Comments Regarding Pfizer COVID-19 Vaccine Phase III Clinical Study, Which Led to the Product’s EUA

from a former FDA clinical reviewer, with valuable references to the law and FDA guidance documents

Prior to the administration of the first doses of the Pfizer coronavirus “vaccine” in December 2020, the message was conveyed that it was 95% effective against infection, replication and spread of COVID-19, that it would protect against severe cases, hospitalization, and death, immunity would be long-lasting, and that good safety outcomes were ensured. However, a shallow dive into the study data which was made available to the public clearly indicates that there was no data to support any of these claims from the pivotal study upon which the authorization was based. In addition, the very definition of the term “vaccine” subsequently had to be changed in order to accommodate the substantial shortcomings of the treatment.

It is important to understand the critical importance of the ramifications of U.S. Food and Drug Administration (FDA) Phase 2/3 clinical outcomes regarding subsequent decision-making concerning drugs, biologics or medical devices under consideration for both authorization and subsequent approval. It should also be understood that the performance of a product during the clinical trial is assumed to be a reliable as well as accurate predictor of performance post-approval. Thus, given that the interpretation of the Pfizer clinical data is unambiguous and inarguable, its performance following authorization would not have been expected to vary much from the clinical study results upon which it was based. It is clear that the results of the examination of the FDA Briefing Document for the Pfizer-BioNTech BNT162b2 COVID-19 Vaccine Phase 2/3 clinical study C45910011, the basis for the Emergency Use Authorization (EUA), reveal a number of serious safety concerns which, when combined with the weak effectiveness outcomes, clearly demonstrate that the purpose of the Pfizer clinical study, and that of the EUA vaccine which followed, were NOT to protect the public health as it relates to COVID-19 and SARS-CoV-2.

Study Exclusion Criteria

The study protocol2 identified several health conditions which excluded potential subjects from study participation. These included, but were not limited to, pregnant or breastfeeding women, people with allergies, with psychiatric conditions, immunocompromised people, people with bleeding disorders, people who had previously tested positive for COVID-19, and people who had been prescribed steroids. That is, as these people were excluded from the study, there was absolutely no data to justify any safety claims regarding the administration of the vaccine to these people. Despite this, following the EUA, the vaccine was administered to those with the above conditions. This illogical action runs completely counter to common sense, as doing so would be considered both unscientific as well as unethical.

Age Demographics

When designing a clinical trial to establish safety and effectiveness of a potential treatment, from a public health perspective, the focus should be on the target population who would most benefit from that treatment. However, in the case of SARS-CoV-2, Pfizer focused on a much younger and healthier demographic, one that would be less likely to need a vaccine, would be less likely to suffer an adverse event, and would be more likely to respond better to the vaccine, compared to the comorbid elderly with poor immune responses, i.e., the at-risk population during the SARS-CoV-2 experience. Table 4 Demographics, Efficacy Population in the FDA Briefing Document indicates that only 4% of the study subjects were > age 75; Table 5 Demographics, Safety Population indicates that while 44% of the > age 75 group had significant comorbidities, only 19% of the remaining age groups had any comorbidities. Therefore, as the median subject in the study was approximately 50 years old with no/few comorbidities, absolutely no conclusions could be drawn regarding vaccine effectiveness of the elderly with comorbidities, those most at risk of death from the SARS-CoV-2 virus, since those > age 75 (48.7% of U.S. COVID-19 deaths) comprised only 4% of the study population.3 Therefore, one can only conclude from this that the study was clearly not conducted in the interest of protecting the public health, for if had it been, the focus would have been on those most at risk from dying. Not having weighted the study population to emphasize the at-risk group runs counter to the fundamental principles of effective clinical trial design.

