FDA shifts gears on COVID boosters, so why is Canada still pushing mRNA shots for all?
Independent journalist report transcript
Watch the videos below for what you won’t hear from CBC or Canada’s mainstream media. The transcripts from these videos is below - for easier quoting.
Part 1: In US.
Part 2: Meanwhile, In Canada.
Transcripts:
Here is the cleaned and readable version of the FDA Press Briefing Transcript, as presented by Dr. Vinay Prasad and Commissioner Dr. Marty Makary. No words were added or removed — only punctuation, spacing, and structure were refined for clarity:
FDA Direct Briefing – May 2025
Dr. Vinay Prasad:
Welcome, everybody, to the U.S. Food and Drug Administration’s announcement about COVID-19 vaccine policy. I’m Dr. Vinay Prasad, the incoming director here at CBER—the Biologics Center—and I’m pleased to be joined by the Commissioner today as I walk the American people through our ideas, our thinking, and our framework, which we call an evidence-based approach to COVID-19 vaccination.
This morning at 11:00 AM EDT, our article appeared in the New England Journal of Medicine as a “Sounding Board” piece. It explains our rationale and thinking about COVID-19 vaccine policy. I'm going to walk you through it here.
Background
I went to high school in LaPorte, Indiana, then earned my undergraduate degree at Michigan State University—go green! I completed my medical degree at the University of Chicago, then trained in Internal Medicine at Northwestern University. I later completed fellowships in Hematology, Oncology, and Cancer Prevention at the National Cancer Institute in D.C., along with a Master’s in Public Health from Johns Hopkins. For the past decade, I’ve practiced as a physician and professor, most recently at UCSF, working at San Francisco General Hospital.
I’m a lifelong advocate for evidence-based medicine—I’ve written two books on the topic—and believe the FDA must always and only act in the best interest of the American people. This new framework reflects that commitment.
Our New Policy Framework
America is deeply divided on the question of repeated COVID-19 boosters. Some are concerned about safety, some demand more access—and most Americans, including many doctors, are simply unsure.
Uptake is low:
<1 in 6 healthcare workers received the latest COVID booster.
Vaccine uptake differs by race and region.
For many Americans, we do not know if a 7th, 8th, 9th, or 10th booster is necessary. FDA’s thinking has evolved. Here's what's changed:
Most Americans have now had COVID, sometimes multiple times.
The risk of severe disease is now lower.
The benefit of repeated doses is uncertain.
The long-term safety is not fully known.
We will continue to monitor this closely.
Key Changes in FDA Strategy
We will convene our vaccine advisory committee this Thursday to determine which strains should be included in upcoming boosters.
Then, we will apply this evidence-based framework:
1. Fast-Track Approvals:
For individuals 65+ or high risk, we’ll continue using immunologic endpoints (i.e. antibody levels).
This covers 100–200 million Americans.
Conditions like obesity, inactivity, depression, and all immunocompromised statuses qualify as “high risk.”
2. Randomized Controlled Trials (RCTs):
Required for ages 50–64 before approval.
Target: Clinical outcomes (not just antibody levels).
RCTs will include people with past COVID-19 infections (8–9 months prior).
Trials must show ≥30% reduction in symptomatic COVID (lower bound of 95% CI).
3. For Younger Populations (<50):
FDA will not require trials but encourages sponsors to conduct RCTs.
These results will be considered if submitted.
Why 50–64?
Many countries limit boosters to 65+. Others go as low as 45. We believe 50–64 is the global zone of equipoise—a true area of uncertainty.
Special Populations & Misconceptions
Children: We encourage RCTs in younger age groups.
For example:
Hospitalization risk (0–4 years): ~30 per 100,000
Risk for 50–64 years: ~55 per 100,000
Proximity vaccinations: There is no high-quality evidence that vaccinating people around the immunocompromised offers added protection. That’s why RSV vaccine approvals do not include caregivers—only those vulnerable.
Public Trust & Transparency
We are committed to restoring trust by:
Publishing in New England Journal.
Hosting direct briefings like this one.
Requiring real data before recommending vaccines for healthy individuals.
"We must develop randomized evidence. We owe it to the American people." — Dr. Vinay Prasad
Commissioner's Remarks (Dr. Marty Makary)
Thank you, Dr. Prasad.
