In September, The New England Journal of Medicine (NEJM) published a new Moderna-sponsored study
on the efficacy of the initial bivalent vaccine targeting BA.1 in comparison to the original monovalent booster.
The primary focus of the study—antibody titers—shows seemingly positive results. In all groups (Omicron being of greatest interest), the bivalent shot created higher antibody levels than the monovalent booster shot.
Based on this finding, the authors conclude, "The bivalent omicron-containing vaccine mRNA-1273.214 elicited neutralizing antibody responses against omicron that were superior to those with mRNA-1273."
Not so fast. There are a number of serious concerns from the study.
First, there was no statistically significant difference in incidence of COVID-19 cases in either arm. In fact, the bivalent group had a higher number
of COVID-19 cases compared to the original booster. As Dr. Tracy Beth Hoeg noted
, in the group without natural immunity, the bivalent arm had three times as many cases as the monovalent arm.
The study sample is quite small (812 participants), so it's entirely unclear if the bivalent shot confers any protection or not.
The demonstrated superior antibody levels and seeming ineffectiveness against infection may appear contradictory, but the two metrics are loosely connected. There's no clear understanding of what levels of antibodies are needed to confer SARS-CoV-2 immunity.
Even though the nebulous endpoint of increased antibody titers was used in the initial Moderna and Pfizer trials, both the Food and Drug Administration
and Centers for Disease Control and Prevention
explicitly recommend against testing antibodies to determine immunity post-vaccination. Moreover, Pfizer has conceded there is “no established correlate of protection” between antibody levels and immunity. Needless to say, reams of real-world data also show the unreliability of broadly deploying vaccines based on antibody studies.
More alarming than unknown bivalent effectiveness is the mounting evidence of "immune imprinting"—a concern initially flagged
by the European Union regulators. As vaccine proponent Eric Topol highlights
in his unusually sober-minded analysis of the bivalent shots, there is a "disturbing trend of much lower antibody induction vs Omicron compared to that mounted against the ancestral (original) strain."
Topol writes, "[I]t’s certainly a concern that there are not much higher levels of neutralizing antibodies, with this metric considered as a surrogate marker for protection vs severe Covid."
Another major problem of the study was its assessment of "safety"—one of its "primary objectives." No "evident safety concerns" were found, but again, the sample size of the study was in the hundreds. The most documented serious adverse event—heart inflammation—occurs, at most, at a rate of 1 in 1,800
in young males. The bivalent arm of the study contained a mere 437 participants (of which 179 were men).
Recall this study tests the BA.1-targeted vaccine. The White House is currently pushing the new BA.5-targeted shot
—which we have no human data for—on all Americans 12 and over. The concerns based on initial human data in the earlier bivalent vaccine are doubly alarming given all the unknowns with this novel version being blindly distributed to the public. If the White House and FDA have become completely corrupted, one may expect public health experts regularly appearing on top media networks to sound the alarm.
However, that doesn't seem to be the case. While a few are starting to wake up, the most influential vaccine promoters continue to plunge into collective psychosis. President Joe Biden appears to have accidentally declared an end to the pandemic, but unvaccinated foreigners are still barred from entering, and, most egregiously, a number of elite universities have announced mandatory bivalent vaccines for all undergraduate students.
Let us hope the evidence against mass administration of mRNA vaccines becomes incontrovertible to the point that vaccine zealots don’t have a modicum of defense.
Views expressed in this article are opinions of the author and do not necessarily reflect the views of The Epoch Times.