The Rules Are Stacked Against Protecting the Public – Welcome to the Hunger Games

Originally posted on America Out Loud.

CDC’s and FDA’s Closed Safety Surveillance Systems: Vaccine Safety Datalink (VSD) and Biologics Effectiveness and Safety (BEST) System – Complementary or Captured?

Read Part One:  VAERS – The Last Bastion of Vaccine Free Speech?

What are the primary closed systems that CDC and FDA use to counter the alleged “misinformation” contained in VAERS? Among others, they include two separate vaccine safety surveillance systems. The first is called Vaccine Safety Datalink (VSD), which is the CDC’s system.³⁸ The second is the Biologics Effectiveness and Safety (BEST) system, which is the FDA’s system.³⁹ According to CDC and FDA, their VSD and BEST systems are “complementary” safety surveillance systems⁴⁰ and work concurrently with VAERS to monitor the safety of the COVID-19 vaccines. But are these two systems truly complementary to VAERS? Or do they simply control the government’s “safe and effective” narrative and counter the damning safety information in VAERS?

Consider: both the Vaccine Safety Datalink (VSD) and Biologics Effectiveness and Safety (BEST) systems are, in many ways, the exact opposite of VAERS. For example, VAERS relies on open and voluntary reports of first-person narrative testimony about an individual’s own experiences with adverse outcomes following COVID-19 vaccination. By way of comparison, the VSD and BEST systems rely on third-party surveillance, which must follow narrow protocols for identifying adverse outcomes, and this data is collected and reported by entities having a financial interest in the research (and perhaps even the outcome) of vaccine safety. While VAERS allows open reporting of any and all adverse events following COVID-19 vaccination, VSD, and BEST allow only pre-specified (and thus closed sets of) adverse outcomes to be reported if they are detected at all. Rather than complementing VAERS, the VSD and BEST surveillance systems seem primarily designed to counter the VAERS data, handing sole control of the safety data over to the CDC and FDA.

The CDC’s Safety Surveillance System – Vaccine Safety Datalink (VSD)

While the CDC and FDA have two similar (but separate) safety surveillance systems, the remainder of this article will focus on the CDC’s system, Vaccine Safety Datalink (VSD), which has existed since 1990. (The FDA’s system, BEST, will be covered in a subsequent article). While VAERS is designed to receive reports of adverse events voluntarily from a variety of individuals with personal knowledge – including the actual person who has suffered the adverse event or those caring for this person – the Vaccine Safety Datalink (VSD) system operates under government control, via safety surveillance conducted by third party health care institutions who are paid healthcare “partners” of the CDC.

The VSD safety surveillance system is a closed system. This means that the CDC and its private healthcare “partners” control and limit all surveillance and data entry facets. As explained at the 178^th meeting of the VRBPAC in January of this year, VSD is a collaborative project between the CDC and nine cherry-picked “integrated healthcare organizations” (which are geographically located on the map below).⁴¹ As far as scope, the VSD safety monitoring system uses electronic health care records for approximately 12.5 million people across its participating sites – which is equal to about 3.6% of the US population.⁴² The VSD system is reported to be updated weekly. It allows third parties access to “rapid chart reviews” to obtain additional clinical information,⁴³ including information which may result in “exclusion” of an adverse event as related to the vaccine.⁴⁴

Vaccine Safety Datalink (VSD)

Research on government spending shows that many of the CDC’s nine partner healthcare organizations have collectively received federal funds in the hundreds of millions of dollars. Additionally, some have taken strong COVID-19 pro-vaccine positions, which seem to have preceded the completion of ongoing safety surveillance and are in conflict with known data about risks – for example, that young adult males have an increased risk of heart issues following COVID-19 vaccination.

