Updated: Why I won't get my Little Ones the Covid Jab
The FDA is set to break its promise to only approve Covid shots with at least 50% efficacy--for the group that is least at risk from Covid. Just one reason I won't trust an EUA vax for kids under 5.
*Updated with some of the abysmal safety and efficacy data newly released.
The FDA is gearing up to grant Emergency Use Authorization for Covid jabs from both Moderna and Pfizer for children aged six months through five years old, with the panel meeting to deliberate scheduled Wednesday. I have three children who would be eligible for getting a Covid shot under this EUA, and like all parents making healthcare choices for their children, I must weigh the potential benefits against the risks, no matter what the headlines read or what pundits and government officials say on TV.
I have personally experienced the anguish of seeing my child struggle to survive in a hospital bed. (As twitter followers may recall, last year Baby G was hospitalized with PPHN for almost a month and sent home on oxygen and a vasodilator.) Like all good parents, I want to protect my babies from preventable harm and I have deep sympathy for parents who fear their children will be struck down by a disease they are told “could have been prevented” by a shot. The trial results Moderna and Pfizer have reported so far, however, combined with my children’s low risk from Covid lead me to strongly distrust claims that this product is likely to provide my healthy children with a net benefit. The following four reasons sum up why I will not be lining my children up for the Covid jab, and I hope other parents will consider them.
1. Reported efficacy against cases is unimpressive
Moderna’s most recent press release cites “51% vaccine efficacy” against infection in those aged six months to two years, but it reports only 37% for those aged 2 to 5 in the 6,700-participant trial.
“These efficacy estimates are similar to vaccine efficacy estimates in adults against Omicron after two doses of mRNA-1273,” the press release states. But as a parent, that isn’t comforting to me. Fully vaccinated and boosted people came down with Covid en masse during the Omicron wave. Any purported efficacy in this trial is only what’s been measured over a couple of months. If 51% or 37% efficacy at the beginning wanes like it does in adults, children would be getting an experimental gene therapy only to have basically no protection from Covid in a matter of months.
Not only are Moderna’s efficacy numbers poor, but the FDA reneging on its promise in 2020 to only approve shots with at least 50% efficacy in preventing or mitigating severity of disease does not inspire confidence in the integrity and rigor of the authorization process. This minimum efficacy is an official but non-binding FDA recommendation for receiving emergency approval and is included in guidance as recent as March 31st of this year, and it appears as if it’s being outright ignored.
On Pfizer’s part, their May 23 press release claims an efficacy of 75.5% and 82.3% for babies and the 2-4 group respectively, but it is based on a “descriptive analysis of “10 symptomatic COVID-19 cases identified from seven days after the third dose.” Not only that, but their confidence interval (the range in which they are 95% confident product efficacy lies) after the third dose is -8% to 98.3% for children 2-4 and -370 to 99.6% for infants 6 to 23 months old. That’s far worse than saying their product is between 0 and 100% effective. Pfizer said they will update their results when more than 21 cases have accrued, but this isn’t just weak sauce, it’s essentially making up numbers that sound palatable for decision-makers. Parents deserve far more robust efficacy data than this.
2. No direct evidence of efficacy against severe disease
More important than efficacy against infection, which most often produces very minor cold-like symptoms in young children, is efficacy against severe disease. Moderna admitted that in their study of 6,700 participants, "The absence of any severe disease, hospitalization or death in the study precludes the assessment of vaccine efficacy against these endpoints” (emphasis mine).
However, in Pfizer’s trial, a report just released by the company ahead of the advisory panel meeting shows 7 children in the 2-4 age group met at least one criterion for “severe COVID-19.” Six of them were in the vaccine group, one of whom was hospitalized (though he did have confirmed co-infection with parainfluenza), and only one was in the placebo group. The vaccine group was twice as big, but that still is evidence against efficacy against severe disease, not for it.
While Moderna may hold up “robust neutralizing antibody titers” among trial vaccinees as “predictive” of protection from severe disease, they admit outright that they could not actually assess whether the vaccine is in fact effective against severe disease. Not to mention, there’s no clear threshold at which antibody titers signal such protection, as staff scientist at the Humoral Immunology Core at the National Institutes of Health’s Vaccine Research Center,Dr. Nicole Doria-Rose told JAMA last October. The same article cites experts who say antibody titers don’t predict protection against severe disease as well as memory T and B cells.
While more information may come to light in the next few weeks, corporate press releases are supposed to make the results of their products look as good as possible and tend to gloss over and ignore the negatives. This imminent authorization comes across as an attempt to push products with low or even negative efficacy out to people with very low risk (as demonstrated by the lack of severe Covid in these trials) to mitigate their chance of getting a cold from one of two hundred viruses that can cause colds.
I’m not giving my kids a poorly tested new technology with poor topline efficacy and known serious adverse effects to protect them from one of hundreds of cold-causing viruses.
