ANALYSIS: Is FDA’s New mRNA Flu Shot Approval Proof of Agency’s MAHA Purge?
Updated
The U.S. Food and Drug Administration (FDA) is the indispensable gatekeeper for vaccines and drugs in the U.S. Nothing reaches the market or can be legally administered without its approval or authorization.
Other agencies play vital supporting or downstream roles, but FDA’s regulatory authority is foundational and unmatched.
When Kennedy arrived at the helm of U.S. Health and Human Services, the panic was on within the halls of industry-conflicted agencies and pharmaceutical companies. Their long, smooth-flowing pipeline of injectable, liability-free products had a real potential to get disrupted. Incalculable profit, market share, and sheer corporate dominance were on the line.
MAHA-inspired FDA trifecta Dr. Marty Makary, Vinay Prasad MD MPH and Tracy Beth Høeg, MD, PhD represented a different, more scientifically responsible way forward for the agency embattled by COVID missteps racking up maximum public distrust.
Makary limited COVID boosters and updated shots mainly to high-risk groups rather than broad recommendations for healthy adults and children. He directed the agency to demand stronger evidence (including placebo-controlled trials in some cases) for annual strain updates and to revise package inserts with more detailed risk language. And he ordered internal FDA re-evaluation of the CDC/ACIP schedule, citing concerns over cumulative aluminum exposure, schedule density, and post-licensure safety signals.
Høeg served for just over a year and went right to work. She led an analysis of VAERS reports fueling an internal memo (leaked to the public) stating at least 10 children had died “after and because of” Covid vaccination.
She also reportedly proposed changing labels on all Covid vaccines to state that risks outweighed benefits for males ages 12–24 due to myocarditis concerns and sought to advance it to the CDC’s Advisory Committee on Immunization Practices (ACIP).
Along with driving for an overhaul of the childhood vaccination schedule to align with other developed countries, the combination set off a chain of events.
She was fired after refusing to resign.
“They [FDA officials] made it clear that it wasn’t their decision…They said it was from someone above them, from someone way above their pay grade.“
Prasad’s tenure was another departure from FDA’s previous operations. In July 2025, Prasad abruptly stepped down or was pushed out from his role as the top vaccine and biologics regulator following intense political pressure and industry clashes.
In August 2025, following a White House review, he was brought back to the agency by then FDA Commissioner Marty Makary just two weeks later.
In March 2026, Makary announced that Prasad would leave the agency a second time, framing it as the end of a prearranged one-year academic leave of absence from UCSF.
Prasad, equal to Høeg, held a line in the sand for both greater scrutiny surrounding vaccine safety and the core scientific methods the agency used to evaluate vaccine products – a right he had in his position as head of the FDA’s Center for Biologics Evaluation and Research (CBER).
His leaked memo to staff spoke volumes about how the FDA could have been up-leveled under his leadership.
“I want to outline a path forward. Our general approach in CBER will be to direct vaccine regulation towards evidence based medicine. This means: we will take swift action regarding this new safety concern, we will not be granting marketing authorization to vaccines in pregnant women based on unproven surrogate endpoints (any prior promises will be null and void), and we will demand premarket randomized trials assessing clinical endpoints for most new products. Pneumonia vaccine makers will have to show their products reduce pneumonia (at least in the post-market setting), and not merely generate antibody titers. Immunogenicity will no longer be used to expand indicated populations– these populations should be included in premarket RCTs.”
This one paragraph alone undoubtedly shook Big Pharma’s unobstructed scientific modus operandi to the core. Prasad continued to announce changes:
“We will revise the annual flu vaccine framework, which is an evidence-based catastrophe of low-quality evidence, poor surrogate assays, and uncertain vaccine effectiveness measured in case-control studies with poor methods. We will reappraise safety and be honest in vaccine labels. I look forward to hearing your thoughts on how to do this better.”
The lines kept getting worse for industry:
“…at FDA, we have not been focused on understanding the benefits and harms of giving multiple vaccines at the same time. This is a concern shared by many Americans. The FDA’s standard has been to require randomized studies too small to draw any conclusions from– creating a false sense of efficacy and safety.”
And finally, one simple sentence altered the vaccine science universe:
“Vaccines will be treated like all other medication classes– no better or worse…”
Prasad has a chapter in the recent FDA mRNA flu vaccine approval. He actually put a stop to Moderna’s shoddy science on their first attempt in February.
Rather than a placebo-controlled trial, Moderna used another vaccine to compare their new shot against, giving them an advantage to hide mRNA adverse reactions – both shots have about the same harms in a short monitoring window; therefore, both shots are safe. That’s the game and always has been. Business as usual, and Prasad tried to put a stop to it.
After his departure. Headlines looked different.
Despite the NY Times reporting, it was clear that “public outcry” didn’t reverse the flu shot’s application course.
So here we are, a new vaccine technology with, to put it lightly, many unanswered safety questions from its Covid shot product line forced on the world through fraud and deceit.
Independent researchers are already picking apart the clinical trial in droves as Focal Points writes:
The FDA’s own briefing document reveals that 75.3% of senior mRNA-vaccine recipients experienced at least one solicited adverse reaction within seven days, compared with 49.3% of those receiving Fluzone High-Dose.
Even more concerning, severe (Grade 3) systemic reactions occurred in 6.7% of mRNA recipients versus 1.7% with the traditional high-dose flu vaccine—nearly four times as frequently.
MAHA’s ascension to power in health, science, and medicine has been an amazing feat, influencing countless archaic regulatory processes and lax oversight, leading to some of the highest prevalence and burden of several major chronic diseases. The population is awake and staring, no longer placated by ‘safe and effective’ slogans as the struggle continues in real time for the levers of regulatory power in America. The midterms offer hope for an entirely new corps of motivated leaders inspired by MAHA and Kennedy’s work.