In March 2020, I watched along with the rest of the world as a new pandemic took hold. SARS-CoV-2, or Covid-19, was its name. As a trained biologist I knew that pandemics are an unfortunate and inescapable part of human existence. Although we hope never to see one in our lifetime, there is a decent chance that we will. And here it was.
Early on, there was mostly unity in our societal approach: “We can get through this together” was a mantra we heard regularly. As the strict measures remained in place, divisions emerged as people started questioning their effectiveness, and it became evident that the measures themselves were inducing suffering. As a scientist, I knew that data would be generated that would begin to either support these strategies or to encourage their reconsideration. And of course, there was historical data to draw upon.
From the beginning, vaccines were touted as being a central part of the pandemic solution. Many scientists began working tirelessly on vaccine development, although we were told that this would likely take time as the normal process takes anywhere from five to ten years. The fastest vaccine ever developed took four years. Many were optimistic, though, that this process could be expedited since our science and technology had become so advanced, and news outlets showed real time “Coronavirus Vaccine Trackers.” Then, on December 2nd 2020, the Pfizer Covid vaccine was granted Emergency Use Authorization (EUA). On December 18th, the same approval was granted to the Moderna vaccine. Both of these vaccines used new mRNA technology. Approval of additional vaccines soon followed.
The biggest concern after the EUA approval was producing and distributing vaccines. This was no small feat. The mass vaccination campaign was initiated in countries around the world, albeit primarily wealthy ones. The health and safety of the most vulnerable members, including the elderly and then front-line health care workers, were understandably prioritized. Others clamored for the vaccine and worried about their health in the interim. Soon, several countries were successful in achieving their goal: To have enough vaccines for every eligible person who wanted one. I received my second dose of the Moderna vaccine in May 2021, making me a “fully vaccinated” person.
The problem was that not every eligible person wanted one. In fact, quite a few people didn’t. This behavior is called “vaccine hesitancy” or “vaccine refusal.” Media outlets are now showing vaccination rates in real time, and in countries with readily available vaccines, the percentage of “fully vaccinated” people varies, with millions remaining unvaccinated (link).
Why the reluctance? A Gallup poll published on July 30th reported that vaccine hesitancy is “a personal decision reflecting individual thinking and decision-making processes.” Many of these individuals are not “data-illiterate,” as shown by a study at MIT. In fact, the association between vaccine hesitancy and education level follows a U-shaped curve, meaning that those with the most hesitancy have both the lowest and the highest levels of education, with the highest hesitancy among those holding a PhD.
This hesitancy has been extremely concerning to governments. The prevailing public health message has long been that mass vaccination is necessary to achieve herd immunity and carry us out of the pandemic. Failure to achieve this goal will result in a devastating loss of life. The unvaccinated have been widely portrayed in the media as the problem, with this even being labeled as a “pandemic of the unvaccinated,” although data shows that this claim is not particularly accurate.
Consequently, the strategy has shifted to one of using the proverbial “stick” rather than the “carrot” to increase vaccination rates. Vaccines are rapidly becoming a mandatory condition of many workplaces and vaccine passport systems are being established in many countries to restrict access of unvaccinated persons to places like restaurants, movie theatres, and gyms, as well as to transportation services such as buses, trains, and airplanes. The message is that the unvaccinated, as carriers and spreaders of Covid-19, cannot be allowed to move freely in society. They should be labelled, partitioned, and excluded, and we are told that we must do this in order to protect everyone else. “Anti-vaxxers” were even recently accused of killing people by the US president, Joe Biden. Very quickly, we have shifted from a message of unity to one of division.
This shift in messaging, from “we are all in this together” and “everyone who WANTS a vaccine will get one” to “everyone MUST get a vaccine or else be excluded from most aspects of society” has led me to ask questions.
As a vaccinated person, I am clearly not an anti-vaxxer. However, I am deeply concerned about our current trajectory, which aims to use a variety of measures (many of which are coercive) to get all eligible people vaccinated against Covid-19. Other measures, such as lockdowns, are also concerning given their demonstrated harmful effects on a variety of outcomes including mental health (especially for young people) and mortality. At the core of my concern is that despite what we’re being told by our government and policy makers, this is not a black and white issue. I have many questions about whether the current Covid trajectory is justified.
Here, I present some of the questions that I have as a mother and academic, about the current Covid-19 trajectory, and share some of what I’ve learnt as I’ve sought to find answers.
Why is there a one-size-fits all approach to vaccination?
People of all ages around the world are vulnerable to infection with Covid. It is indeed a global pandemic. However, the risks of severe illness and death are highly disproportionate across different age groups. A recent analysis by John Ioannidis and Cathrine Axford from Stanford University found the infection fatality rates (meaning, the rate of people who die after being infected with Covid) across different age groups were as follows: 0-19 years 0.0027%, 20-29 years 0.014%, 30-39 years 0.031%, 40-49 years 0.082%, 50-59 years 0.27%, 60-69 years 0.59%. In community dwelling elderly aged 70 or older, the fatality rate was 2.4%, while in the elderly overall it was 5.5%. Although the media regularly shows stories of younger people dying from Covid, which are undeniably tragic, the data show us that the risk of death from Covid is actually very, very low in most age groups.
There appears to be a gross lack of public knowledge regarding the true fatality risk from Covid. Nineteen percent of US respondents in a recent study thought the death rate from Covid is more than 10%, which is well over 100 times the actual rate for most age groups. Most Americans greatly overestimate the risk for younger people. They report that around 8% of Covid deaths are in those aged 24 and younger, even though the proportion of deaths in this group is less than 0.5%. On the other hand, they underestimate the proportion of deaths in those aged 65 and up. This perceptual inaccuracy is important. It speaks to the success of the public health message of a “one-size-fits all solution”, but it also conveys an inability to accurately assess the true health risks from Covid at both the individual and population levels.
Clearly, older people are at a much higher risk of serious outcomes from a Covid infection. Similarly, Covid disproportionately affects people with other health problems, known as comorbidities. A recently published study in the journal Infectious Disease Reports analyzed data from the public health websites of 50 states. It was found that 92.8% of Covid-19 deaths were associated with pre-existing comorbidities. At least in part, this is likely because comorbidities usually weaken the body. For example, it has been shown that 10% of patients with preexisting heart disease who are infected with Covid will die, in comparison to only 1% of comparable healthy patients. Other conditions that increase risk of death include diabetes, hypertension, co-existing infections, cancer, respiratory system diseases, and renal disorders. Unfortunately, a large proportion of people suffer from these conditions, and this proportion increases with age.
Adverse events associated with the Covid vaccine also do not appear to affect everyone equally. In particular, myocarditis and pericarditis are more prevalent in younger age groups, especially males, and occur more frequently after the second dose of vaccine. This side effect is well known at this point in the pandemic, with the CDC website noting that it can occur, although they still recommend that “everyone aged 12 years and older get vaccinated for Covid-19.” Despite this recommendation, a recent preprint study that analyzed data from the US reported that boys aged 12 to 15 with no other medical conditions are four to six times more likely to get vaccine-related myocarditis than they are to be hospitalized from Covid over a four month period. Contrastingly, the risk of myocarditis in young males from Covid infection has been calculated to be higher than from vaccines, which reveals a lack of clarity in the data.
