Caught in their own trap?

Introduction

On January 5, 2024 the Journal of the American Medical Association (JAMA) published an article by Peter Marks and Robert Califf. Both authors are affiliated with the US Food and Drug Administration (FDA). The article, “Is Vaccination Approaching a Dangerous Tipping Point?,” is a discussion about growing vaccine hesitancy in the US, and includes suggestions on how to alter this trend.[1] The article is brief; it contains only nine paragraphs and one figure. The authors claim that vaccines (including the Covid shot) have been carefully developed and are safe and effective. They also argue for the medical community to “redouble its efforts” to provide the public with appropriate information about vaccines.

Unfortunately there are multiple problems with the claims made by the authors. We do, however, agree with their conclusion that “the best way to counter the current large volume of vaccine misinformation is to dilute it with large amounts of truthful, accessible scientific evidence.” In consequence, we think it appropriate to respond to the article by countering their incorrect claims with truthful, scientific evidence. To accomplish this, we consider nine specific claims made in the article.

Claim #1

“Despite the care taken in the development and deployment of vaccines and their clear and compelling benefit of saving individual lives and improving population health outcomes, an increasing number of people in the US are now declining vaccination for a variety of reasons … the situation has now deteriorated to the point that population immunity against some vaccine-preventable infectious diseases is at risk.”

 Response

Contrary to the claims here about how carefully vaccines are produced, the pharmaceutical industry rushed the Covid shot to market after only a few months and an incomplete clinical trial. There was no formal cost/benefit analysis conducted.[2] The shot was not tested to see if it either stopped or reduced transmission. They never tested to see how long the injected material stayed in the body. Toxicity studies were not completed, despite evidence that injected material became widely distributed throughout the body.[3] Therefore, it would be more correct to say that the Covid shot was an untested product, and this despite it being a brand new technology with unknown risk factors.

After rushing an untested product to market, falsely claiming it to be safe and effective, mandating people to take it, all while turning a blind eye to the unprecedented number of adverse events it caused, and then censoring anyone who tried to ask questions, is it any wonder that some people became sceptical of the vaccine industry? The FDA has no one but themselves to blame for this trend. Therefore we conclude that the FDA, albeit inadvertently, caused millions of people to rethink the topic of vaccines and also to permanently mistrust the pharmaceutical industry. Moreover, this trend is quite understandably spilling over into mistrust of mainstream healthcare more generally. Nor are we alone in these conclusions: the Surgeon General of Florida, Dr Ladapo, in an open letter, accused Robert Califf (one of the authors) of causing “deep distrust in the American health care system.” [4]

Claim #2

“Vaccine hesitancy to childhood vaccines … has been found to cluster in middle- to high-income areas among parents with at least a college degree who preferred social media narratives over evidence-based vaccine information delivered by clinicians.”

Response

The fundamental claim being made here is that clinicians are well informed about vaccines and qualified to transmit quality information to patients. While it is certain that some doctors can be praised for their diligence in seeking out scientific evidence about vaccines, this is certainly not true of all. A majority of doctors belong to the latter group of people. During the Covid era, most doctors failed to do something as simple as to read the published papers reporting on the phase 3 clinical trials. Even those involved in publicly promoting the Covid shots rarely examined the evidence themselves, nor did those actually doing the injecting, most of whom were financially rewarded for their participation. Numerous healthcare professionals have affirmed this to be the case, including well-known public figures such as nurse educator John Campbell, [5] cardiologist Dr Aseem Malhotra [6], and relatively unknown doctors such as Robert Jackson.[7] Worse yet, in some regions of the world significant pressure was exerted on doctors to make sure that they did “not communicate anti-vaccine” sentiments, even going so far as to forbid them from saying anything against the official Covid narrative.[8] Coercion and censorship is a far cry from allowing clinicians to freely provide accurate information to their patients.

The secondary claim is that educated people are being misled by wrong information that they find on social media. Although this statement was made in the context of the “measles, mumps, and rubella vaccines,” it is apparent that the authors feel that the same happened with the Covid shot. There are multiple problems with this sentiment. Firstly, all of the big social media platforms, including YouTube, Google, Facebook, Amazon and Twitter aggressively censored content that contradicted the official Covid narrative.[9,10, 11] Secondly, many thousands of medical professionals, having discerned serious problems with the mRNA platform and the Covid shots, went public about their concerns. Despite the censorship, some found creative ways to publish their research.[12,13] Thirdly, given that people rejecting the Covid shot faced public ridicule, lack of access to public revenues, possible discrimination if in need of medical assistance, and total loss of income,[14] it is in fact much more likely that the educated people who rejected the Covid shot did so after carefully investigating the facts. We are not aware of any educated person being misled by preferring false social media narratives instead of evidence-based information. We do know of many who, after diligent research of the evidence, concluded that the Covid shots were neither safe nor effective. In complete contrast to claim #2 above, it is certain that many who accepted the Covid shot did so on account of media reports and public pressure rather than by intelligent examination of evidence-based information.

