This article is not an attempt to support so-called “anti-vaxxers” who oppose using time-tested vaccines on various grounds. This article is an effort to broaden the very narrow conversation surrounding COVID-19 vaccines. There are people with legitimate concerns—on scientific and moral levels—about COVID-19 vaccines. Moreover, this is not a clear, black-and-white issue. As with everything, there is nuance and complexity to it.
Two primary categories drive vaccine hesitation. First are the moral and ethical issues that have arisen during the pandemic. And second, there are scientific objections to the vaccine—especially Pfizer’s variant. Addressing the moral and ethical issues first might help contextualize scientific objections to the COVID-19 vaccine.
If we return to the beginning of the pandemic, a source of contention was the use of masks and the mandated use of them to reduce the spread of COVID-19. To many Americans, this change was the first of multiple transgressions that further degraded their faith in the government. In many ways, Chief Medical Advisor to the President Dr. Anthony Fauci has been the face of the scientific discussion involving the pandemic and came to represent the federal government in their response to the pandemic. Early on, as reported from a June 15, 2020 Insider article, Americans were told that masks were not a necessity and that they would do very little to reduce the spread of the virus. Currently, if we look around, everyone is wearing masks. As reported by The Street in June of 2020, it became clear that medical experts misled the general public to avoid a mask shortage for healthcare workers. Regardless of the intent of this deception, it was a deception nonetheless; a deception that practically destroyed their trust in the federal government’s pandemic response.
A second major element of vaccine hesitation is a deeply-rooted mistrust in pharmaceutical companies. The opioid crisis is still fresh in the minds of many who lost loved ones, not to an external virus, but to the horrors of addiction that were packaged and stamped by the same companies that have produced the vaccines. According to ABC News, Pfizer is a company that has paid the most significant criminal fine in history (2009)-––for misbranding a painkiller with the intent to “defraud or mislead.” In 2004 Pfizer paid $430 million in fines for marketing a drug for unapproved uses—even after scientific evidence showed the drug to be ineffective. Suddenly, Americans are being asked to trust these companies despite their history of lying and manipulation.
Even to this day, a cloud of deception lingers around ‘Big Pharma.’ Though a judge struck down this action, the FDA attempted to delay the release of the Pfizer vaccine safety data by 75 years—not to be seen by the public until 2097. Even more recently, Pfizer has attempted to support the FDA in the delay to protect trade secrets and business proprietary information. As of this writing, that lawsuit is still being reviewed. Even to a non-skeptic, this information seems suspicious. It is very difficult to justify the delayed release of safety data under any circumstances, particularly given the widespread use of the vaccine.
Now, let us turn to potential scientific objections to the vaccine. One of the mantras of the vaccine has been “safe and effective.” Many people know that the vaccine is 95 percent effective, as indicated in the safety and efficacy data per the clinical trials. Here is our first issue. The original Pfizer trial report data said that the vaccine was safe and had a 95 percent efficacy rate seven days after the second dose. What does that 95 percent mean? 95 percent represents that relative risk reduction. That is to say, the risk of contracting COVID-19 at the time of that trial was 0.88 percent if one was unvaccinated. The risk then fell to 0.04 percent when vaccinated. That 95 percent is the relative difference between 0.88 percent and 0.04 percent. Absolute risk reduction was 0.84 percent (0.88 percent minus 0.04 percent). This means the Pfizer vaccine’s net benefit is 0.84 percent, not 95 percent. In fact, the NIH recommends using absolute risk reduction instead of relative risk reduction to make policy decisions. The fact that these statistics were often overlooked and were, for whatever reason, typically only framed in terms of relative risk reduction is yet another example of why many in the general public feel they are being misled and manipulated. This data drastically changes the analysis involved in the vaccine and should beg the question ‘how many would have taken the vaccine with the knowledge of a less than 1 percent overall benefit’?
There are also serious concerns about data integrity and research processes in Pfizer’s trials, according to one whistleblower from a Nov. 2 article published by The BMJ. There have been claims of falsified data, unblinded patients, inadequately trained vaccinators, and delayed follow-up on adverse events reported in the phase III trial. In addition, there were also claims of quality control check staff being overwhelmed by the volume of problems they were finding. The story of 12-year-old Maddie de Garay is perhaps one of the most troubling stories. After taking the vaccine during the trials, this healthy adolescent reported having abdominal pain. The reality of the situation was more unsettling. Twenty-four hours after she arrived at the trial site, she developed crippling pain—abdominal, muscle, and nerve pain. It was described as if someone was “ripping [her] heart out through [her] neck.” The 12-year-old has now been admitted to the hospital three times, developing a host of issues including but not limited to gastroparesis, seizures, verbal and motor tics and drastic and adverse changes in her vision. De Garayis currently confined to a wheelchair; yet per the official Pfizer report she experienced merely abdominal pain in the trial study.
