The Best Ever Discussion I Have Heard Promoting the Vaccines: From New FDA Leads
Why Canadians May Soon Look South for Honest Answers on Vaccine Safety and Risk
I have subscribed to the FDA’s official YouTube channel and encourage you to do the same—it has become a source of some of the most positive and constructive updates on medication and health. Here’s the latest discussion featured there. I sincerely hope that all public servants—both those labeled “pro-vaxxers” and those called “anti-vaxxers” (though I dislike both of these terms, as I believe they were purposefully introduced to instigate division, hatred, and intolerance)—will come together to celebrate the restoration of scientific integrity in the development of vaccine products, as demonstrated by our neighbors south of the border.
Key quotes from this discussion are provided below for your easy reference in conversations with your family doctor and government colleagues.
Your Doctor Is Not the Government: The FDA’s Bold New Message (YouTube)
Key Themes and Insights
1. Transition to Evidence-Based Approvals
Dr. Makary and Dr. Prasad articulate a shift from the previous "one-size-fits-all" vaccination strategy to a more nuanced, evidence-based approach. They argue that while initial emergency authorizations were necessary, the current landscape demands more robust data to support vaccine approvals, especially for low-risk populations.npr.org+1fiercepharma.com+1
“We simply don’t know whether a healthy 52-year-old woman with a normal BMI who has had COVID-19 three times and has received six previous doses of a COVID-19 vaccine will benefit from the seventh dose.”
— Dr. Marty Makary
2. Implementation of Placebo-Controlled Trials
A significant policy change discussed is the FDA's requirement for randomized, placebo-controlled trials to evaluate new COVID-19 vaccines for healthy individuals under 65. This move aims to ensure that vaccine approvals are grounded in "gold-standard" scientific evidence.reuters.com+10medtechdive.com+10nypost.com+10npr.org
“The FDA will approve vaccines for high-risk persons and, at the same time, demand robust, gold-standard data on persons at low risk.”
— Dr. Vinay Prasad
3. Focus on High-Risk Populations
The FDA's new framework prioritizes vaccine approvals for individuals aged 65 and older and those with underlying health conditions, such as asthma, diabetes, or obesity. For these groups, immunogenicity data may suffice for approval, while broader populations will require more extensive clinical evidence.fiercepharma.com+2washingtonpost.com+2clinicaladvisor.com+2
“Our policy also balances the need for evidence. We want to know more about what these products are doing, especially as we enter the seventh, eighth, and ninth dose.”
— Dr. Vinay Prasad
4. Emphasis on Transparency and Public Trust
Both officials underscore the importance of transparency in the vaccine approval process to restore public trust. They advocate for clear communication about the benefits and risks associated with vaccination, moving away from blanket recommendations.washingtonpost.comwashingtonpost.com
“The FDA's new COVID-19 philosophy represents a balance of regulatory flexibility and a commitment to gold-standard science.”
— Drs. Makary and Prasad
Conclusion
This discussion by Drs. Makary and Prasad represents a pivotal moment in public health policy, highlighting a deliberate move towards evidence-based vaccine approvals. Their emphasis on scientific rigor and transparency sets a new standard for regulatory practices, potentially influencing international approaches to vaccine evaluation.fiercepharma.com+9clinicaladvisor.com+9center4research.org+9
For Canadians and others interested in the intricacies of vaccine approval and safety, the FDA's evolving policies offer a model of thoroughness and openness that may inform personal health decisions and public discourse.
Note: For a more in-depth understanding, viewers are encouraged to watch the full discussion on YouTube: FDA is not your doctor: a discussion on a recent COVID-19 vaccine marketing authorization.
PS: US vs. Canada
What makes this discussion from the U.S. FDA so significant is not just the content—it’s the tone and principle behind it. For the first time since the beginning of the pandemic, the American public is being told plainly that public health must respect medical nuance, risk-benefit analysis, and individual autonomy. The FDA’s new leadership—Dr. Marty Makary and Dr. Vinay Prasad—have broken the silence on a taboo subject: that a 7th or 8th COVID vaccine dose for a low-risk person with natural immunity may not be supported by evidence. They are demanding placebo-controlled trials, age-specific guidelines, and the reintroduction of informed consent into vaccine policy.
This stands in sharp contrast to the Canadian context, where vaccine policy is still largely dictated by centralized authority figures like Dr. Theresa Tam, and where deviation from federal recommendations is often stigmatized—even for doctors. In Canada, there is no real equivalent to what the FDA just did: publicly acknowledging scientific uncertainty, prioritizing individual health status, and openly calling for randomized trials before approving vaccines for healthy individuals.
The FDA’s shift sends a powerful signal—not only about how science should be done, but about how public trust is rebuilt. In the U.S., regulatory agencies are reasserting their independence. In Canada, health policy still feels scripted from the top down, with little space for open scientific debate or patient-specific decisions.
For Canadians seeking clarity, transparency, and nuance, the U.S. is now offering a kind of leadership that Canada’s institutions may wish to provide too.
References
Fierce Pharma – FDA limits COVID vaccine approvals
NPR – FDA draws a line on boosters for healthy adults
Reuters – FDA sets new COVID booster guidelines
Acknowledgment
Article is written with assistance from ChatGPT using the following prompt: “Summarize this YouTube discussion between new FDA leads on vaccine approvals, highlighting quotes and implications for Canadians.”
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