The Deception of the FDA’s New COVID-19 Vaccine Guidance

The Great ‘MAHA’ Divide

On May 20, two top Trump administration officials in the US Food and Drug Administration (FDA) published an article in the New England Journal of Medicine (NEJM) titled “An Evidence-Based Approach to Covid-19 Vaccination”.

The article proposed new FDA guidance for the pharmaceutical industry characterized as a dramatic shift in the FDA’s approach to regulating COVID‑19 vaccines.

It indicated a move away from the FDA’s rubber-stamping of these vaccines, we were told, and toward “evidence-based” policymaking.

The authors were Dr. Vinay Prasad, the Director of the FDA’s Center for Biologics Evaluation and Research (CBER), which is responsible for the vaccine approval process; and Dr. Martin (“Marty”) Makary, the FDA Commissioner.

Prior to joining the FDA, both men were vocal critics of the COVID‑19 vaccine recommendations made by the Centers for Disease Control and Prevention (CDC).

They were not otherwise known, however, for seriously questioning the CDC’s routine childhood vaccine schedule like everyone in the health freedom movement.

The FDA is a subagency of the Department of Health and Human Services (HHS), which is headed now by Secretary Robert F. Kennedy, Jr., a longtime critic of so-called “public health” policies who joined with “warrior moms” to found the organization Children’s Health Defense  (CHD) to address the threat to children’s health from the incessant onslaught of environmental toxins—including from the CDC’s vaccine schedule.

Mr. Kennedy is now in the position of serving under the proud executor of “Operation Warp Speed”, the taxpayer-funded project to rapidly develop and distribute COVID‑19 vaccines—the stated endgame of the lockdown madness.

Kennedy had been an independent candidate for president until he quit his campaign to join forces with Donald Trump—despite Kennedy having promised his campaign supporters that “UNDER NO CIRCUMSTANCES” would he do that.

At that point, Kennedy rebranded his political campaign “MAHA”—Make America Healthy Again. It was a play on Trump’s “Make America Great Again” brand, “MAGA”.

The campaign website “TeamKennedy.com” was redirected to “MAHAnow.org”, where members of the health freedom movement were encouraged to help make America healthy again by joining the “MAHA Movement”—which meant by voting for Trump.

“A Vote for Trump Is a Vote for Kennedy”, a banner at the top of the campaign’s website proclaimed.

And members of the health freedom movement lined up in droves to do so. Senior aides in the White House told Politico they believed this alliance was a decisive factor in the November 2024 presidential election.

Since then, the acronym “MAHA” has been used as a euphemism for “the health freedom movement” despite the obvious logical distinction between a grassroots movement and a political campaign.

That distinction has been increasingly forcing itself into the public discourse.

In particular, the controversy over Trump’s nomination of tech entrepreneur Casey Means for the position of Surgeon General has revealed a deep and growing divide within the health freedom movement.

In one group are those who supported Trump from the start or who were so adamantly loyal to Kennedy that they voted for Trump even if only to get Kennedy into a government position, who believe that any perceived lack of significant change is just because Kennedy has to “play the game” of politics, and who insist that we should “trust” his behind-the-scenes plan to get the job done.

In the other group are those who refuse to compromise when it comes to our children’s health, who see recent developments as mere public relations stunts instead of meaningful change, and who do not withhold criticisms of the Trump administration and of Kennedy for what they perceive as his new role of giving his own stamp of approval to the continuation of criminal policies.

At the top of the list of those policies, as agreed by everyone in the grassroots movement, is the FDA’s rubber-stamping of and the CDC’s recommendations for COVID‑19 vaccines—including for infants and pregnant women.

On May 21, the day after the FDA officials’ article was published in the New England Journal of Medicine, Secretary Kennedy hailed it as “a long-overdue return to scientific integrity and medical freedom”— proof that “[the FDA] is finally breaking away from the one-size-fits-all vaccine policy that authorized the COVID shots for every American over 6 months old.”

Many in the MAHA movement have interpreted the article as an announcement of the intent by FDA officials to require COVID‑19 vaccine manufacturers to conduct randomized, placebo-controlled trials to receive continued authorizations or approvals for their products for use in healthy and non-elderly people.

It’s been hailed as a great victory of evidence-based policymaking over the previously prevailing rubber stamping of pharmaceutical products—a clear proof that things are heading in the right direction now that Mr. Kennedy is HHS Secretary under President Trump.

But is it really a victory for health freedom? Or is it just a public relations ploy from the administration that executed “Operation Warp Speed” that aims to disarm longtime critics of public vaccine policies?

Between these two opposing views that have emerged within the health freedom movement, who is right?

As a member of the movement myself since well before Covid and author of the book The War on Informed Consent, which features a Foreword by Robert F. Kennedy, Jr., I respectfully submit that this question is sufficiently answered by a critical examination of FDA guidance proposed by Prasad and Makary in the New England Journal of Medicine.

So, let’s get to it.