Many Americans have already had COVID-19, with some estimates being around 1 in 3. Because of this, many wonder why vaccine mandates still apply to them. A study published in medRXiv in April of 2021 showed that natural immunity has been successful in demonstrating at least as much protection and durability as vaccination. In addition, more attention should be paid to the slogan “A pandemic of the unvaccinated.” People hear this slogan and are left more confused than ever. Despite 75 percent of the US having received one dose and 64 percent being fully vaccinated, the past few weeks have had the most extensive caseload since the pandemic began. Now, there are reasons for this– primarily because COVID-19 has mutated it’s way around the vaccine, but many are left feeling that something doesn’t seem to be adding up. If it’s a “pandemic of the unvaccinated” then why are vaccinated people getting sick? To be clear, rates of infection are much higher in the unvaccinated, but the vaccinated are also being infected at a significant rate. Especially as Omicron appears to be less severe than previous variants, those who don’t feel comfortable with vaccination can’t help but wonder why they’re expected to shoulder the blame for the pandemic.
Finally, I’d like to talk about the CDC’s Vaccine Adverse Event Reporting System (VAERS). Many discredit the VAERS data because of claims it is highly susceptible to manipulation by malicious actors. On the flip side, a report from Harvard Pilgrim Health Care says that VAERS underreports adverse vaccine events by a large margin—only 1 percent of events are reported. No matter how one views the data, a few things are clear: there are potentially dangerous and harmful side effects to this vaccine. Even the producers of the vaccine admit to this. There is no getting around that. If the data is bad, then the CDC failed in providing the American people the ability to make informed decisions. If the data is good, then it speaks for itself—27,000 counts of myocarditis and pericarditis, 22,000 deaths, 11,000 heart attacks after receiving the vaccine. And what happens if only 1 percent of events are actually being reported? Either way, here is another nail in the coffin of public trust. As safe as vaccines are, they are not perfect. This is an issue that stems back decades, most notably in 1955 when 200 children were left paralyzed and ten were killed after receiving the Polio vaccine at Cutter Laboratories—what would become the “Cutter Incident.”
It is important to keep an open mind about COVID-19 vaccination. This has just been an overview of some of the reasons for vaccine hesitation as it pertains to COVID-19. Frankly, there are many more reasons. The increasingly alarming data on children—particularly in regard to heart inflammation in young boys after receiving the vaccine, the cytotoxicity of the spike protein in vaccines, or where the vaccine’s components(particularly the lipid nanoparticles and spike protein) end up in the body and how long they stay there are all concerns as well. To many, the question of whether to get vaccinated is not an easy one. No matter how safe it is now, there is no knowing what five, 10, 15 or 50 years will bring. That uncertainty alone is enough for some. Though one can debate if it’s directly applicable, the Nuremberg code tells us that, “The voluntary consent of the human subject is absolutely essential.” Some have given their consent to receive a COVID-19 vaccine, which is perfectly fine. However, there are some who do not want to make that choice. They are tired of a series of lies and deceptions from companies and the federal government. They yearn for the right of personal freedom to bear the consequences of those decisions. As Abraham Lincoln once said, “No man is good enough to govern another man without his consent.” If we forget the dignity and respect that we owe each other as human beings, the miraculous accomplishment of this vaccine will have been for nothing.
I am substantially disappointed in the Misc for the publication of this piece. Especially with no accompanying counter piece. This directly ignores the broader impacts and origins of the Anti-Vax movement while encouraging readers to sympathize with Anti-Vaxers. I am deeply concerned that the Misc now seems to be in the business of publishing misinformation under the guise of an opinion piece.
This article also fails to ignore the community benefits of the vaccine, opting instead to make an argument from individualistic concern. Clothing itself under a misconstrued argument towards freedom, this article completely fails to recognize the risk of community transmission that is reduced with the vaccine.
I am deeply disappointed in the Misc board for allowing this to be published. Misinformation like this is dangerous, and it ought to be the job of editorial boards to discard positions such as this and not to lend them the hard earned credibility of the paper.
I would like to correct the notion that the vaccines reduces community transmission.
From the CDC: ““Our vaccines are working exceptionally well…what they can’t do anymore is prevent transmission. So if you’re going home to somebody who has not been vaccinated, somebody who can’t get vaccinated… I would suggest you wear a mask in a public indoor setting,” Walensky stated.
Vaccines certainly *reduce* community transmission. They do not completely *prevent* community transmission.
There is actually mixed data on the decrease of transmissibility, so pretending that it is settled science one way or another is patent falsehood.