Another concern is that the “ones-size-fits all” vaccination approach currently being used in North America uses the same amount of vaccine for everyone, regardless of age. Is it possible that it would be safer to use a different dose for young people? There is precedent for this. Following distribution of the smallpox vaccine, myocarditis rates were also increased in healthy US military personnel, which decreased when a lower dose was used. Lower doses have also been shown to induce a sufficient immune response in younger age groups. In the Pfizer vaccine trials, 12-15 year olds who received the usual two-dose regime produced much higher levels of antibodies than those aged 16-25. The soon-to-be approved vaccine for children aged 11 and younger will be using a lower dose. Why are we not similarly considering a lower or single dose regimen for children aged 12 to 15?
Other countries are not using the two-dose schedule with kids. For children aged 12-15 in Sweden, only those with high-risk medical conditions are eligible, while in Norway, only a single dose is currently being offered. In the UK, the Joint Committee on Vaccination and Immunization (JCVI) stated on September 2nd, 2021 that “Overall, the [JCVI] is of the opinion that the benefits from vaccination are marginally greater than the potential known harms… but acknowledges that there is considerable uncertainty regarding the magnitude of the potential harms. The margin of benefit, based primarily on a health perspective, is considered too small to support advice on a universal programme of vaccination of otherwise healthy 12 to 15-year-old children at this time.”
In addition to children, there may also be others who are at a higher risk of adverse events from vaccines. Studies have shown that people who have had a previous Covid infection who subsequently receive a Covid vaccine are more likely to experience adverse events. Studies also show that people with previous infections only need one dose of vaccine to achieve antibody levels that are equal to, or greater, than infection-naive people who have had two vaccine doses. For this reason, only one dose of vaccine is recommended for those previously infected in France. Why is this strategy not being used widely to prevent adverse outcomes?
Some people with preexisting health conditions are also concerned about their unique risk of adverse vaccine events. This is a particular concern for people with immune system dysfunction. It is well known that both viruses and vaccines are able to trigger autoimmune responses and case studies have been published in scientific journals linking the Covid vaccine to autoimmune conditions. According to a Letter to the Editor published in the journal Clinical Immunology, “The administration of a nucleic acid vaccine may…put…individuals [already affected or predisposed to autoimmune or autoinflammatory disorders] at risk of unwanted immunological side effects.” The author recommended that “individuals with a dysfunctional immune response should receive the Covid mRNA vaccine only if the benefits of this approach clearly outweigh any risks and after a careful evaluation case by case.”
To illustrate how vaccine hesitancy can develop, consider the following case. A 12-year-old boy has an autoimmune condition that was likely triggered 1.5 years ago by exposure to an unknown bacterial or viral pathogen. The child is at an extremely low risk of death from Covid, which has a 0.0027% infection fatality rate in his age group. However, the child is in the demographic (male, age 12) that has the highest risk of myocarditis as an adverse event from the Covid vaccine. He also has an underlying autoimmune disorder which makes him susceptible to immunological side effects. In this risk/benefit analysis, the parents may decide that the risk of adverse events to the child do not outweigh the risk of harm reduction from the Covid vaccine. However, there are currently no authorized vaccine exemptions for this scenario in the present universal Covid vaccine approach, which is of questionable logic given emerging data.
These rigid universal vaccination policies are creating suffering. An editorial was recently published in the national Canadian news CBC by a young mother with a spinal cord injury. She experienced a severe anaphylactic reaction to her first Covid vaccine and medical intervention was required. Following the reaction, she was told that there is no exception that can be given to exempt her from the second dose. She knows that the vaccine contains an ingredient to which she is severely allergic. While she has been told that she could take the vaccine under the supervision of an allergist while taking preemptive doses of steroids and antihistamines, she is unwilling to take this risk, especially given her preexisting spinal cord injury. In her words, “at least in my experiences, we don’t often ask people to inject their allergens directly into their bodies. In fact, we actively try to avoid such things, which is why I didn’t think having only one dose would become an issue.” Now, because of the current policies, and the requirement for two vaccine doses to access nonessential activities using a vaccine passport, she is excluded from many parts of society. Could this be considered discrimination?
Does a “one size fits all” approach to vaccination fail to take into account that some people are at a higher risk of serious outcomes from Covid, or that some people are at a higher risk of adverse events from vaccination? Does it consider that different vaccine doses or schedules may reduce the risk of adverse events? Are we failing to base our recommendations for vaccination across different demographics on the best available evidence? And why are different countries drawing different conclusions from analyses of the same data?
Is it possible to eradicate the SARS-CoV-2 virus with the current vaccines?
It is undeniable that there are differences in individual risks associated with Covid. However, the public health message is that these measures are not about individual risks. They are about protection at the population level. We are told that we must get vaccinated in order to protect each other. It is assumed that with high enough vaccination rates, we will achieve herd immunity – which is when enough people in a population become immune to a disease that the disease stops spreading. The stated target for herd immunity has increased already since the vaccine rollout started. In Canada, the current message is that 90% of the population needs the vaccine to reach herd immunity, which is higher than originally thought due to the presence of the highly infectious Delta variant. But is herd immunity actually an achievable target?
In March 2021, an article was published in the journal Nature titled “Five reasons why Covid herd immunity is probably impossible.” As described in the article, “the once-popular idea that enough people will eventually gain immunity to SARS-CoV-2 to block most transmission — a ‘herd-immunity threshold’ — is starting to look unlikely.” Vaccine hesitancy is one reason given, but there are others. New variants are continuously emerging, and the current vaccines do not prevent transmission, a potentially very important consideration of our current trajectory.
Inherent to the “get vaccinated to protect each other” message is that vaccinated people do not transmit Covid. Unfortunately, they do. While the vaccine seems to reduce the risk of severe infection and death – which is enough of an incentive for many people to choose to take it – we now know that vaccinated people are still vulnerable to infections. These are called breakthrough infections.
We have been assured by our governments that breakthrough infections are rare, being told repeatedly that very small percentages of people who are fully vaccinated will experience an infection. But in May 2021, the CDC stopped tracking breakthrough infections except in cases where people were hospitalized or died, which was criticized as irresponsible by some doctors and scientists. In Israel, approximately half of the patients hospitalized with severe Covid infections were fully vaccinated in mid-August. This is thought to be due to waning protection by the Pfizer vaccine (which was used almost exclusively), which Israeli scientists suggest is only 30-40% effective five or six months after vaccination. In the US, a similar decrease in vaccine effectiveness is thought to have contributed to breakthrough infections in vaccinated health care workers in San Diego.
When breakthrough infections occur, vaccinated people infected with Covid appear to carry high viral loads and can infect others. A recent study using data from Wisconsin found comparable viral loads between vaccinated and unvaccinated individuals, confirming previous research. Covid outbreaks are also occurring in places with extremely high vaccination rates which shows vaccinated transmission. Harvard Business School, which boasts almost 100% vaccination rates among students and faculty, had to move classes online in September after an outbreak. Interestingly, an analysis of global data by a Harvard professor found no relationship between recent Covid cases and the percentage of the population that was fully vaccinated, and even found that countries with higher vaccination rates had slightly higher Covid cases per 1 million people.
Despite the public health message that we are currently in a “pandemic of the unvaccinated”, there is accumulating evidence to the contrary. Vaccinated people can and do get infected with Covid. The fact that the current vaccines do not block viral transmission has led some experts to conclude that herd immunity is not achievable through a vaccination campaign. Sir Andrew Pollard, head of the Oxford Vaccine Group, recently said that herd immunity is a “mythical” idea and explained that while Covid vaccines may slow the spread of the virus, new variants will continue to emerge that may be even more transmissible. In his words, “that’s even more of a reason not to be making a vaccine program around herd immunity.”