“If we don’t have adequate data in the greater than 65-year-old and up, then the greater than 65-year-old person shouldn’t get this vaccine, which would be a shame because they’re the ones who are most likely to die from this infection,” said vaccinologist Paul Offit, a previous member of the Centers for Disease Control (CDC) Advisory Committee on Immunization Practices, and one of the most influential architects of current U.S. vaccine policy. “We have to generate those data,” he said. “I can’t see how anybody—the Data and Safety Monitoring Board or the FDA Vaccine Advisory Committee, or FDA decision-makers—would ever allow a vaccine to be recommended for that group without having adequate data.”4 This begs the question of, if the Pfizer clinical study was designed in the interest of protecting the public health, why was the primary at-risk group ignored? An October 28, 2021 International Business Times article sheds some light on this fundamental question, as it reports that as of October 18, at least 10,857 Americans had died of COVID-19 despite being fully vaccinated, and that people aged 65 and older made up 85% of the deaths, according to CDC data.5

Vaccine Effectiveness: Absolute vs. Relative Risk Reduction

Per the study protocol,3 to be qualified as a confirmed case, each subject required a positive nucleic acid amplification test as well as the presence of at least 1 of the several listed symptoms (fever, new/increased cough, etc.). Per the FDA Briefing Document, vaccine effectiveness was 95.0%, with 8 COVID-19 cases (per the protocol qualifying definition) in the Vaccinated group and 162 COVID-19 cases in the Placebo group. Pfizer reported the Relative Risk Reduction, i.e., as 8/162=5%, thereby concluding that the vaccine effectiveness was 95%. However, the Relative Risk Reduction does not describe the overall risk that is reduced by vaccination. For that number, we need to look at Absolute Risk Reduction, which includes the numbers of subjects per group: (Placebo group 162/18,325 subjects) minus (vaccine group 8/18,198 subjects) yields an actual improvement of 0.8%, far less than the 95% Relative Risk reported. However, few outside of statisticians would understand why accounting for the denominator would be of critical importance.

Per the FDA document Communicating Risks and Benefits: An Evidence-Based User’s Guide,6

absolute risks, not just relative risks, should be provided, as patients are unduly influenced when risk information is presented using only a relative risk approach, which can result in suboptimal decisions. Per Ronald Brown, “Omitting absolute risk reduction findings in public health and clinical reports of vaccine efficacy is an example of outcome reporting bias, which ignores unfavorable outcomes and misleads the public’s impression and scientific understanding of a

treatment’s efficacy and benefits. Furthermore, the ethical and legal obligation of informed consent requires that patients are educated about the risks and benefits of a healthcare procedure or intervention.” He adds: “The U.S. FDA Advisory Committee (VRBPAC) did not follow FDA published guidelines for communicating risks and benefits to the public, and the committee failed to report absolute risk reduction measures in authorizing the BNT162b2 … vaccines for emergency use.”7 This questionable action, i.e., ignoring unfavorable outcomes and misleading the public’s impression and scientific understanding of a treatment’s safety and effectiveness, runs counter to common logic. How many people would have taken the vaccine had they known that the actual benefit was barely 1%, and not 95%?

Study Outcomes

2-Month Data, December 31, 20208

The primary effectiveness endpoint was symptomatic PCR-confirmed COVID-19 infections 7 days after the second dose. (Data were insufficient to include as endpoints reduction in Severe COVID-19, hospital admission, or death.) It is commonly understood that having Mild symptoms is a poor predictor of subsequent hospitalization or mortality outcomes, since so few patients progress from Mild to Severe outcomes. Subsequently, the CDC Advisory Committee on Immunization Practices (ACIP) recommended, based on the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) scale, that “Evidence was type 3 (low certainty) for the estimate of prevention of COVID-19–associated hospitalization and type 4 (very low certainty) for the estimate of prevention of death.”9 In other words, the study outcomes should not be used to reliably predict COVID-19 hospitalization or especially death, the critical drivers of concern in the SARS-CoV-2 pandemic. (Besides, even if hospitalization and death had been included as endpoints, this would have hardly mattered, given that the most vulnerable elderly population was de-emphasized.) Conversely, regarding safety outcomes, “Severe local and systemic adverse reactions (grade ≥3, defined as interfering with daily activity) occurred more commonly in vaccine recipients than in Placebo recipients,” with the GRADE evidence as type 2 (moderate certainty) for serious adverse events.9 A subsequent analysis by J. Bart Classen, employing data issued by certain FDA advisory committees, reported a 152% excess number of Severe events in the Vaccine group compared to Placebo, consistent with the ACIP grading.10

6-Month Data, September 15, 2021,11 including Supplemental Appendix12

Per the Pfizer 6 Month Supplementary Appendix Table S3, Participants Reporting at Least 1 Adverse Event from Dose 1 to 1 Month After Dose 2 During the Blinded Follow-up Period Regarding Increased Risk of Illness, the Vaccinated group had 5,241 and 262 total and severe unsolicited treatment- related adverse events (i.e., hospitalization), compared to 1,322 and 150 in the Placebo group. This represents a change in risk of +300% and +75% in the Vaccinated group compared to Placebo. In addition, the Vaccinated group had 127 serious adverse events (i.e., death, life-threatening events, or hospitalization), compared to 116 in the Placebo group. This represents a change in risk of +10% in the Vaccinated group compared to Placebo.

