FDA Approves Bivalent Vaccine For Kids As Young As 6 Months Old

That Same FDA Receives 75% Of Its Drug Review Funding From The Biopharmaceutical Industry

FDA Approves Bivalent Vaccine For Kids As Young As 6 Months Old

That Same FDA Receives 75% Of Its Drug Review Funding From The Biopharmaceutical Industry

On Thursday, the FDA approved the bivalent vaccine for kids as young as 6 months old to 5 years of age. Both Moderna and Pfizer’s updated Covid inoculation will now be administered 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 two-year-old the highly experimental 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: white, wealthy, highly educated, and Democrat-voting.

Statistically, this minority group likely comprising a mix of irrationally alarmed blue voters and perhaps some 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 understanding of safety and efficacy.

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

Table 2:

For children, that number may be far lower as they are lowest at-risk.

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 11%.

KBirb @birb_k

Administration of the 171 million mouse-tested bivalent boosters remains sluggish, with 24% and 38% week-over-week drops in last 2 weeks. White House announces a “six week sprint” to increase vax uptake, with a $474 million taxpayer funded campaign (ads during World Cup, etc.) 1/

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,” he added.

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?

The FDA press release openly states what data they used to approve the bivalent shot in children, such as previous analyses “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 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.