Since the vaccine reduces short-term severe infections and death (at least in the short term), is it not probable that the true number of breakthrough infections has been greatly underestimated? And because of waning vaccine effectiveness, is the risk of breakthrough infections not likely a moving target that changes across time? Are we chasing an impossible target of herd immunity through the current strategy? And could the pursuit of this potentially mythical target be preventing us from putting energy and resources into diversifying our approach to harm reduction?
Are there reliable systems to monitor vaccine adverse events?
Adverse vaccine events in the US are reported in VAERS, the Vaccine Adverse Event Reporting System. Reporting in VAERS is not limited to doctors; anyone can submit to VAERS, as it is a passive reporting system. Adverse events in the US are also being actively followed using the V-safe Active Surveillance System, in which some Covid vaccine recipients complete voluntary web-based health surveys for a year following vaccination. This system was developed exclusively to track and assess the safety of Covid vaccines. In the UK, there is a coronavirus specific reporting system called the coronavirus Yellow Card site that is open to healthcare professionals and members of the public. In Canada, the process is more complex, and requires a health care professional to complete and submit an Adverse Events Following Immunization form. Most countries have their own system of reporting adverse events. These systems are monitored by governments to look for concerning data signals. Many of these systems are transparent and the data may be made available to the public.
There are limitations to these systems. For systems like VAERS that allow reporting by both health professionals and members of the public, the number of reports can be large, making follow up impractical. They also don’t contain an unvaccinated control group. The reports vary in terms of their quality and completeness, and many do not have medical diagnoses. One might also note that these limitations make it easy to dismiss public concerns of vaccine safety because there is an inability to draw a cause and effect relationship (that is, because correlation does not imply causation), something that is happening a lot with Covid-19.
Large numbers of adverse events have been reported following vaccination against Covid, but these are low when taken in the context of the number of vaccines that have been administered. And certainly, fewer deaths have been reported due to vaccines than for Covid. However, adverse events are still concerning to many, especially since systems like VAERS are thought to miss a significant percentage of vaccine injuries, albeit perhaps less so for serious adverse events.
On June 24th, an article was published by researchers in Europe in the journal Vaccines that analyzed data from the Adverse Drug Reactions (ADR) database of the European Medicines Agency and of the Dutch National Register, which are European adverse events reporting systems. This article reported that for every three deaths prevented by the vaccines, two lives were taken through fatal vaccine events. A few days following publication, the article was retracted. The reason given for the retraction was that issue of causality. These reporting systems do not provide reliable data on vaccine-related deaths, because while they report deaths, these deaths are not proven to be due to the vaccine. Of course, they also haven’t been proven not to be either. Is there reason to be concerned when the national systems for vaccine injury reporting are (probably justly) viewed as being unreliable?
A second article presenting a cost-benefit analysis of Covid-19 vaccination using data from VAERS has also been published, specifically for those aged greater than 65, the group at highest risk of deaths from Covid. According to calculations based on the official numbers from the CDC, while the data appears to show that the risk of death from vaccination is 1/270 the risk of death from Covid, when corrected for “real world effects” (which include underestimation in VAERS as well as the little discussed disclosure by the CDC that only 6% of deaths could be attributed exclusively to Covid-19, and not to any comorbidities), this risk changes to approximately 5/1. That is, the study concluded that there is a greater risk of death from vaccines, even in the older age group. While this analysis is complicated by several assumptions and will be widely criticized for being unreliable as a result, the fact that scientists are raising these concerns is deeply troubling, especially when they have nothing to gain and are subject to ridicule for doing so.
One of the primary “reliable” sources of vaccine safety data that will be acceptable for analysis by scientists are the clinical trials being conducted by the vaccine companies. Clinical trials have control groups and are subject to other conditions that make it possible to draw conclusions regarding cause and effect. But what about research bias? This is when a study supports the interests of its financial sponsor – and it is known to be a very real phenomenon, including in pharmaceutical research. Many issues have been noted in studies sponsored by the pharmaceutical industry, the most concerning of which is reporting bias involving withholding publication of unfavorable results.
Consistent with this concern is what happened with the H1N1 Pandemrix vaccine. In an article titled “Pandemrix vaccine: why was the public not told of early warning signals?” published in the British Medical Journal it is reported that in 2009 the vaccine manufacturer and public health officials were aware of adverse events associated with the Pandemrix H1N1 swine flu vaccine that were not disclosed to the public and which ultimately resulted in injuries to over 1,300 people. This was despite public assurances of continual evaluation of all available safety data, similar to what the assurances being given with the Covid vaccines. The adverse events were ultimately judged by many to be causal, although the vaccine companies maintain that a causal association has not been proven. It should be noted that while some scientists see the Pandemrix vaccine experience as being non-transparent, others do not.
The inadmissibility of the deaths assessed by the reporting system in the Vaccines article was because the deaths reported through the systems were not verified by medical authorities. This is surprising. Shouldn’t every reported death be investigated thoroughly? The VAERS website describes that clinical information including death certificates, autopsy and medical records are evaluated, but there isn’t clarity about this process. Could we be doing better with following up reports of adverse events?
There is some evidence to support the idea that at least some reported deaths may be causal. On August 3rd the director of the Pathological Institute of the University of Heidelberg in Germany publicly reported that he performed over forty autopsies on people who had died within two weeks of their vaccinations and estimated that 30 to 40 percent died from the vaccine. The pathologist was criticized for this statement by the German government and others, although he stood by his work. Following this, on September 20th, a team of German pathologists held a press conference in which they described a 20-fold increase in vaccine related deaths in a short period of time. This huge increase was noted even when accounting for the relative increase in the number of vaccines being administered. Said Dr. Werner Bergholz, after acknowledging that all vaccines carry some level of risk, “We have to ask: do we have a risk, or do we have a problem? The answer is, very clearly, yes – we do have a problem”.
Even deaths from Covid infections are not necessarily being tracked properly. There is so much concern over the validity of Covid data coming from the CDC in the US that two Senators from Oregon recently filed a formal petition for a grand jury investigation into “fraudulent data” associated with Covid death reporting, consistent with an expose published in the Atlantic about inadequate tracking of Covid cases, hospitalizations, and deaths. It is critical to have good data about Covid cases in order to accurately assess the risks and benefits of vaccines and other interventions relative to infections. Without these data, how can we properly determine their safety and efficacy?
An article published recently in the New England Journal of Medicine that analyzed data from the largest health care organization in Israel found that the risk of most adverse events was not elevated within 42 days of vaccination, in contrast to several adverse events that were experienced after Covid infection. Unfortunately, most countries do not have organized data sets like in Israel, making these types of analyses difficult to do in many regions. This leaves one to wonder if we could do better with vaccine safety surveillance and reporting in wealthy countries administering large numbers of vaccines. In the absence of a system for vaccine injury reporting that can be relied upon for valid reporting, how can we be confident that the assurances being given of vaccine safety by medical authorities are valid? Should we be doing more to investigate how these vaccines are affecting people in the real-world?
Who is liable for vaccine injuries?
Vaccine manufacturers are not liable for vaccine injuries. This is because in the 1980’s, there were so many lawsuits against vaccine manufacturers in the US that it became untenable for them to keep making them. At one point, there was only one supplier of the diphteria, pertussis, and tetanus vaccines. The US was simply too litigious.