Per the Pfizer 6 Month Supplementary Appendix Table S4, Causes of Death from Dose 1 to Unblinding (Safety Population, ≥16 Years Old), combined with the text in the 6-month report, there were 20 deaths associated with those receiving the vaccine, compared to 14 who were in the Placebo group. Deaths included both before and after unblinding, where the latter included 5 deaths, 3 additional in the Vaccinated group and 2 in the Placebo group who crossed over to take the vaccine. In addition, regarding reported causes of death associated with cardiovascular events (aortic rupture, arteriosclerosis, cardiac arrest, failure congestive and arrest) there were 9 deaths in the Vaccinated group, compared to 5 in the Placebo group.

From an effectiveness perspective, per the Pfizer 6 Month Supplementary Appendix Table S7, Vaccine Efficacy from 7 Days after Dose 2 by Underlying Comorbidities (Evaluable Efficacy Population), relative vaccine effectiveness was 91.3%, with 77 COVID-19 cases (per the protocol qualifying definition) in the Vaccinated group and 850 COVID-19 cases in the Placebo group. However, accounting for the actual headcounts of the Vaccine vs. Placebo populations, this calculates to an absolute risk reduction of 3.7%.

Adverse Events within 7 Days of Any Vaccination

The FDA Briefing Document states on page 41 that there were 409 suspected but unconfirmed [via PCR testing] COVID-19 cases that occurred within 7 days following any vaccination compared to only 287 in the Placebo group. Although understanding what happened here seems fundamentally relevant to safety outcomes, no further details were provided in the document. For example, why did the clinical investigators not determine PCR outcomes for these subjects? Was it because Pfizer knew the results would likely be positive? The narrative reads “It is possible that the imbalance in suspected COVID-19 cases occurring in the 7 days postvaccination represents vaccine reactogenicity with symptoms that overlap with those of COVID-19. Overall, these data do not raise a concern that protocol-specified reporting of suspected, but unconfirmed COVID-19 cases could have masked clinically significant adverse events that would not have otherwise been detected.” This conjecture seems to convey those outcomes which might have occurred in the 7 days postvaccination such as death, blood clots, brain inflammation and damage to the heart, liver and kidneys raised absolutely no concerns to Pfizer. That is, it is apparent that adverse outcomes in the time immediately following vaccine administration were completely ignored. If true, this questionable activity runs counter to the fundamental principles of good clinical practice and clinical trials as understood by FDA clinical reviewers. FDA should have requested additional information, including interviewing the clinical investigators, under oath, for their complicity in this apparent coverup.

PCR Testing to Qualify Study Subjects

The RT-qPCR (PCR) test is an amplification technique; if there is DNA or RNA of the desired element in a sample, it is not identifiable as such. Therefore, this test does not reveal any specific virus, but only parts, or specific gene sequences, of the virus in question. In addition, it was reported that the Pfizer clinical study primarily used a PCR test that employed cycle thresholds up to 44.9 to identify COVID-19 “cases,” despite the fact that “positive” results that require cycle thresholds greater than 30 to 35 are usually false positives.13

It had previously been recommended to FDA that Pfizer employ Sanger sequencing-based nucleic acid amplification test (NAAT) methodology to more precisely identify COVID-19 subjects in the clinical trial, since the PCR test cannot rule out diseases caused by other bacterial or viral pathogens, and produces enough false positive (and negative) results to make the outcomes highly unreliable, thus it cannot definitively qualify subjects as COVID-19 positive.13-16 Therefore, one may argue that erroneously qualifying study subjects may have completely invalidated any subsequent claims regarding effectiveness.

