Vaccination Deliberation

Navigating the Questions While Awaiting Some Answers

T.K. Fenske, MD, FRCPC

The COVID crisis has effectively divided our country, our culture, the provinces, churches, workplaces, social circles, and even our families. Emotions are running high and the dividing lines have been dug deep, separating out pro- and anti-lockdowns, pro- and anti-masking, pro- and anti-government control, and no less pitting those who are pro-vaccination against those who are leery. While I would be rightly placed in the pro-vaccination camp, I can appreciate the vaccine hesitancy that many are holding to in these troubled times. Numerous legitimate questions of concern have been raised regarding the next-generation vaccines developed to counter our pandemic. Adequate answers seem elusive, and are hard to separate out from the maelstrom of bombarding data. As a medical specialist, I too have been overwhelmed by the “info-demic” of daily data. There seems no end to the flood of late-breaking news headlines, YouTube debates, gloom-and-doom podcasts, and medical journal commentaries. Agenda seems rife at every turn and in every piece, and you begin to wonder, who can you trust? 

Although our public health officers maintain a singular focus on vaccination as the only pandemic solution, there are credible practicing physicians who speak of governmental suppression of effective anti-viral therapies for COVID-19. And while mainstream media push for urgent and universal vaccination at every opportunity, alternative news sites recommend delaying vaccinations until after the pandemic has subsided, warning that the vaccination will weaken our innate immune response, making us more susceptible to severe infection. Others even forecast that the COVID vaccines will “decimate the world’s population.” It’s enough to make you want to return to bed, pull the covers up tightly around yourself, and quietly recite “Jesus loves me.”

While I don’t pretend to be an expert in vaccines or virology, I offer the following, as a frontline medical practitioner, in order to provide some clarity amid the confusion. From the outset, it’s important to keep in mind that the COVID-19 pandemic is more than a biological insult on humanity; spiritual forces are at work. As Apostle Paul clarifies, “our struggle is not against flesh and blood, but against the rulers, against the authorities, against the powers of this dark world and against the spiritual forces of evil in the heavenly realms” (Eph 6:12). The devil is having a heyday with the fearmongering and social isolation. But contrary to the popular narrative, COVID-19 is not ultimate; that’s God’s place, Maker of heaven and earth. So, as followers of Christ, we need to counter the misplaced fears of our times, and the misplaced hopes of a salvific vaccine, and “fix our eyes on Jesus, the author and perfector of our faith” (Heb 12:2). My hope is that this offering might be helpful in this regard. While not comprehensive, by any means, this brief review is a follow-up to an earlier article, “Vaccination for the Nation?” which detailed the Christian heritage of vaccines, their mechanism and pitfalls, the ethical issues raised, as well as the societal freedoms challenged. The ambition of this article is to discuss some of the developments which have transpired over these past months, focussing primarily on the safety and efficacy of the available vaccines, and address some lingering concerns.

Nearly half a year has passed since the first COVID-19 vaccines were administered to the first Canadian recipients. In the intervening months since that “V-Day” in mid-December 2020 as some are calling it, much monitoring and research has been done on the available vaccines. While there remain some unanswered questions, a lot has been learned regarding their safety and efficacy – useful information which may help inform a decision as to whether or not to proceed with bearing an arm. To begin with, however, it’s important to acknowledge the good work that has been done here. News of the COVID-19 pandemic stimulated the development of remarkably effective vaccines that have been produced with unprecedented speed using diverse novel technologies, which will revolutionize future vaccine approaches. We discussed viral vectors, lipid nanoparticles, and genetic transfer during my microbiology training back in the early ‘80s, but then it was more along the lines of “dreaming a little dream” than any present immunization reality. The rapid development and global roll-out of the various COVID-19 vaccines has been truly breathtaking and demonstrates what is possible when like minds work together in a concerted effort to achieve a unified goal. Never before has such an undertaking of this magnitude been accomplished, and within such a tight timeline. The population uptake of the vaccine is also unparalleled. To date, there have been close to 1.7 billion doses of vaccine administered worldwide, with over 380 million fully vaccinated, amounting to 5 percent of the world’s population. Canadian vaccine distribution has performed to a similar impressive degree with over 20 million doses given and over 1.6 million Canadians fully vaccinated. Although a large proportion of the vaccine uptake is likely related to governmental fear campaigns intentionally propagated far and wide, the logistical achievement of researching, developing and distributing these novel vaccines is nothing short of astounding, to which kudos are in order.

