Yes, it is “FDA approved” but let's look at the timelines for other drugs. Before drugs hit the market they must go through multiple steps such as preclinical research, clinical research, and FDA review.1 According to the US Dept of Veteran Affairs that takes about 10 years, and even after a SUCCESSFUL Phase 3 trial it generally can take 6-12 months before that drug hits prescriptible status.23 4 The reason I emphasize successful there is a Phase 3 clinical trial, per the FDA, needs to be powered in the 1000’s, Pfizer-BioNTech came in at 332, which was manipulated into the thousands during and after the trial. Phase 1 trial data looked at 7-day safety responses in 45 mostly caucasian people and inferred results with a total of 201 participants.5
Further looking at Pfizer-BioNTech’s presentation on 10 Dec 2020, they stated “The vaccine must be proven effective, meaning it can help prevent COVID-19 in at least a majority of patients”.6 Prevent. Not reduce symptoms, prevent, that hypothesis failed.7 8This trend continues throughout this report. Phase 1 consisted of 45 patients. They went on to state “with robust safety data generated from thousands of people”. Well, they opted to go a bit smaller, with 332 participants in their Phase 3 trial, leaving it woefully underpowered to look at safety, and further went on to assess complete safety after only 4 months.9 While the study only boasted 332 participants, the companies opined at the size of their While the study only boasted 332 participants, the companies opined at the size of their study, with more than 43,000 participants, but this is misleading as those people could not be controlled and were not part of the original clinical trial results that determined safety.1011 It is critical to remember when these safety assertations were pushed down to people, as they are continually moving the goalposts as we see increases in adverse reactions which are discussed in Part 4. Another important note about safety, participants in the initial study self-reported adverse reactions in electronic diaries, which might be hard to diagnose myo/pericarditis, but they did state that in younger populations severe adverse effects were more common.12 In a further glorious attempt at sleight of hand, we were given the lie of efficacy, with the companies stating 95% efficacy rates. The problem here is that we still saw, even in the bloated post safety and efficacy initial studies, a whopping total of 162 symptomatic cases and 9 deaths in the placebo group, that brings us to a 0.746% symptomatic case rate, and a 0.041% fatality rate.131 If we are talking about protecting the military we should probably start requiring Chantix (smoking cessation drug) as it kills 0.14% of the population yearly, or about a 30 fold larger fold percentage in death. We are further starting phase 1 (yes ONE) trials and people ages 2- 30, while Governor Gavin Newsome has pronounced his edict of mandatory vaccination for children in schools. Follow the science right guys?!14 15
"FDA Drug Approval Process Infographic” Horizontal-FDA's Center for Drug Evaluation and Research. Accessed October 12, 2021. https://www.fda.gov/drugs/information-consumers-and-patients-drugs/fda-drug-approval-process-infographic-horizontal
“Study to Describe the Safety, Tolerability, Immunogenicity, and Efficacy of RNA Vaccine Candidates against COVID-19 in Healthy Individuals - Full Text View.” Full Text View - ClinicalTrials.gov. Accessed October 12, 2021. https://clinicaltrials.gov/ct2/show/NCT04368728.
“Va.gov: Veterans Affairs,” How Long Before a Drug is Approved by the FDA? (US Department of Veteran Affairs, April 5, 2007), https://www.hiv.va.gov/patient/clinical-trials/drug-approval-process.asp.
“Drug Approval Process,” U.S. Food and Drug Administration (FDA Center for Drug Evaluation and Research), accessed October 9, 2021, https://www.fda.gov/media/83083/download.
Mulligan, Mark J., Kirsten E. Lyke, Nicholas Kitchin, Judith Absalon, Alejandra Gurtman, Stephen Lockhart, Kathleen Neuzil, et al. “Phase I/II Study of COVID-19 RNA Vaccine BNT162B1 in Adults.” Nature 586, no. 7830 (2020): 589–93. https://doi.org/10.1038/s41586-020-2639-4.
Polack, Fernando P., Stephen J. Thomas, Nicholas Kitchin, Judith Absalon, Alejandra Gurtman, Stephen Lockhart, John L. Perez, et al. “Safety and Efficacy of the BNT162B2 Mrna Covid-19 Vaccine.” New England Journal of Medicine 383, no. 27 (2020): 2603–15. https://doi.org/10.1056/nejmoa2034577.
Mark G. Thompson et al., “Prevention and Attenuation of Covid-19 with the BNT162B2 and MRNA-1273 Vaccines,” New England Journal of Medicine 385, no. 4 (2021): pp. 320-329, https://doi.org/10.1056/nejmoa2107058.
Thompson, Mark G., Jefferey L. Burgess, Allison L. Naleway, Harmony Tyner, Sarang K. Yoon, Jennifer Meece, Lauren E.W. Olsho, et al. “Prevention and Attenuation of Covid-19 with the BNT162B2 and MRNA-1273 Vaccines.” New England Journal of Medicine 385, no. 4 (2021): 320–29. https://doi.org/10.1056/nejmoa2107058.
“Pfizer and BioNTech Conclude Phase 3 Study of COVID-19 Vaccine Candidate, Meeting All Primary Efficacy Endpoints,” Pfizer (Pfizer-BioNTech, November 18, 2020), https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-conclude-phase-3-study-covid-19-vaccine.
Thomas, Stephen J., Edson D. Moreira, Nicholas Kitchin, Judith Absalon, Alejandra Gurtman, Stephen Lockhart, John L. Perez, et al. “Safety and Efficacy of the BNT162B2 Mrna Covid-19 Vaccine through 6 Months.” New England Journal of Medicine, 2021. https://doi.org/10.1056/nejmoa2110345.
“History of Changes for Study: NCT04368728 Study to Describe the Safety, Tolerability, Immunogenicity, and Efficacy of RNA Vaccine Candidates Against COVID-19 in Healthy Individuals.” History of changes for study: NCT04368728. Accessed October 12, 2021. https://clinicaltrials.gov/ct2/history/NCT04368728?V_32=View
“Pfizer and BioNTech Conclude Phase 3 Study of COVID-19 Vaccine Candidate, Meeting All Primary Efficacy Endpoints.” Pfizer. Pfizer-BioNTech, November 18, 2020. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-conclude-phase-3-study-covid-19-vaccine.
Fernando P. Polack et al., “Safety and Efficacy of the BNT162B2 Mrna Covid-19 Vaccine,” New England Journal of Medicine 383, no. 27 (2020): pp. 2603-2615, https://doi.org/10.1056/nejmoa2034577.
“A Phase 1/2/3 Study to Evaluate the Safety, Tolerability, and Immunogenicity of an RNA Vaccine Candidate against COVID-19 in Healthy Children and Young Adults - Full Text View.” A Phase 1/2/3 Study to Evaluate the Safety, Tolerability, and Immunogenicity of an RNA Vaccine Candidate Against COVID-19 in Healthy Children and Young Adults. ClinicalTrials.gov. Accessed October 9, 2021.
“A Phase 1/2/3 Study to Evaluate the Safety, Tolerability, and Immunogenicity of an RNA Vaccine Candidate against COVID-19 in Healthy Children and Young Adults - Full Text View,” A Phase 1/2/3 Study to Evaluate the Safety, Tolerability, and Immunogenicity of an RNA Vaccine Candidate Against COVID-19 in Healthy Children and Young Adults (ClinicalTrials.gov), accessed October 9, 2021, https://clinicaltrials.gov/ct2/show/study/NCT04816643.