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HOW RFK JR. BROKE 60 YEARS OF VACCINE DECISION-MAKING PROCESS  
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Jess Steier, DrPH; David Higgins, MD, MPH; Elana Pearl BenJoseph, MD,
MPH; and Aimee Pugh Bernard, PhD
May 28, 2025
Unbiased Science
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_ Kennedy announced by tweet that Covid vaccines have been removed
from the CDC's recommended schedule for healthy children and pregnant
women, bypassing any rigorous decision process. Health care for
millions is at stake. _

"Robert F. Kennedy Jr. - Caricature (53365432964)", by DonkeyHotey,
licensed under CC BY 2.0

 

Yesterday, in a move that stunned the public health community, HHS
Secretary Robert F. Kennedy Jr. announced via Twitter/X
[[link removed]] that COVID-19
vaccines have been removed from the CDC’s recommended immunization
schedule for healthy children and pregnant women.

This announcement is unprecedented. It bypassed every established
scientific and administrative process typically involved in changing
national vaccine policy. There was no consultation with the CDC’s
Advisory Committee on Immunization Practices (ACIP). No formal
recommendations were issued. No public health agencies released
supporting documentation. As of Tuesday morning, the CDC’s website
still reflected previous guidance recommending COVID-19 vaccination
during pregnancy and for children aged 6 months and older.

And yet, with one unilateral, unprecedented, and unaccountable post,
the Secretary of HHS overrode decades of rigorous vaccine
decision-making processes and likely dismantled vaccine access for
millions.

Worse yet, without any transparency into the decision-making process,
this move takes away people’s freedom to choose an effective tool
for protection against a dangerous disease. _Let’s discuss…_

WHAT WAS ANNOUNCED

Secretary RFK Jr. was joined by NIH Director Jay Bhattacharya, who
called the move "common sense and good science," and FDA Commissioner
Marty Makary, who stated, "There is no evidence healthy kids need it
today."

LET'S BE CLEAR: DETERMINING WHICH GROUPS CONTINUE TO BENEFIT MOST FROM
COVID-19 VACCINES IS A LEGITIMATE SCIENTIFIC QUESTION THAT DESERVES
CAREFUL STUDY.

That’s why the FDA’s advisory committee (VRBPAC) discussed this
just last week, and why the ACIP is scheduled to review it next month.
These committees were already examining whether to narrow COVID-19
vaccine recommendations through the proper evidence-based process,
making this unilateral announcement all the more troubling. However,
good science answers a question like this by rigorously evaluating
evidence and reaching conclusions based on data, not ideology.

While the benefits of COVID-19 vaccination for healthy children may be
modest, pregnant women face elevated risks from COVID-19,
and vaccination provides protection for both mother and baby
[[link removed].].
COVID-19 continues to cause hundreds of deaths weekly in the US
[[link removed]],
underscoring that this remains a significant health threat, warranting
careful consideration of vaccine policy changes.

In fact, the same week that Makary and his colleague Vinay Prasad
published a perspective piece in 
[[link removed]]_The New England
Journal of Medicine
[[link removed]]_ 
[[link removed]]calling for a
more targeted approach to COVID-19 vaccination, they explicitly listed
pregnancy as a condition warranting COVID-19 vaccination. No
explanation has been given for the abrupt reversal.

A post shared by @unbiasedscipod
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WHAT THIS MEANS

The practical implications of this announcement are profound, even if
the legal authority behind it remains unclear:

*
INSURANCE COVERAGE IS AT RISK: Under the ACA, insurers must cover
vaccines recommended by the CDC without cost-sharing. If the COVID-19
vaccine is removed from the schedule, insurers (including Medicare and
Medicaid) may stop covering it for low-risk groups.

*
PROVIDERS MAY STOP OFFERING IT: Most health systems, pharmacies, and
providers follow CDC and ACIP guidance. If a vaccine is no longer
recommended, it may no longer be stocked or administered.

*
THE VACCINES FOR CHILDREN (VFC) PROGRAM COULD BE AFFECTED: This
program only covers vaccines included on the CDC schedule. Millions of
underserved children could lose access.

*
MANUFACTURER SUPPLY MAY DECLINE: If demand collapses due to the policy
change, vaccine manufacturers may stop producing pediatric and
pregnancy-specific formulations.

*
PATIENTS LOSE THE FREEDOM TO CHOOSE: This move does not ban the
vaccine, but removing it from the schedule likely makes it
functionally inaccessible to many who still want it.

*
LEGAL CHALLENGES ARE LIKELY: Policy experts have noted
[[link removed]] this
decision could be challenged in court due to a lack of administrative
process and failure to follow established protocols.

