.; McCullough, P.A. COVID-19 Vaccines: The Impact on Pregnancy Outcomes and Menstrual Function. Preprints 2022, 2022090430 (doi: 10.20944/preprints202209.0430.v1). https://www.preprints.org/manuscript/202209.0430/v1.
10 Pfizer Report. 2021. “5.3.6 Cumulative Analysis of Post-Authorization Adverse Event Reports of PF-07302048 (BNT 162B2) Received Through 28-Feb-2021,” April 30, 2021, pp. 7, 12. https://phmpt.org/wp-content/uploads/2022/04/reissue_5.3.6-postmarketing-experience.pdf.
11 Thorp, Jim. 2022. “Experimental, Untested Genetic Biotechnology Administered in Pregnancy: An Egregious Breach of Bioethics” America Out Loud, November 12, 2022. Accessed February 8, 2023. https://www.americaoutloud.com/experimental-untested-genetic-biotechnology-administered-in-pregnancy-an-egregious-breach-of-bioethics/.
12 Our World in Data. 2023. “Coronavirus (COVID-19) Vaccinations.” Accessed February 6, 2023. https://ourworldindata.org/covid-vaccinations.
13 Shimabukuro TT, Kim SY, Myers TR, Moro PL, Oduyebo T, Panagiotakopoulos L, Marquez PL, Olson CK, Liu R, Chang KT, Ellington SR, Burkel VK, Smoots AN, Green CJ, Licata C, Zhang BC, Alimchandani M, Mba-Jonas A, Martin SW, Gee JM, Meaney-Delman DM; CDC v-safe COVID-19 Pregnancy Registry Team. “Preliminary Findings of mRNA Covid-19 Vaccine Safety in Pregnant Persons.” N Engl J Med. 2021 Jun 17;384(24):2273-2282. doi: 10.1056/NEJMoa2104983. Epub 2021 Apr 21. Erratum in: N Engl J Med. 2021 Oct 14;385(16):1536. PMID: 33882218; PMCID: PMC8117969. https://www.nejm.org/doi/full/10.1056/nejmoa2104983.
14 Google. 2023. “Tom T. Shimabukuro. MD, MPH, MBA: Centers for Disease Control and Prevention.” Accessed February 6, 2023. https://www.eventscribe.com/2018/NFIDFallCVC/ajaxcalls/PresenterInfo.asp?efp=SUhOV09EUVQ0MjE2&PresenterID=491468&rnd=2.500141E-02%20h%0D.
15 Centers for Disease Control and Prevention (CDC). “COVID-19 Vaccine Safety Updates: Primary Series in Children Ages 5-11 Years.” Advisory Committee on Immunization Practices (ACIP). May 19, 2022, slide 1. https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2022-05-19/03-covid-shimabukuro-508.pdf.
16 Naert MN, Khadraoui H, Muniz Rodriguez A, Fox NS. Stratified risk of pregnancy loss for women with a viable singleton pregnancy in the first trimester. J Matern Fetal Neonatal Med. 2022 Dec;35(23):4491-4495. Doi: 10.1080/14767058.2020.1852212. Epub 2020 Nov 22. PMID: 33225797. https://pubmed.ncbi.nlm.nih.gov/33225797/.
17 Pineles BL, Goodman KE, Pineles L, O’Hara LM, Nadimpalli G, Magder LS, Baghdadi JD, Parchem JG, Harris AD. In-Hospital Mortality in a Cohort of Hospitalized Pregnant and Nonpregnant Patients With COVID-19. Ann Intern Med. 2021 Aug;174(8):1186-1188. doi: 10.7326/M21-0974. Epub 2021 May 11. PMID: 33971101; PMCID: PMC8251936. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8251936/.
18 Thorp, Maggie, and Jim Thorp. 2022. “Then They Came for the Doctors…Is the Future of State Regulation of Medicine in Jeopardy?” America Out Loud, November 5, 2022. Accessed February 6, 2023. https://www.americaoutloud.com/then-they-came-for-the-doctors-is-the-future-of-state-regulation-of-medicine-in-jeopardy/page/20/?et_blog.
19 Project Veritas. 2023. “New: Pfizer Director Jordon Trishton Walker Shares Concern for COVID Vaccine Effect on Women’s Reproductive Health… ‘There is Something Irregular About the Menstrual Cycles’ … ‘Affecting Something Hormonal,’” February 2, 2023. Accessed February 6, 2023. https://www.projectveritas.com/news/new-pfizer-director-jordon-trishton-walker-shares-concern-for-covid-vaccine/.