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The Covid Vaccine Trials for Infants and Young Children: What Parents Need to Know

Executive summary: Pfizer and Moderna’s own trials show that we simply do not have enough data on this vaccination to recommend it with a clear conscience.

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Here is the trial data Pfizer and Moderna presented to the FDA

Pfizer:

Vaccines and Related Biological Products Advisory Committee June 14-15, 2022 Meeting Briefing Document- FDA- Pfizer- COVID19 Vaccine for Pediatrics

Moderna:

Vaccines and Related Biological Products Advisory Committee June 14-15, 2022 Meeting Briefing Document- FDA- COVID19 Moderna Vaccine For Use in Pediatrics

Long documents, here are four key takeaways:

There is no data on reducing risk of severe Covid, including hospitalization and death. You’d think that for a vaccine to get FDA approval for preventing you from getting really sick, you’d have to show it prevents you from getting really sick. That’s just the kind of narrow-minded person you are. Yet, in the Moderna trial, nobody got that sick. Not a single vaccinated child, true – but also not a single unvaccinated one! Thankfully, it remains incredibly rare for children to get severe Covid. From the Moderna document above, p.115: “There were no reports of severe COVID-19 cases in participants 2-5 years of age in this study as of the data cutoff.” And p. 154: “There were no reports of severe COVID-19 cases in participants 6-23 months of age in this study as of the data cutoff.”

Ok, that’s Moderna, how about Pfizer? Well, Pfizer got lucky. They did have some of their trial participants get severe Covid, and one even got hospitalized. Unfortunately, 6 of the 8 kids who got severe Covid were vaccinated, and the only hospitalized child was among them. Yes, the only child to be hospitalized out of the entire Pfizer and Moderna trials combined… was vaccinated. I’ve seen a lot of coverage of the FDA decision in the news, yet I don’t think they’ve mentioned that tidbit. Per the Pfizer document above, p.6: “Among all COVID-19 cases accrued from Dose 1 through the data cutoff of April 29, 2022, 1 placebo recipient 6-23 months of age and 7 participants 2-4 years of age (6 BNT162b2 recipients and 1 placebo recipient) met the protocol specified criteria for severe COVID-19 during both blinded and open-label follow-up. Only one of these severe COVID-19 cases (in a BNT162b2 recipient 99 days post-Dose 2) resulted in hospitalization[.]” Read the study more closely and even 8 severe Covid cases is overstating it because several of those children had other infections (parainfluenza, rhino/enterovirus) at the same time, so we don’t know if Covid caused their symptoms. In any case, neither the Pfizer nor Moderna study even attempts to argue that their shots reduce severe covid, including hospitalization and death. Yet whether or not the vaccine protects against severe covid is what parents want to know! The FDA, it seems, does not care.

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The trials demonstrate no effectiveness against current variants. Remember, Pfizer and Moderna came up with this vaccine formulation during the Trump administration, several variants ago. They did not update the formulation for the pediatric trial. All the children in the trials thus got vaccinated against a variant that no longer circulates. Against that old variant, the data does look promising! However, unless mRNA also enables your toddler to time travel (I looked it up, that is not one of the listed side effects), it remains unclear how being vaccinated against a virus that no longer exists will be of use to her.

What does the Moderna trial say about the current variant, Omicron? Well, remember how they couldn’t study effectiveness against severe Covid, because none of their patients got severe Covid? They cleverly get around that by the magic of immunobridging. Immunobridging means that instead of showing the vaccine protects you against disease in real life, the trial just has to show the vaccine increases your antibodies against the disease. Ok, sounds a bit of a stretch, but let’s go with it. Surely, to get FDA approval, the Moderna trial showed robust ‘immunobridging’ protection against the current circulating Covid strain, right? There you go being naïve again! From Moderna p. 174: “Neutralizing antibody titers against the Omicron variant were compared to neutralizing antibody titers against the ancestral strain (D614G) measured using a validated PsVNA assay. Twenty participants from each age group were included in this analysis. At 4 weeks post Dose 2, compared to GMTs against D614G, neutralizing antibody GMTs against Omicron were 28.8-fold lower in adults ≥18 years, 11.8-fold lower in adolescents 12-17 years, and 22.1-fold lower in children 6-11 years.” Translated to English, this means that there is dramatically less antibody production against Omicron. Notice as well that they only tested children age 6 and over, not the younger kids, even though the younger kids are the entire focus of this discussion and this vaccine approval. So, when only the Omicron variant is circulating, and Moderna is asking for approval for their vaccine for young children based on immunobridging studies, Moderna did not actually study immunobridging against Omicron in young children. Solid work, Moderna.