Evidence for decrease in transmission with delta variant:
Evidence for minimal-to-no effect on transmission:
Who cares if you’re disappointed? I’m disappointed in the people of this country thinking it’s okay to force other people into getting a vaccine they don’t feel is safe. This is not misinformation, it’s just information you don’t agree with.
While I understand that there are legitimate concerns of why someone may be hesitant to get the COVID vaccine, this article does not contextualize the alternative of why someone would want to be vaccinated. For instance, cases of myocarditis in younger recipients of the vaccine is a legitimate concern. But it is not contextualized against the far, far greater likelihood of developing myocarditis as a result of exposure to COVID itself.
The slogan “pandemic of the unvaccinated,” is not simply in reference to the vaccinated having lower rates of infection. It is primarily directed at the lower hospitalizations and death rates.
The stated goal of this piece is to offer understanding on the rationale of the vaccine hesitant, excluding Anti-Vaxxers. But the rhetoric of the argument does more like to lead someone to the conclusion that the vaccine is a bad idea, and/or that the benefits are lacking. When you argue for a position such as this, it’s important to be to curb persuasions leading to harmful ideas.
I hope you take this criticism to heart going forward, it really is for you to grow and write more responsibly.
How could you possibly know the risks of myocarditis via “exposure”? There is literally NO data on that. If the never purified SARS-CoV-2 is airborne, and has spread to all over the world … what is the exposure rate, and how is it measured? Who is measuring myocarditis, and how do we factor out the conflating factors – including meningococcal vaccine, and other causes?
Hi, I just want to clear up a few misconceptions that one might get from this article.
1. The case in which Pfizer paid the fine was for a drug that was approved by the Federal Drug Administration (FDA) for both safety and efficacy. Pfizer was fined for misrepresenting to doctors what the drug could do. I don’t think anybody has a real fear that Pfizer is misrepresenting its Covid-19 vaccine as anything other than a preventer of Covid-19. It’s also worth pointing out that there are two other vaccines available in the United States alone.
2. The FDA did not attempt to delay the release of safety data. What happened was that a Freedom of Information Act (FOI) request was submitted to the FDA, and the FDA complied with this request at the normal pace of 500 pages per month (this is because sensitive information, like who the test subjects were, needs to be redacted). This pace would indeed take until 2076 for all the documents to be released, but it’s not that anything is being hidden, this is just standard operating procedure for FOIA requests to be released incrementally at this rate. (See https://www.snopes.com/news/2021/11/19/fda-2076-vaccine-data/)
3. Regarding relative risks versus absolute risks, I think the author neglected to mention the time frame. An unvaccinated individual had a 0.88 percent chance of catching Covid-19 in a given week. Using some laws of probabilities, the odds of an unvaccinated person not acquiring Covid-19 over a two year period is ((100-0.88) / 100) ^ 104 = 0.398, approximately 40 percent. With the vaccine that becomes ((100-0.04) / 100) ^ 104 = 0.959 approximately 96 percent. Assuming a United States population of 330,000,000 and a case fatality rate of 1 percent, that means that the number of deaths if everyone was unvaccinated would be 1,980,000 versus only 132,000 if everyone was vaccinated. (This ignores several things, such as hospital capacity, the fact that Covid-19 became more prevalent even before mutations, and of course, the Covid-19 mutations, all of which would bolster the case for vaccination). To summarize the math, the absolute risk at a society level was almost two million lives in the United States alone.
4. Regarding the British Medical Journal, this article was branded as “missing context” by even the very lenient fact checker known as Meta (nee Facebook). Most medical professionals will tell you that even if what is alleged did occur, because of the widespread rollout of vaccines in the United States and worldwide, there’s ample data to prove the safety and efficacy of the Pfizer vaccine even if we throw out the trials entirely. It’s also worth noting that there are two other widely available vaccines in the United States. (See https://leadstories.com/hoax-alert/2021/11/fact-check-british-medical-journal-did-not-reveal-disqualifying-and-ignored-reports-of-flaws-in-pfizer-vaccine-trial.html)
5. The case of Maddie de Garay is tragic, but it’s not causally related to the vaccine.
6. As far as natural immunity versus vaccination immunity, there isn’t an either or. The fact is that immunity wanes over time, and unless a large subsection wants to be infected with a preventable, deadly, incurable disease with unknown long term repercussions over and over again and potentially pass it along to those who cannot be vaccinated, then they should be open to being vaccinated again.