WHY THIS PROCESS MATTERS

For more than 60 years, the U.S. vaccine recommendation process has
involved careful deliberation by independent scientists and public
health leaders. The ACIP—a diverse panel of independent experts
representing medicine, public health, health economics, ethics, and
the public—reviews evidence and invites public comment before making
any recommendation.

_This decision bypassed all of that._

Even if the ultimate policy conclusion might have been similar, the
process matters. We have these deliberative structures precisely
because vaccine policy affects millions and requires careful,
transparent evaluation of complex trade-offs. As of this writing, no
official policy documents have been released. No clear definitions
have been provided for who qualifies as "healthy" versus "high-risk."
Pregnant women with underlying conditions were not even mentioned in
the announcement.

This type of unilateral decision-making undermines public trust,
erodes the credibility of our health institutions, and politicizes
what should be an evidence-based process.

WHAT OTHER COUNTRIES ARE DOING

Globally, many countries are reassessing their COVID-19 vaccine
policies, particularly for younger and lower-risk groups. But even in
places where universal recommendations have been paused, vaccines
typically remain available, and policy changes follow established
advisory processes.

*
The UK removed COVID-19 vaccine recommendations for pregnancy
[[link removed]] based
on formal cost-effectiveness analysis through their established
advisory process (JCVI). The UK never had universal recommendations
for healthy children, maintaining a cautious approach since the
pandemic began.

*
Most European countries maintain "permissive" policies—vaccines
remain available but aren't universally recommended for healthy
children and during pregnancy. Some countries explicitly state that
pregnancy is a high-risk category that warrants vaccination.

*
PAHO (Pan American Health Organization) still lists pregnant people as
a high-priority group.

KEY DIFFERENCE: Unlike the US announcement, international policy
changes have followed standard advisory processes with formal
cost-effectiveness analyses and transparent deliberation.

WHAT ABOUT OTHER US ORGANIZATIONS?

*
ACOG (American College of Obstetricians and Gynecologists) continues
to recommend COVID-19 vaccination during pregnancy. In a statement
released yesterday
[[link removed]],
ACOG president Dr. Steven Fleischman emphasized how dangerous COVID-19
infection can be during pregnancy, and that “despite the change in
recommendations from HHS, the science has not changed. It is very
clear that COVID-19 infection during pregnancy can be catastrophic and
lead to major disability, and it can cause devastating consequences
for families. The COVID-19 vaccine is safe during pregnancy, and
vaccination can protect our patients and their infants after birth.”

*
After the NEJM article dropped (and before yesterday’s bombshell),
the AAP (American Academy of Pediatrics) expressed serious concerns
[[link removed]] that
children may not have access to COVID-19 vaccines this fall unless
they have underlying health conditions. With today’s announcement,
that is a certainty. AAP leaders stated today that they fear that this
decision will “leave children at risk
[[link removed]]”.

*
The Infectious Disease Society of America (IDSA) released the
following statement
[[link removed]]:
“New COVID vaccine recommendations threaten access, undermine
choice, and will negatively impact health…IDSA strongly urges
insurers to maintain coverage for COVID-19 vaccines so that all
Americans can make the best decisions to protect themselves and their
families against severe illness, hospitalization, and death.”

BOTTOM LINE

This is not just about one vaccine. It’s about how we make public
health decisions.

Good faith experts can disagree about the optimal COVID-19 vaccine
policy for different groups. But those disagreements should be hashed
out through established channels with independent advisors, public
input, and transparent deliberation—not decided by executive fiat on
social media.

Unless this action is reversed through legal or regulatory channels,
it will likely mean that healthy children and pregnant individuals who
want COVID-19 vaccination will no longer be able to access it.
That’s a decision to restrict choices that should not be taken
lightly and should follow the established rigorous scientific
processes for making such a complex and important decision.

It’s not evidence-based. It’s not transparent. And it’s not how
public health should work.

We should all be deeply concerned when a single official can override
decades of process with a tweet.

Stay Curious,

Unbiased Science

P.S. Want to support our work? The best way is to subscribe to our
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_Dr. Jessica Steier [[link removed]]
is a public health scientist with expertise in public health policy,
biostatistics, and advanced analytics._

_David Higgins, MD, MPH, is a physician, researcher, writer, and
speaker standing at the intersection of pediatrics, preventive
medicine, and public health. Subscribe to David
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_Elana Pearl BenJoseph, MD, MPH, is a physician with focus on
pediatrics, health communication, and public health. Subscribe to
Elana
[[link removed]]_

_Aimee Pugh Bernard, PhD, is an immunologist, educator, science
Communicator and science advocate. Subscribe to Aimee
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