“Suspected COVID-19 Cases”

The clinical study did not test all participants for COVID-19. Instead, they left it up to the discretion of their investigators to decide when to test. The FDA Briefing Document indicates on page 42 that there were 3,410 subjects who had presented with COVID-19 symptoms, but with no PCR confirmation. 1,594 of them occurred in the Vaccine group, compared to 1,816 in the Placebo group. There was no further discussion of this in the briefing document, i.e., that 47% of Suspected COVID-19 Cases were in the Vaccine group, compared to 53% in the Placebo group, i.e., no significant difference. As adding the Suspected to the Confirmed cases lowers the relative risk reduction to 19%, this is far lower than the 50% to be eligible for the EUA. This seemingly critical category should have been thoroughly discussed during the EUA review, but it was apparently not discussed at all. As reported by Peter Doshi, “With 20 times more suspected than confirmed cases, this category of disease cannot be ignored simply because there was no positive PCR test result. Indeed, this makes it all the more urgent to understand. A rough estimate of vaccine efficacy against developing COVID-19 symptoms, with or without a positive PCR test result, would be a relative risk reduction of 19% - far below the 50% effectiveness threshold for authorization set by regulators.”17 Because a high level of subjectivity (and bias) was introduced, and that an investigator had the ability to sway the results, the lack of objective systematic testing makes the results unreliable.

Protocol Deviations, Vaccine vs. Placebo Groups

As indicated in the FDA Briefing Document on page 18, Table 2. Efficacy Populations, Treatment Groups as Randomized, there were 311 unexplained protocol deviations on or prior to 14 days after Dose 2 in the Vaccine group compared to 60 in the Placebo group; these subjects were excluded from the efficacy analysis. That is, 84% of the unexplained protocol deviations occurred in the vaccine group. Although the successful explanation of all protocol deviations is typically required in such studies, neither explanations nor resolutions were presented in the briefing document. That is, it would have been impossible to render intelligent conclusions regarding the reliability of the study outcomes.

Early Unblinding of Randomized Control Trial and Elimination of Placebo Group

The Phase 2/3 randomized control trial was intended to commence on July 27, 2020 and to end on May 2, 2023. However, because the 2-month data report was released on December 31, 2020, this effectively unblinded the trial. In addition, most of the Placebo group were given the vaccine, crossing over to the vaccine group. In doing so, not only is it no longer a randomized control study, but by eliminating the control group, the long-term safety data that was planned to be collected up to May 2023 is no longer possible to ascertain. Thus, by deliberately preventing any future test vs control comparisons in the absence of control data, vaccine safety in this study will never be known. This questionable action defies all logic. Interestingly, this action was in direct opposition to Pfizer’s pledge to maintain the control group cohort, as indicated in the FDA Briefing Document on page 10, 2.6. Continuation of clinical trials following issuance of an EUA for a COVID-19 vaccine: “FDA does not consider availability of a COVID-19 vaccine under EUA, in and of itself, as grounds for immediately stopping blinded follow-up in an ongoing clinical trial or grounds for offering vaccine to all Placebo recipients. To minimize the risk that use of an unapproved vaccine under EUA will interfere with long- term assessment of safety and efficacy in ongoing trials, it is critical to continue to gather data about the vaccine even after it is made available under EUA. An EUA request should therefore include strategies that will be implemented to ensure that ongoing clinical trials of the vaccine are able to assess long-term safety and efficacy (including evaluating for vaccine-associated enhanced respiratory disease and decreased effectiveness as immunity wanes over time) in sufficient numbers of participants to support vaccine licensure.” Clearly something happened that prompted Pfizer to violate their intent to preserve the control group comparison.

Conclusions

• The Pfizer Phase 2/3 clinical study, which led to the Pfizer COVID-19 vaccine EUA was not designed in the interest of protecting the public health, and because of this, its emergency use should never have been authorized. Any conclusions drawn or actions taken from the study outcomes have not been relevant with respect to the management of the SARS-CoV-2 situation. The only apparent benefit of the clinical study outcomes was in predicting the poor safety and effectiveness outcomes which have been observed following the EUA, e.g., increased mortality and cardiovascular complications.