Five of the nine VSD partner healthcare organizations are affiliated with healthcare giant Kaiser Permanente. In September of 2021, according to publicly accessible information on government spending, Kaiser Foundation Hospitals was awarded $55.2 million in contract award money from the HHS.⁴⁵ Kaiser Foundation’s $52 million contract award was just one of the numerous federal contract awards totaling over $154 million in obligated amounts awarded to Kaiser Foundation by the federal government since 2008.⁴⁶

Kaiser Permanente has also strongly advocated in favor of COVID-19 vaccination, taking the position that the COVID-19 vaccines were safe as early as March of 2021. It would seem Kaiser Permanente made its mind up early in the rollout of the COVID-19 vaccines about safety. For example, on a Kaiser Permanente webpage dated February 11, 2022, which is entitled, “How We Know the COVID-19 Vaccine is Safe and Effective,” Kaiser Permanente unabashedly proclaims, “The COVID-19 vaccine is among the safest, most effective vaccines ever.”⁴⁷ The earliest website archive of this Kaiser Permanente page was captured on March 31, 2021 – still relatively early in the rollout of the vaccines – with Kaiser Permanente confidently proclaiming on that date that “Data proves the COVID-19 vaccines are safe and effective.”⁴⁸

Kaiser Permanente seems to have put the cart before the horse, taking an unwavering position on the safety of the COVID-19 vaccines before the completion of the CDC’s and FDA’s safety surveillance projects – which commenced in the fall of 2020 and were expected to continue for approximately three years.⁴⁹ This begs a critical question: why would the CDC award Kaiser Permanente (and others) tens of millions of dollars to conduct COVID-19 vaccine safety surveillance projects if the vaccines had already been deemed safe? Enlisting Kaiser Permanente as a “safety” partner seems to have amounted to a paid endorsement for the mRNA vaccines from a leading US healthcare organization.

Moreover, Kaiser Permanente’s declaration of the COVID-19 vaccines as “among the safest, most effective vaccines ever” on February 11, 2022,⁵⁰ seems ludicrous, given the danger data contained in VAERS, as well as reports of injuries and death reported on multiple websites created to advocate for the vaccine injured after they were silenced by corporate media.⁵¹ Kaiser Permanente seems also to have downplayed as serious, disturbing data confirming that young males have an increased risk of heart issues and myocarditis following COVID-19 vaccination – published on January 25, 2022, in JAMA.⁵² Kaiser Permanente also apparently missed Pfizer’s own 90-day 5.3.6 post-marketing experience – which both Pfizer and the FDA had in early 2021 – showing its mRNA vaccine to be the most lethal drug ever rolled out, with 1223 deaths in the first 90 days (page 7), a multitude of adverse pregnancy outcomes (page 12), and a list nine pages long of “Adverse Events of Special Interest” (Appendix).⁵³ Kaiser Permanente’s pro-vaccine webpages touting the safety of the COVID-19 vaccines without noting any risks raise questions about the objectivity of its partnership with the CDC in monitoring mRNA vaccine safety.

As for the remaining four of CDC’s nine partner healthcare organizations in the VSD safety surveillance: Harvard Pilgrim has received approximately $87.2 million in obligated federal contract award amounts since 2008.⁵⁴ Not surprisingly, Harvard University requires all students to be “up-to-date” on their COVID vaccinations in accordance with CDC guidance.⁵⁵ HealthPartners, Inc.⁵⁶ (and its related entity HealthPartners Institute⁵⁷) appear to have collectively received approximately $23 million in obligated federal contract award amounts since 2008. Marshfield Clinic has received approximately $18 million in obligated federal contract award amounts since 2008.⁵⁸ The last of the nine CDC Vaccine Safety Datalink (VSD) “partners” is none other than the CDC itself, located in Atlanta, Georgia.

Rapid Cycle Analysis Protocol – Did the CDC Stack the Rules of the Game in its Favor?