The track record of the COVID vaccines has suffered some blemishes these past few months, if not indelible black marks. Although the risk of serious adverse effects has remained remarkably low – even after vaccination of hundreds of millions of people worldwide to date – the risk isn’t zero, nor would we expect it to be so. We live in a fallen world with sin permeating every part, our biological parts included, as well as our well-intended biological interventions. As the adage goes, “There ain’t no such thing as a free lunch,” every headway to health always seems to face some kicker that rubs. Similar to any medical intervention, then, vaccines have limitations and carry with them the unavoidable potential for side-effects. The four approved COVID-19 vaccines in Canada (the messenger RNA-based vaccines Pfizer-BioNTech and Moderna, and the adenoviral vector-based vaccines, Janssen (Johnson & Johnson), and AstraZeneca), are no exceptions. So, enough with the back patting and champagne toasting, and on to the medical concerns that have been observed with these ‘Next Generation’ vaccines. 

First, there is the risk of anaphylaxis. Within 24 hours of the first vaccination, media reported two individuals developing anaphylaxis minutes after receiving the Pfizer-BioNTech vaccine. While this has always been a possibility to be aware of and prepared for with conventional vaccine administration, anaphylaxis wasn’t expected to occur with these Next Generation vaccines. They don’t make use of gelatin, latex, or egg protein – the usual suspects for causing vaccine-related anaphylaxis – and no severe immune reactions were observed in the large phase 2 and 3 clinical trials. So, it was quite a surprise when the incidence of this catastrophic and potentially fatal immune reaction was found to be considerably higher with the COVID vaccines. By comparison to an incidence of one case for every 1.6 million doses of flu vaccine, anaphylaxis had a reporting rate of 5 cases/million doses following administration of the Pfizer-BioNTech vaccine, and 2.8 cases/million doses following the Moderna vaccine. While these numbers remain small, they were high enough to raise the eyebrows of medical authorities who mandated that all facilities administering COVID-19 vaccines have the necessary supplies and trained medical personnel available to manage anaphylaxis. As well, this is the reason why we have the mandatory 15-minute post-vaccination observation period for all vaccine recipients, and a 30-minute period for those with a history of allergic reactions. Research is ongoing to define the potential mechanisms at play which are causing this increased anaphylactic response in the hopes that risk factors can be identified, and diagnostic testing developed, and in order to prevent this problem with future vaccination programs.

Second, there’s the risk of blood clotting, another surprise. The diagnosis of “Vaccine-induced Thrombotic Thrombocytopenia” or “VITT” is a newly coined medical entity, and the sorry product of our contemporary “Next-Gen-Vaccine” era. Similar to the well-known and much-feared prothrombotic disorder “Heparin-induced Thrombocytopenia” (HIT), which we occasionally see as a complication in patients receiving the intravenous anticoagulant, heparin, VITT can produce a blood clotting storm in the body, which is oftentimes fatal. Similar to HIT, this vaccine-induced clotting crisis occurs more frequently in younger women (people who would be at exceedingly low risk for serious COVID-19 illness). It seems that something in the vaccine (quite possibly the vaccine DNA itself) triggers an immune-mediated antibody response to the platelets, which results in platelet clumping, blood clotting, and resultant consumption of platelets with a severe drop in their number. The clinical presentation can therefore be related to either blood clotting or internal bleeding, or both, and can prove to be an absolute nightmare to medically manage. There was no hint of this problem in the clinical trials, so no one saw it coming. The first reported cases were in Norway. Within 10 days of receiving their first immunization with the adenoviral vector-mediated vaccine (ChAdOx1 nCoV-19, AstraZeneca), five healthcare workers presented with severe blood clotting and markedly reduced levels of platelets, the naturally occurring clotting cells. All were relatively young, ranging in age from 32 to 54 years, and previously healthy, and all presented with unusual sites of blood clotting – portal vein, splanchnic vein, cerebral veins, or a combination – and three of the five vaccine recipients died. Unfortunately, this catastrophe wasn’t an isolated event. To date, there have been reports from all over the world documenting similar presentations occurring between four and 28 days after vaccination. Published estimates of the incidence of VITT range from 1 case per 26,000 to 1 case per 127,000 doses of AstraZeneca vaccine. Considering that these numbers may be underestimates (since reporting is voluntary), concerns are running high. As a result, many countries have understandably instituted age limitations on which patients should receive the adenovirus vector-mediated vaccines, and the American Centers for Disease Control and Prevention (CDC) put a temporary hold on administration of the Johnson & Johnson/Janssen vaccine, as did the U.S. Food and Drug Administration (FDA). As well, the National Advisory Committee on Immunization (NACI) makes a strong preferential recommendation for mRNA vaccines for all Canadians, and that the AstraZeneca and Janssen/Johnson & Johnson vaccine be offered to Canadians 30 years of age and older.

