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RFK JR.’S UNETHICAL AND DEADLY VACCINE TESTING PLANS  
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Michael Hiltzik
May 8, 2025
Los Angeles Times
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_ RFK Jr. plans to require more testing of vaccines before they
approved, in the name of greater rigor. In fact, his proposals are
highly unethical and pose a danger to your health. Here’s why _

Health Secretary Robert F. Kennedy Jr. at a recent news conference
about autism research, C-SPAN

 

Americans have become woefully familiar with Health and Human Services
Secretary Robert F. Kennedy Jr., the purveyor of flagrant
misinformation about medical treatments
[[link removed]].
And with Robert F. Kennedy Jr., the minimizer of health crises
[[link removed]] such as the spreading
measles outbreak. And with Robert F. Kennedy Jr., the antivaccine
crusader
[[link removed](24)02603-5/fulltext].

Now let’s meet Robert F. Kennedy Jr., the promoter of a costly,
time-consuming and distinctly unethical order for testing vaccines.
“All new vaccines will undergo safety testing in placebo-controlled
trials prior to licensure — a radical departure from past
practices,” HHS announced in a May 1 statement. What it didn’t say
was that the “departure” is “radical” because it’s shunned
by medical authorities as a bad thing.

Just this week, Kennedy’s agency doubled down on this order with the
appointment of Vinay Prasad, an oncologist at UC San Francisco,
as head of the Center for Biologics Evaluation and Research
[[link removed]], the
division at the Food and Drug Administration that oversees vaccine
testing.

Prasad was a strident critic of the Biden administration’s approach
to the COVID-19 pandemic, including the COVID vaccines. In a blog post
in late April, he called for clinical testing of COVID boosters, along
the lines of Kennedy’s order. Prasad succeeds Peter Marks, a widely
respected expert who resigned from the FDA in March after clashing
with Kennedy.

“I was willing to work to address concerns regarding vaccine safety
and transparency,” Marks wrote in his resignation letter
[[link removed]].
“However, it has become clear that truth and transparency are not
desired by the Secretary, but rather he wishes subservient
confirmation of his misinformation and lies.”

The HHS announcement about Kennedy’s demand for placebo-controlled
trials was unclear about how it defined “new vaccines.” But his
prior claims about vaccine safety have made clear that he’s
referring not only to first-generation vaccines for diseases, but also
boosters and expanded formulations. That’s an important point, as
I’ll cover in a moment.

The antivaccine camp, of which Kennedy has long been a leader,
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pushed the claim that most childhood vaccines haven’t been
adequately tested for safety because they haven’t been subjected to
placebo-controlled trials — and therefore they may be unsafe.

“Except for the COVID vaccine, none of the vaccines on the CDC’s
childhood recommended schedule was tested against an inert placebo
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meaning we know very little about the actual risk profiles of these
products,” Kennedy’s spokesman at HHS, Andrew Nixon, asserted in
connection with the order.

Both components of that claim are misrepresentations.

Let’s take a closer look, starting with some rudimentary points.

The testing that Kennedy and Prasad advocate are randomized control
trials. They’re correct in asserting that so-called RCTs are the
gold standard in clinical testing of drugs and vaccines.

RCTs typically involve at least two groups of subjects: One receives
the medicine in question and another — a control group — receives
something else, such as a placebo, a concoction that’s designed to
resemble the medicine but is essentially inert, with no evident effect
on the disease. The placebo may be an injectable saline solution, or
water, or a sugar pill.

And Kennedy, like other antivaxxers, is deceptive in saying that the
safety of vaccines should be questioned if it hasn’t been tested
against an “inert placebo.”

That brings us to the ethics of clinical testing, and why Kennedy’s
policy is so dangerous.

Testing a vaccine against a true placebo is ethical and proper when
it’s the first treatment for a disease for which no other safe and
effective treatment exists. That’s not the case, however, when a
known treatment does exist — say after a vaccine has been shown to
be safe and effective and has become the standard of care.

As vaccine specialist Paul Offit of Children’s Hospital of
Philadelphia has explained, subjecting new versions of those vaccines
to placebo-controlled testing — giving some subjects the new vaccine
and the control subjects no treatment, would be _unethical_, because
it would require depriving the placebo group access to a known
treatment. That was the conclusion of an expert panel
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World Health Organization in 2014.

Offit, in a 2023 rejoinder
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Kennedy’s appearance on a Joe Rogan podcast, in which he claimed
that drug companies “never do placebo-controlled trials,” pointed
to what may be the most famous vaccine trial to illustrate this point.

That was the nationwide trial of Jonas Salk’s polio vaccine. In
1954, 420,000 first- and second-graders were given the Salk shot, and
200,000 got a shot of salt water. Salk objected to the trial’s
design. Smaller trials had established the safety and efficacy of his
vaccine, so the plan meant depriving 200,000 children of immunity to a
disease that was paralyzing 50,000 children a year and killing 1,500.

As Offit noted, in the full trial 16 children died from polio; all
were in the placebo group. So were 34 of the 36 children paralyzed in
the course of the trial. “These are the gentle heroes we leave
behind,” Offit wrote.

