FDA Approves Bivalent Vaccine For Kids As Young As 6 Months Old. Why?

Arguably the greatest indictment of the corrupted federal drug regulating agency.

Photo by Spencer Davis on Unsplash

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Ten days ago, the FDA approved the bivalent booster for kids as young as 6 months old to 5 years of age. Both Moderna and Pfizer’s updated Covid inoculation will now be available to all children whose parents are willing to get them up-to-date with their vaccination.

This is precisely the problem.

Who exactly will line up to get their eight-month-old the extremely under-tested bivalent shot?

As Substack writer Justin Hart reports, a CDC phone survey from October showed which demographics were most likely to get their children vaccinated with the novel mRNA biotechnology: white, wealthy, college-educated, and Democrat-voting.

Statistically, this small group — likely comprising a mix of irrationally alarmed blue voters and perhaps some small number of parents with severely immunocompromised children (for whom Covid vaccination *arguably* makes sense) — is a tiny fraction of the American public.

According to the latest CDC data (as of Nov. 30), less than 3% of children under the age of two have gotten their first two mRNA vaccine doses. For children two to four years, the double-vaccination rate is less than 5%.

But these figures are for the primary mRNA vaccine series — for which there is at least some minimal understanding of safety and efficacy.

The benefits and harms of the bivalent vaccine remain largely unknown. The only real-world data in adults show rapidly declining effectiveness against infection at around 40% within the first 3 months (see table 2).

For children, that (hardly re-assuring and heavily confounded) number may be exponentially less meaningful since they are lowest at-risk. For all kids 0-19, the infection fatality rate is 0.0003%. Any deaths in the numerator (total infections would be the denominator) are limited to cases of severely ill and immunocompromised children.

Such deaths are so exceptionally rare, a rigorous German study published last winter — designed to capture all possible child Covid deaths — couldn’t find a single healthy child who died of Covid in the Western European county. Including children with underlying health conditions, only six in between the ages of five and eighteen died of Covid. There are roughly 10 million children in Germany. As the researchers state, the death toll was so infinitesimally low, a case fatality rate couldn’t be established:

The lowest risk was observed in children aged 5-11 without comorbidities. In this group, the ICU admission rate was 0.2 per 10,000 and case fatality could not be calculated, due to an absence of cases.

To give a sense of how rare child Covid deaths are in an American context, last year alone more black children 18 and under died by gunfire than all American kids have died of Covid in all three years of the pandemic so far.

(Prior to my Covid coverage, I used to extensively report on inner-city violence in cities such as Minneapolis and Philadelphia so I’m especially sympathetic to this issue. As a society, our priorities are not straight. Gun violence is a real problem affecting children in many places — Covid is not.)

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Based on the most up-to-date statistics, the number of parents who will get their young kids the bivalent vaccine will likely be less than 1%. For all American citizens, the bivalent vaccine uptake rate is abysmally low at 14% according to latest CDC figures.

The FDA — which receives 75% of its drug review funding from the biopharmaceutical industry — has turned itself into a laughing stock.

In the new FDA press release, Commissioner Robert M. Califf stated:

“More children now have the opportunity to update their protection against COVID-19 with a bivalent COVID-19 vaccine, and we encourage parents and caregivers of those eligible to consider doing so….The more people who keep up to date on COVID-19 vaccinations, the more benefit there will be for individuals, families and public health by helping prevent severe illnesses, hospitalizations, and deaths.”

Is there any clinical evidence to support these scientific assertions?

The very same FDA press release states, “The data to support giving an updated bivalent booster dose for these children are expected in January.”

How can the commissioner of the world’s premier drug regulating agency assert that mass-administering an experimental medical product in the lowest-risk population will “prevent severe illnesses, hospitalizations, and deaths” a month before any data is available?

Is this a science agency or a fundamentalist propaganda arm for Pfizer?

The FDA press release openly states what data they used to approve the bivalent shot in children, such as previously published “immune response data in adults greater than 55 years of age” and the “effectiveness of primary vaccination with the monovalent Pfizer-BioNTech COVID-19 Vaccine.”

None of these data points give any concrete indication of what the safety and efficacy of the new bivalent vaccine will be in children.

Fortunately, as recent trends suggest, the end of mRNA Covid vaccination is near. Alarmism and fear cannot be endlessly sustained. Virtually all Americans understand the pandemic is over and their kids are the least vulnerable.

As public interest for new boosters reaches close to zero, it remains to be seen how the Biden administration will pivot as it still has a largely unused reservoir of 170 million bivalent vaccines. However, one reality is unavoidable: Moderna and Pfizer’s record-high profits are well behind them — and Covid panic can no longer be exploited for monetary gain.

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An earlier version of this article was published in Maajid Nawaz’s Substack