How to Remove a Vaccine from the Immunization Schedule
A Key to Understanding the Steps Involved in Making Lasting Change
FDA Changes COVID Vaccine Guidance
In a sharp shift from earlier guidance, which recommended seasonal COVID vaccination for everyone 6 months and older, the FDA now recommends COVID-19 vaccines only for adults 65 and older and people at risk for severe illness, such as those with chronic health conditions.
For healthy children and adults under 65, the FDA will require new clinical trials to prove vaccine efficacy before recommending or approving further COVID-19 vaccinations for these groups.
FDA leaders say this change aligns the U.S. with other high-income countries and is meant to rebuild trust by demanding stronger evidence for low-risk groups.
Why are Many MAHA Supporters Upset with this Guidance?
This new guidance seems like a significant step forward for MAHA (Make America Healthy Again). So why are so many MAHA supporters upset with this shift on the COVID vaccine? The FDA’s new policy limits COVID vaccine recommendations to high-risk groups, but many MAHA supporters remain dissatisfied, seeking a full ban on mRNA vaccines and more aggressive action on vaccine safety. Many MAHA supporters are frustrated because they want the FDA to go further and ban mRNA COVID vaccines entirely, not just restrict them for most people.
Some believe the FDA is still influenced by pharmaceutical companies and has not done enough to highlight vaccine risks or ensure informed consent. There is disappointment that the FDA’s move, while restrictive, does not fully address MAHA concerns about vaccine safety—especially regarding mRNA technology and its use in children and pregnant women.
Can the Secretary of Health and Human Services (HHS) Alone Remove a Vaccine from the Market?
For those MAHA supporters who are calling upon Secretary Kennedy to take more drastic action, it is paramount to note that the Secretary of Health and Human Services (HHS) cannot unilaterally remove a vaccine from the market, even if it’s on the childhood immunization schedule. The process involves multiple federal agencies and regulatory frameworks, primarily the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC), with distinct roles:
1. **FDA Authority**: The FDA has primary authority over vaccine approval and market authorization under the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act. If safety concerns arise (e.g., through adverse event reports or post-market surveillance), the FDA can suspend or revoke a vaccine’s license, but this requires evidence reviewed by FDA scientists and advisory committees, not a unilateral decision by the HHS Secretary. The Secretary oversees the FDA but cannot bypass its regulatory process.
2. **CDC and ACIP Role**: The childhood immunization schedule is set by the CDC’s Advisory Committee on Immunization Practices (ACIP), a group of independent experts. ACIP makes recommendations based on scientific data, which the CDC Director approves. While the HHS Secretary oversees the CDC, they cannot directly alter ACIP recommendations or the schedule without following the committee’s evidence-based process. A vaccine could remain on the market (FDA-approved) even if ACIP removes it from the schedule, as market authorization and schedule inclusion are separate.
3. **HHS Secretary’s Limitations**: The Secretary can influence policy, direct agencies to prioritize reviews, or issue emergency orders (e.g., under a Public Health Emergency), but they lack the statutory power to single-handedly pull a vaccine. Legal frameworks like the National Childhood Vaccine Injury Act and the Public Readiness and Emergency Preparedness Act further constrain unilateral action by embedding vaccine decisions in structured processes involving data and stakeholder input.
Why are Secretary Kennedy and HHS Taking this Slower, Methodical Approach to Rolling Back the COVID Vaccine?
Secretary Kennedy and his HHS agencies are approaching the rollback of the COVID vaccine slowly and methodically for several important reasons.
After years of lies, misinformation, and coverups from US health agencies during the pandemic, Secretary Kennedy has made it a cornerstone of his administration to restore public faith in US health agencies through radical transparency. Kennedy has spoken at length of his desire to focus on world-class science and publicly accessible data. Making a unilateral decision to remove a vaccine from the market - as many in the MAHA camp are demanding - would be totally contrary to Secretary Kennedy’s appeal for transparency, as transparency is dependent upon finding scientific consensus around publicly available data. Regardless of whether it would be the correct move or not, the Secretary would not achieve his cornerstone goal of transparency by taking unilateral action. Only concurrence with the FDA, CDC, and the greater scientific community around publicly reviewable data would achieve this goal of transparency.
Kennedy has maintained for years that science - placebo-controlled studies and publicly accessible data - should drive vaccine policy. Disgracefully, efficacy and injury data for most vaccines, including the COVID vaccine, has been routinely suppressed and hidden from the American public for decades by the CDC and FDA. To that end, Del Bigtree’s Informed Consent Action Network (ICAN) and their lawyer, Aaron Siri, filed suit last week against the CDC to demand disclosure of their Vaccine Safety Datalink data. Siri wrote on X last week, “If CDC was confident this data showed vaccines were safe, it would be public. The fact it insists on hiding it from independent scientists should concern every parent.”
It is important to note that the FDA’s new COVID vaccine guidance includes a directive for new clinical trials to further study the efficacy and potential harms of the vaccine. That new clinical data - along with existing CDC data that legal action will compel them to release - will go a long ways towards building a scientific consensus against this obviously harmful vaccine.
If the Secretary attempted unilateral action to remove a vaccine from the market, not only would it face immediate legal challenges, but it would require the FDA and CDC concurrence to be effective. All MAHA supporters should instead view this new FDA guidance as a significant step forward towards the ultimate goals of transparency and placebo-controlled studies behind vaccine policy. Taking these measured, data-reliant steps to build scientific and public consensus around the efficacy and dangers of vaccines is the only way for Secretary Kennedy to make a lasting impact on vaccine policy that the American people can trust.