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The first case of Omicron in the U.S. was reported on Dec. 1, 2021. As of Dec. 25, 2021, the Centers for Disease Control and Prevention (CDC) estimates Omicron accounts for 58.6% of SARS-CoV-2 infections in the U.S.

Omicron’s rapid emergence is indicative of the variant’s increased transmissibility and the lack of efficacy vaccines have against this strain.

The predominance of the Omicron variant prompted the Office for the Assistant Secretary of the U.S. Department of Health and Human Services (HHS) to pause allocation of two commonly used monoclonal Antibody therapy combinations — bamlanivimab/etesevimab (Eli Lilly) and REGN10933/REGN10987 (Regeneron) — to regions of the country that have greater than 80% prevalence of the Omicron variant.

According to HHS, “These two products are not expected to be effective in patients infected with the Omicron variant…”

Monoclonal antibodies are synthetic. They can substitute for vaccine-induced or naturally produced antibodies in response to an infection. They generally are reserved for patients who have a high risk of serious complications from a known or probable infection.

If the CDC estimates of Omicron predominance are accurate, then this decision would be sensible given these antibody therapies have been demonstrated to have little neutralizing activity against the Omicron variant compared to the original Wuhan strain.

Table 1
Table 1 taken from Gruell et al.

Omicron evades vaccinal antibodies, too

Cameroni et al found that sera taken from individuals fully inoculated with Pfizer’s vaccine demonstrated a 44-fold drop in neutralizing against Omicron compared to the original Wuhan strain.

This staggering decline is not surprising. The SARS-CoV-2 Omicron variant harbors at least 37 amino acid substitutions in the spike protein, 15 of which are in the receptor-binding domain (RBD).

The RBD of the spike protein is the major target of mRNA vaccine-induced antibodies.

Omicron’s predicted ability to evade vaccine-mediated protection is confirmed in this early study where Pfizer’s vaccine effectiveness against symptomatic infection dropped to 34% – 37% within 15 weeks from the second dose.

Comparatively, two doses of Pfizer continued to have 63.5% effectiveness against the Delta variant 25 weeks after dose two.This article, also in preprint, provides an analysis of data taken from Danish nationwide registries. It demonstrates that both the Pfizer and Moderna vaccine’s efficacy against Omicron was nearly zero within 60 – 90 days, entering well into the negative range thereafter:



A negative efficacy means the vaccine causes an increased risk of infection.

Although the analysis is small, preliminary and has not been corroborated by larger studies, it does pose important questions especially given how large the negative effect seems to be.

FDA, CDC at odds with each other and themselves

On Oct. 29, 2021, the U.S. Food and Drug Administration (FDA) extended Emergency Use Authorization of the Pfizer-BioNTech COVID-19 Vaccine for the prevention of COVID-19 to include children 5 through 11 years of age.

This decision is scientifically, empirically, logically and ethically indefensible as explained here by Toby Rogers, Ph.D. Pfizer’s claim of 90.7% vaccine efficacy in this age group is based on a total of 19 children (three in a group of 1,450 vaccinated and 16 in a group of 736 placebo recipients) who developed mild symptoms during the brief trial.

No child in the trial died or required hospitalization from COVID. Without any clinical outcomes of significance, no meaningful calculation of vaccine efficacy can be made.

These results should have ended any consideration of granting Pfizer authorization of its product in this age group. Pfizer’s trial essentially proved the drugmaker’s COVID vaccine, when appropriately dosed and tested against placebo in a randomized study of young children, would reduce the risk of developing common cold symptoms by approximately 2%.

With the FDA’s audacity on full display to anyone paying attention, the agency instead chose to infer a prevention effect against hospitalization and death based on antibody levels that were suggestive of protection in 16- to 25-year-olds.

Beyond the leaps of logic and apparent disinterest in scientific rigor — why would any medical regulatory body simply assume the same antibody levels in a 5-year-old and 25-year-old will result in the same risk of hospitalization or death from COVID without any evidence? — this unjustified assumption allowed Pfizer and the FDA to avoid taking the appropriate and necessary action: conducting a bigger and longer trial.

Bringing in more participants and waiting for meaningful clinical outcomes would, of course, potentially clarify any risk of the intervention as well.

Though the CDC and FDA decided to allow Pfizer to make this monumental assumption in its underpowered trial, the FDA has long urged the public to not use antibody levels as a measure of immunity.

The CDC also echoes this position in the executive summary of its COVID-19 Science Brief which was released, ironically, on the very same day the FDA granted Pfizer emergency use authorization for children: “Data are presently insufficient to determine an antibody titer threshold that indicates when an individual is protected from infection.”


Today our country is facing a new antibody-resistant strain in Omicron, and our medical authorities’ internally inconsistent and conflicting approach is impossible to overlook.

They have sensibly guided patients and providers away from some interventions that will probably not work. After all, why use monoclonal antibody infusions that have little benefit and only risk?

On the other hand, current vaccine formulations also have waning efficacy, especially against Omicron, yet the pressure to vaccinate at any cost continues unabated.

Furthermore, monoclonal antibody therapies are usually reserved for those having the highest risk of severe disease after an infection when known exposure to the virus has been confirmed, while vaccinations are implemented as a preventive measure on the general public and now young children, who have the lowest risk for hospitalizations and death from SARS-CoV-2 infection.

In other words, from a risk/benefit perspective it is more logical to continue monoclonal antibody infusions, even if they are only marginally effective, and halt childhood vaccinations immediately.

The CDC’s and FDA’s mystifying position can only be the result of their systematic denial of any possibility of vaccine adverse events despite the enormous and mounting evidence to the contrary.