The University and the Vaccine
Brock University in St. Catherines, Ontario, just announced its Fall 2021 return-to-campus procedures. The decision that "vaccines will not be mandatory", which is highlighted in the title of the announcement, is a welcome distinction from certain other universities' approaches. For example, under the guise of "safety first", Western University in London, Ontario, "mandates vaccinations for students in residence", noting possible exemptions under the Ontario Human Rights Code, and the University of Toronto requires students to have at least the first dose of a COVID-19 vaccine in order to provide a "safe and welcoming residence experience" (no exceptions mentioned). Unfortunately, my university just announced a 180-degree turn from last week and followed its big sister across town to require vaccines for students living in residence on campus. Our spokesperson is quoted saying "This measure is necessary to support students’ safety, growth and development".
Does a mandatory COVID-19 vaccine really provide a "safe and welcoming residence experience" and contribute to "safety, growth and development" of our students? It may indeed bestow a feeling of safety, which I argue is misconstrued as a consequence of persistent, possibly willful, ignorance of the science behind the vaccine trials and an outdated COVID-19 risk assessment.
The protocols for the vaccine manufacturers' Phase 3 trials that were conducted during the summer of 2020 were designed to obtain specific results, measured by "primary endpoints". These represent the goals of the vaccination and enabled the manufacturers to issue preliminary results once certain statistical conditions were met. Quoting from an editorial in the venerable British Medical Journal dated 21 October 2020:
Contrary to prevailing assumptions ..., none of the vaccine trials are designed to detect a significant reduction in hospital admissions, admission to intensive care, or death. Rather than studying severe disease, these mega-trials all set a primary endpoint of symptomatic covid-19 of essentially any severity: a laboratory positive result plus mild symptoms such as cough and fever count as outcome events (table 1). These studies seem designed to answer the easiest question in the least amount of time, not the most clinically relevant questions.
Source: https://www.bmj.com/content/371/bmj.m4058
The symptoms listed in the quoted Table 1 of the BMJ editorial are cough, sore throat, cough and fever, and cough and headache for the Moderna, Pfizer, AstraZeneca, and Janssen (J&J) trials respectively. The efficacy bar in reducing or eliminating symptomatic COVID in the vaccinated trial participants was set to only 50%. As you probably know, Pfizer and Moderna reported over 90% efficacy. But this is a relative measure of risk reduction; I have already written about the difference between the high (60-95%) relative and low (<1%) absolute risk reduction from these trials. In conjunction with the trial endpoints, we could very well have seen a perfectly valid news headline like:
"mRNA vaccines reduce COVID symptoms by 0.7%"
More importantly, the trials did not prove anything about the transmission of SARS-CoV-2. If you search the Web for the question whether the vaccines reduce transmission, you will find a lot of word acrobatics of the type "a growing body of evidence indicates that people fully vaccinated with an mRNA vaccine ... are less likely to have asymptomatic infection or to transmit SARS-CoV-2" (CDC). Fact is that we do not have scientific studies that conclusively demonstrate a reduction or elimination of transmission from vaccinated to other people, thus at this point it makes no logical sense to require vaccination to reduce the spread. In other words, the "community safety" argument is not supported by scientific evidence from the vaccine trials.
Based on common sense, I would even argue that vaccinated people, who are somewhat protected from developing COVID symptoms but can still carry the virus, will now be more likely to spread it to unsuspecting family and friends, because the symptoms, which would have signalled to stay home and recover, are now suppressed. Maybe, instead of mandatory vaccines, we should instead prohibit vaccinated students, staff, and faculty from coming to campus in the future?
In addition to the questions about the benefit of mass vaccination outlined above, you might ask whether there is any harm? The short answer is: we don't know yet. Consider the Government of Canada's COVID-19 vaccine safety reports at https://health-infobase.canada.ca/covid-19/vaccine-safety/. They claim that the benefits of the authorized vaccines outweigh the risks and that the safety of the vaccines is being closely monitored. Two specific risks are mentioned: thrombosis (blood clots) associated with the AstraZeneca vaccine and reported cases of myocarditis after mRNA shots. A total of 7,408 "adverse events" were reported as of June 11, 2021 (report dated June 18), with a total of 28,156,222 vaccine doses administered.
A graph shows the weekly number of adverse event reports, which have hovered somewhere over 200 since late January and gone up to over 400 in one week in late April. Among these, serious side effects ranging from persistent or significant incapacity to hospitalization and death made up between 25 and 60 per week from mid-January to mid-April, but have more recently climbed to a range of 105 to 151. For decision-making we would be advised to consider the rate rather than count of adverse events, and fortunately the rate of serious complications has remained around only 4 to 7 reports per 100,000 vaccinations in recent weeks. Yet, if we deal with vaccine side effects in the same way in which we dealt with COVID-19 ("every death counts" etc.) then knowing that some 100 to 150 Canadians are being seriously harmed or killed by the vaccines each week might give reason to pause.