Unlike VAERS, which allows reporting of any and all adverse events following COVID-19 vaccination, VSD’s closed system uses a narrow screening process and methodology seemingly designed to limit the emergence of safety signals. The VSD safety monitoring for the COVID-19 vaccines uses a prospective protocol called “Rapid Cycle Analysis.”⁵⁹ Under this protocol, only 23 pre-specified outcomes are surveilled by the CDC’s partner medical institutions.⁶⁰ Moreover, the methodology used for VSD’s safety analysis is quite narrow – it calculates the cumulative incidence of these 23 pre-specified outcomes observed in two 21-day risk intervals, and then compares these cumulative incidences to what would be “an expected count.”⁶¹ Day of vaccination adverse outcomes is expressly excluded from this analysis.⁶²

The Rapid Cycle Analysis protocol used by VSD not only limits the type of adverse outcome which can be observed, excluding the day of vaccination, but it also restricts the diagnostic code for all but 4 of the outcomes to codes that are assigned in the emergency room and inpatient setting.⁶³ This seems to be another way of saying that only 4 of the 23 pre-specified adverse outcomes can be counted outside of an emergency room and hospital setting (and these include Bell’s Palsy, Immune thrombocytopenia, narcolepsy/cataplexy, and venous thromboembolism).⁶⁴ Restricting the diagnostic code to certain settings begs the question, if first observed in an outpatient setting – for example, at your physician’s office – are the other 18 outcomes being reported at all?⁶⁵

VRBPAC Slide showing pre-specified adverse outcomes being monitored by VSD system’s Rapid Cycle Analysis.⁶⁶

Compounding the integrity issue within the VSD safety surveillance system is the comparison or control group. Ideally, a control group should be identical to the experimental group, except the experimental group is subjected to the intervention believed to result in the outcome of interest, while the control group is not. This basic rule is violated in the VSD safety surveillance protocols: The Rapid Cycle Analysis protocol currently used by the VSD system for the COVID-19 vaccines largely uses vaccinated persons as the compare or control group during its safety surveillance.⁶⁷ Yes, you read that right: Instead of using unvaccinated persons as a control group and comparing them to a vaccinated group, Rapid Cycle Analysis compares earlier mRNA-vaccinated individuals to later mRNA-vaccinated individuals. It is these later vaccinated individuals who serve as the primary “control” group for safety comparison purposes.

As explained in the VRBPAC’s January 2023 meeting, VSD’s Rapid Cycle Analysis protocol currently compares individuals 1-21 days after their bivalent vaccination to other bivalent vaccinated individuals of the same age, sex, and race, who are 22-42 days out from their vaccination. This latter-vaccinated group, who are 22-42 days out from vaccination, is the primary control group, even though they had the same intervention as the earlier group. As if to narrow the window even more, the VSD safety surveillance compares the data of what happened in the earlier vaccinated group to the later vaccinated group on the same calendar day.⁶⁸

In summary, the VSD’s Rapid Cycle Analysis protocol seems designed to limit the discovery of adverse outcomes following COVID-19 vaccination by kind, time, setting, methodology, and lack of an effective primary comparison group. Nevertheless, a statistical safety signal still emerged for stroke in for Pfizer booster for 65+,⁶⁹ with a significant cluster noted between 11-22 days after vaccination.⁷⁰

The Rules are Stacked Against Protecting the Public – Welcome to the Hunger Games

Which begs the question: What happens if a safety signal emerges? When the stroke signal emerged in the 65+ age group, supplemental analyses were then performed comparing bivalent boosted persons to eligible but un-boosted persons who had received the mono-valent primary series.⁷¹ Even for this supplementary study, there was no true unvaccinated control group, as everyone in the control group had already received the monovalent series (just not the booster).

The most remarkable about the emergence of the signal is what did not happen. Unlike the pulling of the swine flu and rotovirus vaccines after association with serious harm to health, regarding the COVID-19 vaccines, there has been no pause in any age group while investigations and research take place. There also has been no sufficient warning to the public, no acknowledgment that the COVID-19 vaccines have been dangerous, and no requirement that informed consent take place prior to vaccination.

