Instead of admitting that novel genetic therapeutics against Covid ultimately failed to end the pandemic, the United States federal government is doubling down by attempting to make the shots a seasonal routine.
On Monday, the U.S. Food and Drug Administration (FDA) revealed its intention to task its vaccine advisory panel (VRBPAC) with weighing a proposal to make a single Covid jab an annual immunization routine for most Americans in order to “simplify” the immunization schedule. Along with “harmonizing the vaccine strain composition” of primary series and booster doses among different vaccine brands, the agency expects such changes would “contribute to more facile vaccine deployment, fewer vaccine administration errors, and less complex communication, all potentially leading to improved vaccine coverage rates and, ultimately, to enhanced public health.” Note carefully the word “potentially” in the statement.
Indeed, top health officials have shown their frustration with the low appetite for the updated boosters among the “eligible” populace. According to the U.S. Centers for Disease Control and Prevention (CDC), while nearly 70 percent of Americans have completed their “primary” vaccination series, only 16 percent of those over the age of 5 have gotten the updated bivalent boosters that were given emergency use authorization (EUA) last August.
The U.S. Department of Health and Human Services (HHS), for example, has taken to social media to “warn” people of all ages that they aren’t protected without a bivalent booster.
“It’s impossible to predict how COVID will affect your kids,” one HHS message says, claiming children are at risk from “Covid’s worst outcomes” without a booster. Another ad targets college students.
A post for a general audience claims that both vaccinated and previously infected people risk “severe illness, hospitalization and death from Covid” if they don’t take an updated booster.
Some Twitter users expressed their skepticism that the HHS has any data to support these claims.
As for the complexity of the official Covid immunization advice, it is, indeed, hard to keep up with. Most Americans are recommended to first get two doses of the original jabs spaced at least three to four weeks apart, followed by a booster dose a few months later.
Pfizer’s and Moderna’s primary vaccinations for children and immunocompromised people involve three doses followed by a bivalent shot two months later.
Now, the FDA is trying to make it “easy”:
Review of the totality of the available evidence on prior exposure to and vaccination against SARS-CoV-2 suggests that, moving forward, most individuals may only need to receive one dose of an approved or authorized COVID-19 vaccine to restore protective immunity for a period of time.
At the same time, however, the agency is proposing two shots a year for “certain young children,” the elderly, and the immunocompromised.
Notably, if the panel votes in favor of the proposal, Pfizer and Moderna bivalent shots would be used for all Covid inoculations, the primary series as well as the boosters.
The lack of scientific evidence to support the move was pointed out over the weekend by, among others, The Wall Street Journal in a concise, well-documented opinion piece by Allysia Finley, who identified three major issues with the poor efficacy of mRNA Covid shots.
The most distinctive advantages of the mRNA technology were, presumably, its plasticity and timeliness — the vaccine makers were said to be able to quickly “tweak” the genetic sequences in the formulations to target new variants as they occurred.
This assumption was shredded by reality.
First, the virus’ mutation outpaces the speed at which shots can be tested and produced, which was evident back in August 2021, when “breakthrough Covid cases” became commonplace.
Second, the doses of the original formulations have “hard-wired” people’s immune systems against the Wuhan strain that has long ceased to exist, leaving people to “churn out fewer antibodies that neutralize variants targeted by updated vaccines,” said Finley, and “[mount] an inferior antibody response to other variants,” as VRBPAC member Dr. Paul Offit postulated in a recent NEJM article.
Another NEMJ study quoted by Finley similarly suggested that “immune imprinting by previous antigenic exposure may pose a greater challenge than is currently appreciated for inducing robust immunity against SARS-CoV-2 variants.
Third, the antibodies that are produced as a result of boosting are extremely short-lived, waning within just a few months. Therefore, the 12-month interval between the doses seems rather arbitrary.
Finally, one must consider the health implications of continuous boosting. The latest data suggest that the more doses one receives, the more likely he is to catch Covid. According to a large pre-print Cleveland study, a higher number of doses received directly correlates with a higher rate of Covid infections.
And there’s another methodological flaw in the FDA’s approach: Its preoccupation with the measurement of antibodies makes little sense in terms of ensuring the shots’ actual ability to protect a recipient from the “worst Covid outcomes.”
“Antibodies elicited by these products (I hesitate to call them vaccines) are not proven in any way to be the thing that provides protection, to infection, replication, spread, disease or death,” notes Dr. Robert Malone, a pioneer of mRNA platform technology.
On top of concerns about the efficacy and timing of the boosting, the FDA has continually demonstrated uninterest in addressing glaring signals of vaccine side effects, other than weighing in on the risk of stroke in Americans older than 65 after receiving a Pfizer shot.
The scenario of annual Covid vaccinations was “predicted” back in 2021 by Pfizer CEO Albert Bourla. And in May 2022, top FDA officials published an article entitled “COVID-19 Vaccination — Becoming Part of the New Normal,” in which they wrote,
It is time to accept that the presence of SARS-CoV-2, the virus that causes COVID-19, is the new normal. It will likely circulate globally for the foreseeable future, taking its place alongside other common respiratory viruses such as influenza.
Joe Biden expressed his “expert” opinion on annual vaccinations in October, when apparently receiving his bivalent booster. He said, “For most Americans, one Covid shot each year will be all they need,” adding, “And if you get it, you’ll be protected. And if you don’t, you’re putting yourself and other people at unnecessary risk.” Well, the data suggest that it is the other way around.
VRBPAC’s meeting to consider the proposal will be held Thursday, Jan. 26. The agenda, live feed, and other materials can be found here.