• As anyone involved in clinical decision-making at FDA understands, benefit-risk assessment is the cornerstone of the regulatory review of human drugs, medical devices and biologics. That is, unless the benefit of a product exceeds its risk, there is no need to further consider product viability. In the case of the Pfizer-BioNTech BNT162b2 COVID-19 vaccine, because those greater than age 75 with comorbidities (the at-risk population in the SARS-CoV-2 pandemic) comprised only 4% of the study population, no conclusions could be drawn regarding vaccine safety or effectiveness of this most critical group. Since FDA and Pfizer did not conduct an adequate evaluation of this most vulnerable group, this clearly indicates there was no intention of helping them, and more importantly, in protecting the public health. Therefore, as FDA violated their own October 6, 2020 EUA guidance document18 regarding the assurance of safety and efficacy, the EUA should not have been authorized, as it could not possibly have been concluded that benefit exceeded risk for the elderly with comorbidities.

• Following the authorization of the EUA, those who agreed to take the experimental vaccine were falsely led to believe that it provided long-lasting immunity, protection against viral infection and transmissibility, very strong vaccine effectiveness, diminished chances of hospitalization/ death, and ensured good safety outcomes. However, none of these claims were true. Instead, the study’s principal effectiveness outcome indicated only that there was no more than a 1% improvement in mild COVID-19 symptoms in favor of the Vaccinated compared to the Placebo subjects, in a population whose average subject was a 50-year old person with few or no comorbidities, as opposed to the older and much less healthy actual at-risk population.

• A critical thinker would have struggled with the elimination of the Placebo cohort which occurred at 6 months, as by deliberately preventing any future test vs control comparisons in the absence of control data, vaccine safety as predicted by the study outcomes will never be known. This intentional action violated the fundamental principles of good clinical practice and fundamental clinical trial design. On the other hand, the spirit of the elimination of the control group is not inconsistent with FDA’s decision to authorize the emergency use of the Pfizer vaccine in the first place.

• A critical thinker would have questioned the designation of the PCR test to identify COVID-19 positive subjects, as this test, in addition to being open to manipulation, was never designed to qualify subjects as COVID-19 positive. Thus, having employed this faulty methodology, instead of one proposed by experts, seems to have completely invalidated the study effectiveness outcomes, as poor as they were.

• The failure to discuss at the EUA meeting the 1% Absolute Risk Reduction, the actual treatment effectiveness, as opposed to just presenting the 95% Relative Risk Reduction, constituted a violation of FDA published guidelines as well as the ethical and legal obligation of informed consent for communicating risks and benefits to the public.

• Regarding safety outcomes, the ACIP conclusions after 2 months were “Severe local and systemic adverse reactions (grade ≥3, defined as interfering with daily activity) occurred more commonly in Vaccine recipients than in Placebo recipients,” with the GRADE evidence as type 2 (moderate certainty) for serious adverse events in those who were vaccinated. The 6-month data underscored these findings, as the Vaccinated group had 5,241 and 262 related adverse events and severe adverse events, compared to 1,322 and 150 in the Placebo group; there were 20 deaths associated with the Vaccinated cohort, compared to 14 who were in the Placebo group. Regarding reported causes of death associated with cardiovascular events, there were 9 deaths in the Vaccinated group, compared to 5 in the Placebo group.

• Following the authorization, it became obvious that most of the harms, including death, occurred soon after the administration of the COVID-19 vaccines. However, during the clinical trial, as well as following the authorization, one was only considered as Vaccinated two weeks following the second Pfizer vaccination. That is, those harms were, and continue to be, attributed to the Unvaccinated. This abhorrent action cleverly serves to cover up much of the injury which has occurred closely following vaccination.

• The numbers of “Suspected COVID-19 Cases” were similar between the Vaccine (1,594) and Placebo (1,816) groups, indicating very little difference between the two study cohorts in the clinical trial. Although further discussion would ostensibly have impacted the EUA decision, instead, it was completely ignored.

• The failure to discuss the reasons for the substantially greater number of Protocol Deviations in the Vaccinated group (311 vs 60 for the Unvaccinated), and whose data was not included in subsequent analysis, was a significant omission. Why was an explanation not provided? The omission of this critical discussion should have been sufficient to have placed the EUA on hold until adequate information was made available to enable an informed decision.