Third, since the track record for these novel vaccines is relatively short, many are worried about the potential for long-term sequalae, and in particular the negative impact these vaccines might have on fertility. This is not the first time that vaccines have been implicated in potentially causing infertility. In 2003, such fears resulted in the boycott of the polio vaccination program in northern Nigeria, and more recently, the human papillomavirus vaccine has come under similar fire. It’s certainly understandable that people would be apprehensive, specifically about receiving a mRNA vaccine, as this is a relatively new technology. Although the majority of adverse events can typically be ruled out in clinical trials, surprises can still occur, as recently witnessed with the increased incidence of anaphylaxis in the novel vaccines and the development of VITT. While most serious side-effects become evident in the first two months of vaccine implementation, events such as infertility – that could potentially occur decades into the future – are harder to entirely discount. And even though it’s somewhat reassuring that the first human trials of mRNA vaccines began back 2006, providing a 15-year view into potential long-term problems arising from this platform, nonetheless, the fertility question at hand represents an area of intense and ongoing monitoring and investigation. To adequately address these and other issues, more information is needed; information that will take time to carefully gather. In order for questions about long-term efficacy and safety to be properly answered, tried-and-true methodical study is required, and patience on our part is needed.

Reviewing the available evidence, however, it appears that vaccination with the mRNA vaccines will not harm fertility. Earlier concerns that the similarity between the vaccine spike protein and the human placental protein, syncytin-1, might cause antibodies to recognize and cross-react with syncytin-1 and cause placental damage, have not stood up to scrutiny. While there may be some protein similarity, this parallel homology doesn’t involve the active binding site of the target spike protein. So, it’s close but no cigar. Besides, if such cross-reactivity did occur, even natural infections would be expected to be associated with placental pathology, which has not been shown to be the case. The record of women who were infected with COVID-19 shortly before conceiving or early in their pregnancy demonstrates that they were no more likely to miscarry than their uninfected peers, and just as likely to carry their babies to term. Similar findings occurred in the vaccine trials. Even though pregnant women were intentionally excluded from the COVID vaccine trials, and participants in the trials were asked to avoid becoming pregnant (since animal reproductive toxicity studies had not been completed), many partakers seemed to suffer from selective hearing. There were 57 pregnancies during the vaccine trials, despite the counsel to abstain, indicating that the vaccination neither prevents pregnancy, nor results in an increased rate of miscarriages…nor diminishes libido, apparently. As a result, regulatory bodies in the United Kingdom, European Union and United States have recommended that pregnant women be offered the vaccine, and particularly for pregnant workers on the frontline and those with pre-existing conditions. By mid-February of this year, over 20,000 pregnant women have received a COVID-19 vaccine, and despite the enhanced pharmacovigilance of these vaccine recipients, no concerns have been raised thus far.

As a cardiologist working on the frontline during this pandemic, I’ve seen firsthand some of the devastation of the COVID contagion, as well as the immense collateral toll wrought by the Governmental restrictions. Needless to say, I was quite pleased that a vaccine was developed and distributed in such a timely fashion, and relieved to receive my double shot. Hopeful that the nightmare would soon to be over, I didn’t hesitate to get immunized, nor was I picky about which vaccine variety I’d receive. Not that I didn’t consider the potential for side-effects or how limited its duration of benefit might be, I’ve long ago accepted my need for vaccinations, and not just against COVID-19, but for all the common viral threats we potentially come into contact with. Over my professional lifetime, I’ve been the recipient of dozens of vaccines, many of which have been mandated for me to travel and work in overseas mission fields. Afterall, getting immunized is part and parcel of a healthcare worker’s job. It’s the protection we take to face the day-to-day risks of viral exposure. Nonetheless, considering what we know about the COVID-19 vaccines and are learning, some caution is prudent, particularly for the young and healthy among us. We need to carefully weigh and balance the risk of infection against the potential risks and benefits of immunization, which will vary depending on age and health status. And as Christians, we shouldn’t put our final hopes in vaccinations, anyways, but must hold fast to the Gospel of Christ, and understand, in no uncertain terms, that our ultimate remedy is found in Christ alone and his salvific work on the cross. Vaccines have many benefits, to be sure, but they don’t provide salvation, and it shouldn’t surprise us that they have a downside.