(Second of two parts)
With the recent approval of the Philippine Food and Drug Administration (FDA) of the use of Pfizer and BioNTech’s COVID-19 vaccine on adolescents aged 12-15 years old, quite a number of parents were glad that their adolescent and teenage children can now avail of the vaccine, in preparation for the possible resumption of in-person classes by August this year.
Since adolescent children are not of legal age and parents have to legally decide for them, it is incumbent upon the parents to diligently study the expected benefits vis-à-vis the potential risks of inoculating their adolescent and teenage children.
Impressive but misleading
We discussed last week the importance of looking at the absolute risk reduction (ARR) being offered by the vaccine, rather than the relative risk reduction (RRR), which may sound impressive but misleading. The real or absolute benefit depends on the magnitude of the risk in each age group. Hence, one must find out what is the actual risk in each age category.When the risk of dying from COVID-19 is high, such as in the elderly and those with significant comorbidities, the ARR is expected to be also big; but if the risk is so small as in less than a hundredth of a 1-percent risk, then even if the vaccine manufacturers claim a 90-percent RRR, that doesn’t mean anything in actual benefit.
Ninety percent of P100,000 may be considered big and worth risking one’s limb to get; but 90 percent of one centavo is certainly not worth the risk of fracturing one’s leg. We may be exaggerating the point a bit for emphasis, but parents may have to consider that their decision to vaccinate their children may not be a very sound decision to make.
Sure, we get rare deaths in the 10- to 19-year-old category, and the parents of these unfortunate casualties may think they should have had their children vaccinated, but if all parents thought that way, more than 300,000 adolescent and teenage children should be vaccinated to save one life. But you exposed hundreds of thousands to the potential serious side effects of the vaccine without any clear benefit to them.
Worst-case scenario
Thinking of a worst-case scenario in the next 12 months wherein the cases of COVID-19 infections would double compared to the first 12 months of the pandemic, we calculate the risk of getting infected to be 2 percent or around 2.2 million new infections.
That means that even in the worst-case scenario, 98 percent of the population will not get infected, but 100 percent of the population will have to endure the physical, mental, social and economic consequences of lockdowns and other measures aimed at preventing transmission.
If you don’t have COVID yet now, your risk of dying in the next 12 months is only 0.03 percent or a risk of three chances in 10,000. The odds are 9,997 in 10,000 that you’ll still be alive in the next 12 months, provided you practice the standard health protocols our health officials advise.
So, your chances of survival in the next 12 months is 99.97 percent, certainly not that gloomy, Indian variant and all.
Now, zeroing in on the 10- to 19-year-olds whom the FDA has given the go-signal to vaccinate with the Pfizer vaccine, the risk of dying in the next 12 months is 0.0003 percent or three in a million chances, or one in 333,000.
This was what we were saying earlier that you have to vaccinate 333,000 10- to 19-year-olds to save one life, but you’re exposing 332,999 to the potentially serious risk of the vaccine such as myocarditis or swelling of the heart muscles, and pericarditis or swelling of the covering of the heart. These two serious complications can lead to heart failure and life-threatening irregular heart rhythm.
Side effects
There are now accumulating reports from Israel and the United States of these side effects of the Pfizer and Moderna vaccines, which are more commonly seen in the 12- to 24-year-old age group. It’s probably because the natural immunity of young people is quite strong, so their immune cells try to mount a strong reaction against the vaccine components, which are considered foreign intruders in the body.
There’s an emerging hypothesis on the current unexpected vaccine side effects that even the inventor of the mRNA and DNA vaccine technology, professor Robert Malone, admits he and his fellow vaccine scientists miscalculated. They thought it was the SARS-CoV-2 virus that triggers the severe immune system reaction and organ damage.
Now, Malone says it’s a fair assumption to make that it’s actually the spike protein of the virus, which is toxic to the body and causes all the deleterious effects. Vaccines program the body to produce these spike proteins, and they’re not only limited to the inoculation site, which is the deltoid muscle of the arm. Autopsy reports of some vaccinated individuals who died indicate that the spike proteins are found in practically all organs of the body.
The vaccine manufacturers should not dismiss these as isolated reports and coincidental findings. The various FDAs should obligate them to look into this more seriously and withhold vaccination particularly in young people.
Reliable immune systems
Since teenagers and young adults have excellent and reliable immune systems, why do we have to mess with it by vaccinating them? We must have a strong justification to do it, except in the few with known medical conditions that make them immunocompromised.
When we first proposed suspending vaccination among 40-year-olds and younger several months ago, we were heavily criticized by the expert groups as unduly confusing the public with baseless and dangerous hypotheses. I told some heads of medical societies that it was mass vaccination that was untenable. A targeted vaccination to protect the vulnerable sectors of the population is the more rational application of a vaccination program. It must be a sniperlike precision strategy, and not an indiscriminate ground-zero-creating explosion of a potent ammunition.
A few days ago, the Australian drug regulators revised their recommendation for the AstraZeneca vaccine, advising against the use of the vaccines in nonseniors. They estimated that 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.
In short, the younger the age of the vaccinees, the higher the risk of potentially serious reactions, mainly blood clot complications that may lead to death.
Although it was partly intuitive when we made that recommendation several months ago to suspend vaccination among 40-year-olds and younger, the emerging figures from the risk of vaccination appear to support it. It’s not such a wild hypothesis, as it was branded by our esteemed colleagues.
Hardest hit
We don’t have yet the figures to calculate the risk for myocarditis and pericarditis in adolescents, teenagers and young adults. All we know is that they’re the hardest hit.
Following an emergency meeting, Dr. Tom Shimabukuro, the deputy director of the Centers for Disease Control and Prevention’s (CDC) Immunization Safety Office, reported last week 789 cases of myocarditis/pericarditis after being vaccinated with the Pfizer/BioNTech and Moderna vaccines, most commonly after the second dose. Of these, 475 were 30 years old and younger. Majority of the cases are in the 12-24 age group.
Shimabukuro was reported as saying: “We’re still learning about the data … As we gather more information, we’ll begin to get a better idea of the postvaccination rates and hopefully be able to get more detailed information by age group.”
If the CDC main vaccine expert admits that they’re still in the learning curve on the potentially serious side effects of the vaccine in young people, why should we risk the lives of our children with all the unknown perils that await them in the short-, mid- and long-term?
Since no clear benefits can be demonstrated by vaccination in the younger-than-40-year-olds, our FDA should only allow emergency use authorization (EUA) on the elderly and the 40-year-olds and older with comorbidities. The EUA on younger adults, especially in adolescent and teenagers, should be withdrawn.
Longer safety studies and full licensure, rather than EUA, should be required for all vaccines before they’re allowed for the younger age categories. We should avoid the pitfall of the treatment being worse than the disease. INQ