7. The unvaccinated are hospitalized and die at rates five to twenty three times higher than the vaccinated. No matter how you slice it, the pandemic of the unvaccinated is called that because nine out of ten people in hospital with Covid-19 are unvaccinated. (See https://thehill.com/policy/healthcare/592289-cdc-study-hospitalizations-23-times-higher-for-unvaccinated-than-boosted)
8. Preventing infections at this point is not the goal. That ship has sailed. The point is now preventing hospitalizations (preserving a standard of care for those in hospital for Covid-19 or for other reasons) and preventing deaths. All three vaccines are very good at those two things.
9. Regarding the Vaccine Adverse Event Reporting System (VAERS), that “1 percent of events are reported” quote is almost assuredly bad data. That number is spun out of whole cloth. (See https://twitter.com/BadDataTakes/status/1476998603717632007)
10. As for the VAERS counts, it is very disingenuous to represent them as absolute numbers. Even if the data are accurate (highly, highly dubious), this still represents a much lower risk of death or adverse event than being infected with Covid-19.
11. The Cutter incident was one mistake 70 years ago, when people used to pipette with their mouths. One, science has gone a long way since then. Two, and this is the only time I’ll stoop to actually being insulted, how dare you try to cast doubt on the Polio vaccine. The Polio vaccine is safe and effective, and its invention ended an actual scourge.
12. Personal freedom is important, but many are abridged for the public health. People aren’t allowed to drive on the wrong side of the road, and they are required to buy health insurance. One can make an argument that this particular right shouldn’t be abridged in this particular instance, but those arguing in favor of the public health have a very strong case.
13. Getting vaccinated is not slavery. I didn’t think I had to write that one down.
Overall, I think this article requires far too much of the reader to fact check. To the Opinions Editor, I suggest that more time be taken in the future ensuring that the argument is not based on faulty premises, especially on such a contentious issue. There’s worse things than running an ad or filling a spread with photos. This may very well be one of those things.
Thanks for the response. I’ll do my best to address some of the things you said here, corresponding to your order:
1) Yes, Pfizer was fined for that. I wasn’t claiming that Pfizer was misleading people about what this vaccine can do, I was just hoping to establish that pharmaceutical companies don’t exactly have great track records.
2) I could have done a better job of characterizing the way in which the data was being released, however, I think a delay is a fair characterization given the circumstances. The FDA wants to operate under ‘normal’ circumstances, but I can hardly see how that’s justified seeing how mass vaccination is happening–and has already happened across the world. This is anything but normal circumstances. I still don’t think there is any excuse for such a long time frame. I think the court order does a good job of expressing this sentiment(“Stale information is of little value” https://www.sirillp.com/wp-content/uploads/2022/01/ORDER_2022_01_06-9e24e298ae561d16d68a3950ab57077b.pdf). Further, this does little to explain why Pfizer has attempted to slow the release of information. Being “disclosed inappropriately” seems like a poor excuse to me.
3) While an important point– the timeframe argument also works in reverse. On 1 week’s worth of data so much is left out– including vaccine effectiveness over time. I could have done a better job of clearing up this discrepancy, but I think this still goes to show the failure on the part of leaders to make clear the full picture. Even now we’re beginning to see new side effects that could not have been detected in short trial periods, for example the vaccine’s effect on Menstrual(https://pubmed.ncbi.nlm.nih.gov/34991109/) cycles. While the effect was small, what else could we have yet to discover? Or, the vaccine, with it’s incredible specificity to the spike protein, may have been responsible for some of the mutations that made things worse not better. This is not a claim of fact, but it’s important to realize that these are hardly single variable systems.
4) There’s an element of integrity owed to people. It isn’t just about how accurate/correct the data is. With something this big– a world pandemic– absolute transparency, honesty and accountability are paramount. Cover up, accidental– I don’t think it really matters. Of course accidents happen, but when they do it is essential that organizations are clear in communicating that. It should not have been a whistleblower than brought these things to light. In matters of public health, it’s the duty of the FDA, pharma companies and the like to give people a reason to trust them. That doesn’t look like waiting until a whistleblower comes along. That means proactively clarifying and clearing up accidents when they happen. It doesn’t take a complicated analysis to guess what might happen if claims of faulty trials come about.
5) I think Maddie Degray’s symptoms are only half of the issue here. The other is the lack of reporting on the part of Pfizer. In my view, there’s a duty, morally or otherwise, to report that kind of thing. (Off the top of my head, I’m fairly sure that the FDA requires adverse reporting, regardless of of the linking to the vaccine or not)
6) First, I’m afraid I’ll have to take issue with unknown long term repercussions. The same can be said for the vaccine. I would also question preventable and incurable here. Vaccination does not guarantee protection as you state in #8. As for curability– I’m not quite sure what you mean here, there are people who have contracted COVID and then later tested negative(and presented with no symptoms). Maybe we’re using different definitions of curable? And further, while vaccination does reduce spread, it does not stop transmission of COVID. Also(from last I checked, this may have now changed), studies out of Israel seem to be suggesting that boosters are ineffective against Omicron. I think there still is a lot of research to be done in this area, and these kinds of definite statements about evolving issues are exactly what contributes to people beginning to have doubts about this sort of thing.