Claim #3

“Anyone doubting the benefits of vaccination need only look to low-income parts of the world where measles vaccination is inaccessible, and many thousands of children continue to die each year due to preventable disease.”

Response

This statement violates a fundamental rule for conducting medical studies, namely the importance of comparing outcomes between groups with similar characteristics. For instance, all other things being equal, one would expect lower mortality rates in a younger group than an older one. In the same vein, it is not proper to compare childhood mortality rates between low and high-income countries, and then to use the difference to assert that vaccines are beneficial. Low-income countries typically have issues with the availability of clean drinking water and nutritious foods. It is reasonable to suspect that poor water quality and scarce food is the principal reason for excess childhood deaths in these countries, not vaccine accessibility. Indeed, malnutrition has been identified as the most common underlying cause of death among children.[15] Vaccines do not fix malnutrition.

Claim #4

“Communication regarding the potential benefits of vaccination can hopefully also improve the number of individuals accepting vaccination to protect against COVID-19, influenza, and respiratory syncytial virus disease.”

Response

We humbly submit that the solution to low uptake of the Covid shot is to communicate the truth rather than the “potential benefits.” The truth that people need to hear from the FDA is that the shot was a colossal failure at stopping ‘Covid’. Indeed, as one study found: “The higher the number of vaccines previously received, the higher the risk of contracting COVID-19.” [16,17] The FDA also needs to admit that the Covid shot resulted in an unfathomable number of adverse events, including the deaths of many hundreds of thousands of people.[18] Put bluntly, what we need from the FDA is an honest and sincere apology for the global disaster that they caused by promoting an unproven vaccine platform. Further, the FDA needs to immediately suspend approval of the Covid shots.[19] If the FDA did these things, it is possible that the general public might regain some of its lost confidence.

Claim #5

“Contrary to a wealth of misinformation available on social media and the internet, data from various studies indicate that since the beginning of the COVID-19 pandemic tens of millions of lives were saved by vaccination.” 

Response

In order to back up this claim, the authors provide two bar graphs (Figure 1 in their article), in which it is visually reported that the unvaccinated have a significantly higher mortality rate from Covid than do the vaccinated. The data used for this graph comes from the CDC, which defined “Vaccination status” as “A person vaccinated with at least a primary series and had SARS-CoV-2 RNA or antigen detected on a respiratory specimen collected ≥14 days after verifiably completing the primary series of an FDA-authorized or approved COVID-19 vaccine.”

The term “primary series” refers to the minimum number of shots recommended to complete the manufacturer’s specifications. In the case of Pfizer and Moderna mRNA shots for Covid, the primary series includes two shots.

What this means is that if a person tested positive for Covid six months after receiving their first Covid shot but a few days before their second shot, and subsequently died, they were treated as unvaccinated because the test specimen was taken before the primary series was completed.

Likewise, if the test was taken 13 days after the second shot, and the person subsequently died, they were still regarded as unvaccinated because the specimen was taken less than 14 days after the second shot.

By excluding these time periods from their analysis they have arbitrarily increased the effectiveness of the vaccine. Indeed, it has been demonstrated mathematically that even by excluding just two weeks it is possible to make a saline shot (that does nothing) appear to have a vaccine efficacy of 95%.[20]. Worse than this, since the Covid shots have been demonstrated to cause an increase in infections especially during the two weeks following an injection, by excluding this period vaccine efficacy is falsely increased even further.[17]

Furthermore, we have previously demonstrated that the claim that the Covid shots saved tens of millions of lives is impossible.[21]

Even if the vaccine did save some lives, in order for it still to be a worthwhile product the lives lost on account of adverse events from the shot would need to be less than the lives saved. Sadly, this article in JAMA fails to mention this requirement, let alone provide any estimates of deaths caused by the shot. In contrast, we have shown that even by a conservative estimate the Covid shots had a higher fatality rate than Covid did.[18]

Claim #6

“The current reversal of vaccine acceptance has already resulted in hundreds of thousands of excess deaths from COVID-19.”