Now let’s examine Kennedy’s order as it applies to modern
vaccines. As the veteran pseudoscience debunker David Gorski has
pointed out, contrary to the assertion by Kennedy’s spokesman,
almost none of the vaccines on the current childhood vaccination list
is a first-generation vaccine
[[link removed]] warranting
placebo testing. (An exception is Gardasil, which safeguards against
human papilloma virus.) They’re upgraded preparations of vaccines
that themselves underwent placebo-controlled trials, or formulations
aimed at new variants of the targeted disease, or shots that inoculate
against several diseases all at once.

To demand that every new formulation be tested against an inert
placebo would mean turning back the clock to reproduce trials that may
have taken place decades ago, but resulted in the licensing of the
original vaccine after safety and efficacy were established.

That means it would have been unethical to test the new version
against a saline control, because the control group would be deprived
of any effective treatment. “The bottom line,” Gorski writes,
“is that, if you trace back the history of the vaccines developed
for a disease like, say, measles, you will eventually find the RCT
testing the first effective vaccine against it and that vaccine will
have had a placebo control.”

He’s right. In a tweet thread
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Peter Hotez traced back the history of several vaccines to their
initial RCTs.

What makes Kennedy’s order especially cynical is that designing and
implementing a clinical trial is an extraordinarily complex, costly
and time-consuming process. As a team of Canadian researchers observed
in a 2018 Nature article
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a full-scale Phase 3 clinical trial — the level at which drugs and
vaccines are studied for safety, efficacy and dosing — requires as
many as 3,000 participants and can take as long as four years.

In an online posting last month
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Prasad ridiculed “the mainstream media” for being upset about the
idea that COVID boosters should in effect receive full randomized
clinical trials before approval. He took particular issue with an
article by Helen Braswell of STAT
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that such a requirement might well delay approval of a vaccine
targeting a new COVID variant until it was too late to protect users
from that variant. Prasad called the argument false, because “the
virus spreads year round.”

Is that so? At the height of the pandemic, new COVID variants
sometimes appeared within months of one another
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virulent Delta variant, for example, appeared in the spring of 2021
and was overtaken by the Omicron variant, which also caused severe
disease, that November.

Delays in rolling out vaccines to combat newly emergent disease
strains and variants could cost millions of lives. Under existing
vaccine approval protocols, the COVID vaccines prevented as many as
20 million deaths
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year after they were introduced early in 2021.

Prasad’s new job will put him in charge of developing vaccine
testing policies and overseeing the design and approval of clinical
trials. I asked him via email what policies he would pursue, whether
he was in alignment with Kennedy’s approach, and how he expected
vaccine developers to reconcile the costs and time constraints of
undertaking clinical trials on the scale he advocates with the
imperatives of public health. I didn’t receive a reply.

So far, the Kennedy regime at HHS has lived down to the worst
expectations of his critics. His devotion to unnecessary testing of
vaccines that have already shown their safety and efficacy is only one
aspect of a comprehensive assault on public confidence in
science-based medicine.

In a recent appearance on Sean Hannity’s Fox News program, Kennedy
dismissed the severity of the current measles outbreak and denigrated
the effectiveness of the measles vaccine. The current outbreak of 935
cases is by far the worst in the U.S. since 2019, when 1,274 cases
were recorded; at the current rate, we are on the path to nearly 3,000
this year.

Kennedy has promoted almost useless nostrums against measles, such as
Vitamin A, while describing vaccination as a personal choice. That’s
devastatingly wrongheaded. Kennedy confuses “medicine” and
“public health.” The former concerns itself with the individual;
the latter with the community. Vaccine policy belongs in the latter
category because vaccines are most effective when the effort is
communitywide.

Measles is among the most contagious diseases known to humankind,
which means that communal vaccination is crucial. Professionals have
concluded that a 95% vaccination rate is the minimum required to
protect the most vulnerable, such as infants, from infection; as of
2024, the U.S. vaccination rate among kindergartners had fallen from
95.2% in 2019-20 to 92.7%.

The Centers for Disease Control and Prevention, which falls within
Kennedy’s jurisdiction, says the decline in measles vaccinations
leaves 280,000 kindergartners at risk. Two children in the U.S.
already have died from a disease that was thought to have been
eradicated in the U.S. in 2020; Kennedy doesn’t seem concerned that
the toll on his watch is poised to get much worse.

_Pulitzer Prize-winning journalist Michael Hiltzik has written for the
Los Angeles Times for more than 40 years. His business column appears
in print every Sunday and Wednesday, and occasionally on other days.
Hiltzik and colleague Chuck Philips shared the 1999 Pulitzer Prize for
articles exposing corruption in the entertainment industry. His
seventh book
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“Iron Empires: Robber Barons, Railroads, and the Making of Modern
America,” was published in 2020. His latest book, “The Golden
State,” is a history of California. Follow him on Bluesky
at hiltzikm.bsky.social
[[link removed]], on X
at twitter.com/hiltzikm [[link removed]] and on
Facebook at facebook.com/hiltzik [[link removed]]._

_The Los Angeles Times [[link removed]] is the largest
metropolitan daily newspaper in the country, with more than 40 million
unique latimes.com visitors monthly, Sunday print readership of 1.6
million and a combined print and online local weekly audience of 4.4
million. The Pulitzer Prize-winning Times
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has been covering Southern California for more than 143 years._

* RFK jr.
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* vaccines
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* public health
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* Polio
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* measles
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* COVID-19
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* Science
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