FDA Advisors Admit They're 'Angry' With Moderna For Not Revealing Data Showing New Boosters Weren't More Effective
Just a few months ago, new bivalent boosters rolled out to the public in the latest attempt to prevent the unpreventable.
After years of mass vaccination with mRNA products from Pfizer and Moderna and endless masking, COVID was still spreading, defying expert expectations.
But the bivalent boosters were targeted to the dominant strain of the virus at the time. Despite the fact that the virus is continuously mutating, the new formulation led to expectations from experts like Dr. Fauci that it would significantly outperform previous doses targeted to earlier strains.
During an interview with The Hill last summer, Fauci said that using Omicron specific boosters would be significantly more beneficial.
“As we get into the fall, you’d want to boost with a BA.5 — so that if you get BA.5 or something closely related to that, you will enhance the immunity against that particular variant."
According to Fauci, this meant that they were the country's "best guess" at slowing the spread heading into fall and winter.
His assertions were backed up by other experts like Dr. Ashish Jha, the head of the White House COVID response.
Jha spoke to the American Medical Association last fall about the bivalent booster and the rationale behind it. He stated that effectiveness of the original vaccines against infection and transmission had waned, but that new boosters would recover that benefit.
"But over time, we saw vaccine effectiveness against infection and transmission slowly get chipped away by viral evolution. And what that meant in my mind very clearly, and certainly the minds of the scientists at NIH and FDA, was we needed to make an update. And when Omicron hit, that decision was made by companies, that we needed to make an update. They built a bivalent vaccine.
And so when it comes to this decision—first of all, it clinically makes all the sense in the world. You want a vaccine that targets the virus out there, not the virus that was around two and half years ago. But the evidence behind it is actually quite strong," Jha said.
According to him, the "evidence behind it is actually quite strong."
Both of these powerful, influential bureaucrats immediately pushed for every eligible American to get the new, updated booster dose. The expert community at large also assured the public that it would dramatically reduce the risk of infection and transmission among vaccinated people. Claiming that there was substantial evidence supporting that assertion.
Which makes recent news that much more predictable.
CNN reported Wednesday that Moderna hid data on the rate of infections among those who got the updated booster compared to the original shots. That data, which was not presented to the authorization committee, showed the new dose may not be any more effective at preventing infections than the original vaccination series.
WASHINGTON, DC - MAY 17: Director of the National Institute of Allergy and Infectious Diseases Dr. Anthony Fauci testifies during the Senate Appropriations Subcommittee on Labor, Health and Human Services, and Education, and Related Agencies hearing to examine proposed budget estimates for fiscal year 2023 for the National Institutes of Health on Capitol Hill on May 17, 2022 in Washington, DC. (Photo by Shawn Thew-Pool/Getty Images)
Moderna Hid Data on Booster Efficacy
According to CNN, the data Moderna neglected to present showed that among study participants, rates of infection were higher amongst those who got the bivalent booster.
"It found that 1.9% of the study participants who received the original booster became infected. Among those who got the updated bivalent vaccine – the one that scientists hoped would work better – a higher percentage, 3.2%, became infected."
That data is shocking considering Ashish Jha claimed the "evidence behind it" fixing waning efficacy against infection and transmission was quite strong. Not to mention Fauci's reassurances that vaccinating specifically against a variant would lead to enhanced immunity.
Several government advisors said they were "disappointed" and "angry" to learn that Moderna didn't present the results during meetings last year.
Dr. Paul Offit, one of the members of the Vaccines and Related Biological Products Advisory Committee who helps advise the FDA on vaccine authorizations, expressed his frustration.
“I was angry to find out that there was data that was relevant to our decision that we didn’t get to see,” Offit said. “Decisions that are made for the public have to be made based on all available information – not just some information, but all information.”
Even though the data was collected early on and had several limitations, the lack of transparency was extremely concerning. Especially considering the massive price taxpayers paid to purchase doses of the new boosters.
Last summer, the U.S. Department of Health and Human Services announced that the Biden administration had purchased 66 million doses of the Moderna booster. That agreement included the option to buy hundreds of millions more doses with additional funding from Congress.
After spending billions to purchase the new booster doses, which have gone mostly unused, the Biden administration then unsuccessfully spent $475 million on a marketing campaign to persuade the public to take it.
Billions of taxpayer dollars going to purchase and promote a booster with data behind it showing higher rates of infection compared to those who took previous doses. Data that the pharmaceutical company involved in producing it purposefully hid from regulators.
It's not hard to see why Moderna executives were able to purchase hyper luxury homes so easily.
READ: MODERNA EXECUTIVES SPENT MILLIONS ON LUXURY HOMES DUE TO COVID VACCINE SALES
Increasing Distrust of The Experts™
Even staunchly pro-vaccine experts expressed disbelief that Moderna would not present a full and complete picture of the data.
CNN quoted William Schaffner, an infectious disease specialist at Vanderbilt saying the data was "informative" and should have been included.
"The data are limited, but they are informative, and I think one would have anticipated that a complete presentation would have included them,” said Schaffner.
Another former FDA vaccine expert concurred with that assessment.
“The company’s failure to present this information at the and the omission of discussion about the data at that meeting raises questions about the ability of the process to provide a full and transparent review of the data,” said Philip Krause, former deputy director of the FDA's Office of Vaccine Research and Review.
Despite the lack of "full and transparent review," the FDA and CDC rushed to authorize the bivalent boosters for children as well.
Krause continued by expressing concern that public trust in the FDA would likely be harmed by this revelation.
“That’s the critical thing,” Krause added. “The FDA’s objective review of the data is what is providing the great, great value to the American people, because this way they know that somebody who doesn’t have a stake in the outcome has looked at the deepest possible level at these data.”
Months ago, it was glaringly obvious that the new boosters were not nearly as effective as Fauci and Jha originally claimed.
READ: NEW COVID BOOSTER SHOTS DON’T WORK AS WELL AS ‘EXPERTS’ CLAIMED
CNN also quoted another professor involved in authoring a study showing the concerning lack of efficacy to the new boosters.
“We essentially see no difference” said Dr. David Ho, a professor of microbiology and immunology at Columbia. Within a month of receiving the bivalent booster, Ho's research found there was virtually no difference between the updated version and the original series.
But "experts" rushed full steam ahead into relentless promotion of the boosters, regardless. Fauci told the American people with his closing message that the most important thing they could to protect their families was to get the new booster.
Yet outside advisors like Paul Offit are now saying that their faith in the authorization process for the bivalent shots is now wavering.
“This was not acceptable. I understand we’re in the middle of a pandemic. I understand we’re building the plane while it’s still in the air, but you can’t do this,” Offit said. “It did shake my faith. It shook my faith in how these decisions were being made.”
This news is far from shocking to most who've followed the behavior of experts throughout the pandemic. They repeatedly oversold what interventions, products and mandates could do. Including the original vaccination series.
Repeatedly, the public was told that getting vaccinated would eliminate the risk of future surges, protect others, and ensure that they wouldn't become infected or even experience symptoms.
They rushed to judgment based on poor quality, limited data, and then made assertions and predictions with near certainty. Only to be proven wrong soon afterwards. That process has certainly repeated itself in this situation. And will likely be repeated again down the road.
This bivalent booster revelation will undoubtedly further erode trust in expertise and how the government makes public health decisions.
But if all that wasn't bad enough, according to CNN, the six FDA and CDC advisers they spoke to said the hidden data "wouldn't have changed how they voted" anyway.
Of course not.