Vaccines often seem to be in their own special, sacred category of pharmaceuticals, yet the science is often far from settled.

THERE’S NEVER BEEN A VACCINE FOR A HUMAN CORONAVIRUS and yet a vaccine for SARS-CoV-2 seems to be the holy grail we’re all waiting for. If so, we could be in for a very long wait.

Vaccine development is tricky and the kind of immunity that most would find acceptable—protecting against excess deaths and sickness—may never be achieved. There has never been an effective vaccine for a coronavirus, so to think we’ll develop one within 12-18 months, as experts are saying, seems farfetched. Any shortcuts taken to approve a vaccine may compromise safety and effectiveness for speed. We may all hope and pray for a vaccine, but it would be most preferable if we had a vaccine that worked. And it’s worth noting, that all technology bites back. Sometimes fatally.

Before the pandemic, a friend, an expert who is writing a book on vaccine safety, thought I might have some thoughts on where we are going on vaccines and whether vaccine mandates might be used. He sent me a list of questions, which I answered and now have adjusted in light of COVID-19.

1. What have you learned about vaccines, their effectiveness against infectious diseases, and the risks they might pose for some individuals?

I have learned a lot from the scientific literature and working with colleagues who study the safety of drugs. In the drug world, often experts will assert the “facts” of a drug’s safety are solid and unassailable, but we later find out we were mislead. In fact, if I had one universal thing to say it would be that expressing certitude concerning effectiveness or safety of a drug or vaccine is a naïve position. Those who are honest about the science will often say that proper and unbiased research to establish a true picture of safety is often not done.

People need some level of comfort that they are making the right choices for themselves or their children. In this vein, the benefits of the six basic childhood vaccines (combined in the DPT—diphtheria, pertussis, and tetanus—and MMR—measles, mumps, rubella—vaccines) likely exceed the harms and can improve population health. Have some people been harmed by these vaccines? Yes. It’s very unhelpful to label people who have legitimate concerns about vaccine harms as “anti-vaxx” and disregard them. It is delusional to think vaccines only have benefits and no harms.

2. Do you believe vaccines are an important component of modern medicine? Please provide examples to illustrate your opinion.

Nobody would ever say all drugs are important, but many will claim that “all vaccines are important.” For some vaccines, it’s not yet established if they are important or not. Asking people to “vote” on whether they’d get a COVID-19 vaccine (if it is ever produced) is stupid. Like any drug, the right answer is, it depends.

On my list of “possibly useless” or “not yet proven to be beneficial” vaccines, I’d put shots for rotavirus, pneumonia, flu, chicken pox and HPV (human papilloma virus). Some people might benefit from a flu shot, but in a healthy population the benefit is vanishingly small. Despite the hype over the HPV, the first mass vaccination to prevent cervical cancer, it hasn’t shown any lifesaving benefits yet. And chicken pox? Meh. Most kids challenged by chicken pox will have a few days off school and be rewarded with lifetime immunity. Not a bad deal, huh?

3. Do you have concerns about vaccine adverse effects? Which ones in particular, if any?

Indeed. For some vaccines we don’t know the magnitude of adverse effects, the type of person who might be at higher risk if immunized, whether the recommended vaccine schedule itself causes adverse effects, or even if medically-trained people can properly diagnose a vaccine-related adverse effect. Rare yet nasty immune-system harms have been linked to some vaccines. There are several medical clinics in Europe designed to help girls suffering the adverse effects of the HPV vaccine. Have these families cooked up a conspiracy against HPV vaccine manufacturers? Unlikely. Again, labelling vaccine-injured people as “anti-vaxx” isn’t helpful. It’s a much more mature conversation if you can accept that people are sometimes helped and sometimes hurt by vaccines.

4. Do you feel that on this subject the science is settled? Do you feel that the same claim can be made about any other branch of science or hypothesis/theory?

No. No. No. Nothing is settled. Proclaiming “the science is settled” on the usefulness and safety of vaccines is the biggest barrier to producing quality, independent science. The scrutiny of any COVID-19 vaccine is going to be intense and before any mass immunization plans come together we need solid proof the real benefits exceed the harms.

This may come as a shock to people but many prescription drugs swallowed by millions of us every day are either not proven in quality trials, have proof of harm, or haven’t been proven either way. A Health Canada stamp of approval is no guarantee that we can fully trust the science underlying that approval. Scientific debates over the value of some drugs and some vaccines are frequently “unsettled” and, frankly, unsettling.

5. What do you feel the role of the pharmaceutical industry is, if any, in controlling the discussion about vaccines in general?

Like any big business or monopoly industry, the goal is to maintain and increase shareholder value. Pharma companies, which make both drugs and vaccines, have only one main legal requirement: to maximize shareholder value.

Over the last 25 years I have seen how the pharmaceutical industry has used its prestige, power and financial might to purchase a central role in the practice of medicine. It holds inordinate power over how we think about sickness and medicine, a kind of “cultural hegemony” where the beliefs and explanations, perceptions, values and mores of a society have been imposed by a ruling class manipulating the culture of that society (rephrased from Wikipedia).

Let’s be clear about one thing: The drug industry doesn’t just manufacture products, it manufactures consent about its products. Can our public health people work in a healthy alliance with the hegemony of the pharmaceutical industry? Will trustworthy, independent, evidence-based assessments of a new COVID-19 vaccine prevail? In our haste for a vaccine will we continue to live in this strange dual world where many of us are deeply and appropriately skeptical of the pharmaceutical industry’s hegemonic power in medicine, yet somehow blindly believe that vaccines are in a special, sacred category?

6. What is your opinion about the need for “vaccine mandates”? Why?

Mandates are about forcing people to accept a medical treatment when they may not want it, for whatever reason. They are seen as a way to put pressure on vaccine-hesitant people, through regulations and laws. Problem is, mandates can be ineffective because they are likely to backfire. Mandating the injection of a chemical into someone’s body is unlikely to achieve the objective of increased immunization rates. Thankfully Dr Bonnie Henry, our Provincial Health Officer, doesn’t think a mandate is necessary. She told CTV news “we have no mandatory immunization in the province and I do not expect we will have mandatory COVID-19 immunization.”

7. Do you have any concerns about such mandates for civil or natural rights?

Absolutely I’m concerned about legislating vaccines. The biggest problem with forced vaccines is that Canada has no compensation system for people who are vaccine-injured. Would it be good policy to order everyone to drive a car but tell them they can’t buy car insurance? If you are injured and medically damaged for the rest of your life, tough luck. Too bad sucker. You’re on your own.

I would be very concerned if our politicians relied on a hastily developed and launched COVID-19 vaccine policy that could ultimately harm people. What if it produces antibodies but people get sick anyways? Or worse, healthy people become injured by a vaccine designed to help them? Lockdowns might drive people crazy, but an uninformed public might push hard for a mandatory immunization policy. Before even thinking of a mandate, public health people will need hard evidence that there is a vaccine that is rigorously scrutinized, proven effective and safe. This is a very, very tall order…

Alan Cassels is a pharmaceutical policy researcher and lives in Victoria.