So, the government stepped in and passed the National Childhood Vaccine Injury Act (NCVIA), later amended to the National Vaccine Injury Compensation Program (VICP), in which a surtax was collected on vaccines to help compensate people outside of the traditional legal system in what is often referred to as “vaccine court.” This program was developed to ensure vaccine supply, stabilize vaccine costs, and provide a forum for compensation for vaccine-injured people. The program is administered by the US government and has paid approximately 4.4 billion in total compensation.
Covid vaccine injuries are not on the list of eligible vaccines for VICP. Instead, they are processed under the Countermeasures Injury Compensation Program (CICP), which provides benefits to eligible people who suffer serious injuries from pharmaceutical companies, which are “protected” from liability (the one exception to liability is if there is willful misconduct by the company). The CICP pays far less money than VICP, covering only up to $50,000 per year in lost wages, while the VICP covers lost wages as well as medical and legal expenses. CICP also must be filed within a year of injury, unlike VICP, which provides a three year window. For these reasons, some have recommended that Covid vaccines be covered by VICP instead. Other countries have similar vaccination protection programs, and most are giving vaccine manufacturers exemption from legal liability.
Liability breeds responsibility. Responsibility breeds trust. Is it not reasonable that the current system, which provides protection for vaccine manufacturers without similarly providing support to even cover medical expenses, is concerning to many people? This is especially true given the massive profits being made by vaccine sales. To their credit, manufacturers such as Pfizer are providing vaccines to low- and lower-middle-income countries at a reduced price, but staggering profits are still being made from wealthier countries. Covid vaccine sales are expected to yield $33.5 billion for Pfizer in 2021. It is well known that “the most important ingredient in all vaccines is trust”. Why, then, are we creating a scenario that engenders mistrust?
Why is there no public health messaging around important modifiable risk factors?
According to the current public health message, there is only one way out of this pandemic: mass universal vaccination. Other external measures are also used to reduce virus transmission, such as mask wearing, school closures, social distancing, and limits on personal contacts. However, the official public health narrative does not include anything that one can do for themselves to reduce their personal risk.
In contrast, many medical experts have shared suggestions about how to strengthen the human immune system to reduce risk during the Covid pandemic. Talking about immunity has been widely criticized by authorities who see this as distracting from the one and only solution -vaccines. The goal of vaccination is to decrease the incidence and severity of infection by triggering the immune system to generate antibodies against the Covid spike protein, but the immune response consists of many different players. Are there other ways to improve immune function that might provide protection against Covid-19?
Vitamin D, which is produced in the body through exposure to sunlight, occurs naturally in some foods and can be taken as a dietary supplement, is an important modulator of human immune function. Several studies have previously found that vitamin D supplementation can reduce the risk of influenza, although research findings are not unequivocal. There are also some observations that suggest vitamin D could be involved in Covid infections. The most recent meta-analysis on vitamin D and Covid concluded that Covid-19 patients supplemented with vitamin D are more likely to demonstrate fewer rates of ICU admission, mortality events and RT-PCR positivity.
While clinical trials are needed to provide clarity, huge numbers of people in Northern climates are vitamin D deficient. Given the important role of this nutrient in immune function, supplementation could be encouraged. This was the recommendation given in an article published in the Royal Society Open Science Journal, which stated “We urge UK and other governments to recommend vitamin D supplementation at 800–1000 IU/day for all, making it clear that this is to help optimize immune health and not solely for bone and muscle health. This should be mandated for prescription in care homes, prisons and other institutions where people are likely to have been indoors for much of the summer…There seems nothing to lose and potentially much to gain”. Unfortunately, this recommendation hasn’t been implemented.
Interestingly, a JAMA article that cautions against the use of vitamin D states that “the credibility of clinical trials requires a hands-off approach from funders” and that studies funded by vitamin D supplement manufacturers are of concern due to a conflict of interest, since the manufacturers stand to profit if vitamin D deficiency is shown to worsen Covid-19 outcomes. Why are medical authorities not similarly concerned about the conflict of interest in studies of vaccine safety and efficacy by their manufacturers? This seems hypocritical, especially since vitamin D supplements are incredibly inexpensive, with prices ranging from $0.03 to $1.67 per serving.
Selenium is another micronutrient involved in the immune response. A study of patients with Covid in India found that they had lower blood selenium levels than healthy age matched controls. Selenium deficiency was associated with Covid mortality in another study. As with vitamin D, selenium deficiency is also widespread, and supplementation could be encouraged.
Iron also predicts poor outcomes from Covid. Among hospitalized patients in Iran, the prevalence of anemia (iron deficiency) was high, and was associated with use of a ventilator and ICU admission. Low levels of iron in the blood were identified as an independent risk factor for Covid-19 death in another study. One author even suggested that the presence of anemia “shall be regarded as an important factor in future risk stratification models for Covid-19”, although this has yet to happen.
The importance of proper nutrition to improve health during the pandemic has been promoted by scientists such as Dr. David Katz, founder of the Yale University Prevention Research Centre. Dr. Katz states that it is “absurd” to ignore that “diet is the single greatest driver” of the comorbidities that increase the risk of severe Covid.
In addition to nutrition as a modifiable risk factor for Covid, body weight is also critically important. The association between obesity and Covid is so undeniable that even the CDC website describes that “obesity worsens outcomes from Covid-19.” In fact, being obese “may triple the risk of hospitalization due to a Covid-19 infection”, and is linked to impaired immune function, decreased lung capacity, and death. Obesity is modifiable through a wide variety of diet and lifestyle interventions. Why are people not being educated and supported in ways to maintain a healthy body weight?
Lastly, stress has been shown to greatly reduce the ability of the immune system to fight disease and makes people more susceptible to infection. The fact that stress weakens the immune system has been well known for decades. A web page from the American Psychological Association reads “Stressed out? Lonely or depressed? Don’t be surprised if you come down with something”. A meta-analysis of 30 years of research found widespread negative effects of psychological stress on immune system health in humans.
Why can’t we acknowledge that there are other ways to help reduce the risk of infection and harm from Covid? Why can’t we have more than one tool in our “toolbox”? Why does the fear of detracting from the message of vaccination have to come at the cost of ignoring everything else? Why are we exclusively focused on vaccines when we know that many of the public safety measures currently being used (such as lockdowns and school closures) will be increasing the rates of social isolation, physical inactivity, and poor nutrition – all of which harm the immune system?
Why is there a lack of emphasis (and even outright denial) on early interventions for Covid infections?
In addition to failing to acknowledge other tools to help prevent Covid infection, the current vaccine-centric trajectory also fail to acknowledge that there are early intervention treatments that can help to prevent severe infection and death.
The one that is the most controversial is undoubtedly Ivermectin (IVM), for which the media assault has been horrific. IVM is continuously described in the mainstream media as a dangerous “horse dewormer”. Given how widespread this denunciation has been, it would probably surprise many to know that while it can be used for non-human animals, the discovery of IVM was awarded a Nobel Prize in 2015 for its ability to treat tropical diseases such as onchocerciasis and lymphatic filariasis in humans.
