Dr. Istrail is a physician and author of The POCUS Manifesto: Expanding the Limits of our Physical Exam with Point-of-care Ultrasound
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Twitter has been abuzz with the news of the Advisory Committee on Immunization Practices (ACIP) adding the Pfizer and Moderna Vaccines to the “Vaccine for Kids” program, which offers vaccines at no cost to kids who cannot afford them. On Thursday, October 20th, the ACIP met again and voted to recommend that COVID vaccines be included in the routine vaccine immunization schedules for all children 6 months and older.
This has created anger, fear, excitement, relief, and confusion among the millions of parents in the United States that want to do what they believe is best for their children. There has been an appalling level of fear-mongering from those opposed to this decision, as well as a despicable amount of sugar-coating and willful ignorance for those in favor.
It is worth taking a deep breath, a step back, and reviewing the data with sober eyes.
With any drug or vaccine given to any person of any age, the proven (or presumed) benefits should be balanced by what - if any - negative consequences may arise. This is especially true in children. Such a decision can be evaluated with the following principles:
How bad is the disease?
How good is the drug or vaccine at treating or preventing this disease in this population?
Are the adverse reactions known? And if so, what are they, and how common are they?
What are other countries doing?
Answering these questions with brutal honesty and intellectual integrity, seeking the best available data from both sides of the argument may hopefully provide some insight.
How bad is the disease?
Infection Fatality Rate
This is a question with many answers that vary dramatically by age, which variant of SARS-CoV-2 is dominant, and whether or not someone has been previously infected or vaccinated. But what is clear is that age plays an enormous role.
From Dec 2020, one systematic review of 113 studies found that the infection fatality rate (proportion of people who die from COVID-19 out of those who were infected, IFR) in people who were not previously infected or vaccinated (there was no vaccine yet) was 0.002% at age 10 and 0.01% at age 25. So if 100,000 kids were infected prior to September 2020, 2 of them would die. This rate increased exponentially to 15% at age 85.
This comfortingly low IFR for kids was an order of magnitude worse than that found in another meta-analysis of 40 studies from 38 countries also using data from the pre-vaccine time period. They found that the median IFR for kids 19 and under was 3 deaths per million infections (0.0003%). For those aged 20-29 it was 0.003%, numbers the authors note “suggests a much lower pre-vaccination IFR in non-elderly populations than previously suggested.”
This IFR for young kids was further corroborated by an April 2022 Lancet study using data from April 2020 to Jan 2021, which found that the IFR for kids under 10 was about 3 per 100,000. This increased linearly with age to a terrifying IFR of 42.7% for 100-year-olds.
This fortunate sparing of our youngest was seen in a German study of 10,000 kids which found that among those ages 5-11 with no significant other illnesses, there were zero deaths. Or in a study of 1700 kids during the first three waves of the pandemic in Iceland, where there was no severe disease or hospitalization. This was largely confirmed in a study of 12 million kids under 20 years old from England. During a 22-month follow up there were only 20 deaths from COVID infection in previously healthy children: 81 deaths from COVID-19 in total, with 61 in children with severe neurodisability or who were immunocompromised.
Despite all this, in the U.S. 198 children sadly passed away from COVID-19 in 2020 and 378 in 2021, numbers similar to that of the 2018-2019 influenza season. It is important to remember, though, that these estimates were from a time when there was a far more dangerous virus in circulation, coupled with no vaccine, no immunity from previous infections, and no treatments.
MIS-C
Apart from death, there have been countless other concerns raised about the lingering effects of COVID infections. In kids, most concerning was the development of multi-system inflammatory syndrome, or MIS-C, an inflammatory condition that can cause tragic irreversible damage like congestive heart failure. The reported incidence of MIS-C varies dramatically in the literature, but fortunately, with Omicron, this is largely a condition of the past.
It was 1 in 4,100 (or 0.02% of infections) based on 23 MIS-C patients out of 93,397 infected from a Danish study from March 2020 to Feb 2021. It was 2 per 100,000 in New York Between March and May 2020, or 10 per 100,000 in an Italian study from March 2020 to June 2021. Similar results were seen in Israel, with about 0.05% of those infected developing MIS-C during the Alpha wave. Yet with Omicron incidence reduced about 10x to only 0.0038%. This was also seen in Denmark and the UK with a nearly 90% reduction of MIS-C cases during Omicron as compared to the initial wave.