How does Pfizer compare? Well, since the majority of severe Covid cases in their study insisted on turning up among the vaccinated, Pfizer too needed immunobridging to do its heavy lifting. Oddly, just like Moderna, it completely slipped Pfizer’s mind to show that its vaccine significantly increased antibodies against Omicron. The people in charge were all probably too busy counting their profits, you know how time consuming that can get. From Pfizer p. 35: “The descriptive analyses indicate that post-Dose 3 in both age groups, neutralizing antibody GMTs against the reference strain and against the Delta variant were similar, while neutralizing antibody GMTs against the Omicron variant were notably lower.” Give Pfizer credit, though, at least they did test this out with the 6 month to 5 year old age group, so we do know definitively that vaccinating those children does not produce antibodies against current variants of concern. In short, unless Pfizer’s next big invention is a flux capacitor, the shots seem useless.

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There is no data on children who have been previously infected. Your three year old had covid a few months ago, or a year ago, and recovered – should she get the vaccine? Considering that the vast majority of children have already had Covid – estimates range from 75 to 90% of them! – this would seem to be an important question for a trial evaluating covid shots in children. Which is why, naturally, the trials did not even attempt to answer it. Both Moderna and Pfizer deliberately enrolled an overwhelming percent of infection-naïve children, completely different from your nearest kindergarten. Pfizer pp.29-30 show roughly 90% of the trial participants did not have prior infection. Moderna too used a population that was 90% without prior infection (p 106 and p 146) and includes helpful statements like “in all pediatric age cohorts, there were insufficient COVID-19 cases among participants with evidence of prior SARS-CoV-2 infection at baseline to reliably estimate VE for this subgroup” (p.11). Notably, in the ages 2-5 trial, Moderna discloses on p.114 that 7 children with prior Covid infection got reinfected by Covid during the trial – and of those 7, 6 were in the vaccinated arm!

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The companies have no confidence in their own data. I’m not reading their mind, I’m talking statistics. These types of studies use confidence intervals. The broader a confidence interval, the less faith one has in the result; the Pfizer and Moderna trials have some of the most comically broad confidence intervals I’ve ever seen. This is in large part because the trials were so very small (you may have noticed, in the discussion above, talk of one patient here, six patients there, instead of the tens of thousands or even millions from prior vaccine studies). On Pfizer p.39, for example, you see confidence intervals for vaccine efficacy ranging from -370% to +99%. This means that they can’t tell if the vaccine is 99% effective against Covid, or 370% effective against you. Moderna has similarly absurd numbers. My favorite little nugget is on Moderna p. 114, where the trial finds a vaccine efficacy of -15.4% in obese 2 to 5 year olds. That is, according to Moderna’s own data, overweight kids are more likely to get Covid with their vaccine than without it. I didn’t see that fact reported in the news. True, it likely does not mean anything, for the confidence interval for that finding ranges from -381% to +63%. If I was trying to talk you into an experimental medicine and told you, “Well, there’s anywhere from a 99% chance it will cure you to a 300% chance it will hurt you,” would you take it? Apparently, the FDA would.

Oh, and the news coming out from the trials that the vaccines are safe for that age group? Maybe they are, maybe they’re not… but would you trust a study to have conclusively ruled out all bad side effects when the trial size is so small it can’t come within 300% of a right answer? Pfizer p. 23 reveals that the number of children 6 months to 23 months of age in their safety study who received all 3 shots in the series was… 386. So if there’s a 1 in 400 chance of spontaneous combustion after the third Pfizer dose, the trial wasn’t big enough to detect it.

Speaking of safety concerns, if you would like to see what a study with narrow confidence intervals looks like, check this one out. Published just last week in a prestigious journal, it studied 32 million people (roughly 32 million more than were in the Pfizer and Moderna studies) and found, with narrow confidence intervals, “that vaccination with both mRNA vaccines was associated with an increased risk of myocarditis and pericarditis within the first week after vaccination.” Perhaps the FDA should look into that.

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In summary, the trials tell us nothing about severe illness, nothing about current variants, and nothing about the previously infected - and they tell us all that nothing with no confidence!

Maybe one day the FDA will take a break from banning British baby formula in the midst of a formula shortage to investigate whether covid vaccines may be of use to children, but that day is not today.