People may also be surprised to know that the Nobel co-laureate for the IVM discovery, Dr. Satoshi Omura, conducted a review of IVM against Covid-19, and concluded that there is good evidence that it reduces both morbidity (illness) and mortality (death). The article describes that by February 27th, 2021, 42 clinical trials including approximately 15,000 patients had been analyzed and “it was found that 83% showed improvements with early treatment, 51% improved during late-stage treatment, and there was an 89% prevention of onset rate noted”. And the articles keep coming: the October 2021 issue of Current Research in Translational Medicine includes an analysis of IVM research by scientists in Spain who reviewed the current scientific literature and concluded that there is “sufficient evidence about the safety of oral ivermectin, as well as the efficacy of the drug in the early-treatment and prophylaxis of Covid-19”. Yet despite the existence of quite a large body of research related to IVM and Covid, the claim is continuously made that the evidence is weak to support IVM’s use and that there isn’t enough proof that it works. Studies that deny efficacy are used to support these claims, while those that support its use are ignored or refuted.
The battle against IVM in many countries, especially the US, is deeply concerning. Even if it isn’t a slam dunk, how can we justify not providing people with this treatment? In the US, patients are being denied treatment with IVM in hospitals, despite lawsuits being filed by the families of dying patients to gain access. Doctors who prescribe IVM to Covid patients are told they could have their medical licenses revoked. In Australia, the Therapeutic Good Administration placed a national prohibition on general practitioners prescribing IVM, overtly citing interruption of the vaccination program as one reason for their decision.
Despite the mainstream media campaign against IVM, a different message is being sent by some physicians. The Front Line Covid-19 Critical Care Alliance (FLCCC Alliance) is a group of physicians who banded together at the start of the pandemic to develop protocols to treat Covid patients. These are the people who literally are on the “front lines.” Many of them are highly specialized ICU doctors. Dr. Paul Marik, one of the FLCCC Alliance founding members, is the second most published critical care doctor in history, having authored more than 500 scientific journals and books. Dr. Pierre Kory, another founding member, has served as the Medical Director for the Trauma and Life Support Center at the medical center of the University of Wisconsin, and is a highly trained critical care specialist. By all accounts, these are the people that we should be turning to first for insight into how to save patients infected with Covid.
Right from the start, they worked tirelessly to save patients’ lives. These are the heroes of the pandemic. Their protocols developed and morphed over time as they continued to treat patients and included intravenous vitamin C and other low cost, readily available drugs. Despite their altruistic intentions, these doctors were criticized by the medical establishment and mainstream science writers almost from the beginning because their protocols were not verified with randomized, double-blind studies, although these have subsequently been published, with many showing positive results. But they were saving lives, and they continued to use and share their protocols. IVM is part of their I-MASK protocol. The message these doctors send by continuing their work is powerful. They have so much to lose, and nothing to gain, but yet they push forward because they believe (based on firsthand experience) that they are saving lives.
Three interesting articles about IVM have been published in the last six months that present a view that is very different than that being portrayed by the mainstream media: “The Battle for Ivermectin”, by Matt Walsh, a veteran US newspaper editor of 45 years; “Believe It: A Top Old School Journalist Stands Up for Ivermectin and Free Speech”, by Michael Capuzzo; and “The Drug That Cracked Covid”, also by Michael Capuzzo. What is presented in these articles is deeply disturbing. Michael describes how the mainstream media is publishing articles containing “deceptions” and “falsehoods” in the course of the “most misleading, murderous coverage of a global issue in modern times, the assassination of poor little ivermectin.”
The confusion is mind boggling to the average person. On the one hand, scientific articles are being published in peer reviewed journals by Nobel prize winners and epidemiologists who state that based on their best review of the evidence, IVM should be used to treat Covid. There are also physicians using IVM on the front lines who believe so strongly in its efficacy that they are risking their medical licenses giving it to patients. On the other hand, the CDC and mainstream news articles state that IVM has no benefits and is even harmful – even though billions of doses of IVM have been administered safely for years. How can different groups talk about the same thing in such diametrically opposite ways?
Proponents of IVM suspect that this may be about money. Most of the existing early treatments, including IVM, cost almost nothing, and because they are off-patent there is no money to be made from their use. In contrast, there are billions to be made from the use of vaccines. Pharmaceutical companies are also in a race to develop new and expensive antiviral medications. On October 1st, Merck (the manufacturer of IVM) reported that their novel antiviral drug, Molnupiravir, reduces the risk of hospitalization or death by approximately 50%. Molnupiravir costs $700 US for a full course, in contrast to IVM, which costs less than $5.
Merck is seeking Emergency Use Authorization for Molnupiravir as soon as possible, and there has been great excitement about this new drug. Mainstream media headlines tout its remarkable ability to reduce the risk of hospitalization and death. What they fail to mention is that the absolute risk reduction conferred by the drug is only 6.8%. There is also no mention that the drug acts as a mutagen, causing the DNA of the SARS-COV2 virus to mutate. Unfortunately, it may also cause mutations in the host DNA. This means that a person being treated with Molnupiravir might develop cancer or birth defects, although proponents state that this is highly unlikely to occur using the recommended short-term (5 day) course of treatment Concerns about the safety and approval process of Molnupiravir (also known as EIDD-2801) were raised by immunologist Rick Bright in spring 2020. It is confusing that so much criticism has been levied against IVM, with repeated claims of a lack of data (despite the existence of dozens of clinical trials), while simultaneously readily embracing a new drug for which there is evidence of potential for long-term harm. Is there a double standard here?
A real time analysis of nearly 1000 studies using a variety of early treatments, including IVM and many others, against Covid-19 can be found here. Many of these early interventions are proving to be helpful. Why are people being denied treatment with potentially life-saving interventions? Shouldn’t we be using any and all tools available to us in the battle against Covid?
Is a universal and global vaccine centric strategy the best long-term solution?
Sometimes outcomes look very different when viewed in the short- versus long-term. But both are important considerations. When it comes to the short-term, the data seem clear: the vaccines work. Fewer people die, and fewer people get severely ill, even though vaccine efficacy is slightly less for the Delta variant. But what about the long term?
Some concerned scientists have raised the question about what the long-term effects of vaccination are on viral evolution. Even prior to widespread vaccination, Sars-CoV-2 was found to be evolving rapidly. Could it be that vaccination increases this selection pressure? Scientist Geert Vanden Boscche has publicly stated that “mass infection prevention and mass vaccination with leaky Covid-19 vaccines in the midst of the pandemic can only breed highly infectious variants”. Vanden Bossche, who holds a PhD in virology, has written an open letter to the World Health Organization (WHO) appealing a reconsideration of the mass vaccination strategy given what is known about virus selection pressure. Luc Montaignier, a French virologist and Nobel Prize winner, has similarly said that mass vaccination against coronavirus during the pandemic is “creating the variants”. Both scientists have been viciously derided and their ideas widely criticized by mainstream media. However, this is not simply a fringe idea.
Scientists at Harvard, the University of Washington, MIT, and others have explored the possibility of Sars-CoV-2 evolution due to vaccine pressure with mathematical modelling. In an article published in the journal PLOS One they state that “[Covid] vaccines that do not provide sterilizing immunity (and therefore continue to permit transmission) will lead to the buildup of large standing populations of virus, greatly increasing the risk of immune escape”. As shown by these models, “the more widely a given epitope [such as the spike protein, the single target of current mRNA vaccines] is targeted by biomedical intervention, and the more effective it is, the more rapidly it will generate resistance.”
In other words: because the vaccines currently being used don’t prevent transmission of the disease and only trigger an immune response to a single viral protein, the virus is likely to mutate in response and become resistant to the existing vaccines. In response to these findings, the authors recommended strategies for viral elimination, including using vaccines that are better able to resist the evolution of the virus. It is interesting to note that many experts who are critical of the current Covid trajectory are 100% pro- vaccine – but they don’t support mass vaccination strategies using the current vaccines.
