So big doings today (actually yesterday) as Moderna declares they have achieved the Holy Grail; they have cracked the uncrackable code and have FINALLY produced a vaccine for babies and toddlers to protect those little cherubs from the unquenchable maw of the evil coronavirus. HALLELUJAH!!
Couple things though. Before all you good parents rush out and trample Grandma on the way to getting Junior vaxxed, you should have a better picture of what’s really going on here. Something a bit more in depth than headlines like (my caps or bold for emphasis) “Moderna SAYS Covid vaccine for young kids generates STRONG IMMUNE RESPONSE” from NBC “News” or “Moderna SAYS vaccine is EFFECTIVE for babies, toddlers” from ABC “News”. I guess as long as Moderna “SAYS” so then all is well. Interestingly, the subtitle on the NBC piece is “The shots didn't protect well against infection from the omicron variant in children, 6 months to age 6, although there were no cases of severe illness or deaths.” Ah, details, details. Let’s take a look.
First, if you’ve been following along with my little circus, you’ll know that the vaccine trials in kids have a primary endpoint (the thing the study is looking to find out) of “non-inferior geometric mean antibody titer”. Basically what they’re looking for is, does the vaccine produce at least the same antibody response in a two-year old as it does in people 18 years to 25 years old. They’re not looking at whether your kid gets sick or not, just does his or her immune system have the at least the same reaction as an older teenager. Interestingly, Moderna actually provides some efficacy data – how “protective” was the shot, which is curious because it ain’t good. Maybe that's because they've vaccinating people against a strain of the virus that is essentially extinct. We’ll get back to that.
If we look at Moderna’s press release from March 23, 2022 we read “Moderna Announces its COVID-19 Vaccine Phase 2/3 Study in Children 6 Months to Under 6 Years Has Successfully Met Its Primary Endpoint” We’re told “interim analysis showed a robust neutralizing antibody response in both age groups [6 months to under 2 years and 2 years to under 6 years] after a 25 µg two-dose primary series of mRNA-1273” Further “In both age groups, two doses of 25 µg provided similar immunogenicity to the 100 µg two-dose primary series in adults ages 18 to 25 years, meeting the non-inferiority criteria and immunobridging, and INDICATING that the benefit of mRNA-1273 conferred to adults ages 18 to 25 are also conferred to children and infants as young as 6 months.” Moderna also announced it is submitting to the FDA for Emergency Use Authorization (EUA) for 6-11 year olds (at two 50 microgram doses) as well as updating it’s EUA submission for 12-17 year olds (at two 100 microgram doses). So be aware that if Moderna gets its way, you could easily find yourself with your seven year old daughter, who might weigh 25% less than your five year old son, getting TWICE THE DOSE as her younger, heavier brother. Or your four year old could get two 25 microgram doses of Moderna while your eight year old gets two doses of Pfizer at only 10 micrograms each. The same scenario could easily play out if your kids are around 11 and 12. SCIENCE!!
It’s important to note here that Pfizer failed in this age group (6 months to 5 years) with 3 microgram doses in a series of two shots; they’re now trialing a third shot. But Pfizer is at 3 micrograms, Moderna is at 8 TIMES MORE at 25 microrgrams. Similarly, Pfizer’s adult dose is 30 micrograms while Moderna’s is 100. Also, Moderna has a much higher rate of myocarditis in males, so there’s that.
You can also take comfort in knowing that “Moderna is preparing to evaluate the potential of a BOOSTER dose for all pediatric populations, including those age 6 months to under 6 years, 6 to under 12 years, and adolescents.” So for those concerned, don’t worry, they’ll be plenty of shots in the future for Junior.
You should also understand that while there are about 20,000,000 kids in this cohort (6 months to 6 years), Moderna tested their product (who exactly are the parents who said “Sure, here’s my baby, have at it.”) on all of 6,700 kids. And it should also make you feel good that “All participants will be monitored for 12 months after their second injection to assess long-term protection and safety.” Well we already know the vaccines begin to wear off precipitously in as little as three months; and a whole 12 months you say to track “safety”? Cool. Remember, the long-term consequences of this shot, with a never-before used technology deployed to billions of people, are UNKNOWABLE and anyone who tells you different is a LIAR.
But here’s what’s really important to consider. Getting back to the “efficacy data” we touched on earlier, Moderna reports “…vaccine efficacy in children 6 months to 2 years was 43.7% and vaccine efficacy was 37.5% in the 2 to under 6 years age group.” First, they don’t provide the actual data, but second, those numbers SUCK. Not only do they SUCK but if you remember way back in early 2020 when the FDA laid out guidelines for the vaccine that would save the world, they said “To ensure that a widely deployed COVID-19 vaccine is effective, the primary efficacy endpoint point estimate for a placebo-controlled efficacy trial should be at least 50%...” Now I’m no mathematician (just like I’m not a virologist, immunologist, epidemiologist, or tiny little lying sac of crap with a Napoleon complex), but I’m pretty sure 43% and 37% aren’t at least 50%. So why would Moderna even bother submitting this data? More importantly why would the FDA even consider it? Maybe they won’t, we’ll see. And a 50% benchmark to begin with was ridiculous. To be clear, that means that your government wanted a vax that would “work” in at least half the people who got it. They may have in fact gotten their wish.
Also, remember the subtitle from NBC cited above. “The shots didn't protect well against infection from the omicron variant in children, 6 months to age 6, although there were no cases of severe illness or deaths.” The CDC reports as of yesterday some 355 “provisional” COVID deaths in the cohort 0-4 years old, with research showing NO otherwise healthy children dying. With somewhere around 16,000,000 kids in that age group (0-4), you have a population fatality rate of about 0.002% or two one-thousandths of one percent. That works out to about one death for every 45,000 kids. Those numbers would be recognized as statistically ZERO. So with one death in every 45,000 kids, the fact that “there were no cases of severe illness or deaths” in 6,700 kids doesn’t mean much. They might as well have said “Our tiger-repelling rock works!” in the middle of Manhattan.
Lastly, as we have discussed before, Moderna’s application is for Emergency Use Authorization. With about 175 COVID deaths per year in this cohort and a chance of your young child dying from COVID down around two one-thousandths of one percent (really one one-thousandth of one percent on an annual basis), where EXACTLY is the “Emergency”?
As it is mathematically impossible to improve your child’s risk ratio against a significant interaction with COVID (you cannot improve upon zero risk), and an UNKNOWABLE potential for adverse events in the future, you should think twice before you vax your babies.