You’ve made clear this is a polarizing and dogma-laden issue. During the pandemic, we made decisions under uncertainty. But now, with data in hand, we must pivot.
Q: Will RCTs be required every year?
No. The virus doesn’t follow a calendar. Boosters shouldn’t either. We’ll adapt based on antigenic shift, not dates.
Q: What about T-cell/B-cell immunity?
This must be studied. Immunology is complex. We shouldn’t assume annual shots are optimal. Only data can tell us.
Q: Are you “anti-vax”?
Absolutely not. Both Dr. Prasad and I have administered thousands of vaccines, especially for immunocompromised patients. We believe in vaccines done right, with evidence.
Historical Context
Not all vaccines succeeded. The swine flu, anthrax, and rotavirus vaccines were withdrawn or failed.
But great milestones, like Jenner’s smallpox vaccine, saved millions. The lesson: Medicine evolves through open inquiry and humility, not rigid certainty.
Final Thoughts
FDA won’t rubber-stamp annual boosters.
We won’t remove previously approved vaccines either.
This is about risk-based access + evidence-based confidence.
"Doctors want data. If the evidence supports benefit, most will recommend it." — Dr. Prasad
We will continue publishing, talking with the public, and hosting FDA Direct episodes. Transparency is our duty.
Thank you.
FDA Direct Podcast: Episode 2 (Clean Transcript)
Marty:
Unscripted, no make-up, live from the FDA. Welcome Vinay Prasad—great to see you.
Vinay Prasad:
It’s great to be here, Marty. It’s great to be joining.
Marty:
And we got Sanjula Jain-Nagpal, who is an awesome PhD health policy expert with us in the Commissioner’s Office. So great to see both of you guys. I don’t know exactly what we’re doing, but we’re having a conversation. This is just going to be some civil discourse here—having fun. And I think it’s good for people to see what we’re talking about, how we’re thinking about things, instead of the FDA kind of being a black box of, you know, “what’s going on inside the agency?”
Vinay:
Absolutely, Marty. I think ultimately the FDA serves the American people, and it’s really great for the American people to directly have access to the Commissioner—to hear what you're thinking and what initiatives you’re sparking here. And too often, so many articles about the FDA are behind a paywall for industry insiders only. We're going to try to make the FDA accessible to the average person in America.
Marty:
The glass box.
Vinay:
In the glass box here, with a beautiful view of FDA campus—not the black box.
Marty:
Look at this beautiful campus here. It is going to be lined up with a farmer’s market on Tuesday. Shout out to Melanie, who’s in the background there. It’s going to be every week. Maybe even some seed oil-free food trucks. Who knows?
Sanjula:
Healthy food is an important initiative that you’re taking on.
Marty:
Yeah, big part. That’s part of what you’re working on, Sanjula—healthy food. We’ve got big goals on that front. So it’s great to have Vinay Prasad here:
Because he’s a great scientific mind.
He wants to serve our country.
He thinks and looks like Albert Einstein in terms of his hair.
Vinay:
Now that you say that, yeah.
Marty:
It’s the regulatory haircut.
Vinay:
It’s the regulation, yes.
Marty:
But I’m excited to be here, to join FDA and try to work in service of the American people—and to bring innovative products to market.
Vinay:
And you're going to be working at CBER. You want to tell folks what CBER is?
Vinay:
CBER governs a huge portfolio of medical products, including vaccines, gene therapy, cellular therapy. A lot of the most innovative things you read about in the news come from CBER. Not to say the other departments here don’t do innovative products—they do. But I’m particularly excited about what’s been coming out in the last decade through CBER. And we hope to always strike the balance between data, evidence, innovation, and the entrepreneurial spirit of America.
Sanjula:
Sounds exciting, although I have a lot of questions about how you're going to approach it.
Marty:
OK, so tell me. There are a lot of headlines out there about you being a critic of the administration and how things were handled in the past with a lot of those products we talked about. Maybe you're “anti-vax,” but I know that’s not true. So tell us—why have you been critical, particularly in the vaccine space? Help people understand your thinking.
Vinay:
Vaccines are like drugs: when given at the right time to the right person, they’re life-saving. But just like drugs, they need to be evaluated case-by-case and always in context.