History has also shown that vaccines are able to encourage the development of more virulent strains. A paper published in 2015 in PLOS Biology described the role of vaccination in facilitating more dangerous strains of the virus that causes Marek’s disease in chickens. The authors write that “anti-disease vaccines that do not prevent transmission can create conditions that promote the emergence of pathogen strains that cause more severe disease”. If this happens with the current Covid vaccines, which do not prevent transmission of the virus, is it not possible that the current campaign using single antibody generating vaccines could create more harm than good in the long term?
Of course, it is impossible to predict the future. But even if the vaccines currently being used save lives in the short-term, shouldn’t we consider the potential long-term consequences of different scenarios? If harmful virus selection due to vaccination is an even unlikely possible outcome, is this not inconsistent with the messaging that the only way out of this pandemic is through a mass global vaccination campaign using the current vaccines?
What are the long-term effects of vaccines on health?
An article published in the journal Toxicology Reports prior to the vaccine rollout in October 2020 by scientists from the US, Italy, Israel, Russa, Romania, and Greece was focused on vaccine safety. The article outlined several short-term adverse effects that could be induced by a vaccine, as well as potentially harmful mid- and long-term adverse vaccine effects. Yet the authors point out that these mid- and long-term effects “cannot be identified in short-term human clinical trials characteristic of vaccine efficacy testing.” These short-term human clinical trials are the studies that have been done to date. They also note that “There is an incompatibility between the accelerated vaccine development times being pursued by government and industry and the long times required for validation of vaccine safety.” The author’s conclusion? “It is difficult to see how safe Covid-19 vaccines can be developed and fully tested for safety and development time scales of one or two years”.
The operative word in that statement for many people would be “fully.” Certainly, the vaccines currently being used have undergone short term safety and efficacy testing (although as described later, there are some criticisms about how this was done). But we are not even “mid” or “long-term” into the Covid pandemic, let alone into the testing of safety and efficacy. Case in point: Vaccines seem to confer good short-term immunity against severe infection and death. When they were rolled out, many believed that this could be lifetime protection. In April, Dr. Rochelle Walensky, Director of the CDC, said “Vaccinated people do not carry the virus – they don’t get sick,” citing both clinical trial and real world data. In August, she admitted that vaccine effectiveness is waning and can’t prevent transmission of disease, which was blamed on the shift to the Delta variant.
The waning of immunity across a period as short as a few months has come as a surprise. The long-term effectiveness of the current vaccines is therefore unknown, as is the long-term effectiveness of repeated boosters. Does this not illustrate that we do not know what is going to happen as the pandemic continues? Especially since the current trajectory continues to use vaccines developed against the original Wuhan strain of the virus, despite the predominance of the Delta variant which has been shown to be eight times less sensitive to antibodies produced in response to the vaccine?
There are many possible long term adverse health effects that could be induced by a vaccine. As described in the Toxicology Reports article, these include: vaccine associated virus interference, in which people vaccinated against one respiratory disease are more susceptible to other respiratory viruses; vaccine-associated imprinting reduction, in which vaccines decrease protection afforded by natural infection; non-specific vaccine effects on the immune system, in which the vaccine affects susceptibility to other diseases; alteration of the gut microbiome; continuous activation of the immune system; and others. Other concerns specific to vaccination of children are mentioned in a second article, including adverse cardiovascular, gastrointestinal, neural, immune and endocrine effects. It is important to note that these concerns are being raised by scientists in the accepted academic forum of publication of scientific articles in peer reviewed journals, rather than claims being made by “anti-vaxxers” or Trump supporters, as is often suggested.
A second article published by the same research group described that the safety studies on which vaccine approval was based failed to measure the appropriate biomarkers. Biomarkers are biological markers that indicate a problem before it has fully manifested. These biomarkers include things like d-dimers, CRP, troponins, occluding, claudin, and blood oxygen levels (among others). Yet, these still aren’t appearing in published research. This omission would result in an assessment only of short-term adverse events and death. Excluded would be “early warning indicators of potentially serious symptoms/disease [that] might occur with much higher frequencies at this early stage than the rare serious symptoms”. Could it be that a different story would be told if these biomarkers were included in safety assessments? Why is this research not being actively pursued?
While we are repeatedly assured that the Covid vaccines are “safe and effective”, is a more appropriate statement, given the currently available data, that they are “safe and effective at reducing certain adverse events and death in the short-term”? Mid- and long-term safety is assumed by authorities, who say that any risks are greatly outweighed by the benefits of the vaccine, which are all related to the decrease in harm related to Covid infections. Is it possible, though, that these mid- and longer-term outcomes (that have not yet been assessed) could actually yield significant harm across time? Is it also possible that even in the short-term, biomarkers that could indicate problems are being missed?
What is the cumulative effect of repeated vaccines and boosters on individuals across different age groups?
It is now clear that vaccine effectiveness wanes across time, although public health messaging around this topic is still vague. As the vaccine rollout globally is still less than a year old, it isn’t fully evident how long vaccine-induced immunity lasts. Data from Israel suggest a “strong effect of waning across all age groups after six months”, so much so that they are currently undertaking a booster campaign. Boosters are also being recommended in the US to all Americans eight months after their second dose, although there has recently been conflict between the government and the FDA, who only recommend boosters for certain vulnerable populations.
Even the vaccine manufacturers are presenting data showing waning immunity in a bid to get approval for giving boosters in the US. While the vaccine offers short-term protection, there is emerging data that shows that the duration of protection is limited. Since frequent boosters were not even on the radar (at least publicly) at the beginning of the vaccine rollout, is there a good understanding of how this will play out long term? Will individuals continue to be protected with repeated booster shots? And is there increased potential for long term adverse effects from repeated vaccination?
At present, there’s only very short-term data to suggest booster effectiveness, quite simply because boosters have only been used for such a short period of time. Is there reason to expect that there may be limited protection from boosters over time? Yes, there is. In 2015, an article was published in the Canadian Medical Association Journal (CMAJ) showing that repeated flu shots reduce the effectiveness of the vaccine in subsequent seasons. Like Covid, the flu is a respiratory virus, and as with the flu vaccine, Covid vaccines are likely to require repeated vaccination as we now know that they don’t offer lifetime immunity. The CMAJ article recommended that “a return to targeted, high-risk flu vaccine programs, rather than universal coverage, seems warranted.” This approach of targeting high risk individuals with Covid vaccination has been recommended by several high profile scientists, but has been denied as an acceptable strategy by public health authorities in many countries, even though it has historical precedent.
Several other potential long-term safety concerns related to vaccines that could be amplified with repeated boosters have already been mentioned, including chronic immune system activation, vaccine associated virus interference, non-specific vaccine effects on the immune system, harmful effects on the gut microbiome, and others.
Is the adoption of a universal, mandated approach to Covid-19 vaccination that includes regular boosters consistent with what we know about the safety and effectiveness of vaccines in the long term? Does the apparent rapid waning of vaccine efficacy nullify the logic of requiring vaccines for all people? And would a targeted approach in which those most vulnerable to serious infections and death be more appropriate?
Why are the opinions of experts that run counter to public health messaging being denounced and censored?
Harvard University. Oxford University. Stanford University. Johns Hopkins University. Yale University. Karolinska Institute. And many more. These are the professional affiliations of some of the scientists who do not support at least one aspect of the current Covid trajectory. A few of these people do not support using the current vaccines at all. Some do, just not as they are being currently recommended, through mandates or coercion to each and every eligible person in society. Some have concerns over vaccine safety. Some are opposed to other aspects of the trajectory, such as the repeated use of societal lockdowns.