An additional table on the same "Health Infobase" web page shows the counts and rates of adverse events reported for each of the three authorized vaccines, with Moderna and AstraZeneca responsible for some 40 reports per 100,000 doses and Pfizer a lower 20/100,000. For serious events, AstraZeneca has a rate greater than 11, followed by Pfizer with less than 5 and Moderna with around 3.5 per 100,000 doses.
While the Canadian adverse events reporting comes from doctors and nurses, anyone can submit a record to the Vaccine Adverse Event Reporting System (VAERS) in the United States. A report does not require evidence that the issue was caused by a vaccination rather than being coincidental, thus introducing the risk of over-reporting. Conversely, the "Guide to Interpreting Data" also notes the known issue of under-reporting to VAERS. With these limitations in mind, the number of reported events dated up to June 4, 2021, is 316,929, of which 4,700 were fatal. If we put these numbers in relation to the total number of doses dispensed in the US by the same date, 299 million according to Our World In Data, we find that 0.1% or 106 in 100,000 doses resulted in an adverse event report, and of those almost 1.5% were deadly.
What analysts have also noticed is the far higher number of reports in conjunction with the COVID-19 vaccines in 2021 as compared to all previous years of VAERS data. I am providing a comparison with just the last three years here. The reports with fatal outcome have jumped proportionately even higher from the 2018-2020 baseline as compared to the total number of reports. Of course, there will be some increase due to the large number of COVID-19 vaccines dispensed and the immense public attention paid to SARS-CoV-2. However, a six-fold increase in reports and a 25-fold increase in death reports seems concerning.
UPDATE, 27 June 2021: It has come to my attention that there is a significant delay in the publication of VAERS reports. I examined this by comparing the reports dated up to June 4 from the June 17 download with a June 27 download. There are approximately 39,500 additional reports included in the more recent dataset, primarily dated between April 20 and May 20. This means that there is a baseline two-week delay (June 4 being the last date included in the June 17 download) plus a significant, partial delay of report clearance of up to 10 weeks (April 20 to June 27). This needs to be taken into account if we want to use VAERS as an early warning system for serious vaccine risks. In addition, I need to clarify that the data shown here are from the VAERSDATA file that includes the case description but not the vaccine administered. Based on the VAERSVAX file from June 27, about 98.8% of vaccines reported on are for COVID-19. The VAERSVAX file includes 384,644 reports involving COVID-19 vaccines, while the VAERSDATA from the same date includes "only" 356,435 reports. I am not sure about the source for this discrepancy.
Back to Canada, COVID-19 vaccines are imported, sold, and used under an "expedited authorization" by interim ministerial order dated 16 September 2020. This is the equivalent of the better-known Emergency Use Authorization (EUA) in the US. Some important points to note for Canada (emphases are mine):
The vaccines are "authorized", not "approved"
Quoting directly from the Regulatory Decision Summary for the AstraZeneca vaccine, "Important limitations of the data at this time include the lack of information on the long-term safety and efficacy of the vaccine, interactions with other vaccines, and the lack of or limited data in sub-populations (e.g. pregnant/breastfeeding women, pediatric population <18 years of age, immunocompromised patients and patients with chronic or debilitating conditions, use in subjects with severe and/or uncontrolled underlying disease)."
Several clinical (Phase 3) trials are ongoing for AstraZeneca
The summary document for Pfizer/BioNTech's mRNA vaccine reads "One limitation of the data at this time is the lack of information on the long-term safety and efficacy of the vaccine. The identified limitations are managed through labelling and the Risk Management Plan. The Phase 3 Study is ongoing and will continue to collect information on the long-term safety and efficacy of the vaccine. There are post-authorization commitment for monitoring the long-term safety and efficacy of Pfizer-BioNTech COVID-19 Vaccine."
According to the Summary Basis of Decision (SBD) for Pfizer-BioNTech COVID-19 Vaccine, only 19,000 out of 36,500 Phase 3 trial participants are involved in the "safety analysis".
The manufacturer committed to providing a 6-month safety update for 6,000 participant of their Phase 2/3 trial as well as a 2-year safety update for the larger Phase 3 trial. Thus, there should be a safety update this month (June 2021) and the Phase 3 trial really only ends in late 2022 or early 2023.
Pfizer subsequently also applied for authorization of their product for children aged 12-15 years old, who were previously excluded. Phase 3 trial data for 2,260 adolescents were assessed by Health Canada. About half of the children were in the vaccine, the other in the placebo group. None of the participants in either group suffered severe COVID-19 or died. The vaccine efficacy was found to be 100%, which means that some kids in the placebo group got a light form of the disease while none in the vaccine group did. Raw counts can be gleaned from a Pfizer-BioNTech press release indicating that 18 participants in the placebo group (1,129 participants) got COVID-19 during the trial. We could thus say - similar to what I outlined above - that the "Vaccine Prevented the Sniffles in 1.6% of Kids".