Immunity from Previous Infection
Fast forwarding two years to the post-Omicron Era, despite all our best efforts, nearly all children in the United States have been infected with SARS-CoV-2. According to the CDC, as of February 2022, 75% of kids under 12 had evidence of previous infection, up 30% from just 2 months prior. And as of August that number is at least 86%, which means that as of October 2022, the vast majority of American kids have had COVID. In multiple studies comparing vaccination vs previous infection, natural immunity generally provides better protection from reinfection, hospitalization, and death than the vaccines can offer.
As Dr. Anthony Fauci put it in a C-SPAN interview in 2004 discussing someone who had the flu,
“If she got the flu for 14 days, she’s as protected as anybody can be, because the best vaccination is getting infected yourself. If she really has the flu, she definitely doesn’t need a flu vaccine … the most potent vaccination is getting infected yourself.”
All this to say that this leaves us in a relatively fortunate position, with a much milder viral strain infecting a group of people least at risk of severe disease, the vast majority of which already have immunity from previous infection.
How good is the vaccine at treating or preventing this disease in this population?
With the characteristics provided above, even if it was the most effective vaccine in history, there is already very little room for reducing risk in a very young and healthy person, especially one who was previously infected.
The American Academy of Pediatrics (ACP) recommends COVID-19 vaccination “for all children and adolescents 6 months of age and older who do not have contraindications using a vaccine authorized for use for their age.” This was based in part on the FDA’s authorization which reports the vaccine effectiveness of both Moderna and Pfizer Vaccines.
The Pfizer & Moderna Vaccine
For the Pfizer Vaccine, the FDA reported that while “the immune response to the vaccine for both age groups of children was comparable to the immune response of the older participants,” the determination if this in fact translated into less COVID infections, or less severe infections was “determined not to be reliable due to the low number of COVID-19 cases that occurred in study participants.”
This is because, in the group studied there was only one (One!) COVID infection in the vaccine group and only two in the placebo. This resulted in a non-statistically significant estimated effectiveness of 75% with a comically large confidence interval of -369 to 99.6. In other words (paraphrasing here…) “we think this will reduce the infection risk by 75%. It might even reduce your risk as much as 99%, but it could also increase your risk by 369%.” Of course, with such a small sample of infections, no such conclusion could be made.
The Moderna vaccine fared better. In the 70 days following the second dose, it was 50.6% effective in preventing COVID-19 infection among participants 6-23 months, with 51 cases in the vaccine group and 34 in the placebo group. It was 36.8% effective in kids ages 2-5, with 119 cases in the vaccine group and 61 cases in the placebo group.
It is important to remember that the initial Pfizer vaccine trial in adults also showed a dramatic reduction in cases in the vaccine group in the first two months as well, only for us to later learn that was just a temporary phenomenon.
In both vaccine studies, they also used the immune response as a surrogate for the actual prevention of cases, hospitalization, or death. This is at best wishful thinking and at worst inappropriate. We know from other studies that the antibody levels wane after 2 months or so, so even if immune response was a good surrogate, it would likely only provide protection for weeks to months. The CDC itself reported this for adults, explaining that vaccine effectiveness after the mRNA vaccines goes from about 79% right after the vaccine to as low as 29% 120 days later.
Are the adverse reactions known? And if so, what are they, and how common are they?
Vaccine adverse events can only be discovered once the vaccine is given, whether in a clinical trial setting or once it has been released to the public (post-market surveillance). Events that cluster in a specific population are only seen once that population receives large numbers of the vaccine, especially if it is a rare event. This is why there was no knowledge of myocarditis risk in young men from the initial randomized trial. They included men 16 years and older, but the median age was 52. The myocarditis risk was not known until the vaccine was given to millions of people, allowing rare, but real adverse events to present themselves. Yet even by the end of 2021, despite many reported cases of myocarditis, the CDC did still not think there was a relation.
On December 31, 2021 the CDC published a report on their findings from the Vaccine Adverse Event Reporting System (VAERS), a “passive vaccine safety surveillance system co-managed by CDC and FDA.” VAERS is notoriously confounded by a million factors. Anyone can submit an event, even people with ulterior motives, though it is usually a healthcare provider. It is also limited by the fact that the data is entirely self reported. Though it’s required by law for clinicians to report presumed cases, it is not really enforceable. Physicians inclined to believe the vaccine has no adverse events may be less likely to report an event, while one skeptical of vaccines may be more likely. What it is good for is detecting trends among rare events that may have a causal relationship to the vaccine.
From November to December 2021, they received 4,200 reports for kids 5-11 who received the Pfizer vaccine, the majority of which were deemed “nonserious,” as well as 100 deemed “serious.” Serious events included 29 reports of fever, 21 of vomiting and 15 of increased troponin (myocarditis). There were two deaths (both “under review” at the time of this report). They concluded that out of the 8 million doses given, “11 verified reports have been received,” and “no chart-confirmed reports of myocarditis were observed.” Of course, the key word here is verified, as they get thousands of reports and have a limited staff to independently confirm them all.