Marty and I, throughout the pandemic, were proponents of vaccines for the people who had a huge benefit. But we were skeptical—scientifically—about overdoing it in low-risk populations.
Marty:
Wait—you don’t think a healthy, thin 12-year-old girl needs a seventh COVID shot?
Vinay:
Seventh versus the eighth versus the ninth. I mean—it’s unknown. And the U.S. has never been in line with peer nations in Europe. That’s not anti-vax. It’s pro-science—trying to bring the best available science to answer these questions.
Marty:
The media often misrepresents what we’re doing at the FDA. They miss the nuance. But you’ve been a professor and a heme-onc doctor—probably no one has given as many vaccines as you. You've taken care of a lot of patients post-autologous stem cell transplant. You had to give vaccines.
Vinay:
Exactly. We love vaccines when done right—appropriately, based on solid evidence. And we’re going to hold up that standard at the FDA.
Marty:
I saw a headline this morning saying the scientific community is finally seeing everything you both championed during the pandemic—early tracking of evidence.
Vinay:
Yes. Our positions were probably the center point of most Americans. People came to our position 6 months, 12 months, or 2 years later—and forgot they once disagreed. The data caught up.
Marty:
We were critics of prolonged school closures, masking toddlers—from the beginning.
Vinay:
The public is close to us on these issues.
Sanjula:
How do you balance speed with scientific rigor in crisis moments? Especially with the new post-approval monitoring process and big data capabilities?
Vinay:
Our positions were mainstream. But decisions in a crisis don’t always wait for randomized evidence. Still, we can’t rely on groupthink. We need to follow the best science available.
Marty:
Some of those FDA-approved products—85% of healthcare workers didn’t want the booster. We still aren’t sure about how many doses kids or healthcare workers need post-infection.
Vinay:
It’s time to bring gold standard science and common sense together. Rare diseases are different—randomized trials may be impossible. We’ll be flexible but cautious. We want to protect patients, even as we support innovation.
Marty:
You’ve been advocating for AI in the agency. Tell us about that.
Vinay:
Day one: we said no more AI conferences—let’s do it. We launched an initiative and completed the first AI-assisted scientific review. A process that used to take 3 days now took 6 minutes. Thousands of pages reviewed quickly. Let scientists focus on science.
Marty:
Exactly. What drove me crazy in clinical practice wasn’t the work—it was redundant admin. If we can reduce that, reviewers will love their jobs more.
Sanjula:
People have been doing things the same for 20–30 years. We’re in an era of constant innovation—we must modernize submissions and processes.
Vinay:
Institutions must adapt. And yes, I’ve seen my new office—it has a beautiful view of campus!
Marty:
FDA reviewers do amazing, often invisible work. They deserve great tools—and maybe some seed oil-free food trucks.
Vinay:
Should we do more public conversations like this? Bring in stakeholders, media, patients?
Marty:
Yes. We’ll invite reporters, advocacy groups, industry experts. Real discourse, roundtable format. No red tape.
Vinay:
The FDA has been a black box too long. Even I could only learn about decisions by poring through JAMA editorials or dense review letters. This podcast is a change of pace.
Marty:
Yes—we can’t discuss ongoing product reviews, but we can share how we think.
Vinay:
Developers value predictability. We can’t reply publicly when companies spin letters—but we can explain our principles.
Marty:
FDA reviews are like a pomegranate: there’s fruit in there, but it’s tough to get it out.
Vinay:
Science isn’t black and white. Everyone contributes. No tribalism.
Marty:
Earlier I said I had a limo story. So… foreign manufacturers pick up FDA inspectors in limos! These are announced visits. Not real inspections.
Vinay:
Exactly. Domestic inspections are random and strict. Foreign ones? Red carpet. We’re changing that: surprise inspections abroad, just like in the U.S.
Marty:
No more limos. But they keep their badges.
Vinay:
I don’t get one at CBER—badge-free zone!
Marty:
So… was this a colossal failure or a success?
Vinay:
Let’s see what people think.
Marty:
We’ll bring in the public, collect questions, and keep doing this.
Vinay:
And yes, the headline will probably say I look like Einstein. I’ll take it.
Marty:
Thanks so much, folks. We’ll do it again.
