Covid Vaccines #4: Are They Safe?

In the previous post, I looked at the latest available data to see if the covid vaccines are effective. Despite challenges from the new delta variant, it is hard to dispute that the vaccines remain remarkably good at preventing infections, or, in the case of relatively rare breakthrough infections, preventing hospitalizations and deaths. If you want to protect yourself and those around you from covid, it makes sense to get vaccinated… unless the vaccine itself is a significant threat to your health.

I have waited until the end of this little series on covid vaccines to talk about safety issues for a couple reasons. First, I think this is one of the most difficult objections to engage, because it is an emotionally charged issue tied up with sad stories we’ve heard from friends or seen circulating on social media. One can’t—and shouldn’t!—simply dump a pile of safety studies on someone convinced that the vaccines injured or killed someone they love. However, our responsibility before God as stewards of our own health and of our neighbors’ wellbeing means we do have a responsibility to think carefully about even such difficult stories.

This brings me to the second reason I wanted to address safety issues last. As I have surveyed some of the main arguments against the vaccines in my earlier posts, I wanted you to see the way in which motivated reasoning and carelessness with the truth have so polluted this debate for more than a year. Many who should have known better have negligently passed along bad “facts” without much apparent effort at verification, simply because the claims fit a narrative they assumed to be true.

This blizzard of misinformation has, of course, been reinforced by Dr. Fauci’s self-confessed dishonesty, by the hypocrisy and abuse of authority by many in power, and by very reasonable skepticism about the trustworthiness of our government, the media, and Big Pharma. In a low-trust environment, we are mentally primed to believe the worst.

Seeing patterns, even when they aren’t there

After more than a decade as a logic teacher, one of my favorite fallacies is the post hoc fallacy. Its full name is post hoc ergo propter hoc (Latin for “after this, therefore because of this”). Some years ago, I came out of my local bank to discover that my car battery had died. I had the car jumped and everything seemed fine. A week later, I came out of that same bank, got in the car, and couldn’t start it. The battery had died again. I finally located the problem and had it fixed, but the next time I went to my bank, I couldn’t help worrying as I put my key in the ignition to head back home. That concern was completely irrational: How could stopping at the bank possibly affect my car battery? But that’s the post hoc fallacy in action.

Our brains are designed to notice patterns. Our ability to see connections and draw inferences is a major part of what makes the human mind so amazing. But in a fallen world, not all our thinking is trustworthy. One way our minds can misfire is by jumping to assume cause and effect where none exists. Just because I went to the bank and then the car died didn’t mean going to the bank made the car die. But our minds naturally leap to make connections like that—especially when we’re worked up and primed to expect that such connections exist.

Back in January, baseball legend Hark Aaron died 17 days after getting his first dose of the Moderna vaccine. Aaron was 86 years old, and the medical examiner ruled his death was simply from old age, but that didn’t stop a wave of social media posts suggesting Aaron had died from the vaccine. Aaron died 10 years past the average life expectancy for an American male, but because our antennae were already up, his death became one more piece in a picture of deadly vaccines. But, by itself, it’s really no evidence at all. Roughly 85% of Americans over age 75 (nearly 20,000,000) have received at least one vaccine dose; statistically, some of those 20 million are likely to die within the few weeks following vaccination.

And the elderly aren’t the only people who die, nor who die unexpectedly. When nearly 205,000,000 Americans have received at least one dose, some of them are statistically certain to die strange and unexpected and tragic deaths within a few weeks afterward, completely by coincidence; and that, by itself, tells us nothing about vaccine safety.

This doesn’t mean we should completely ignore what is sometimes called “anecdata” (drawing conclusions from a few examples we’ve heard of personally), but we need to recognize that our brains are going to be make connections and draw patterns—even if none are really there.

So, what do we know about vaccine safety?

There are basically five possible sources for information on vaccine safety. First, there is the trial data gathered by the manufacturers themselves and then evaluated by the FDA for an emergency use authorization (and in the last few days, full authorization for Pfizer’s vaccine). Second, there are a huge number of independent studies from researchers around the world who have been analyzing the vaccines since last year. Third, the media can track and report possible safety issues. Fourth, individual doctors can describe what they have seen in their own practices, and fifth, social media makes it possible for millions of people to share their own stories.

Each of these possible sources has its own strengths and weaknesses, and none should be trusted unconditionally. However, each of them has something to add to our picture of vaccine safety.