Response

         Again, the reality is the opposite of what is claimed here. There is plenty of evidence not only that the Covid shots actually increased the number of Covid cases[17], but also that they damage the immune system.[22]. Since there is no credible scientific evidence that the shots reduced the infection fatality rate of Covid in breakthrough cases,[23] there is reason to conclude that declining vaccine acceptance saved lives, not the other way around.

Claim #7

“To reduce deaths, hospitalisation, and the burden on families and the health care system, all those directly interacting with individuals in a health care setting, ranging from front office staff to retail pharmacists to primary care physicians, need to focus at every appropriate opportunity on helping to ensure that individuals have the necessary information to make informed choices regarding vaccination, considering the benefits and risks.”

Response

We completely concur with this sentiment. However, what the authors have couched in this sentence is the falsehood that the FDA provided “necessary information,” encouraged people to make “informed choices,” and provided data on the “risks” of the Covid shots. Nothing could be further from the truth. Regarding giving the public access to information, the FDA “asked a federal judge for permission to make the public wait until the year 2096 to disclose all of the data it relied upon to licence Pfizer’s Covid-19 vaccine.”[24] As for “informed choices,” the public was coerced into taking the shots or risk financial ruin (or worse in many other countries). Regarding “risks,” even in this article the authors mention nothing at all about any known risks of the Covid shot, let alone the unknown risks or long-term effects of this unproven technology. Instead, the entire article is written as if the FDA is still persuaded that the Covid shot is both safe and effective.

Claim #8

“COVID-19, influenza, and respiratory syncytial virus disease… [are] vaccine-preventable illnesses.”

Response

Unfortunately, none of these diseases can be prevented by our current vaccines. Not even after 17 years of research was anyone able to develop a vaccine for SARS-1.[25] Studies have demonstrated that the flu shot is probably ineffective.[26] The number of breakthrough cases of Covid was so large that the CDC stopped recording them.[27] And even Dr Fauci himself recently admitted that “past unsuccessful attempts to elicit solid protection against mucosal respiratory viruses and to control the deadly outbreaks and pandemics they cause have been a scientific and public health failure that must be urgently addressed.”[28]

Claim #9

“We will do our part at FDA by continuing to provide health care clinicians and the general public with timely and accurate information in plain language to help explain the benefits and risks of vaccination.”

Response

As the forgoing responses have demonstrated, the FDA is not in a position to “continue” doing what it has not yet done. At the very least they could begin by mentioning some of the “risks of vaccination.” 

In conclusion, one is left wondering if the authors are biassed on account of financial ties to the pharmaceutical industry.