This is where some in favor of vaccinating children against COVID-19 (often in response to fear-mongering against it) lose their intellectual curiosity. Case in point Dr. Hotez, a dedicated and renowned vaccine scientist responding to Megyn Kelly on Twitter:
In the era of siloed news, if discovering the truth is the goal, one must put their emotions aside and venture into the world of reasonable people with alternate views to see what real evidence there is (or isn’t) for adverse events. Though exceptionally rare, a simple search on PubMed or Google Scholar will find autopsy-proven cases of kids and adults who died after getting vaccinated. See here, here, here, here, here, or here.
Myocarditis & other adverse events
The most notable known adverse event is myocarditis. Despite the CDC’s report from December 2021, the vaccine-induced myocarditis is a rare, but real finding that results in cardiac cell damage. The degree of severity varies greatly, from no observable long-term consequences, to severe heart injury and reduced heart function, or to cardiac scarring which can predispose to dangerous or deadly arrhythmias. This is why one must abstain from any physical exertion for months.
When measured in all age groups, the incidence is extremely low, but we now know it is much more likely to occur in young men. In this population, the incidence after the second dose was as high as:
1 in 62,000 after Pfizer and 1 in 17,500 after Moderna in a Danish study
1 in 16,800 after Pfizer and 1 in 3,338 after Moderna in a Canadian study
1 in 6,600 after Pfizer in an Israeli study, resulting in one death from ‘fulminant myocarditis’ and 4 cases of heart failure, with the remaining cases relatively mild
1 in 14,000 after Pfizer in a U.S. study
1 in 4,500 after Pfizer in a study from Hong Kong
Depending on which study you choose, the myocarditis cases are relatively rare. Though, this depends on one’s definition of “rare.” The rotavirus vaccine (Rotashield), for example, was approved by the FDA for children but was pulled from the market for causing 2 excess cases of intussusception per 10,000 vaccinations, a serious but easily treatable cause of bowel obstruction.
These myocarditis rates suggest that for every 1,000,000 young men in the 15-30 age range, between roughly 16 and 299 would develop myocarditis, numbers that are almost certainly underestimates since most myocarditis cases are only found when the patient is symptomatic enough to present to a hospital. There is some degree of mildly symptomatic to asymptomatic myocarditis, the rate and long term consequences of which, remain unknown.
In addition to myocarditis, the vaccine may prolong womens’ menstral cycles by a couple days, cause or worsen tinnitus, or may hasten certain cancers.
What are other countries doing?
While our CDC and FDA interpret the data and make their own recommendations, it can be quite revealing to look at what other countries are doing.
Denmark no longer recommends the vaccine for anyone under 18.
“Children and adolescents rarely become severely ill from the Omicron variant of covid-19…From 1 July 2022, it was no longer possible for children and adolescents aged under 18 to get the first injection and, from 1 September 2022, it was no longer possible for them to get the second injection. A very limited number of children at particularly higher risk of becoming severely ill will still be offered vaccination based on an individual assessment by a doctor.
Finland recommends the vaccine for all kids over 12 and only for kids aged 5-12 that are immunocompromised or have other serious illnesses. They do not recommend it for kids under 5. They are also not offering the Moderna vaccine to men under 30 due to the myocarditis risk.
Iceland does not recommend the Moderna Vaccine for men under 30. They note that no child aged 5-11 had to be hospitalized for COVID, but do not explicitly comment on if they should be vaccinated.
Norway does not recommend all children be vaccinated.
‘Children rarely become seriously ill, and knowledge is still limited about rare side effects or side effects that may arise at a distant time. There is little individual benefit for most children, and the Norwegian Institute of Public Health has not recommended that all children aged 5–11 be vaccinated.
Sweden only offers vaccines for kids 12 years and older. They decided against vaccinating kids 5-11:
"With the knowledge we have today, with a low risk for serious disease for kids, we don't see any clear benefit with vaccinating them," Health Agency official Britta Bjorkholm told a news conference.
Germany recommends one dose for children 5-11 years old and two doses for those who are immunocompromised or with pre-existing conditions.
On the global stage, it does appear that the United States is the outlier for recommending COVID vaccines to young children. For an argument against vaccination of kids, consider reading Against COVID-19 vaccination of healthy children.
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Dr. Istrail is a physician and author of The POCUS Manifesto: Expanding the Limits of our Physical Exam with Point-of-care Ultrasound