Appendix B: Rebel News
Here is the YouTube transcript cleaned for readability—no words have been changed, added, or removed. Only punctuation, spacing, and structure were adjusted for clarity:
With the United States now moving to limit the modified RNA COVID-19 shots to high-risk groups and demanding more robust clinical trials, when will Canada start to follow the evidence-based science—especially when other countries have scaled back or banned them entirely?
Let’s dig in.
Let’s start with a post that caught my eye by the Independent Medical Alliance, formerly known as the FLCCC Alliance—which stands for the Frontline COVID-19 Critical Care. On May 16th, they asked:
"Why is America still recommending mRNA COVID-19 shots when countries around the world restricted or banned them years ago?"
And it only took the Trump administration days to respond.
FDA Director for the Center for Biologics Evaluation and Research, Dr. Vignyak Prasad, announced an evidence-based approach to COVID-19 vaccination on May 21st:
"We have evolved on this topic with changing evidence. We have a changing regulatory framework."
And what has changed?
Well, we have a population where many Americans have been multiply infected with COVID-19—sometimes without even knowing they had COVID-19. The risk of severe disease and hospitalization, thank goodness, has fallen among the American people.
The efficacy of repeat doses of these vaccines to further reduce severe disease and symptomatic illness is uncertain, and there are important safety considerations whose long-term impact is not fully known. And we will continue to monitor those closely.
So, FDA strategy in this space—here’s what we’re going to do:
We will hold this year’s vaccine advisory committee later this week, on Thursday. That’s a committee of experts that helps FDA decide which target strains—which antigens—to recommend for this year’s vaccine that companies target.
And going forward, we will apply the following evidence-based framework to evaluate all the COVID-19 vaccines.
So based on prior immunologic endpoints—that means proof that the vaccine can create antibodies in people—companies can apply for, and we will consider approval for:
Those 65 and older, and/or
People at high risk of severe COVID-19.
If you’re older than 65 or you’re high-risk for COVID-19, we’re going to use the immunologic endpoints we’ve been using to grant approval.
This is a tremendously broad category. This effectively means 100 to 200 million Americans—those with the most favorable benefit-to-harm balance—will be covered by such approvals.
Dr. Prasad detailed the endpoints they hope to study going forward—which begs the question: why this wasn’t done before. But regardless, here we are.
"Fit primary endpoint"—but we’re also going to look at severe disease, hospitalization, and death, which are endpoints I think Americans and their physicians care a lot about.
We want the companies to follow these people for at least 6 months, because we want to make sure that if the booster has a reduction in symptomatic SARS-CoV-2, that effect isn’t washed away 5 or 6 months later—that those benefits persist.
And finally, we must develop randomized evidence. We owe it to the American people. We have launched down this multi-year campaign of booster after booster after booster and distrust of the American public, and we do not have gold standard science to support this for average-risk, low-risk Americans.
It’s not just our view here in the current FDA—commissioner and myself—it’s the prior FDA commissioner as well.
This is Rob Califf in JAMA. He writes:
"COVID vaccine uptake is now low enough that large randomized control trials are feasible to evaluate the efficacy and safety of new updated boosters."
And again, he restated it on May 9th:
"In the case of COVID-19, I believe it is now quite reasonable—and even advisable—to conduct placebo-controlled trials for ‘boosters’ using updated versions of the vaccine in people who are not high-risk."
Just a couple more points.
What about vaccinating healthy people near or around an immunocompromised person?
He goes on to explain that there is exactly zero evidence to justify vaccine mandates, such as for healthcare workers, with the concept—and once widely believed dogma—that vaccinating healthy people protects those that they interact with.
He further details how trust in institutions—especially those tasked with overseeing pharmaceutical product regulation and recommendations—is at rock bottom.
I could see almost two interpretations of the very low uptake of the recent COVID booster in healthcare workers:
Healthcare workers don’t find value in it.
Healthcare workers would like to see some updated clinical evidence before taking it.
And I think if we’re being honest, we don’t know the rationale—but it would seem as if the universe of possibilities would include a desire to know whether or not clinical evidence supports a benefit to taking it that outweighs the risks.
I mean, I can speak personally—if you proved to me that there’s a benefit to someone like me, I will take it. And most of the doctors I know are responsive to that evidence.