Many experts are asking questions that challenge the rationale behind several aspects of the current Covid trajectory, including vaccinating people with natural immunity, vaccinating children, mandatory vaccine mandates, vaccine passports, and lockdowns. Yet when they do so, they are silenced and even threatened with severe repercussions. Anything that runs contrary to the public health messaging around Covid-19 is viewed as “misinformation” and/or “disinformation.” However, many doctors and scientists are pushing back publicly. I have already discussed the FLCCC Alliance who continue to promote inexpensive early interventions to prevent and treat Covid. Others are responding in different ways.
As of September 22nd, 2021, 14 981 medical and public health scientists and 44 167 medical practitioners had signed the Great Barrington Declaration, which suggests using a focused protection approach. This declaration states that the development of herd immunity in a population “can be assisted by (but is not dependent upon) a vaccine” and proposes a “compassionate approach” that balances risk and benefits and adopts measures to protect those who are most vulnerable. Despite being based on previously accepted health protection measures, the declaration was widely criticized for prioritizing individuals over the public good, with the assumption being that these measures are all necessary for public protection. Dominic Cummings, the political strategist and the UK Prime Minister’s Chief Advisor, undertook a public “propaganda smear campaign” to discredit the Great Barrington Declaration, which misrepresented both the ideas presented in the declaration as well as the three lead authors, who were scientists at Harvard, Oxford, and Stanford Universities.
A rebuttal to the declaration was published in the prestigious medical journal the Lancet called the John Snow Memorandum that stated that lockdowns were “essential to reduce mortality”. Unfortunately, it is becoming increasingly clear that this is not the case. A recent comprehensive study by the Rand Corporation found that lockdowns (or “shelter-in-place”) policies did not save lives and in fact resulted in excess mortality in some places. As with the waning of immunity from vaccination, is this not yet another example of how the emphatically stated hypotheses of public health authorities may prove, in time, to be inaccurate?
In Canada, the Declaration of Canadian Physicians for Science and Truth has been signed by over 4700 physicians and citizens who are concerned that the College of Physicians and Surgeons of Ontario (CPSO) is censoring and aggressively preventing doctors from “voicing their expertise on…important matters”, particularly lockdowns. Wrote Dr. Shawn Whatley, former president of the Ontario Medical Association, “Despite undeniable suffering due to lockdowns, the CPSO wants Ontario doctors to stay quiet”.
Also in Canada, over 2000 vaccinated and unvaccinated health care workers have organized the “Health Professionals United” group in protest against mandatory Covid vaccines, stating that “As front-line health care workers, we have witnessed serious adverse events, including deaths, that were temporally, closely associated from the administration of these vaccines”, as well as concerns including the increasing numbers of vaccinated people who are being hospitalized in their province. The group has written an open letter outlining their concerns to the President of the provincial health service.
Similarly, the “Physicians Declaration” has just been created by a group of doctors and scientists from around the world that presents concerns about government overreach, including an assault on doctor’s ability to care for their patients, use of a “one size fits all” treatment strategy, and prevention of open dialogue and denial of the right to provide treatment to their patients. Within a week, the declaration had over 4,200 signatures. As of October 5th, over 10,000 doctors and scientists had signed the declaration.
Even government advisory committees have questioned aspects of the current Covid trajectory. In many countries, vaccine passports have been implemented that require people to show proof of vaccination in order to gain entry to certain places. Yet in the UK, the Public Administration and Constitutional Affairs Committee determined that despite the Government’s claim that Covid passports would be needed to reopen the economy, there was no evidence to support this claim. The Committee Chair stated: “With recent analysis suggesting that vaccinated people carry as much of the virus as the unvaccinated into any setting, the disappointing lack of any scientific basis for the Government’s decision to go ahead could reasonably lead people to conclude that there is in fact no such basis. If the real goal is to drive vaccine uptake, then it is a deeply cynical approach that will be counterproductive”. If there is no scientific evidence to support the use of Covid vaccine passports in the UK, how can this approach be justified in other countries? Why are we adopting costly measures like vaccine passports when there is little evidence to support their use?
Censorship of information that runs counter to public health messaging about Covid is extremely complex. The Trusted News Initiative was developed as “an industry collaboration of major news and tech organizations [that] will work together to rapidly identify and stop the spread of harmful Coronavirus disinformation”. The initiative includes Facebook, Google/YouTube, Twitter, Microsft, BBC, AFP, Reutors, European Broadcasting Union, Financial Times, The Wall Street Journal, The Hindu, CBC/Radio-Canada, First Draft, and the Reuters Institute for the Study of Journalism. While well intended, this initiative has led to a one-sided narrative in the mainstream media despite the emergence of data that may run contrary, particularly in the academic literature. Why are we attempting to silence experts who may have something important to lend to the conversation?
There are many people speaking out on the topic of the current Covid trajectory in different ways. Large numbers of highly educated and credentialed people are giving opinions (usually supported by data) that run counter to public health messaging in some way or another. If these people were fully and publicly supporting the current trajectory, we would be using their credentials to support their claims. Are we to believe that they are wrong simply because their opinions run counter to public health messaging? There is clearly more than one side to this story – why are we not being allowed to hear it?
Are there any concerns about the vaccine approval process?
Vaccine testing got off to a rapid start. At least in the case of Moderna, this is because development of the Covid-19 vaccine was already underway in January 2020, in collaboration with the US National Institutes of Health (NIH). According to the Moderna Securities and Exchange Commission document for the 2019 fiscal year, “In collaboration with the VRC, we are developing an mRNA-based vaccine designed to express the coronavirus Spike (S) protein based on the genomic sequence of SARS-CoV-2. On January 13, 2020, the NIH and our infectious disease research team finalized the sequence for the SARS-CoV-2 vaccine and we mobilized toward clinical manufacture. As of February 24, 2020, the first clinical batch [was] shipped to and received by the NIH for use in their planned Phase 1 clinical trial in the U.S”. The development of the Moderna Covid vaccine preceded the first confirmed case on US soil, which was identified on January 21st, 2020. Since the foundation for the mRNA vaccines was already established in early 2020, the initial clinical trials were planned by the time the WHO declared a pandemic on March 11, 2020.
The vaccines that began to be used in December 2020 were given Emergency Use Authorization (EUA) rather than full approval by the US government. Full approval is a much lengthier process, requiring longer term data from phase III clinical trials. As noted in the clinical trial registry clinicaltrials.gov, the Pfizer phase III study started on August 28th, 2020, and was estimated to be completed on February 14th, 2023. As stated by Pfizer in 2020, the longer term monitoring was supposed to “assess long-term protection and safety for an additional two years after their second dose”. Yet the Pfizer vaccine received full approval on August 23rd, 2021 in the US, setting a precedent for other governments to follow suit. Why was the long-term monitoring not required before full approval, and what are the limitations of using a shorter surveillance period?
One major shortcoming of the short study period is that it failed to take account of vaccine efficacy. In December 2020, Pfizer senior vice president told the FDA advisory committee that they were “going to be looking very intently at the durability of protection”. This did not happen, and it’s an important omission, because a vaccine that is over 95% effective over an extended period is not the same as one that is 95% effective for two months but then decreases. In an article published on TrialSite News, author Dr. David Wiseman points out that six studies were omitted from the full vaccine approval analysis that showed waning immune effectiveness. Dr. Wiseman questions this omission, and presents evidence that at least two papers were available before the cutoff date of August 20th and should have been included.