There has been a complete failure to act on the part of the CDC and FDA – despite the growing numbers of adverse events reported in VAERS, despite the emergence of a stroke signal in the 65+ age group in the CDC’s closed VSD safety surveillance program, and despite the widely confirmed increased risk of heart issues and myocarditis following vaccination in young adult males, as recognized by JAMA and by the FDA. While the FDA’s safety surveillance system (BEST) is not the focus of this article, it should be noted that the BEST system detected a safety signal for myocarditis/pericarditis for the 18-35 age group following both the Pfizer bivalent vaccine and monovalent vaccines.⁷² Echoing a kind of hunger games mentality, the CDC’s Rapid Cycle Analysis protocol used by the VSD safety surveillance system instructs:

Signaling criteria will not be considered “stopping rules.” Surveillance will continue to be updated weekly after the threshold for a signal has been met, and supplementary analyses will be added to help interpret the apparent vaccine-outcome association.⁷³ (Emphasis mine).

What does this mean – “Signaling criteria will not be considered ‘stopping rules’”? Disturbingly, it seems to indicate that, under the VSD protocol for safety surveillance of the COVID-19 vaccines, there is simply no stopping point. If this is true, then we are no more than pawns in a deadly game involving the most dangerous experiment ever conducted on humanity.

In this game, major healthcare institutions in the US have been paid off, essentially paid to push a false narrative that the COVID-19 vaccines are safe. Leading medical organizations have also been paid off⁷⁴ to silence their member frontline physicians about the risks of the COVID-19 vaccines. Prominent academic and health institutions have been brought into play, selected for their tremendous influence, and then softened with federal money and perhaps the promise of power. For all of these organizations, and countless others who pushed the experimental COVID-19 vaccinations onto unsuspecting Americans, it is a “play for pay” game. This is tragic news for those like Ms. Baker, who hold out hope for acknowledgment and resolution after experiencing an injury, or those grieving the death of a loved one following vaccination. This is also tragic news for countless Americans who will continue to suffer because of an unstoppable mRNA agenda with no informed consent and no stopping point. Welcome to the hunger games.

Read Part One:  VAERS – The Last Bastion of Vaccine Free Speech?

Listen to the audio version on America Out Loud here.

James A. Thorp, MD
Board Certified ObGyn
Board Certified Maternal Fetal Medicine

References

³⁸ U.S. Centers for Disease Control and Prevention. (2023.) “Vaccine Safety Datalink.”  Accessed June 4, 2023. https://www.cdc.gov/vaccinesafety/ensuringsafety/monitoring/vsd/index.html .

³⁹ US Food and Drug Administration. (2023.) “CBER Biologics Effectiveness and Safety (BEST) System.” Accessed June 4, 2023. https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/cber-biologics-effectiveness-and-safety-best-system .

⁴⁰ US Food and Drug Administration (FDA). FDA Docket Number FDA-2022-N-2810. “178^th Meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC)” (recorded live broadcast). Posted on YouTube, January 26, 2023. Accessed May 31, 2023. https://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-january-26-2023-meeting-announcement . See also, CDC: Centers for Disease Control and Prevention. 2023. “FDA and CDC Response to the Florida Surgeon General.” CDC Newsroom. March 10, 2023. Accessed May 31, 2023. https://www.cdc.gov/media/releases/2023/p0313-letter.html .

⁴¹ US Food and Drug Administration (FDA). FDA Docket Number FDA-2022-N-2810. “178^th Meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC)” (recorded live broadcast). Posted on YouTube, January 26, 2023. Accessed May 31, 2023 (slide at 1:34). https://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-january-26-2023-meeting-announcement . See also 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. Accessed May 31, 2023. https://www.cdc.gov/vaccinesafety/pdf/VSD-1342-COVID19-RCA-Protocol_FinalV1.1_508.pdf

⁴² US Food and Drug Administration (FDA). FDA Docket Number FDA-2022-N-2810. “178^th Meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC)” (recorded live broadcast). Posted on YouTube, January 26, 2023. Accessed May 31, 2023 (slide at 1:34). https://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-january-26-2023-meeting-announcement . See also, 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. 7-8. Accessed May 31, 2023. https://www.cdc.gov/vaccinesafety/pdf/VSD-1342-COVID19-RCA-Protocol_FinalV1.1_508.pdf .

