Gilbert Berdine, MD – September 11, 2020
The post-covid-19 world is a surrealistic nightmare. Businesses have been shut down arbitrarily without any evidence that these shutdowns save any lives. Tens of millions of Americans have become unemployed due to these shutdowns. There are already demands for mandatory covid-19 vaccination even before a vaccine is available. “Make vaccines free, don’t allow religious or personal objections, and create disincentives for those who refuse vaccines shown to be safe and effective.” This is an empty statement, as any vaccine available will neither be 100 percent safe nor 100 percent effective. Based on the initial study of the Russian vaccine in a very limited number of patients, it is not even clear that the vaccine will be safer than the disease itself.
Justifications for Mandatory Vaccines
If a vaccine is 100 percent effective, there is no justification for mandatory vaccination. Anyone who wishes to be protected can voluntarily take the vaccine. It would not be possible for someone declining the vaccine to harm someone who voluntarily takes the vaccine. Any call for a mandatory vaccine is an explicit admission that the vaccine is not 100 percent effective.
If a vaccine were 0 percent effective, there would be no justification for anyone taking the vaccine. There must be some intermediate percentage of effectiveness that maximizes the utility of mandatory vaccination. As the vaccine becomes more effective, fewer people can possibly benefit from mandatory vaccination. As the vaccine becomes less effective, a lower percentage of people who could possibly benefit from mandatory vaccination will actually benefit.
Utility of mandatory vaccination requires that the vaccine be effective in some of those who would not voluntarily take it (conscripted helpers), that the vaccine be ineffective in some of those who would voluntarily take it (beneficiaries), and the stipulation that conscripted helpers interact with beneficiaries, that these interactions lead to extra infections despite other means of prevention, and that the extra infections result in serious illness or deaths. That is a lot of ifs. There is no way to know what this optimal effectiveness would be. There is no way to know how many coerced vaccinations are necessary to prevent one infection or to prevent one serious illness or death (number to treat). Given that the number to treat cannot possibly be known prior to vaccination, mandatory vaccination cannot be ethical even by utilitarian calculation.
Concerns about Efficacy
An ideal vaccine induces an immune response that neutralizes a pathogen. The immune response can be antibody or T-cell activity. Claims that a covid-19 vaccine will prevent infection are not precisely true. Immune responses are not like antimissile defenses that destroy the missile before it reaches the body. A better analogy for an ideal vaccine would be the inducement of an immune response that prevents invading pathogens from breaching a wall using siege ladders or battering rams. The immune defenses cannot act until triggered by the presence of the invading pathogen. An ideal vaccine can neutralize the pathogen before it enters tissue cells, replicates within the tissue cells, enters the blood, invades distant organs, and causes clinical disease or death. The process of neutralizing the virus is not instantaneous, so while the battle between immune defense and invading pathogen is taking place, the host is technically infected and theoretically can transmit the pathogen to others. The best that we can hope for is to prevent clinical disease, and to minimize the duration of time that the host can transmit the pathogen to others.
Studies of the Russian vaccine did not measure efficacy in terms of prevention of clinical disease. The measure of “efficacy” used was detection of antibody response to the vaccine antigen. But there is no guarantee that the presence of antibody will prevent infection, prevent clinical disease, or prevent death. There is no evidence that severe disease or death from covid-19 is due to the absence of antibody. Studies on immune response in patients with covid-19 show that patients with severe disease have higher antibody levels than patients with mild disease. There are concerns that cytokine storm, a consequence of too much immune response rather than too little immune response, may be an important cause of death in covid-19. Cytokine storm is a potential side effect of any vaccine. As usual, the devil is in the details.
Concerns about Safety
Advocates for mandatory vaccination always stipulate that the vaccine be safe. What is safe? No vaccine can possibly be 100 percent safe. The elephant in the room is always: How large is the risk? The Lancet‘s study on the Russian vaccine studied 76 subjects. There were 38 in the vaccine group and 38 in the control group. A study of this size would not be expected to detect a vaccine fatality rate of 1/50. Fever occurred in 100 percent of one subgroup (20 subjects) and 31/38 subjects receiving the Gam=COVID-Vac agent. The ages in the study ranged from 18–60. The mean age of the subgroups was 25–32 years of age. Given the low age of the participants and the high percentage of asymptomatic covid-19 cases in young patients, it is not clear that the vaccine was even safer than infection with the virus.
Several decades ago, the Centers for Disease Control and Prevention decided to eliminate tuberculosis from the United States. The plan was to test everyone with PPD and treat all the positive PPD patients with a drug called INH. This plan had to be stopped after fifty patients died from liver failure due to INH toxicity. The liver toxicity was missed by small-scale clinical trials but was discovered by the much-larger-scale public health program. Neither the CDC nor the Food and Drug Administration can know that a treatment or vaccine is safe. The more people are vaccinated, the more side effects will be discovered. This is a huge ethical problem for mandatory vaccination. If everyone is required to be vaccinated, there will be no control group for comparison of safety and efficacy.
Advocates of mandatory covid-19 vaccination assure the public that the vaccine will be safe. Why was it necessary for government to indemnify the vaccine manufacturers against any liability for their vaccine prior to production? This is a clear case where one should ignore what government says and watch what government does. Government clearly knows something that is not being disclosed to the public. This is the opposite of transparency, yet anyone who opposes vaccination is labeled as stupid, uniformed, or inadequately concerned about their elderly neighbors.
Catastrophic Tail Risks
Some risks are not known ahead of time. Some risks will not be manifest until years later. Consider a hypothetical situation where a vaccine causes sterility ten years later. There would be no way to detect this risk ahead of time. Imagine that all of humanity is vaccinated with this vaccine. Humanity would be wiped out when the last person dies. No matter how small the risk for an existential threat, why would humanity take this chance over something as ordinary as a bad flu? Rather than treating antivaxxers as a threat to civilization, we should be grateful that some people will always volunteer to be controls in our medical experiments by declining treatment.
Markets Offer the Best Solutions to Complex Problems
How efficacious will the vaccine be? How safe will the vaccine be? We don’t even have an American vaccine to assess, yet authorities are calling for mandatory American vaccination. Even when vaccine options are available, we will have limited information about efficacy and safety. There are no objective answers available about efficacy and safety, so how can objectively correct decisions be made balancing risks and benefits? Markets offer the best solutions to these subjective questions. Just as markets determine value by the process of price discovery, the balance between risk and benefit of a vaccine can only be determined by how many people are voluntarily willing to take the vaccine.
Vaccines are a wonderful hedge against the risks of contagious disease. We are fortunate to have vaccines as options. However, mandatory vaccination can never be justified. If a vaccine were clearly 100 percent efficacious and 100 percent safe, there would be no need for coercion; people would voluntarily line up to take the vaccine. Real vaccines are never 100 percent efficacious or 100 percent safe. Judgments about risk versus benefit can only be made by individuals facing the risk. People who decline vaccines are not stupid, nor are they misinformed, nor do they have callous disregard for their neighbors. Advocates of vaccines who are disappointed by the number of people willing to accept the vaccine should stop blaming those who decline and reevaluate their poor abilities of persuasion. Vaccine skeptics are necessary as controls in ongoing assessment of efficacy and safety. Vaccine skeptics are necessary as a hedge against catastrophic errors by experts.
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