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Horowitz: The indefensible rush to experiment on children

Op-ed
Angela Weiss/AFP/Getty Images

Riddle me this: If the COVID vaccine for adults is so impervious and miraculous that it justifies emergency and immediate use for children after just a few months of trials, then, by definition, there is no need for children to take the vaccine. It can only potentially cause harm, since the virus doesn't affect them, when we already know that any adult has had access to the vaccine for quite some time. If it really works, there should be no concern of unvaccinated children spreading it to vaccinated adults, especially when children's transmission rates are so low to begin with. So what is motivating this frantic rush to experiment on children?

Nobody can justify an emergency use authorization for a novel mRNA vaccine on children because the risks far outweigh any potential benefits. Even if we are to trust Pfizer's own trial data (p. 27) and allow the foxes of profit to guard the academic henhouse, there is a 1-in-333 risk for a serious adverse event (SEA) from the vaccine. Their trial resulted in 5 SEAs out of 1,127 12- to 15-year-olds in the vaccine group, as opposed to 1 in the 1,127 of the placebo group. That was the number of serious adverse events in just 30 days. If this excess absolute risk of 0.003 (0.3%) for SAEs holds up, that means for each 333 children 12-15 years old who are vaccinated, there would be one serious adverse event.

One in 333 doesn't sound like a lot, but it's a lot more than zero, and it's their own biased data. Plus, we have zero trials longer than just one month, so we have no idea about the long-term effects.

So, what are the benefits? There is no data on children, but we know from Israeli data on the Pfizer vaccine for adults published in the New England Journal of Medicine (p.22), that the "needed to treat" number of vaccines to save a life from COVID is 27,778. Their study showed 19 fewer deaths in the vaccine group over the placebo group out of 526,877 people. That is 1/0.00036, which is 27,778.

As Dr. Andy Bostom of Brown University points out, if children 12-15, on average, suffer a serious adverse event every 333 doses, that would add up to about 84 SAEs before you get to one life saved at roughly 27,700 doses.

But the risk vs. return is likely much worse than an 84:1 spread. Remember, the Israeli data covered vaccination for adults only. Now that adults already have access to the vaccine and anyone who is vulnerable is protected, there is zero benefit to going a step farther from the current baseline and vaccinating children. They are exponentially less likely to get seriously ill from the virus and are also much less likely to spread it. And again, any adult who is vulnerable is already vaccinated, so there is no value add to vaccinating kids. Thus, the number needed to treat to save a life at this point for children in a universe of vaccinated adults is likely much higher.

According to statute (21 U.S.C. §360bbb–3(c)(2)(B)), a medical product can only be offered under emergency use if "the known and potential benefits of the product, when used to diagnose, prevent, or treat such disease or condition, outweigh the known and potential risks of the product." There is simply no way this condition can be fulfilled with kids.

Remember, the vaccine companies are absolved of all liability. The entire justification for such a move is that the need for a vaccine is so compelling that we must override all norms related to research, development, and liability. How can anyone possibly say that the risk to children justifies the use of a truncated study period?

Now riddle me this: Why is it that they are rushing an experimental, never-before-used, mRNA on children who don't get critically ill from this virus, yet the government refuses to approve the use of ivermectin, which has been dispensed 3.7 billion times, even for seniors on ventilators with zero options? It takes a court order just to get hospitals to comply.

The answer is that they have to shut down all alternative treatments in order to approve the vaccine. The same statute ((c)(3)) states that the treatment, in this case the vaccine, can only be approved under emergency use if "there is no adequate, approved, and available alternative to the product for diagnosing, preventing, or treating such disease or condition." Were people to know that there are numerous early, middle, and late-stage treatments, it would nuke the market for the vaccines. As such, they must judge the early therapeutics, including those used regularly for other ailments, with an impossible standard, while rushing through the vaccines at all costs.

Haven't we used children enough to assuage our guilt the past year? Can we just leave them alone?
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