1. Trial data

Vaccine manufacturers obviously have an incentive to say their products are safe so they can bring them to market. However, they also have an incentive to avoid a reputation for killing patients. Furthermore, they know their data will be scrutinized by federal regulators. The FDA exists to prevent dangerous medical products from being sold, and it has frequently been criticized for being too cautious about how much safety data it requires before approving a new treatment.

Contrary to online rumors, each approved covid vaccine had to undergo animal testing and the full three phases of human testing which are required for any vaccine. (I explained how the process was sped up while still fulfilling all required trial phases in my first post.) The Pfizer trial included over 43,000 participants. The Moderna trial included over 30,000. The Johnson & Johnson trial included just under 44,000. Each study evaluated both vaccine efficacy and safety. While it has been alleged the studies contained no control group, that is false. The study populations were each split 50/50 between those who received the vaccine and those who received a placebo, though those who received a placebo were offered the chance to receive the live vaccine later.

Except for children and pregnant women (who have been included in subsequent studies), all three studies were required to include participants across a representative spread of age, gender, and race. In contrast, US approval of the UK’s AstraZeneca vaccine was held up by regulators over concerns that its reported data appeared partially outdated and unrepresentative. The fact that over 150 covid vaccines began development and only three have thus far received FDA approval says something about the rigor of the process.

Obviously, neither vaccine manufacturers nor federal regulators have a perfect track record, and they each have their own incentives apart from a mere disinterested search for the truth. However, it would be foolish to completely discount the results of large studies which followed the same rules which have been used for thousands of other pharmaceutical products for decades.

2. Independent studies

While the manufacturers’ trials where the first major studies of the new vaccines, they were hardly the last. Searching “covid vaccine safety” in the US National Library of Medicine’s database of clinical studies brings up 381 studies. The same search in the New England Journal of Medicine brings up six pages of results. The same search on the JAMA Network brings up five pages of results. I hope it’s obvious that this doesn’t mean every one of these studies is well-designed and trustworthy. But it does mean that a lot of different doctors and scientists, from many institutions, in many countries, have been scrutinizing the covid vaccines for months, evaluating both safety and efficacy.

Would some of these researchers be biased in favor of drug companies? Surely. But all of them? When anyone who discovered a credible danger from a widespread medical treatment would gain great visibility and prestige in their field? I find it odd that many vaccine skeptics point to other pharmaceutical products which were found to have safety issues as a reason to distrust the vaccines as well, seemingly ignoring the fact that the same systems of independent research and evaluation which found those problems are also scrutinizing the covid vaccines—and in fact, much more so, given the unprecedented worldwide interest in these particular products.

These independent studies have not given the vaccines an entirely clean bill of health. Probably the most serious risk uncovered is a very small chance of myocarditis, or inflammation of the heart muscle. Among others, an Israeli study released last week compared health records of about 885,000 vaccinated people with the same number of unvaccinated to search for a number of possible adverse events. The main danger they found was a slightly elevated risk of myocarditis, between 1 and 5 more cases per 100,000 people. However, they also discovered that covid itself caused approximately 11 additional cases of myocarditis per 100,000 people, as well as a number of other serious health risks.

This sort of independent, systematic review, comparing huge numbers of vaccinated and unvaccinated people, is the most credible and reliable way to detect true safety risks. Because both covid and covid vaccines are so widespread, these assessments can gather data much more rapidly than if they had to work from smaller populations. Of course, their one limitation is that researchers cannot time travel: they cannot tell us the safety profile of the vaccines over a period of many years, since the vaccines have not existed that long. However, as I wrote in my first post on the vaccines, “We should bear in mind that we similarly lack long-term data on the effects of covid after five years, or ten years, or twenty. Just as Lyme disease and other illnesses can linger for a lifetime, sometimes with debilitating effects, there is good reason to think that some of covid’s strange harms to body systems ranging from the brain to the circulatory system may persist as well. Given a choice between the unknowable long-term effects of a vaccine developed by medical doctors working under the eyes of the world, versus the unknowable long-term effects of a novel bat virus which was possibly enhanced in a Chinese lab and has killed millions of people, I’m inclined to go with the vaccine.”

3. The media

Do I trust most media reports to be either unbiased or knowledgeable? Not at all. Some of the covid reporting has has been quite good, especially from science writers, but a lot has been absolutely terrible. However, even if we cannot trust the media (generally speaking) to report carefully and accurately on covid and vaccination, we can rely on it to do one thing: sensationalize the news.