7) You’re right, and there’s no denying that(although I’m having some trouble finding the 9 out of 10 figure). We also have to consider the broader picture though. While important, deaths and hospitalizations are not the only figures that are reported on. Caseload is another factor that plays into this– and the vaccinated are still getting sick. Also, I think you’re potentially unfairly skewing this. Per the study you cited the overall percentages are still low: “Unvaccinated persons were most likely to be hospitalized (2.8%), admitted to an ICU (0.5%), and require intubation for mechanical ventilation (0.2%); these outcomes were less common in fully vaccinated persons with a booster (0.7%, 0.08%, and 0.03%, respectively) and fully vaccinated persons without a booster (1.0%, 0.12%, and 0.05%, respectively) (p<0.001). Deaths were also more likely to occur among unvaccinated persons (0.3%) than among fully vaccinated persons with a booster (0.07%) or without (0.08%) (p<0.001). “
8) I agree. It seems COVID is likely to be endemic at this point. However, I don’t think it’s clear that the vaccine is the end all be all here. At the risk of opening another can of worms, I’ll say there are ways to treat COVID without a vaccine and leave it at that for now.
9) Yes. This is exactly my point. The CDC’s reporting system is, to use your words, “almost assuredly bad data.” I thought I made myself pretty clear in the article– regardless of the data quality, VAERs presents an issue. People are supposed to be able to trust public health agencies– not be baraged from all sides about the validity of data. I’d also note that other vaccine adverse reporting agencies(like the EU’s- https://dap.ema.europa.eu/analytics/saw.dll?PortalPages – for example) have also reported higher than usual event counts. There needs to be some kind of reconciliation(between the claims of good and bad data), otherwise there will always be mistrust of what’s going on.
10) Regarding the numbers see my response to #9. As for the lower risk of death/adverse event, I’m willing to take your word that the risk is lower than COVID. However there is an ethical issue here– particularly regarding mandates. If a person gets the (mandated) vaccine and dies from it, in my view that is much different ‘death’ than a death from COVID.
11) Let me be explicitly clear. In NO way did I mean to cast doubt on the Polio vaccine. I’m well aware of what it has done. The Cutter Incident was a tragedy, but by no means should it be written off as simply “one mistake.” We never get to make the assumption that something is safe in the medical space until it is clearly shown to be so– and this is exactly why the Cutter Incident is relevant. Poor regulatory errors led to the assumption of safety. To this day, the FDA still recalls(https://www.drugwatch.com/fda/recalls/) something like 4500 drugs/devices a year– despite their approval. Unfortunately, we don’t get it right all the time.
12) This goes back to an ethics issue here– one which we may just have to agree to disagree. I don’t think your car analogy works because by driving on the wrong side of the road, people(the reckless drivers) also take on the risk of getting into an accident. When we mandate a vaccine people are forced to take on the associated risk without personal say in the matter. Again I think this difference is primarily because I have a pretty heavy bias towards personal freedoms.
13) I’m a little confused how slavery is relevant to this conversation. I don’t think it’s slavery either. I think you’ve presented a little bit of a strawman– it is possible to advocate for personal freedom without a corresponding claim of enslavement. We obviously aren’t living in any kind of slavery. I simply prefer that people are able to make choices– particularly about their own bodies for themselves.
I was reading all your points, giving you the benefit of the doubt, right before no 5.
“5. The case of Maddie de Garay is tragic, but it’s not causally related to the vaccine.“
After reading this, i realized how skewed your view on the matter is, and how you are extremely biased towards your opinion.
To the point that you would consider something a fact when you dont have anything to base it against.
Literally no logical counter argument.
“Its not causally related to the vaccine, cause it just isn’t!”
I wonder if you still hold the same arguments Jonas, 12 months later, now that we know that the Covid vax does not stop transmission, and it is in fact the quadrupled vaxed who are filling the hospital beds and the morgues rather than the unvaccinated. Surely you now realise these mRNA drugs were untested and are creating a host of side effects, many deadly, as well as impairing the immune system leading to an escalation of a host of medical conditions. We also now learn that Pfizer “amended” their trial results, and used relative risk reduction rather than absolute to deceive the pubic. Why seek to hide trial results for 75 years? I’m sure you’ve had to rethink your position if you are at all open at looking at the data and the science.