References

1. Marks P, Califf R. Is Vaccination Approaching a Dangerous Tipping Point? JAMA. 2024;331(4):283–284. doi:10.1001/jama.2023.27685  
2. Fraiman Joseph et al, “Serious adverse events of special interest following mRNA COVID-19 vaccination in randomized trials in adults,” Vaccine, Volume 40, Issue 40, 2022, Pages 5798-5805, ISSN 0264-410X, https://doi.org/10.1016/j.vaccine.2022.08.036.
3. Palmer, Michael, Bhakdi, Sucharit, “The Pfizer mRNA vaccine: pharmacokinetics and toxicity,” 2021, https://doctors4covidethics.org/wp-content/uploads/2021/07/Pfizer-pharmacokinetics-and-toxicity.pdf
4. Ladapo Joseph, Open letter to Drs Califf and Walensky, 2023, https://twitter.com/FLSurgeonGen/status/1656449256679432193/photo/1
5. Campbell, John, “The Pfizer documents,” 2023, https://m.youtube.com/watch?v=7YOD9drZasM&feature=youtu.be
6. Malhotra, Aseem, “Dr Malhotra on calling for vaccine data transparency: ‘The information has evolved considerably,” 2023, GBNews, https://m.youtube.com/watch?v=7YOD9drZasM&feature=youtu.be&t=435
7. Jackson, Robert, “Rheumatologist Robert Jackson: 40% vaccine injured; 0.33% dead,” 2023, https://rumble.com/v132f7g-rheumatologist-robert-jackson-40-vaccine-injured-0.33-dead.html
8. Yang, Ethan, “Canadian Doctors Are Being Censored,” 2021, AIER, https://www.aier.org/article/canadian-doctors-are-being-censored/
9. Schechner, Sam et al, “How Facebook Hobbled Mark Zuckerberg’s Bid to Get America Vaccinated.” 2021, WSJ, https://www.wsj.com/articles/facebook-mark-zuckerberg-vaccinated-11631880296?redirect=amp#click=https://t.co/dHODPpeAUv
10. Perry, Luke, “YouTube to Advance its Crack-Down on Vaccine “Misinformation”, 2021, https://dailysceptic.org/2021/09/29/youtube-to-advance-its-crack-down-on-vaccine-misinformation/
11. Berenson, Alex, “Andy Slavitt’s censorship efforts at the White House even extended to Amazon and the books it sold,” 2024, https://alexberenson.substack.com/p/andy-slavitts-censorship-efforts
12. Shir-Raz, Y., Elisha, E., Martin, B. et al, “Censorship and Suppression of Covid-19 Heterodoxy: Tactics and Counter-Tactics.” Minerva 61, 407–433 (2023). https://doi.org/10.1007/s11024-022-09479-4
13. Anonymous, “Declaration of International Medical Crisis due to the diseases and deaths co-related to the Covid-19 Vaccines,” 2023, https://medicalcrisisdeclaration.com/
14. Miller, “An Honest Doctor’s Experiences on the Front Lines During COVID-19,” 2023, Substack, https://www.midwesterndoctor.com/p/an-honest-doctors-experiences-on
15. Bassat Q, Blau DM, Ogbuanu IU, et al, Causes of Death Among Infants and Children in the Child Health and Mortality Prevention Surveillance (CHAMPS) Network. JAMA Netw Open. 2023; 6(7):e2322494. doi:10.1001/jamanetworkopen.2023.22494
16. Nabin K. et al, “Effectiveness of the Coronavirus Disease 2019 (COVID-19),” medRxiv 2022.12.17.22283625; doi:https://doi.org/10.1101/2022.12.17.22283625
17. Verduyn, Thomas, et al, “How many lives were actually saved by the Covid-19 vaccines?,” 2023, Panda, https://pandata.org/how-many-lives-were-actually-saved-by-the-covid-19-vaccines/
18. Verduyn, Thomas et al, “Did side effects from the Covid shots cause any excess mortality?,” 2023, Panda, https://pandata.org/did-side-effects-from-the-covid-shots-cause-any-excess-mortality/
19. Palmer, Michael, Bhakdi, Sucharit, “Vascular and organ damage induced by mRNA vaccines: irrefutable proof of causality,” 2022, https://doctors4covidethics.org/vascular-and-organ-damage-induced-by-mrna-vaccines-irrefutable-proof-of-causality/
20. Fenton, Norman, Neil, Martin “The illusion of vaccine efficacy revisited,” 2023, https://wherearethenumbers.substack.com/p/the-illusion-of-vaccine-efficacy
21. Kenyon, Todd et al, “It is impossible that the vaccines saved 14 million lives in 2021,” 2023, Panda, https://pandata.org/it-is-impossible-that-the-vaccines-saved-14-million-lives-in-2021/
22. Boretti, A. “mRNA vaccine boosters and impaired immune system response in immune compromised individuals: a narrative review.” Clin Exp Med 24, 23 (2024). https://doi.org/10.1007/s10238-023-01264-1
23. Ophir, Yaakov et al, “The Efficacy of COVID-19 Vaccine Boosters against Severe Illness and Deaths: Scientific Fact or Wishful Myth?” 2023, https://jpands.org/vol28no1/ophir.pdf
24. Siri, Aaron, “Why a Judge Ordered FDA to Release Covid-19 Vaccine Data Pronto,” 2022, Bloomberg Law, https://news.bloomberglaw.com/health-law-and-business/why-a-judge-ordered-fda-to-release-covid-19-vaccine-data-pronto
25. Li YD, Chi WY, Su JH, Ferrall L, Hung CF, Wu TC. Coronavirus vaccine development: from SARS and MERS to COVID-19. J Biomed Sci. 2020 Dec 20;27(1):104. doi:10.1186/s12929-020-00695-2. PMID: 33341119; PMCID: PMC7749790
26. Fireman B, Lee J, Lewis N, Bembom O, van der Laan M, Baxter R. “Influenza vaccination and mortality: differentiating vaccine effects from bias.” Am J Epidemiol. 2009 Sep 1;170(5):650-6. doi:10.1093/aje/kwp173. Epub 2009 Jul 22. PMID: 19625341; PMCID: PMC2728831.
27. Tayag, Yasmin, “Why has the CDC stopped collecting data on breakthrough Covid cases?” 2021, Guardian, https://www.theguardian.com/commentisfree/2021/aug/06/cdc-covid-coronavirus-data-breakthrough-cases
28. Fauci, Anthony et al, “Rethinking next-generation vaccines for coronaviruses, influenza viruses, and other respiratory viruses,” 2023, Cell Host & Microbe, DOI: https://doi.org/10.1016/j.chom.2022.11.016