For months, the media has sensationalized covid risks so that many who rely on mainstream media reports have a very exaggerated sense of the risk of infection. Critics argued this was part of a scheme to convince people to get vaccinated. Then, once the vaccines were introduced, the same media outlets hyped reports of rare breakthrough infections, like an NBC headline (later revised) which blared that 125,000 fully vaccinated Americans had tested positive for covid and only later mentioned this was out of 164,200,000 vaccinated people, a rate of 0.08%. This is not the stuff of a sophisticated pro-vaccine propaganda effort; it’s an effort to grab clicks by getting people worked up.

You know what would really get clicks? Credible reporting on large numbers of deaths and adverse reactions to vaccines. According to some estimates I’ve heard from vaccine skeptics, around 3% of vaccine recipients have serious adverse reactions and tens of thousands have died. In the past week, we’ve watched many mainstream media outlets tear apart the Biden administration for its botched handling of the Afghanistan withdrawal. If huge numbers of Americans were being injured or dying from vaccines, don’t you think at least some of these same media figures would be hunting a Pulitzer for blowing open the cover-up?

4. Individual doctors

Individual doctors don’t have the big-picture perspective of a researcher combing through tens of thousands of records, but they do see a lot of patients come through their doors. If vaccine injuries were as common as many skeptics suggest, wouldn’t we expect to hear thousands of doctors raising the alarm (to superiors? to federal regulators? to the media?) about patterns of injury they were seeing? Instead, doctors like this physician who practices just down the road from me are begging patients to get vaccinated.

Of course, there are vaccine-skeptic doctors. A few have made the rounds of podcasts and blogs raising the alarm about what they believe to be vaccine harms. When I have investigated such claims, I have found reasons for skepticism. But the larger point is simply this: while not every single doctor in America agrees that vaccination is safer than the alternative, plainly the vast majority do. It doesn’t seem intellectually consistent to elevate the few doctors who disagree with vaccination as courageous truth-tellers while ignoring the large majority who hold the opposite view.

5. Social media and word of mouth

The most difficult source of information to assess is “anecdata”: what you heard from someone who knows someone who had something happen. Some of these stories are terribly sad and seem compelling. I have seen a number of Facebook posts by worried parents or friends who report that someone they love received the vaccine and is now exhibiting strange symptoms of one sort or another. It is difficult to know how to evaluate claims like this, but I have found it helpful to bear a few principles in mind:

  • Some social media posts are simply intentional lies. In both the US and Europe, Russia, China, and other hostile nations have ongoing, sophisticated misinformation campaigns using social media to sow distrust and confusion. There are also online “trolls” who make a game of posting false information for laughs. This certainly does not mean every tragic post is a lie, but unless you know the source personally, it’s worth bearing that possibility in mind.
  • Worried friends and family are not in a good place for dispassionate scientific evaluation, and it’s easy to confuse coincidence with causation. Every day, people across America come down with strange and inexplicable symptoms and syndromes for any number of reasons, or for no apparent reason at all. When a large majority of Americans have been vaccinated, some of those strange symptoms will come soon after a vaccination, even if they are completely unrelated.
  • Social media makes it easy to group together all of these stories in a terrifying flood of examples. There are entire Facebook groups where anyone can post a story of vaccine injury, and the most compelling ones quickly rocket around the internet. Imagine scrolling through a feed of 100 terrible stories of vaccine injuries. Now imagine that every single story was true. Psychologically, that is a powerful argument against vaccination! Yet in the context of 370,000,000 vaccine doses given, amid a pandemic which has killed hundreds of thousands of people, 100 true stories of vaccine injury wouldn’t change the argument for vaccination at all. A social media feed just isn’t a good way to assess this sort of risk.

I am not in a position, nor is it my right, to assess every story of vaccine injury that you or I may have heard. However, “anecdata” can’t tell us the real risk. For that, we need to depend on the big-picture perspective of clinical trials, independent studies, medical professionals, and even media reports. If these sources of better information strongly suggest the vaccines are generally safe (and they do), then we should allow that perspective to inform our reading of individual stories of vaccine injury, even while grieving for any who have truly suffered.

But what about all the injuries in VAERS?

According to some vaccine skeptics, the argument I just made is undermined by the fact that the government’s own numbers through the Vaccine Adverse Event Reporting System (VAERS) show that thousands of people have already died from covid vaccines. However, this displays a complete misunderstanding of how VAERS works.

Healthcare providers are required by law to report any deaths or other serious adverse events following a covid vaccination, and are encouraged to do so “whether it is or is not clear that a vaccine caused the adverse event.” Furthermore, literally anyone, including patients and family members, can submit a report as well.

