The Wall Street Journal Sunday took vaccine makers and federal agencies to task for pushing the bivalent COVID-19 boosters without having any data to demonstrate that they are either safe or effective. Today, the U.S. Food and Drug Administration said it is eyeing changes to the booster program.
The Wall Street Journal (WSJ) Sunday took vaccine makers and federal agencies to task for pushing the bivalent COVID-19 boosters without having any data to demonstrate that they are either safe or effective.
In an op-ed, Allysia Finley, a WSJ editorial board member, said people shouldn’t be surprised by the “deceptive advertising” touting the boosters on radio stations across the country, which is sponsored by the U.S. Department of Health and Human Services.
“Federal agencies took the unprecedented step of ordering vaccine makers to produce them and recommending them without data supporting their safety or efficacy,” she wrote.
Today, the U.S. Food and Drug Administration (FDA) posted a briefing document indicating it wants to change the COVID-19 vaccine protocols by simplifying the composition of the vaccines, the immunization schedule and decisions about how the vaccines are updated.
The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) is scheduled to meet on Thursday to discuss the future of COVID-19 vaccine regimens, and will be asked to vote on whether they recommend parts of the FDA’s plan.
Finley: 3 problems with ‘tweaking’ mRNA vaccines
According to Finley, the idea behind the mRNA technology was that vaccine makers could quickly “tweak” the genetic sequences in the vaccines to target new variants. The bivalent vaccines targeted a combination of the original Wuhan strain and the BA.4 and BA.5 Omicron variants.
But, she wrote, three major scientific problems have emerged. First, the virus evolves faster than the vaccines can be updated.
Second, the vaccines have “hard-wired” people’s immune systems against the original strain, so they “churn out fewer antibodies that neutralize variants targeted by updated vaccines.”
Third, the antibodies that are produced wane quickly — within just a few months.
Finley outlined several recent studies as evidence, beginning with two studies in the New England Journal of Medicine (NEJM) showing that bivalent boosters did not produce significantly more neutralizing antibodies against the BA.4 and BA.5 variants than the original boosters.
The authors hypothesized that immune imprinting “may pose a greater challenge than is currently appreciated for inducing robust immunity against SARS-CoV-2 variants,” Finley explained.
In other words, a person’s first exposure to a virus shapes the outcome of subsequent exposures to antigenically related strains.
That means people who received the original vaccine were “primed” to respond to the Wuhan strain and “mounted an inferior antibody response to other variants,” as University of Pennsylvania’s Dr. Paul Offit explained in a NEJM article.
The findings contradict press releases from Pfizer and Moderna claiming the bivalent vaccines produced a response to the Omicron variants that was 4 to 6 times better than that of the original boosters.
Neither vaccine maker conducted randomized trials. Instead, “the vaccine makers designed their studies to get the results they wanted,” Finley said.
They did this by testing the original and bivalent boosters at different times during the Omicron surges and by testing for antibodies at different time intervals for the two boosters, which allowed them to select for data that backed their claims.
Despite the flawed studies, “public-health authorities didn’t raise an eyebrow,” Finley said, “but why would they? They have a vested interest in promoting the bivalents.”
In June 2022, the FDA told the vaccine makers to update the boosters against BA.4 and BA.5. They then rushed to authorize the bivalent boosters before clinical data were available, as The Defender reported.
CDC recommended bivalent boosters without clinical trial data
The Centers for Disease Control and Prevention (CDC) also recommended the bivalents without any clinical trials.
Vaccine makers could have performed small randomized trials by the end of last September, but instead, public health officials rushed the vaccines, according to Finley.
“And now we know why,” she wrote.
In November, the CDC published a study finding that at peak efficacy — which waned quickly — the bivalents were only 22% to 43% effective against infection.
Another CDC study in December reported the bivalent booster showed high efficacy against hospitalization among boosted seniors relative to seniors who were unvaccinated or had the original booster.
But neither study controlled for confounding factors. And many experts, Finley said, “after zealously promoting the bivalents,” have criticized the studies.
Even the FDA seems to be backpedaling on its claims, she said.
“There’s a growing consensus that we need better vaccines and treatments to protect those still at risk. But we also need honest public-health leaders,” Finley concluded.
This wasn’t the first time Finley wrote an op-ed critical of the COVID-19 vaccines. In July 2022, she questioned the rush to approve the shots for toddlers. And earlier this month, she detailed evidence suggesting the COVID-19 vaccines may be fueling new variants.
FDA admits data on boosters ‘complicated,’ but plans to recommend yearly boosters
According to the FDA, only approximately 16% of eligible Americans over the age of 5 have received the bivalent booster.
The agency’s new briefing document said there are now “multiple studies describing neutralizing antibody responses” to the bivalent boosters.
Conceding many of the points Finley made, the agency said:
“Interpreting the data from these studies is complicated because of the limited sample size, the variability in the assays used and the status of assay qualification, the populations tested, and the intervals between vaccination and serum collection.”