Thanks for the article. I appreciate your detailing of the deception by the federal government regarding the use of masks early in the pandemic and the distrust sown by the opioid epidemic. That said, I’d like to outline what I see as a few spurious claims throughout this piece.
* “a deception that practically destroyed their trust in the federal government’s pandemic response” as applied to “Americans” in general is an exaggeratory and unsupported assertion, especially considering that 45.0% of Americans approve of Joe Biden’s response to the coronavirus crisis per daily polling data from FiveThirtyEight (https://projects.fivethirtyeight.com/coronavirus-polls/)
* Pfizer has often been reported as paying the largest criminal fine in history (a 2009 ABC article appears to label it, rather, the “largest health care fraud settlement in history”), but that title belongs to the Tepco in the wake of the Fukushima disaster ($448,966,650,000). Pfizer does indeed hold the largest healthcare-related fine (and is the fourth-largest healthcare company in the world), but I would suggest changing this in the spirit of combating misinformation.
* I also find your apparent connection to this suit and potential vaccine harm to be irresponsible and misleading. In your linked 2009 article, it states that Pfizer promoted a painkiller, Bextra, for off-label uses such as knee replacement surgery, while it had only been approved for marketing for rheumatoid arthritis, osteoarthritis and menstrual pain. (Like all FDA-approved drugs, Bextra could be prescribed by doctors for any use whatsoever). Although I see a connection to corporate greed and irresponsibility, I fail to see how marketing a drug OK’d for menstrual pain to knee surgery recipients (and legal for them to take with doctor’s orders) should translate to suspicions that a company is knowingly intending to injure people with a vaccine for profit, an ethical violation of a far greater degree. Others might feel differently, of course, but I think it is only appropriate to list the details of the suit here.
* The second lawsuit to which you link involves Pfizer knowingly marketing a drug for a condition in which it only produces a placebo effect. I don’t doubt that this is a serious accusation with a potential for patient risk if such drugs are incorrectly prescribed in place of others, but again would like to emphasize that this does not correspond to knowingly injurious products.
* “Though a judge struck down this action, the FDA attempted to delay the release of the Pfizer vaccine safety data by 75 years—not to be seen by the public until 2097.” This sentence is misleading. Under the FDA’s original proposed schedule, the last of the vaccine safety data would be published in 2097, and the company would release 500 pages a month until then. I would request that the editors clarify this phrasing, as it appears to an unknowing reader that the FDA was planning to deliberately withhold data for 75 years. Although it is up to the reader to determine what “seems suspicious,” I believe they deserve to know that this pace is broadly consistent with standard timelines for the FDA’s FOIA office (which currently has 10 employees and more than 3,000 requesets backstanding at the end of 2020 (https://www.hhs.gov/foia/reports/annual-reports/2020/index.html). For those interested in FOIA delays prior to the COVID-19 pandemic or worried about a hidden information, I recommend the following article, https://www.snopes.com/news/2021/11/19/fda-2076-vaccine-data/, op-ed https://www.washingtonpost.com/opinions/2021/12/13/55-years-fulfill-records-request-clearly-fda-needs-serious-reform-its-data-sharing-practices/ or law review https://dlj.law.duke.edu/article/foia-inc-kwoka-vol65-iss7/.
* The misinterpretation of relevant and absolute risk in this article trended on social media and was subsequently debunked several months ago in this Reuters fact-checking article (reuters.com/article/factcheck-thelancet-riskreduction-idUSL2N2NK1XA). Two clarifying quotes from said article: “Natalie E. Dean, assistant professor of Biostatistics at the University of Florida, understood why the ARR numbers might have confused users on social media and explained why the RRR is the ‘usual scale’ considered by the medical community when talking about vaccine efficacy. ‘Because (the ARR) is a much lower number, it feels like it is saying that the other number (RRR) isn’t true,’ but this is not accurate, ‘they are both capturing some aspect of reality, just measuring it in a different way,’ she told Reuters via telephone. Vaccine efficacy, expressed as the RRR means the vaccine will reduce the risk of infection by that reported percentage irrespective of the transmission setting. ‘It is more meaningful,’ she said.” and “Verdict: Misleading. The Relative Risk Reduction (RRR) and the Absolute Risk Reduction (ARR) are two measurements that are calculated differently. In terms of measuring how a vaccine impacts a population, they are complementary and not contradictory.” That “this data drastically changes the analysis involved,” as you claim here, is misinformation.