⁴³ US Food and Drug Administration (FDA). FDA Docket Number FDA-2022-N-2810. “178^th Meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC)” (recorded live broadcast). Posted on YouTube, January 26, 2023. Accessed May 31, 2023 (quoted material at ~1:35). https://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-january-26-2023-meeting-announcement .

⁴⁴ 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. See Appendix 1, pp. 29-31, for a list of exclusions for outcomes of interest. Accessed May 31, 2023. https://www.cdc.gov/vaccinesafety/pdf/VSD-1342-COVID19-RCA-Protocol_FinalV1.1_508.pdf .

⁴⁵ USASPENDING.gov. 2023. “Kaiser Foundation Hospitals.” Accessed May 31, 2023. Accessed June 1, 2023. https://www.usaspending.gov/award/CONT_AWD_75D30121C12297_7523_-NONE-_-NONE- .

⁴⁶ USASPENDING.gov. 2023. “Kaiser Foundation Hospitals.” Accessed May 31, 2023. Accessed June 1, 2023. https://www.usaspending.gov/recipient/d192652e-3551-3991-1674-6885c846fff2-C/latest .

⁴⁷ Kaiser Permanente. 2023. “How We Know the COVID-19 Vaccine is Safe and Effective.” February 11, 2022. Accessed June 1, 2023. https://healthy.kaiserpermanente.org/northern-california/health-wellness/coronavirus-information/vaccine-learn/safe-and-effective .

⁴⁸ Kaiser Permanente. 2021. “How We Know the COVID-19 Vaccine is Safe and Effective.” March 31, 2021. Accessed June 1, 2023, via internet archive WayBack Machine: https://web.archive.org/web/20210613015639/https://healthy.kaiserpermanente.org/health-wellness/coronavirus-information/vaccine-learn/safe-and-effective .

⁴⁹ 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. 23. Accessed May 31, 2023. https://www.cdc.gov/vaccinesafety/pdf/VSD-1342-COVID19-RCA-Protocol_FinalV1.1_508.pdf.

⁵⁰ Kaiser Permanente. 2023. “How We Know the COVID-19 Vaccine is Safe and Effective.” February 11, 2022. Accessed June 1, 2023. https://healthy.kaiserpermanente.org/northern-california/health-wellness/coronavirus-information/vaccine-learn/safe-and-effective .

⁵¹ RealNotRare. 2023. Accessed June 1, 2023.

https://www.realnotrare.com/

. See also React19. 2023. Accessed June 1, 2023. https://react19.org/stories/ .

⁵² Oster ME, Shay DK, Su JR, et al. “Myocarditis Cases Reported After mRNA-Based COVID-19 Vaccination in the US from December 2020 to August 2021.” (Jan. 25, 2022) JAMA. 2022;327(4):331–340. doi:10.1001/jama.2021.24110. https://jamanetwork.com/journals/jama/fullarticle/2788346 .

⁵³ Pfizer 5.3.6 Post Market Data, December 1, 2020 to February 28, 2021. Accessed June 1, 2023. https://phmpt.org/wp-content/uploads/2022/04/reissue_5.3.6-postmarketing-experience.pdf .

⁵⁴ USASpending.gov. 2023. “Harvard Pilgrim Health Care.” Accessed June 1, 2023. https://www.usaspending.gov/recipient/c0103b26-3b3f-708e-e041-01c60221a8b9-C/latest.

⁵⁵ Harvard University: Health Services. 2023. “Vaccine Information.” Accessed June 1, 2023. https://huhs.harvard.edu/covid-vaccine-info#gsc.tab=0 .