It added, “Their [the boosters] deployment has been associated with significant implementation complexities.”
Despite this, the FDA concluded, “Both of the bivalent mRNA vaccines have been demonstrated to produce improved neutralizing antibody responses to the BA.5, BQ.1.1, and XBB variants as compared to the original vaccines.”
Yet, the report urged a shift in vaccine composition and delivery to “reduce complexity” in the process.
The new plan will recommend one yearly booster shot, although it recommends two doses of the shot for very young children and the elderly.
The FDA said it expects to assess the evolution of COVID-19 annually to determine which strains to vaccinate for, a process they likened to the one followed for the flu vaccine.
Experts, including Dr. Vinay Prasad, have already raised concerns about this approach, arguing that the vaccines will “always be chasing the last variant.”
Dr. Céline Gounder, a senior fellow at the Kaiser Family Foundation, today told NPR, “It’s unclear whether updating the booster formulations and repeatedly boosting people is the most effective approach to controlling COVID at this stage.”
“I’d like to see some data on the effect of dosing interval, at least observational data,” said Dr. Eric Rubin, one of the FDA advisers and editor-in-chief of the NEJM told The New York Times. “And going forward, I’d like to see data collected to try to tell if we’re doing the right thing.”
Despite conceding the failures of existing data, the documents don’t address the question of new randomized trials, existing and widespread concerns about vaccine side effects or the fact that the vaccines do not stop the spread of disease.
CHD posted a call-to-action for the public to submit comments to the VRBPAC prior to Thursday’s meeting.
Dr. Meryl Nass, a member of CHD’s scientific advisory committee, will live blog the Thursday meeting here.
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They gonna need a bigger UFO hoax.
Dr. Peter McCullough: ‘Justice Will Have to Come’ for the FDA
“The FDA caused harm,” expressed
@P_McCulloughMD
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“The FDA’s actions [horse paste propaganda] led to unnecessary deaths. And I think justice will have to come. The FDA now should be broadly sued.”
@VigilantFox
United States Government has to be the most corrupt organization in the world.
They will be happy to pay for many NGOs to publish reports to the contrary.
Chasing the tiger by its tail.
I hope people wake the Hell up.
The whole fucking government is completely off the rails for everyone to see.
We simply must abolish the state for the rest of all time – out of unambiguous self-defense. Birx has even PUBLISHED her full confession to unprecedented crimes in her bloody book! I mean, Nuremberg 2.0, already!
EXCERPT:
Unlike the pretentious “Dr.” Jill Biden, Ron Paul is a real doctor—a physician—and thus is in an excellent position to expose the lies behind Covid: “After two years of unprecedented government tyranny in the name of fighting a virus, the prime instigators of this infamy are walking free, writing books, and openly pretending they never said the things they clearly said over and over.
Take Trump’s White House Covid response coordinator Deborah Birx, for example. She was the principal architect of the disastrous ‘lockdown’ policy that destroyed more lives than Covid itself. Birx knew that locking a country down in response to a virus was a radical move that would never be endorsed. So, as she admits in her new book, she lied about it.
She sold the White House on the out-of-thin-air ‘fifteen days to slow the spread’ all the while knowing there was no evidence it would do any such thing. As she wrote in her new book, Silent Invasion, ‘I didn’t have the numbers in front of me yet to make the case for extending it longer, but I had two weeks to get them.’
She was playing for time with no evidence. As it turns out, she was also destroying the lives of millions of Americans. The hysteria she created led to countless businesses destroyed, countless suicides, major depressions, drug and alcohol addictions. It led to countless deaths due to delays in treatment for other diseases. It may turn out to be the most deadly mistake in medical history.
As she revealed in her book, she actually wanted to isolate every single person in the United States! Writing about how many people would be allowed to gather, she said: ‘If I pushed for zero (which was actually what I wanted and what was required), this would have been interpreted as a “lockdown”—the perception we were all working so hard to avoid.’
She wanted to prevent even two people from meeting. How is it possible that someone like this came to gain so much power over our lives? One virus and we suddenly become Communist China?
Last week in a Fox News interview she again revealed the extent of her treachery. After months of relentlessly demanding that all Americans get the Covid shots, she revealed that the ‘vaccines’ were not vaccines at all!
‘I knew these vaccines were not going to protect against infection,’ she told Fox. ‘And I think we overplayed the vaccines. And it made people then worry that it’s not going to protect against severe disease and hospitalization.’
So when did she know this? Did she know it when she told ABC in late 2020 that ‘this is one of the most highly-effective vaccines we have in our infectious disease arsenal. And so that’s why I’m very enthusiastic about the vaccine’?
If she knew all along that the ‘vaccines’ were not vaccines, why didn’t she tell us? Because, as she admits in her book, she believes it’s just fine to lie to people in order to get them to do what she wants.
She admits that she employed ‘subterfuge’ against her boss – President Donald Trump – to implement Covid policies he opposed. So it should be no surprise that she lied to the American people about the efficacy of the Covid shots.
