The past month revealed a plethora of evidence on the reduced effectiveness of Pfizer’s mRNA vaccine offering for kids 6 months through 17 years old. That said, 4 weeks ago, damning data was released showing poor covid vaccine efficacy for kids 6 months up through 4 years which ironically was followed by a slew of other studies supporting the same conclusion for most children under 18. Considering the available evidence, specifically, the trend of plummeting vaccine effectiveness in kids, their already low risk for severe outcomes, and increased odds of side effects vs benefits, the Pfizer vaccine should no longer be recommended for young healthy children.
Let’s back up to February 11th 2021. In lieu of meeting non-inferiority of antibody titers during clinical trials, Pfizer backed out of submitting their data for kids 6 months through 4 years to the FDA for EUA approval, which in turn triggered the ACIP to push back their vaccine review for an additional 2 months.
Just so it’s clear, the Pfizer vaccine was unable to produce adequate protective antibody titers (at least non-inferiority- see image directly below from Pfizer’s own press release about this matter) for all age groups in the above referenced clinical trial, so they withdrew. That was the first red flag and beginning of a trend.
As a side note, check out the poor clinical trial results below. All the specifics are broken down so you can understand why Pfizer inevitably withdrew their application for EUA from the FDA for kids 6 months to 12 years old.
Soon after all that, things began moving further south for the pharmaceutical giant. Jump ahead to February 28th 2022. The New York State Department of Public Health in conjunction with University of Albany, released a study showing the Pfizer covid shot failing to elicit proper antibody protection against Omicron in kids aged 5-11 and to a lesser degree, 12-17, between November 30th 2021- January 30th 2022.
First, let’s examine the data for kids 5-11. To set the table, the aforementioned cohort was given 2 10 mcg doses nearly 4 weeks apart and considered fully vaccinated 2 weeks after final inoculation. Well, within 28 days, vaccine effectiveness against infection and hospitalization dropped from a measly 65% to 12%. Whats worse, by day 42 it dropped to -41% (see graph below).
So, what about the 12-17 year old cohort? There’s no doubt this group of kids faired better. However, that’s likely because this group was given 2 30 mcg doses, unlike the other cohort (5-11) given 2 smaller 10 mcg doses. Regardless, at baseline, vaccine effectiveness was 76%, then at the 28 day mark plunged to 56%. Finally, at 42 days, effectiveness dropped to a staggering 46% (see graph below).
With the previously cited figures expressed, please keep this in mind. The minimum bar for approval during the original Pfizer/Moderna clinical trials was around 60% vaccine efficacy. That means, vaccines had to be at least 60% effective against severe disease and death to receive FDA EUA approval (emergency use authorization). As you can see from this novel New York study, after only a month and a half, both groups of kids fell below that 60% bar. What’s more, the bar wasn’t even against severe disease/illness, it was against infection and hospitalization (which doesn’t necessarily translate to severe disease or death). In other words, Pfizer vaccine efficacy meant much less in this New York child study compared to original clinical trials. Why lower the bar for kids? Just for some context, effectiveness of vaccines from the original Pfizer/Moderna trials ended up being 90%+ which lasted at least 8 months before waning. Conversely, with this New York data you see an immediate drop in protection against Omicron within a month. All bad news.
Moving along, a 3rd major blow was dealt to Pfizer on March 11th 2022 by CDC. The agency released a study in their MMWR journal which focused on the effectiveness of Pfizer’s vaccine in kids 5-15 within a 6 month window. In summary, the data revealed 31% vaccine effectiveness against any symptomatic and asymptomatic infection after 2 doses within 14-82 days. Moreover, the paper also shed light on how vaccinated individuals experienced more symptomatic disease than unvaccinated (see chart below). Albeit, the sample size was small, but the repeating trend is the important part here. Said differently, this is the 3rd data set released within a short period of time indicating waning protection from Pfizer’s covid vaccine in healthy children under 18.
Now let’s talk about risk vs benefit. All and all, the risk of vaccine side effects compared to protection conferred doesn’t pan out here. Essentially, the odds of vaccine injury after receiving Pfizer are greater than the benefits potentially derived. To be specific, many studies show the risk of myocarditis after dose 2 in young males aged 12-24 occurring every 1/1000 - 1/10,000 doses. That means, the harms will likely outweigh the benefits in this cohort with even a few adverse events that will certainly occur.
Next, Omicron is mild for most and highly transmissible so infection and transmission can not be stopped regardless of vaccination. To that point, a vaccine with -41% & 46% effectiveness after 42 days has no consequential stopping power. In other words, Pfizer’s diminished protection against Omicron will not prevent the virus from spreading and will not curtail infection by any order of magnitude that will bend the trajectory of this pandemic. Nevertheless, everyone has a date with the mild symptom inducing variant, which will confer broad and robust immunity. So, vaccinating young healthy kids against a mild variant they will surely experience regardless of vaccination status should be advised against.
But, the vaccine prevents severe disease, illness, and even death, right? No. What currently prevents severe disease, illness, and death is a mild variant coupled with previous infection and vaccinal immunity. Thus resulting in a population with mostly positive seroprevelant kids (antibodies & separately CD8+, and CD4+ t-cells). It should also be stated, at this point even those who say they have not been infected, have been, they simply weren’t symptomatic so they never realized it. To sum things up, exposure to multiple variants and vaccines over the past 2 years trained most kids immune systems and protected them against severe illness and death, so there’s no need to administer an ineffective Pfizer vaccine as it will not trump the other immunity received.
On a more positive note, kids do very well with the virus. To be specific, the risk of severe symptomatic disease and death is already impossibly low for them. Truth be told, even an effective vaccine wouldn’t likely provide a meaningful reduction in death or serious symptoms for said cohort.
On the whole, kids under 18 shouldn’t be recommended a covid vaccine unless they are immunocompromised, or have comorbidities. For most healthy young children, the risk of vaccination outweighs the benefits. That coupled with reduced vaccine effectiveness as low as -41% should be enough to deter any physician from prescribing it. Having said that, do you feel we should be vaccinating young healthy kids?
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