• From a safety perspective, it is clear that the performance of the Vaccine cohort was inferior to that of the Placebo control group. It is equally clear that the absolute risk reduction in COVID-19 cases provided by the Pfizer vaccine was minimal, and completely failed to represent the at-risk elderly-with-multiple-comorbidities population. Therefore, it should be apparent even to a layman, that there is no benefit to a reduction in cases if it comes at the cost of increased sickness and death.

• The decision-making by Pfizer in conjunction with FDA as related to the clinical study, and the subsequent actions taken, violated not only FDA regulations, but the fundamental principles of benefit/risk determination as well as the assurance of good clinical practice.19-24

• The FDA had attempted to delay the release of Pfizer’s COVID-19 vaccine safety and effectiveness clinical data for 75 years, despite having authorized the product after only 108 days of clinical review on December 11th, 2020.25 However, in early January 2022, Federal Judge Mark Pittman, after hearing testimony from the Public Health and Medical Professionals for Transparency, ordered the FDA to release 55,000 pages per month over the ensuing eight months.26 The released reports continue to be reviewed by Daily Clout.27 Daily Clout has written numerous reports using primary source Pfizer documents since they gained access to the data. For example, Report 84 revealed that there were more cardiovascular deaths in the vaccinated than in the unvaccinated cohort in Pfizer’s clinical trial. Furthermore, Pfizer did not report the 3.7-fold cardiovascular adverse events signal and also delayed reporting deaths so that it favored the vaccinated arm of the trial.28

References:

1.

Vaccines and Related Biological Products Advisory Committee Meeting-December 10, 2020, Retrieved December 8, 2020 from https://www.fda.gov/media/144245/download

2.

A Phase 1/2/3, Placebo-Controlled, Randomized, Observer-Blind, Dose-Finding Study to Evaluate the Safety, Tolerability, Immunogenicity, and Efficacy of Sars-Cov-2 RNA Vaccine Candidates against Covid-19 in Healthy Individuals, Retrieved March 8, 2021 from https://cdn.pfizer.com/pfizercom/2020-11/C4591001_Clinical_Protocol_Nov2020.pdf

3.

Age, Sex, Existing Conditions of COVID-19 Cases and Deaths, Retrieved February 18, 2020 from https://www.worldometers.info/coronavirus/coronavirus-age-sex-demographics/

4.

Doshi P. Will COVID-19 Vaccines Save Lives? Current Trials Aren’t Designed to Tell Us. BMJ. 2020 Oct 21;371:m4037. doi: 10.1136/bmj.m4037. PubMed PMID: 33087398.

5.

10,857 Fully Vaccinated Americans Have Died Of COVID-19; 30,000 Hospitalized, Retrieved October 29, 2021 from https://www.ibtimes.com/10857-fully-vaccinated-americans-have-died-covid-19-30000-hospitalized-3326930

6.

Communicating Risks and Benefits: An Evidence-Based User’s Guide, Retrieved November 6, 2021 from https://www.fda.gov/media/81597/download

7.

Brown, R.B. Outcome Reporting Bias in COVID-19 mRNA Vaccine Clinical Trials. Medicina 2021, 57, 199. https://doi.org/10.3390/medicina57030199

8.

Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine. Polack FP, Thomas SJ, et al. N Engl J Med. 2020 Dec 31;383(27):2603-2615. doi: 10.1056/NEJMoa2034577. Epub 2020 Dec 10. PMID: 33301246

9.

The Advisory Committee on Immunization Practices’ Interim Recommendation for Use of Pfizer- BioNTech COVID-19 Vaccine — United States, December 2020, Retrieved December 16, 2020 from https://www.cdc.gov/mmwr/volumes/69/wr/mm6950e2.htm

10.

Classen JB. US COVID-19 Vaccines Proven to Cause More Harm than Good Based on Pivotal Clinical Trial Data Analyzed Using the Proper Scientific Endpoint, “All Cause Severe Morbidity”. Trends Int Med. 2021; 1(1): 1-6.

11.

Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine through 6 Months. Thomas SJ, Edson D Moreira Jr, ED, et al. N Engl J Med. 2021 Nov 4;385(19):1761-1773. doi: 10.1056/NEJMoa2110345. Epub 2021 Sep 15.

10

12.

Supplement to: Thomas SJ, Moreira ED Jr, Kitchin N, et al. Safety and efficacy of the BNT162b2 mRNA Covid-19 vaccine through 6 months. N Engl J Med 2021;385:1761-73. DOI: 10.1056/NEJMoa2110345

13.