* I appreciate you sharing the disturbing and substantiated whistleblower report at one of Pfizer’s contract research companies as published by the BMJ. Per your linked article, these include “One photo, provided to The BMJ, showed needles discarded in a plastic biohazard bag instead of a sharps container box. Another showed vaccine packaging materials with trial participants’ identification numbers written on them left out in the open, potentially unblinding participants,” “drug assignment confirmation printouts were being left in participants’ charts, accessible to blinded personnel,” (corrected two months later), “a Ventavia executive can be heard explaining that the company wasn’t able to quantify the types and number of errors they were finding when examining the trial paperwork for quality control,” failure to keep up with data entry queries, and an issue in which “a Ventavia executive identified three site staff members with whom to ‘go over e-diary issue/falsifying data, etc,’ one of them was “verbally counseled for changing data and not noting late entry,” a note indicates.” The whistleblower herself identified the following problems: “Participants placed in a hallway after injection and not being monitored by clinical staff • Lack of timely follow-up of patients who experienced adverse events • Protocol deviations not being reported • Vaccines not being stored at proper temperatures • Mislabelled laboratory specimens, and • Targeting of Ventavia staff for reporting these types of problems.” Another employee noted the failure to swab all trial participants displaying COVID-19 symptoms and concluded “I don’t think it was good clean data.” I list this out to show how troubling these allegations truly are, but also emphasize that they seem to derive from carelessness and not an organized cover-up. The linked article also notes the history of lax FDA oversight prior to the COVID-19 epidemic, which might extend any hesitancy deriving from this to vaccinations in general. This site was one of 153 used in the phase III trial.
* I have yet to find a credible news source linking Maddie de Garay’s condition to vaccination. An NBC News article says the following: “The cause of the girl’s condition is unclear. Her mother said on a panel held Tuesday in Washington, D.C., hosted by Sen. Ron Johnson, R-Wisc., that she was injured by a Covid vaccine administered as part of a Pfizer trial at Cincinnati Children’s Hospital. (Johnson has been widely criticized for spreading misleading claims about the vaccines.) The family’s lawyer, Aaron Siri — who also represents the country’s largest anti-vaccine organization, the Informed Consent Action Network — claims the doctors investigating the case misdiagnosed her myriad injuries as unrelated to the vaccine then downplayed them as abdominal pain. In the meantime, anti-vaccine activists have made the girl a poster child for their cause. The mother of the girl and the group behind the ad have not provided any evidence that the girl was diagnosed as harmed by a Covid-19 vaccine. The ad was paid for by the Vaccine Safety Research Foundation, an anti-vaccine group founded last month by veteran Silicon Valley entrepreneur Steve Kirsch, known for inventing the optical mouse, and more recently for advocating unproven Covid cures and against vaccines, which he calls ‘toxic.’ Burgert [spokesperson for the American Academy of Pediatrics] warned these tactics could be effective. ‘They’re going to get their claws into a new group of hesitant families that otherwise have got all of their vaccines on time,” she said. “I’m concerned that they’re going to be able to use their manipulation tactics and psychological tactics to harness a new group of formerly pro-vaccine families into vaccine hesitancy.’” By insinuating that both the “official Pfizer report” (which I would appreciate a link to, as I was not able to find this report) and the doctors that treated her are attempting to misdiagnose her condition, you are suggesting a conspiratorial cover-up. This is a serious allegation that is not properly substantiated and deeply misinformative. Also, I believe it is Miscellany News style to cite or link to all quotes; the “ripping [her] heart out through [her] neck” is a quote from De Garay’s mother describing her pain. I gather it originated in a Tucker Carlson Tonight interview that made its rounds in July 2021, but if the quote was from somewhere else its place of origin should be cited regardless so that the reader may ascertain the veracity of the source for themselves. (https://www.foxnews.com/opinion/tucker-carlson-if-public-officials-keep-acting-like-this-there-may-be-a-revolution).
Official Pfizer document with abdominal pain for maddie garay is here (page 30)
found it quoted in the lawyer’s letter here (page 4)
and copy+pasted the excerpt into google
Thanks for the response. I’ll do my best to address some of the things you said here, corresponding to your order:
1)I think the figure you cited speaks for itself. 45% is disappointingly low. Less than half of the country thinks things are being done well.
2)I agree. That’s entirely my fault. I was referring specifically to the United States (https://marketrealist.com/p/who-paid-largest-criminal-fine-in-history )
3) I wasn’t claiming that Pfizer was misleading people about what this vaccine can do, I was just hoping to establish that pharmaceutical companies don’t exactly have great track records.