If the companies conduct these studies and those studies are glowingly positive, I think doctors will embrace it and be able to counsel patients in a way they haven’t been able to honestly counsel.
How do you counsel a healthy, thin, 50-year-old in your office who’s had COVID three times, had five shots? How do you counsel that person about boosters? It’s almost impossible with the current evidence base.
Dr. Marty Makary, who is the 27th Commissioner for the Food and Drugs, overseeing the FDA portfolio, posted:
"Doctors are hungry for data on COVID-19 boosters."
"If a 52-year-old perfectly healthy patient came to me asking if they should get their fifth or sixth COVID booster, I wouldn’t have any evidence to inform a strong, educated recommendation. It’s been a guessing game."
Now, this FDA update on yearly COVID boosters is now following the actual science: approving vaccines for high-risk persons, while also demanding robust, gold standard data on persons at low risk, with clinical trials that will inform future directives and provide information that is desperately craved by healthcare providers and the American people.
This follows recommendations that have been in place in countries like Denmark, Finland, and Sweden, which hit the brakes on these shots for certain groups—especially younger people—as early as 2022.
Why? Because they saw the signals: heart issues like myocarditis and pericarditis, and a whole lot of questions about long-term safety.
Yet here we are in 2025, and the National Advisory Committee on Immunization—called NACI, the ones who set the tone for Canada’s vaccine policies—well, they’re still recommending these mRNA shots.
Yes—and that includes to babies as young as 6 months of age, and of course, indiscriminately to everyone who works in a healthcare or other care provider setting.
These modified RNA shots have been—and are increasingly being—questioned by scientists and doctors worldwide. But Health Canada is sticking to their script.
Under "Benefits of Vaccination", they say:
"COVID-19 vaccination may reduce your risk of becoming infected. If you do become infected, having been vaccinated before infection reduces the risk of severe illness, hospitalization, and death."
And as the new FDA leadership emphasizes—this claim lacks any foundation in clinical trials, where it was neither studied, tested, or established as an endpoint.
So how does Health Canada make this assertion?
Well, I reached out to the media relations line at Health Canada to make sure that we had the facts to report to you—and to see why the science is different here compared to our southern neighbors and other countries abroad.
I asked Health Canada:
What steps it’s taking to align with evolving science, following the updated FDA guidance on COVID-19 vaccines and boosters.
How it plans to update its recommendations based on current evidence.
And why its approach might differ from that of the U.S. and other international regulators.
Now, I’m not here to tell you what medical choices to make—that’s entirely up to you. Informed consent matters, and your health decisions should always be respected.
But it’s fair to ask—especially at this point—why the disconnect?
Why have other countries not only scaled back, but are taking the lead in pushing back, while Canada continues on with claims founded in missing information?
Is it the influence of pharmaceutical interests? The billions locked into contracts? Or is it simply easier to keep the momentum going than to pause and admit perhaps some things didn’t quite go as planned?
Now here’s the thing: science isn’t a monolith. It’s supposed to evolve, to question, and to adapt.
But when NACI and Health Canada keep parroting the same line—“benefits outweigh the risks”—without addressing the growing pile of studies, the adverse events reports, the real-world data from other countries—it starts to feel less like science and more like dogma.
And I get it. The massive psychological operation deployed on the general public—coupled with things like sweeping mandates and vilified speech—worked on a large segment of the population who wanted to believe in a silver bullet.
They were led to believe that they could protect their loved ones, their communities.
But five years later, with all we know now—about side effects, about waning efficacy, about natural immunity and immune suppression post-injection, about the undisclosed contaminants, the manufacturing scale-up that changed the makeup of the shots completely, the inappropriately applied regulations—
Can we at least have an honest conversation?
Can we ask why Canada's still recommending these shots for babies?
Why they're still pushing them on everyone when other countries have clearly said, enough is enough?
Canadians deserve better than recycled talking points, because our health, our kids’ health, and our future matter—and it depends on it.
For Rebel News, I’m Tamara Ugolini.
If you’d like to see more reports on this topic—and perhaps support my work—you can do so at: NoMoreShots.ca
Would you like a side-by-side comparison of Canada vs U.S. policy from this and the previous transcript for Substack?
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