.
When in the actual fuck will we arrest these miscreants and try them for crimes against humanity? How could this possibly be continuing? CBDC financial lockdowns seem likely to begin any month now, and they’re working on lacing foodstuffs with vaxes (and who knows what they’re spraying us with from the weather-mod apparatus).
Yes, it is a criminal syndicate.
It’s complicated maintaining a continual psy-op. The lies get harder and hard to keep believable.
That’s the problem with lies….
Yes, but even your future will eventually become the past. Face it. Lies are all around us, past, present and future. If you walk in the Light, at least you can see them!
Dominoes clicking over one by one. All set up before hand like a plot twist. Vaxx-19 was never supposed to work, it was always supposed to fail spectacularly after enough billions were injured/culled so that USA would be financially and reputationally destroyed. The goal, the whole time, was for US govt to be sued world-wide for inevitable vaxx-19 damages, (which explains why Israel sacrificed a few million peasants), which would dilute our currency through hyper-inflation, which then blows up financialized derivatives bomb, trashing the world economy, VOILA… world wide reset, and globalist to the rescue with regionally locked digital currency, UBI slavery, bug paste, and Zelensky-like Mayor of Clown World anti-christ figure to rub it in for build back bitter laughs.
I hate it, but there it is. T.Fauci, R.Walensky, Trump (his Judas Goat advocacy makes sense in this theory), et al just played the role of stupid authoritarian cheerleader for MSM sausage making along a necessary time window (2 years) while dealing out the real weapon, the “cures”.
I think the semi-serious flailing around at Russia’s expense in Ukraine and poking China with Taiwan is just to soak up time until CDC/NIH/DoD/Pfizer/Moderna carnage really starts sinking into all the national psyches that allowed American aid, rescue, advice. US managed the Gain-of-Function advances and funded vaxx-19 development through DoD Warp Speed. Our Reps foot-dragged the whole discovery thing, courtesy an engineered 2020 election to stack the committees, but they allowed Sen. Paul to solo tilt at windmills a bit. Yes, WHO will be dismantled but our country will bear the brunt of the rage (as a certain losing side did 80 years before us).
Other countries, no matter how culpable their own govts, will make us own it all, if only to deflect from their not doing proper diligence or acceptance of our institution’s bribes/favors. We’ve been had, amigos. The tell of this con was the globally coordinated fear mongering of COVID-19’s actual risk, the organized Ivermectin suppression by untraceable threats to docs and pharmacists, and censorship of DoD research lab tinkering/origins.
Why do this? What motive? A criminally insane cabal successfully made their stain on history, but will be remembered forever for this apex crime using only stagecraft machinery and a tiny bit of poison for children. So easy to forget high-functioning psychopaths don’t care about people, they aren’t burdened with empathy. They are burdened with boredom and thrill-seeking at other’s expense. Maybe Epstein organized them into a hierarchy.
None of the crap has worked and we are still talking about this as if it really has some importance. It does not. You want justice then take action.
FDA has got nothing to do with it.
It’s been a DoD operation from the beginning.
‘Complicated’ – not showing the results we wanted
Or, we need more time to lie some more.
But, she wrote, three major scientific problems have emerged. First, the virus evolves faster than the vaccines can be updated.
They already claimed at NHS that corona rna rna viruses mutate every generation/10 hours.
One researcher recently repeated one of the most inconvenient truths: the IFR for this flu is 0.023% … less than 1 in 400 people who get this flu die from it — and, as others have admitted time and time again, more than 85% of those dying from it are elderly (over 80) with 4 or more comorbidities.
I also recall from 3 years ago when practicing physicians and medical researchers tried to warn US that you do not — cannot — vaccinate your way out of a ‘pan(dem)ic’ … the best course is to let nature take its course via ever-weakening strains of the ‘virus’ …
The only ‘testing’ on the newest bi-valent jabs was on 8 mice … and even then BigPharma lied to US about the outcomes.
So many practicing physicians and medical researchers have pointed out since the November, 2020, release of the original PFE data (conveniently delayed until after the election so that Trump would lose) that PFE totally lied about the numbers — totally misrepresented what the data actually showed … playing fake ‘statistics’ games.
And, of course, all of this wouldn’t have been so very important if TPTB had just let practicing physicians treat symptoms … via IVM or HCQ or any of the other means at their disposal.
But, of course, that would have meant that the NWO would have been delayed … that the biomedical surveillance state would have not happened to US right now … that BigPharma wouldn’t have made hundred$ of billion$ of dollar$ in profit$ from these fake jabs … that the WHO wouldn’t be in the position to be pushing a treaty from every Sovereign Nation on the planet to submit to its whims and its goals and its agendas … ‘by any means necessary’.
They could have had this discussion 18 months ago and had the same conclusions. Money talks around the CDC and FDA. All officials of these two organizations and their Boards of Directors should be removed now. They can await their trials later.