5) I could have done a better job of characterizing the way in which the data was being released, however, I think a delay is a fair characterization given the circumstances. The FDA wants to operate under ‘normal’ circumstances, but I can hardly see how that’s justified seeing how mass vaccination is happening–and has already happened across the world. This is anything but normal circumstances. I still don’t think there is any excuse for such a long time frame. I think the court order does a good job of expressing this sentiment(“Stale information is of little value” https://www.sirillp.com/wp-content/uploads/2022/01/ORDER_2022_01_06-9e24e298ae561d16d68a3950ab57077b.pdf). Further, this does little to explain why Pfizer has attempted to slow the release of information. Being “disclosed inappropriately” seems like a poor excuse to me.
6) They do go hand in hand, but a critical component of this is that one of the hands was missing. Absolute risk reduction was not commonly talked about. And I still think knowing the absolute risk changes a person’s analysis of a situation. If it didn’t, then we’d always be walking around in bubble wrap(you never know when you might trip and fall), never getting on airplanes(they could crash), and never driving cars(again, crashes). Like you said, we need the whole picture to understand what’s going on.
7) There’s an element of integrity owed to people. It isn’t just about how accurate/correct the data is. With something this big– a world pandemic– absolute transparency, honesty and accountability are paramount. Cover up, accidental– I don’t think it really matters. Of course accidents happen, but when they do it is essential that organizations are clear in communicating that. It should not have been a whistleblower that brought these things to light. In matters of public health, it’s the duty of the FDA, pharma companies and the like to give people a reason to trust them. That doesn’t look like waiting until a whistleblower comes along. That means proactively clarifying and clearing up accidents when they happen. It doesn’t take a complicated analysis to guess what might happen if claims of faulty trials come about.
8) I’m incredibly sorry that those sources didn’t end up in the final article. This is my fault. Having never written one of these before I wasn’t sure how the Misc wanted sources included and that led to me (obviously) missing some. Here is the letter( https://www.sirillp.com/wp-content/uploads/2021/10/Letter-to-Federal-Health-Agencies-Regarding-Maddie-and-Clinical-Trials-for-Children.pdf ) from Maddie de Garay’s lawyer. Here is the Pfizer report (https://www.fda.gov/media/148542/download). My understanding is that the FDA requires the disclosure of any adverse events– regardless of correlation or not. Whether Degray’s situation is related to the vaccine or not, it seems Pfizer did not fully report her symptoms.
Regardless of the truth or falsity of what you have written here, it was very brave of you to publish this under your real name in the current climate. Sincere kudos for that.
This article is beyond embarrassing. Not well researched or well written, and the opinions exhibited are downright dangerous. The misc should be ashamed for this.
This is written as if it’s somebody’s debate in a high school history class. You’re not John Locke, you’re a freshman student athlete with an inferiority complex. Do better.
I mean it’s a college newspaper, what do you expect? You’re just being a jerk because the author says something that offended you
Good points. Thank you for your civility.
Given the climate of the (lack of) dialogue today, I want to commend the author for his courage in writing this article, and Miscellany News for publishing it.
This is the crux of the issue: do the vaccines work? As a vaccinated person, I would hope so.
We already know the vaccines do not prevent transmission. This means that I am just as likely to spread COVID as an unvaccinated person.
If the vaccine works to prevent hospitalization and death, then I am protected. I don’t feel the need to push the vaccine on those who don’t want it, since their status has no bearing on my health. Further, I think that the vilification of the unvaxxed masses is unwarranted and frankly awful.
And to be honest, I am concerned about the data that is surfacing on possible vaccine-related injury.
Given the positive data on Omicron, we have reason to hope that we are entering the endemic stage of this virus. I would like nothing better than to put this discussion behind us and have a normal college experience. It is long overdue.
Sorry, there is no “Omicron.” That appellation implies that anyone has ever purified (virology speak for what normal people call “isolated”) any SARS-CoV-2. See Kaufman (2021); Thomas Cowan; and Stefan Lanka. (Their lectures and presentations are found on Bitchute and other fora).
Please review the literature on PCR, what Kary Mullis said about using PCR as a diagnostic tool, and the problems with the theory of exogenous viral contagion.
My family and I have been living in Shanghai nearly three years – still never vaxxed – not masking – not sick. But we do take supplements, get sunlight, exercise, and avoid processed foods.
Dear Joseph Cocozza & dear commentators,
thank you for your article. Before 2020 this would have been considered critical thinking and constructive debate. In our times it is labeled various degrees of treason. That in itself should make people think.
Further to force a drug, that is surrounded by controversy, on people rather than leaving it to choice, again, seems controversial. To offer it to pregnant women and children – after Thalidomide and when we advise pregnant women to avoid all kinds of things (Thalidomide, a rapidly approved drug, was banned in the early 1960s after it was discovered to cause birth defects in newborns.) – I actually am lost for words.
All that said, I was impressed with the civil discourse on this page, vast amount of research links.
Thanks again Joseph Cocozza for your courage.