⁵⁶ USASpending.gov. 2023. “HealthPartners, Inc.” Accessed June 1, 2023. https://www.usaspending.gov/recipient/e9a5b002-4243-9958-1a5a-c08e8af1d78c-P/latest .

⁵⁷ USASpending.gov. 2023. “HealthPartners Institute.” Accessed June 1 2023. https://www.usaspending.gov/recipient/b550c77e-dada-818e-69fc-09235e73bdf9-C/latest .

⁵⁸ USASpending.gov. 2023. “Marshfield Clinic.” https://www.usaspending.gov/recipient/296e7eea-b345-bc95-ab5f-313b0c27795c-C/latest .

⁵⁹ 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. Accessed May 31, 2023. https://www.cdc.gov/vaccinesafety/pdf/VSD-1342-COVID19-RCA-Protocol_FinalV1.1_508.pdf .

⁶⁰ US Food and Drug Administration (FDA). FDA Docket Number FDA-2022-N-2810. “178^th Meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC)” (recorded live broadcast). Posted on YouTube, January 26, 2023. Accessed May 31, 2023 (Slides at ~1:36:40; 1:58:38). https://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-january-26-2023-meeting-announcement .

⁶¹ 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. 5. Accessed May 31, 2023. https://www.cdc.gov/vaccinesafety/pdf/VSD-1342-COVID19-RCA-Protocol_FinalV1.1_508.pdf .

⁶² 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. 9. Accessed May 31, 2023. https://www.cdc.gov/vaccinesafety/pdf/VSD-1342-COVID19-RCA-Protocol_FinalV1.1_508.pdf .

⁶³ Id.

⁶⁴ US Food and Drug Administration (FDA). FDA Docket Number FDA-2022-N-2810. “178^th Meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC)” (recorded live broadcast). Posted on YouTube, January 26, 2023. Accessed May 31, 2023 (~1:58:38). https://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-january-26-2023-meeting-announcement .

⁶⁵ 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. 9. Accessed May 31, 2023. https://www.cdc.gov/vaccinesafety/pdf/VSD-1342-COVID19-RCA-Protocol_FinalV1.1_508.pdf. For a detailed explanation of the Rapid Cycle Analysis protocol used by VSD, see pages 8 et seq.

⁶⁶ US Food and Drug Administration (FDA). FDA Docket Number FDA-2022-N-2810. “178^th Meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC)” (recorded live broadcast). Posted on YouTube, January 26, 2023. Accessed May 31, 2023 (Slide at ~1:55). https://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-january-26-2023-meeting-announcement .

⁶⁷ Id. (Slide at ~1:34:12).

⁶⁸ US Food and Drug Administration (FDA). FDA Docket Number FDA-2022-N-2810. “178^th Meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC)” (recorded live broadcast). Posted on YouTube, January 26, 2023. Accessed May 31, 2023. https://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-january-26-2023-meeting-announcement . You can listen to this process starting at ~1:36:40, with a chart at ~1:37:04.

⁶⁹ Id. (~1:40:01)

⁷⁰ Id. (Slide at ~1:44 and at ~1:52:03).

⁷¹ Id. (~1:48:20).

⁷² US Food and Drug Administration (FDA). FDA Docket Number FDA-2022-N-2810. “178^th Meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC)” (recorded live broadcast). Posted on YouTube, January 26, 2023. Accessed May 31, 2023 (~2:10:17). https://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-january-26-2023-meeting-announcement .

⁷³ 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. 14. Accessed May 31, 2023. https://www.cdc.gov/vaccinesafety/pdf/VSD-1342-COVID19-RCA-Protocol_FinalV1.1_508.pdf.

⁷⁴ Thorp, Maggie and Jim Thorp. 2023. “FOIA Reveals Troubling Relationship between HHS/CDC & the American College of Obstetricians and Gynecologists.” America Out Loud, May 7, 2022. Accessed June 2, 2023. https://americaoutloud.news/foia-reveals-troubling-relationship-between-hhs-cdc-the-american-college-of-obstetricians-and-gynecologists/ .