Another shortcoming of the abbreviated study period is that it did not adequately consider data related to the effectiveness of the vaccine against the Delta variant. The current mRNA vaccines were based on the original viral strain, even though Delta now dominates in much of the world. There is evidence of waning and reduced immunity against the Delta variant.
As stated in a recently published article in the British Medical Journal “waning [vaccine] efficacy has the potential to be far more than a minor inconvenience; it can dramatically change the risk-benefit calculus. And whatever its cause—intrinsic properties of the vaccine, the circulation of new variants, some combination of the two, or something else—the bottom line is that vaccines need to be effective. Until new clinical trials demonstrate that boosters increase efficacy above 50%, without increasing serious adverse events, it is unclear whether the 2-dose series would even meet the FDA’s approval standard at six or nine months”. This article was written by Dr. Peter Doshi, British Medical Journal editor and Associate Professor of pharmaceutical health services research at the University of Maryland School of Pharmacy, who is an expert in drug approval processes.
These short study periods mean that none of the mid- or long-term adverse events that have been suggested as possible outcomes associated with vaccines have been assessed. There simply is no way around this: these research studies lasted for months, not years, and nothing other than limited short-term outcomes have been assessed.
Another concerning aspect of the full approval process is that despite stating in August 2020 that they were committed to using an advisory committee with independent experts to ensure transparency, the US government did no such thing. As stated by Kim Witczak, drug safety advocate, ““These public meetings are imperative in building trust and confidence especially when the vaccines came to market at lightning speed under emergency use authorisation…The public deserves a transparent process, especially as the call for boosters and mandates are rapidly increasing. These meetings offer a platform where questions can be raised, problems tackled, and data scrutinised in advance of an approval…It is already concerning that full approval is being based on 6 months’ worth of data despite the clinical trials designed for two years”. This has done nothing to bolster public confidence in the approval process.
The rush to approve the Pfizer vaccine seems to have been largely driven by the push to get every eligible American vaccinated. Polls suggested that approximately 30% of vaccine hesitant people in the US would get vaccinated if there was full approval. This motivation was made clear by Dr. Rochelle Walensky, Director of the CDC, when she said after approval was granted that “We now have a fully approved Covid-19 vaccine and ACIP has added its recommendation. If you have been waiting for this approval before getting the vaccine, now is the time to get vaccinated and join the more than 173 million Americans who are already fully vaccinated”. Does the desire to increase vaccine uptake justify a rushed approval process?
The rushed approval process of the Pfizer Covid vaccine raises many questions. Why wasn’t all data including that showing waning immunity and reduced efficacy against the Delta variant included? Why was approval granted without completion of the full study period, with no consideration of mid- and long-term outcomes (both in terms of effectiveness and adverse events)? And why was all of this done behind closed doors, without inclusion of an independent advisory committee?
Why are we implementing policies that are discriminatory and increase racial and economic inequalities?
It has been well demonstrated that vaccine hesitancy is highest among some minority groups, especially Black Americans. And it has been similarly well argued that this hesitancy is justified. Reasons for this hesitancy are many and largely center around the US history of racism that has permeated both medical research and medical care.
The vaccine-centric public health trajectory in many countries is unilateral: get vaccinated or lose access, usually to non-essential services, workplaces, and transportation services. But there is an underlying inequality here. If minorities have some of the highest rates of vaccine hesitancy, they will also experience the most severe outcomes associated with this personal choice. They will lose their jobs, their ability to move around freely, and access to amenities. The implications are tremendous.
It is widely recognized that vaccine passports may worsen inequality. As stated in a Human Rights Pulse article in April 2021, “The proposed Covid-19 passport focuses on the vaccination status where vaccinated equals safe, and unvaccinated equals unsafe. This binary indicator provides the foundation for dividing populations and controlling what they can and cannot do – essentially providing a new basis for discrimination and inequality. Dividing people and countries into the dos and the don’ts, the wills or the won’t’s presents a risk in its potential to establish even greater polarisation and deeper social divisions”. In April, this was a hypothetical scenario. Now, it is an unfortunate reality.
The alternative to mandating vaccines in some cases is the requirement of a negative Covid test. But these cost money, and while costs have been decreasing, they are still very prohibitive to many people. Some employers are requiring weekly or biweekly tests at the employees’ expense, which is not an equitable solution.
More broadly, vaccine passports instituted by higher income countries will also have harmful effects on lower- and middle-income countries. Many of these countries still have very limited access to vaccines and likely will for a long time, making citizens of these countries unable to travel anywhere that vaccine passports are required. Says author Steven Thrasher, “It is morally reprehensible (not to mention epidemiologically self-defeating) that countries can prevent vaccines from crossing their borders and want their own citizens to be able to cross those borders and travel to countries that are denied vaccines—and then use the threat of infection to keep the people of those unvaccinated countries inside them”.
The Covid pandemic has already contributed greatly to widening inequality. There has simultaneously been a global recession resulting in over a hundred million people being pushed into extreme poverty and an increase in the wealth of the world’s billionaires by 54%. Covid infections have also been disproportionate, with Indigenous, Black and Pacific Islanders in the US experiencing much higher death tolls than White Americans. Why are we deliberately choosing approaches to managing the pandemic that will make this inequality worse?
We have already seen many instances during the Covid pandemic where despite assurances to the contrary, things did not evolve as expected. It seems clear that we simply don’t know what is going to happen next, or what the consequences of our actions and choices will be. What is perhaps most troubling is that this acknowledgement has been almost completely absent from the rhetoric of our leaders and decision makers. It does not show ignorance or weakness to be honest about this reality, it shows wisdom and discernment. That is what we should strive for.
The more I try to make sense of what is happening in our world, the more I am convinced that a one-size-fits-all vaccine centric solution using punishments and rewards is misguided. Instead, we should consider individual risks and rewards in the context of the benefits of vaccination. We should be encouraged to use every tool at our disposal to help prevent disease, as well as to treat infections when they arise.
Shouldn’t we enhance public trust through accountability for injuries? Shouldn’t we look beyond the immediate reduction in cases and deaths to include the breadth of possible outcomes across the short and long-term? Shouldn’t we be open to hearing different opinions and perspectives? Shouldn’t we be treating everyone with respect regardless of the choices they make for themselves or their opinions, beliefs, and values? And shouldn’t we be doing everything possible to minimize increasing inequities that are already so pervasive both within and between countries?
One of my favorite stories is of Indian leader Mahatma Gandhi, leading a march to protest against the British, who were occupying his country. There were many people marching with him, and there was great enthusiasm among his followers. After a few days Ghandi realized that the protest would not achieve his desired intentions and would cause harm. So, he stopped the march. When challenged by his lieutenants that he couldn’t do this, people had left their jobs and were following him, that they couldn’t stop now – Ghandi said: “I have a misunderstanding….I’m only human, I don’t understand at all. My understanding of truth changes from day to day. My commitment is to truth not to consistency.”
Similarly, our commitment during this pandemic must be to truth and not to consistency or we risk making choices with potentially grave consequences. Clearly, finding our way out of this pandemic is the most important issue humanity has faced in a long time. I’ve presented a lot of questions here about whether our current trajectory is the right one. These are deep and complex issues that I think that we need to engage with. I don’t have the answers to these questions, but I do know the following: there is uncertainty about what we are doing and where we are going, and we could do better.