At least one of my kids had cold symptoms at any given time for most of the winter, and many parents I’m sure can relate. A minimally tested product that doesn’t even meet official FDA recommendations is not going to send me running out for injections to maybe (and likely only temporarily) lower their chance of getting yet another mild viral infection.
3. No evidence the shots can protect children against “long Covid”
Some parents are worried about their child getting “long Covid,” even after a mild initial infection. This concern doesn’t appear to be well-founded in more rigorous studies, however. In one UK study cited by this StatNews write-up of the data, only 1.8% of children who reported having had Covid had symptoms for longer than eight weeks, while some children who tested negative for SARS-COV-2 also had “persistent burdensome illness.” What’s more, Pfizer and Moderna have yet to claim to have demonstrated protection against “long Covid” in young children. I’m not going to get my kids the jab on a hunch this might be the case, particularly when there are other causes of “persistent burdensome illness” among my little ones, not least of which are serial infections with other seasonal viruses.
4. Adverse effects may be worse than the disease in children
So, if the child-calibrated mRNA shots aren’t very effective, are they at least very tolerable and safe like most other childhood vaccines?
Pfizer’s press release did say that the tolerability of the shot was similar to placebo, though given what’s been released so far from the Pfizer document dump and the fact they tried to have it embargoed for half a century, their credibility is, to put it nicely, quite lacking. And their report only bolsters suspicion. As Jessica Rose has written, nearly half of the placebo recipients in the 6-23 month group experienced systemic adverse reactions. Half? What are they being injected with? Something here is not on the up-and-up. Worse, 17 out of 1178 experienced a severe adverse event, a rate of 1 in 71. Pfizer will again tell you the rate was similar to that experienced by the placebo group. But how is that possible? And why would I ever want to give my kid a drug with no evidence of efficacy that has a 1 in 71 chance of causing them substantial harm?
Moderna, on the other hand, says their product’s tolerability was “generally consistent with that observed in children age 6 to under 12, in adolescents age 12 to 17, and in adults.” While they have not publicly reported any cases of myocarditis or pericarditis in their trial, “tolerable” is in the eye of the beholder. Moderna has reported a rate of severe adverse events of 1 in 83 within 28 days of vaccination (again, see Jessica Rose’ Substack) for the under-2 group. And seeing as Moderna is spinning their results as “similar to adults,” we must look at rates of adverse reactions in Moderna’s first trial as stated on the CDC website (see Table 3). More than 60% of people between 18-64 years old reported fatigue, headaches, or myalgia (aches and pains) after dose 2 of Moderna’s mRNA shot. Nearly half reported chills, a fifth reported nausea, and 17.4% reported fever. These are all common cold, flu, and Covid symptoms. Eighty-one percent reported any kind of systemic reaction (not localized, like a sore arm) after dose 2.
Not only are these widespread ill effects a turn-off for parents who want to spare their children additional suffering, but it seems especially ridiculous given the recent CDC estimate that 75% of those under age 11 (my kids very likely included) have already been infected with SARS-COV-2 and thus have naturally acquired immunity, the protectiveness of which is well documented in studies.
It shouldn't been to be said at this point, but I'll say this, too: the shots don't substantially mitigate transmission, either. This is abundantly clear in the real world data, so this neither is a reason to administer an injection to children, even if it weren't unethical to use children as human shields through experimental pharmaceuticals (which it is).
Risk to young children is very low
Any death or suffering of a child is a tragedy, but overall risk from Covid is extremely low, especially for healthy children. Cumulative hospitalizations for children four and under (the closest age group match the CDC offers) over the last two years are 3,971, according to CDC data, compared to 21,046 during the 2018-2019 flu season alone.
Since the onset of the pandemic, the CDC currently reports 23 total in-hospital Covid deaths for children under four and 26 for those aged 5-17 for the 2020-2021 season. Even the 1070 total deaths “involving COVID-19” listed for the 0-17 age group over the last two-plus years show roughly the same risk as that posed by the 2017-2018 flu season’s 526 estimated deaths.
Given the very low risk my children face from Covid, I need highly persuasive evidence of strong and durable efficacy against severe disease as well as ample evidence of short and long-term safety for my children to get an injection. I’m extremely unlikely to get evidence of the former any time soon--certainly not by the time the FDA makes a decision on June 15—and evidence of long-term safety is years away.
To grant an EUA, the FDA is statutorily obligated to determine whether, “The known and potential benefits of the product, when used to diagnose, prevent, or treat the identified serious or life-threatening disease or condition, outweigh the known and potential risks of the product.” They must take into account the high rates of adverse reactions, widespread naturally acquired immunity in young children, and low overall risk in addition to reported efficacy against infection. The FDA is evidently prepared to say the Covid shots for children under six fulfill this statute. However, my own risk-benefit analysis comes up deeply negative for these shots. Even if the FDA grants emergency authorization, my little ones will not be getting them.