In March, even before global scientists sounded the alarm on mass vaccination, we proposed to suspend the vaccination in 40-year-olds and younger, and in all healthy young adults, after looking at the available risk-benefit data.
There is no good data up to now really showing that the benefit outweighs the risk in this relatively low-risk population. At most, we can say it’s an equipoise, neither for or against vaccination. What is boosting the meager data is the collective opinion of international health agencies and some expert societies endorsing the vaccination even in young adults with apparently robust immune systems. All the more so in teenagers 18 years and younger, wherein the risk of dying from COVID-19 is exceedingly rare, compared to the risk of developing heart swelling (myocarditis) and heart failure, which may have long-term consequences and could cut short their lives.
As late as four months ago, a doctor would have been immediately labeled as incompetent and out of his/her mind if he/she recommended vaccination in minors. Now it’s recommended, and might even be made mandatory as a requisite for resumption of in-person classroom instruction. The same mandate and rationale will likely be made for small kids in the near future.
Yale University professor Dr. Harvey Risch, one of the most respected American epidemiologists, advises parents to pull their healthy children out of public schools and just homeschool them rather than allow them to be vaccinated. That may be an option parents here will have to consider if their adolescent and teenage children are required to be vaccinated first before they get enrolled.
The strange thing about this conundrum is that many parents seem to be convinced that they should have their minor children vaccinated at all costs. An acquaintance even brought their minor children to the United States just to have them vaccinated. One of them developed a constantly fast heartbeat upon return here, and had to be placed on medication.
In previous commentaries, we’ve suggested to the Department of Health (DOH) to explain to the public, not in general or relative terms, but in real and absolute terms what the benefits and risks of vaccination are for each age category, especially for minors. The DOH sometimes overwhelms the public with impressive-sounding but unnecessary information that may not really be useful.
We reiterate that expressing data on effectiveness and safety in terms of relative risk reduction (RRR) can be misleading. We’re sure the DOH or the Food and Drug Administration (FDA) have no intention to mislead us, but they seem to be fascinated with RRR figures, and have unwittingly misled themselves and the public.
We’ve given this example before but it’s worth repeating for better clarity. If the risk to suffer from a COVID-19 complication is 10 in 100 million cases or a 0.00001-percent risk, and you reduce that with vaccination to one in 100 million, that would be a 90-percent RRR, and that sounds very impressive indeed. But if you express the real absolute risk reduction (ARR), it’s only a 0.000009-percent reduction of the risk or actual benefit to be expected.
It’s good to consider both the ARR and the RRR but, as far as we know, most policymakers look more at the ARR to decide when evaluating various treatments and interventions for public health problems such as COVID-19. In the example given, a 90-percent RRR in the risk of a minor to die from COVID-19 complications sounds very impressive, which to some is like saving nine minors out of 10. This is grossly incorrect!
Our health officials should inform the public what the actual or real risk is for a minor to die from COVID-19. If the risk is infinitesimally small like one in 300,000, as some calculate the risk to be, that will help the parents balance the equation and decide for their children. Is vaccinating 300,000 minors to save one worth all the potential risks of the vaccination being considered?
Compare this small benefit with the risk of harm. The number needed to vaccinate is 300,000 to save one life. What is the number needed to vaccinate to seriously harm a minor? Scanning the literatures, varying figures are given for this, but a fair estimate is something like one in 25,000.
It’s true though that majority of vaccine-related myocarditis and/or pericarditis cases (swelling of the sac covering of the heart) are not serious. But, if we go by the general life course of individuals afflicted with myocarditis, a third develop a progressively worsening course. That suggests that the number to seriously harm is about one in 75,000.
The data are really insufficient to make definitive conclusions. But as it looks now, the risk of harm appears to outweigh the benefit in minors. The prudent thing to do is wait until we get clearer data on the long-term complications.
Our health officials and the public must snap out of their trance and start asking relevant questions until they’re fully convinced they’re doing the right thing for their minor children. We urge the media and the public to keep on asking the ARR from our health officials, and stop being mesmerized with RRRs.
We have pointed out previously that we only talk about RRRs in theoretical, scientific dissertations and discussions, but not for policy decisions involving serious public health concerns such as this pandemic.
The RRR stats are like the Hollywood building props. They look real from afar but if you come closer and scrutinize, they’re just facades with no solid backing. Propping the false facades with lame generic explanations that the benefit outweighs the risk may create an illusion of rationality, but the whole thing will fall on some people’s faces in due time.
We urge our DOH and FDA to invest in simple but reliable analysis of local data so we don’t have to rely on hand-me-down data from other countries.
A few months ago, the Australian drug regulators revised their recommendation for the AstraZeneca vaccine, and advised against the use of the vaccine in those less than 60 years of age. Based on their data analysis, the risk of potentially serious or fatal blood clot complications with the vaccine is one in 71,430 in those aged 60 and older; one in 37,000 in the 50-59 age group; and one in 32,250 in the younger than 50 age group.
Their analysis indicates that the younger the age of the vaccinees, the higher the risk of potentially serious reactions, mainly blood clot complications that may lead to death. They’re better off taking their chances with COVID-19 than their risk of dying from the vaccination.
These are simple but very useful data culled from analytics. Our problem here is that we need to accurately collect our data first, so we can be confident that any conclusion or even just impression derived from them, would not be erroneous.
We don’t have to belabor the real-world problem here that the published data and actual field observations don’t match, and the system of adverse reaction reporting for vaccines is faulty and not truly reflective of actual incidence of serious side effects. Most physicians we’ve talked to say that the vaccine-related adverse effects are grossly underreported, and many cases have been quickly dismissed as not vaccine-related, despite the temporal relationship of vaccine administration and occurrence of serious side effects.
In summary, we appeal to the FDA, our health officials and expert advisers to rethink the decision to vaccinate minors. If even experts from the Centers for Disease Control amd Prevention in the United States admit that they’re still in the learning curve on the potentially serious side effects of the vaccine in young people, why should we join the popular bandwagon of mass vaccination and risk unknown perils for our children?
Whatever happened to the primary maxim of “First, do no harm (Primum non nocere)” in the dispensation of medicines and treatments?
Why is an inhibitory “abundance of caution” exercised for some tried-and-tested medicines like ivermectin, but conveniently trivialized for an experimental vaccine that has a pile of unresolved issues and concerns?
What is happening to our country, and the world?