Pathologist: FDA ‘Misled the Public’ on Pfizer Vaccine Efficacy, Retrieved February 27, 2021 from https://childrenshealthdefense.org/defender/fda-misled-public-pfizer-vaccine-efficacy/?itm_term=home

14.

Borger, P., Malhotra RK, et al. Addendum - Corman Drosten Review Report by an International Consortium of Scientists in Life Sciences (ICSLS). ResearchGate, DOI 10.5281/zenodo.4433502.

https://www.researchgate.net/publication/348406857_Addendum_-_Corman_Drosten_Review_Report_by_an_International_Consortium_of_Scientists_in_Life_Sciences_ICSLS

15.

PCR Tests and the Rise of Disease Panic, Retrieved December 8, 2021 from

https://brownstone.org/articles/pcr-tests-and-the-rise-of-disease-panic/

16.

Shaibu, J. O., Onwuamah, et al. Full Length Genomic Sanger Sequencing and Phylogenetic Analysis of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) in Nigeria. PloS one, 16(1), e0243271. https://doi.org/10.1371/journal.pone.0243271

17.

Doshi, P: Pfizer and Moderna’s “95% Effective” Vaccines-We Need More Details and The Raw Data, Retrieved January 21, 2021 from https://blogs.bmj.com/bmj/2021/01/04/peter-doshi-pfizer-and-modernas-95-effective-vaccines-we-need-more-details-and-the-raw-data/

18.

FDA Issues Guidance on Emergency Use Authorization for COVID-19 Vaccines, Retrieved June 5, 2021 from

https://www.fda.gov/news-events/fda-brief/fda-brief-fda-issues-guidance-emergency-use-authorization-covid-19-vaccines

19.

Ensuring the Safety of Clinical Trials (Investigations), Retrieved March 5, 2021 from FDA Web site: https://www.fda.gov/media/87679/download

20.

Regulations: Good Clinical Practice and Clinical Trials, Retrieved May 7, 2021 from https://www.fda.gov/science-research/clinical-trials-and-human-subject-protection/regulations-good-clinical-practice-and-clinical-trials

21.

Code of Federal Regulations 21 Part 50 Protection of Human Subjects, Retrieved October 2, 2021 from https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-50

22.

Code of Federal Regulations 21 Part 312 Selecting Investigators and Monitoring, Retrieved October 2, 2021 from: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-D/part-312/subpart-D/section-312.53

11

23.

Code of Federal Regulations 21 Part 312.64 Investigator Reports, Retrieved September 20, 2021 from https://www.ecfr.gov/current/title-21/chapter-I/subchapter-D/part-312/subpart-D/section-312.64

24.

FDA In Brief: FDA Issues Guidance on Emergency Use Authorization for COVID-19 Vaccines, Retrieved October 30, 2020 from

https://www.fda.gov/news-events/fda-brief/fda-brief-fda-issues-guidance-emergency-use-authorization-covid-19-vaccines

25.

FDA Now Wants 75 Years to Release Pfizer Vaccine Documents. (n.d.), Children’s Health Defense. Retrieved March 2, 2022 from https://childrenshealthdefense.org/defender/fda-75-years-release-pfizer-vaccine-documents

26.

Judge Scraps 75-Year FDA Timeline to Release Pfizer Vaccine Safety Data, Giving Agency Eight Months (January 7, 2022), Retrieved January 28, 2022 from https://denvergazette.com/news/judge-scraps-75-year-fda-timeline-to-release-pfizer-vaccine-safety-data-giving-agency-eight/article_f007b8b4-ad66-59b4-a270-4709bc3e4814.html

27.

Daily Clout Pfizer Documents Analysis (n.d.), Retrieved May 19, 2023 from https://dailyclout.io/category/communities/pfizer-documents-analysis/

28.

Report 84: War Room/DailyClout Research Team Breaks Huge Story: More Cardiovascular Deaths in Vaxxed Than Unvaxxed; Pfizer Did Not Report Adverse Event Signal; Death Reporting Delays Favored Pfizer/Vaccinated (September 5, 2023), Retrieved October 21, 2023 from

https://dailyclout.io/report-84-warroom-dailyclout-research-team-breaks-huge-story/