There's Finally Been A Major Change in COVID Vaccine Recommendations In The US

COVID vaccine recommendations are finally set to reflect reality, science, and data after years of ignoring the evidence in favor of politically-motivated posturing.

That's not hyperbole; it's quite literally exactly what happened with previous administrators within the FDA or other health agencies. One of the top former decision makers at the FDA, Dr. Peter Marks, for example, essentially admitted in testimony before Congress that he set out a target date for the initial full approval of COVID vaccines based on his own personal panic over new variants and inaccurate expectations.

In 2024, Rep. James Comer asked Marks about that process, and his removal of doctors who disagreed with his rushed, fear-driven process: "So why were you pressuring the doctors, and then removing them from the approval process when they disagreed?"

"The approvals process was one that needed to move as rapidly as possible," Marks said. 

"The experts" in a nutshell.

Why did it need to move so rapidly? Marks' answer to that was somehow even worse. And that attitude, thankfully, is no longer part of the FDA.

Martin Makary, M.D., M.P.H., Commissioner, United States Food and Drug Administration (FDA), speaking at a hearing of the Senate Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies at the U.S. Capitol in Washington, D.C. (Photo by Michael Brochstein/Sipa USA)

COVID Vaccine Recommendations A Welcome, Late Change

During that previous testimony, Comer asked whether the hurried approval process could have been to justify private businesses or government agencies imposing vaccine mandates. Sure enough, Marks said there was an "acknowledgement" that full approvals "could allow vaccine mandates to occur."

Marks then set an arbitrary deadline, demanding approvals by August 20th, 2021. It was then approved, over the objections of several scientists who resigned in protest, on August 23rd. The military imposed its vaccine mandate on August 24th. 

No media attention, no outrage, no condemnation of a rushed, obviously pre-determined process to achieve the political goals Marks and his partners in the Biden administration desired. It was a perfect summation of the abuses of the pandemic era, where health agencies demanded compliance with unjustified policies. With this week's new announcement, those days are officially behind us.

The update to COVID vaccine recommendations comes as a result of new Trump administration appointees at the FDA finally turning the agency into a home of evidence-based medicine. 

Dr. Marty Makary and Dr. Vinay Prasad wrote in the New England Journal of Medicine about how they intend to alter government policy on yearly COVID boosters, testing, trials, and recommendations. Doing what should have been done years ago.

"Over the past 5 years, the United States has moved toward an annual Covid-19 booster program," they write. "Each fall, Covid-19 booster shots are developed, alongside seasonal influenza vaccines, and are recommended for every American. As compared with vaccination policies in all European nations, the U.S. policy has been the most aggressive. While all other high-income nations confine vaccine recommendations to older adults (typically those older than 65 years of age), or those at high risk for severe Covid-19, the United States has adopted a one-size-fits-all regulatory framework and has granted broad marketing authorization to all Americans over the age of 6 months.  The U.S. policy has sometimes been justified by arguing that the American people are not sophisticated enough to understand age- and risk-based recommendations. We reject this view."

How refreshing is it to hear this clear, science-based reasoning from those in positions of authority? 

This type of clear, level-headed thinking has been almost entirely absent from debates over COVID vaccines since they were released in late-2020. Instead of acknowledging that a "one-size-fits-all" framework is unnecessary and potentially harmful, Anthony Fauci and his allies like Peter Marks demanded everyone listen to them instead of assessing their own personal risk. Now? Makary and Prasad are, as they say, rejecting the view that Americans are too stupid to understand nuance.

And it gets better; they're actually, *gasp*, demanding evidence before implementing authorizations and recommendations.

"..The benefit of repeat dosing — particularly among low-risk persons who may have previously received multiple doses of Covid-19 vaccines, had multiple Covid-19 infections, or both — is uncertain," they explain. "The American people, along with many health care providers, remain unconvinced.

"Less than 25% of Americans received boosters each year, ranging from less than 10% of children younger than 12 years of age in the 2024–2025 season to 50% of adults over 75 years old. Even health care workers remain hesitant, with less than one third participating in the 2023–2024 fall booster program. There may even be a ripple effect: public trust in vaccination in general has declined, resulting in a reluctance to vaccinate that is affecting even vital immunization programs such as that for measles–mumps–rubella (MMR) vaccination…"

The American people have tuned out the FDA and their recommendations because they've realized that the FDA has put their own priorities, and even those of Pfizer and Moderna, ahead of making science-based decisions. And right on cue, ABC News got comment from Paul Offit, who criticized the change in process.

"The only thing that can come of this will make vaccines less insurable and less available," he said. 

Really? That's the only thing? Not increased confidence that if boosters are authorized or recommended, it'll be based on evidentiary standards? Not a more thorough testing process to separate pharmaceutical company press releases from actual science? Just "less insurable" vaccines? The reaction tells you where the priorities truly lie; with universal, one-size-fits-all policy, not following the science.

Makary and Prasad weren't done there. They laid out that moving forward, pharmaceutical companies will be required to submit randomized controlled trial data on actual clinical outcomes if they want their products granted licenses.

"For all healthy persons — those with no risk factors for severe Covid-19 — between the ages of 6 months and 64 years, the FDA anticipates the need for randomized, controlled trial data evaluating clinical outcomes before Biologics License Applications can be granted," the paper says.

"The FDA’s preferred primary end point in these trials will be symptomatic Covid-19, with special attention paid to several secondary end points: severe Covid-19, hospitalization, and death."

It sounds so obvious, it's hard to believe this wasn't always the standard. But it hasn't been. Because instead of demanding rigorous RCT's with logical, necessary endpoints, previous authorizations were instead based on the production of antibodies. Unsurprisingly, that proved insufficient and ultimately ineffective, with vaccine efficacy being wildly exaggerated, then rapidly waning over time. Especially against infection, where initial claims of "100% effectiveness" were proven catastrophically wrong almost instantly. 

Under this new FDA? That would never have happened.

It gets even better. Makary and Prasad will also now require these companies to include those with natural immunity. Because, again, as should be obvious, an endemic respiratory virus will eventually infect everyone. 

"People who have had Covid-19 in the past year should not be excluded — since evidence is needed for the average American," the paper says. "Follow-up should extend for a minimum of 6 months to ensure that early booster gains persist. The control group could receive a saline placebo, to permit documentation of the full adverse-event profile. "Ultimately, these studies alone can provide reassurance that the American repeat-boosters-in-perpetuity strategy is evidence-based."

We've already seen it demonstrated in study after study that natural immunity can be more protective than vaccines against severe outcomes from COVID. And yet, for too long, the FDA and other health agencies have relied on data collected from those without evidence of prior infection to make sweeping, blanket recommendations for all Americans. It's this type of unscientific decision-making that's finally coming to an end.

Naturally, the media's reaction to these objectively improved standards has been one of condemnation and criticism. Any changes from "every single person over six months old should get every COVID vaccine and booster ever produced" is viewed as "anti-vaccination" extremism. Somehow completely ignoring that almost other every major country has moved past those recommendations years ago.

Years of Fauci, the FDA, and CDC making a mockery of science has taken their toll. Those years are coming to an end. If only it hadn't taken this long.