While it is common for vaccine skeptics to say VAERS reports several thousand deaths from covid vaccination, what is actually true is that VAERS shows several thousand deaths after covid vaccination. This is a huge difference. Considering the number of vaccine doses administered—and at especially high rates to the elderly—it would be astonishing if thousands of people hadn’t died relatively soon after vaccination.

Doctors at the CDC review each VAERS report and try to track down those which are credible to detect any true safety issues. These analyses helped to uncover the slight risk of myocarditis mentioned above. It is what VAERS is intended to accomplish. But simply querying VAERS records for deaths following covid vaccination and then tallying the results doesn’t tell us anything at all.

But what about experts who disagree?

It is true that some experts dispute the general consensus that the vaccines are safe. Perhaps the most prominent skeptic is Dr. Robert Malone, who describes himself as “the inventor of mRNA vaccines.” This self-description is rather misleading. As a young grad student, Dr. Malone wrote two papers in 1989 and 1990 which are generally acknowledged as foundational in the field of mRNA research. (On a side note, it is curious that many of the same people who argue that mRNA technology is brand new also credit Dr. Malone with having invented it more than 30 years ago.) After publishing these papers, Dr. Malone was employed by two pharmaceutical companies whom he feels did not give him credit for his work, and he has expressed bitterness against those who have received more acknowledgement for developing mRNA technology in recent decades. In other words, Dr. Malone’s presentation of himself as an unbiased leading expert in the field does not seem entirely accurate on either count.

That being said, even Dr. Malone’s critics acknowledge his scientific qualifications. His concerns cannot be dismissed lightly. However, when pressed for specifics, Dr. Malone and other credible critics of the vaccines tend to be worried that relatively low risks are not being adequately weighed or communicated to the public, not that vaccines are wildly unsafe. Dr. Malone himself writes that risks “are rare but by no means trivial.” In another interview, he argued that “the risk-benefit ratio for those 18 and below doesn’t justify vaccines,” a relatively modest claim (and one being investigated in a number of ongoing studies).

Ultimately, we have to pick one side or the other. As I wrote in an earlier post, the prevalence of covid means we are most likely choosing between vaccination and eventually getting sick (and then potentially passing covid along to others). To me, it seems wisest to believe the pro-vaccine side, which appears to have the large majority of more credible experts, especially since their perspective is continually being reinforced by ongoing studies finding low risks from the vaccines—risks certainly far lower than those of the disease they protect against.

Why aren’t manufacturers liable?

One final argument which I’ve heard frequently is that the vaccine manufacturers aren’t legally liable for covid vaccine injuries, thus proving they don’t believe in their own products. It is true that early in 2020, the Trump administration invoked a law called the Public Readiness and Emergency Preparedness Act (PREP Act) to provide legal immunity for “activities related to medical countermeasures against covid-19,” which would include vaccine manufacturers. Anyone who can demonstrate a harm from a vaccine can still seek compensation through the government’s Countermeasures Injury Compensation Program, and manufacturers themselves are still liable for “willful misconduct.”

The goal of removing legal liability from vaccine manufacturers was to encourage more companies to make the attempt. Even unsuccessful lawsuits can cost significant time and money; for years, we have heard how rampant medical malpractice suits are driving many doctors out of their profession. Much like qualified immunity is intended to protect law enforcement officers so they can do a difficult and high-risk job, the PREP Act was intended to motivate manufacturers by protecting them from potentially company-destroying liability if something went wrong. Both qualified immunity and the PREP Act have their critics, but the sheer fact that such legal protections exist doesn’t prove anything is actually wrong in a particular situation. If there is good data to suggest the vaccines are safe, the potential liability of their manufacturers is largely irrelevant.

But the fact that manufacturers would be worried about liability for vaccines is a helpful reminder that there is no such thing as a no-risk scenario. No medical product has zero risk. No vaccine has zero risk. Obviously, no disease has zero risk. A lot of us, ranging from “never vaccinate” to “lockdowns forever” seem to have forgotten that living in a fallen world means living with risk. As wise stewards of our own life and health, all we can do is pray for wisdom, gather as much relevant information as we reasonably can, and then act, trusting God to watch over us and work out his good purposes for us.

My assessment has been that vaccination is the wisest course based on the available credible information. I may be wrong about that. Another consequence of living in a fallen world is that both our data and our reasoning can always be questioned. But we do have a responsibility to try to understand things as well as we can and to avoid spreading falsehoods, and I hope this series has helped you in that regard. In my next and final post, I’ll look at the political side of all this and offer a few closing thoughts on the covid vaccine debate.

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