In terms of safety in the children's trial, almost all participants had a follow-up one month after receiving their second dose, but only 58% had a two-month follow-up. Adverse reactions within 7 days included "pain at the injection site (90.5%), fatigue (77.5%), headache (75.5%), chills (49.2%), muscle pain (42.2%), fever (24.3%), joint pain (20.2%), injection site swelling (9.2%), and injection site redness (8.6%)", with up to 3.5% considered severe. None of the most worrisome vaccine injuries - Bell's palsy, myocarditis, thrombocytopenia, or deep vein thrombosis - nor any deaths were reported among the 12-15 year old trial participants, but "The Phase 3 study is ongoing and will continue to collect information on the long-term safety and efficacy of the vaccine."
I quoted extensively from the approval documents to hit a couple of points home: There is absolutely no information on the longterm safety of the COVID-19 vaccines and the trials and followup have not been completed, neither for safety nor even for long-term efficacy. In addition, neither Health Canada nor the US authorities nor the European Medicines Agency conducted their own studies; their risk assessments and authorization decisions are based on a review of the vaccine manufacturers' trial data and reports. In this situation, I do not feel that anyone, never mind young adults (university students) or children, should be pressured or forced to "take the jab".
ADDITION, 2 July 2021: Some sceptics argue that people who take the COVID-19 vaccine are involuntarily participating in an ongoing medical experiment. They view the continuation of mass vaccination as a breach of the Nuremberg Code. The Code was established by the post-war nazi tribunal in Nuremberg to prevent medical experiments on human subjects from ever happening again without fully informed, voluntary consent. Depending on their research methods, many Canadian researchers are constrained by research ethics considerations, and the "Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans" is a extension and practical implementation of the principles of the Nuremberg Code. In "Bioethics of Experimental COVID Vaccine Deployment under EUA: It’s time we stop and look at what’s going down", Dr. Robert Malone, the inventor of the mRNA vaccine technology, writes succinctly and convincingly why the current mass vaccination campaign would never be approved by an institutional research ethics board. However, my view of the COVID-19 vaccination program is that it is not so much a research experiment as it is an emergency medical "procedure". Yet even as such, it should be entirely voluntary, free from any form of pressure, and the decision to undergo the treatment should come after full disclosure of benefits and risks by a medical professional.
Back to youth vaccinations for COVID-19, eminent infectious disease researchers Dr. Martin Kulldorff and Dr. Jay Bhattacharya just wrote about "The ill-advised push to vaccinate the young" in The Hill (17 June 2021). As co-signatories of the Great Barrington Declaration, Bhattacharya and Kulldorff have long advocated in favour of vaccines as part of a targeted protection strategy for elderly and vulnerable people. In the article, the state what should be obvious, "all medical interventions should pass the test of providing more benefits than risks". They find the risk-benefit calculation for COVID-19 vaccines works out for at-risk populations but not for children and young adults who have virtually no risk of dying from COVID. Therefore, "Even a slight risk of a serious vaccine adverse reaction could tip the benefit-risk calculation, making the vaccine more harmful than beneficial." Reports of blood clots and myocarditis associated with the vaccination of young people would trigger this reversal. Drs. Kulldorff and Bhattacharya conclude that it is therefore unethical for universities and other organizations to mandate vaccines for persons they are responsible for (students, employees).
Still in the US, The Hill also reports that the Republican Governor of Arizona overwrote a policy at Arizona State University by making it illegal to mandate the vaccine for students, to collect students' vaccination status, or even to conduct COVID-19 testing at the university. Masks are also not to be enforced for in-person instruction. This seems perfectly acceptable to me, with the only condition that any faculty, staff, or student who feels they need the vaccine had an opportunity to get fully vaccinated before returning to campus.
The World Health Organization (WHO) states that "Children should not be vaccinated for the moment" (21 June 2021 - the sentence has been removed as of 23 June 2021 without explanation). But the opposite is happening in Canada right now, with some municipalities encouraging children as young as 12 years old to get the shot without the need for parental consent. For example, Toronto Public Health writes that "Consent from parents may not be needed if the young person is capable of making the decision. This means the young person must understand information about the vaccine, why it is being recommended and what will happen if they accept or refuse vaccination." Informed consent of the patient is one of the most fundamental principles in health-care. From personal conversations, I know that adult friends and acquaintances have not informed themselves about the vaccines prior to being vaccinated. For example, they did not know at all that there have been numerous reports of suspected deaths from the vaccines (see above). Then how do we expect a 12- or 15-year old to give informed consent?
Lastly, with a view on the uncertain return to campus, or return to remote teaching, for the Fall 2021 term, I'd like to recommend "We Cannot Teach in Masks" by Drs. Michael Lewis and Sinéad Murphy. The text from 6 September 2020 is as current as ever. The two Newcastle University philosophy professors note the hypocrisy in the university's boilerplate commitment to safety as its primary goal, when it should instead focus on its mission to educate. They argue that the "atmosphere of the [hospital] operating theatre" with masks and distancing is not conducive to the human interaction essential for learning. Furthermore, the process of "totalitarian imposition of face coverings and social distancing" is in direct contradiction of the foremost learning objective: critical thought. With the mandatory vaccination and COVID-19 testing policies, we are entering the next phase of the dissonance between the university's ideals and its complicity in suppressing these ideals in students and faculty.