RFK Jr Calls For Placebo Trials For All New Vaccines. Experts Say You Can’t – And Shouldn’t – Do That

In a statement first given exclusively to the Washington Post, the department called the move “a radical departure from past practices”. But experts have since labelled this as misleading, pointing out that vaccines already undergo placebo testing, and that in some cases using an inactive placebo – like a saline shot – is not an ethical way of conducting a trial. So, what’s the truth about how vaccines are tested, and what could any new regulations mean for vaccine access?

How are vaccines tested?

Placebo-controlled trials are considered the gold standard for testing new drugs. In their most basic format, participants in such a trial are either given the new drug or a sham treatment – like a pill or shot containing no active ingredients – so that investigators can compare the two to be sure that the new medication is having an effect beyond what might just happen by chance. 

When the vaccines that are familiar to us all today were first developed, this was how they were tested. Professor Peter Hotez, scientist, pediatrician, and global public health advocate, listed numerous studies in a post on X, showing the trial history for the MMR, rotavirus, polio, pertussis (whooping cough), varicella (chicken pox), and flu vaccines. 

Where things get a bit more complicated is when developers are producing a new version of an existing vaccine. 

As a hypothetical, let’s say scientists were tweaking the MMR vaccine in the hopes of making the protection kick in even faster. When they’re ready to test their new formulation, one group of trial participants will be given the new vaccine. But in this scenario, the other group will not be given a saline shot. Instead, they will be given the existing, licensed MMR vaccine.

“If we have vaccines or treatments that work, it’s wrong to give some research participants nothing,” explained Professor Seema Shah, director of research ethics at Ann & Robert H. Lurie Children’s Hospital of Chicago, in a statement. 

There are some exceptions to this, Shah explains. For example, when testing a new seasonal allergy medicine, the risk to participants from giving them a placebo is low – worst case scenario, they’ll have their usual hay fever symptoms. This equation is very different when it comes to withholding protection from a potentially deadly disease like measles. 

The same is true in other medical fields. When new chemotherapy regimens for cancer are being tested, the American Cancer Society explains, they are trialled against the current standard of care, meaning that trial participants don’t miss out on getting the best treatment available for their cancer. The exception would be for cancers that don’t currently have an effective treatment, in which case a traditional placebo may be used.

When it comes to vaccines, Shah continued, “for many diseases, scientists already know how to measure if the vaccine is giving the immune system the information it needs to fight the disease, and there is no need to use a placebo injection.”

“A blanket rule to use placebos will force scientists to treat people unethically. It seems like another way to gum up the works so fewer people will be protected against infectious diseases in the future.”

COVID vaccines – a unique case

When the COVID-19 vaccines arrived against the backdrop of a once-in-a-generation international health crisis, some expressed fear and skepticism about the speed of the approval process. These vaccines, perhaps more than any others in recent years, have been at the center of concerns around vaccine trials and safety. 

It’s true that several vaccine options for COVID, including the still in-use mRNA vaccines developed by Moderna and Pfizer-BioNTech, were approved speedily. But experts are quick to point out that that doesn’t mean any corners were cut. 

“The reason it was so fast is money and work,” Dr Paul Offit, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia, told KFF Health News in 2021. 

Research into mRNA vaccines had begun decades prior, so scientists were not starting from scratch when COVID came along. The urgency of the situation also meant huge amounts of funding were poured into clinical testing, which was conducted on an incredible scale – somewhere between 30,000 and 45,000 participants enrolled in the first trials.

“These studies are so much bigger than the studies we do for many licensed vaccines,” added Dr Ruth Karron, founding director of the Johns Hopkins Vaccine Initiative. 

The fact that the use of these vaccines is grounded in all this initial safety data – not to mention the millions of doses that have since been administered, giving scientists a huge amount of post-approval evidence of their safety and efficacy – means that when the shots needed to be updated for new COVID variants, this could be done without a whole new set of trials.

The same happens annually for the seasonal flu shot. If you’re just tweaking the formula, there’s no need to test it all over again. 

It seems, however, that this standard practice is no longer to be given blanket acceptance by US authorities.

The Food and Drug Administration (FDA), under the leadership of Dr Marty Makary, has recently been accused of “slow-walking vaccine approvals” by requesting new trial data for updated shots. The controversy specifically centers around the Novavax COVID vaccine, a protein-based vaccine that offers an alternative to the mRNA shots. 

Novavax is seeking approval for an updated version of the vaccine targeted against the JN.1 COVID variant. However, in a post on X, Makary suggested that this was a “new” product and would thus require new clinical trials. 

“Under this administration,” he wrote, “we are prioritizing the Gold Standard of Science – not what saves pharma companies ‘tens of millions of dollars’”.

The problem, some have argued, is that the prohibitively expensive nature of these trials – which remember, according to the current scientific standards, are unnecessary – may just result in drug companies stepping back from vaccine development altogether. 

“It just worries me that [this is] part of an overall general strategy to weaken vaccine efforts,” Offit commented to NBC News. 

But HHS appears to be in lockstep with the FDA on this one. A spokesperson gave the following statement to The Hill: “As we’ve said before, trials from four years ago conducted in people without natural immunity no longer suffice. A four-year-old trial is also not a blank check for new vaccines each year without clinical trial data, unlike the flu shot, which has been tried and tested for more than 80 years.”

“A waste of everyone’s time and money”

This is by no means the first time that Kennedy has called vaccine testing into question, nor the first time during his tenure as HHS Secretary that he has propagated misleading claims about vaccine science and medical treatments. 

Some public health experts are sufficiently concerned about the direction of traffic that they have come together in the Vaccine Integrity Project, an unprecedented initiative seeking to safeguard vaccine access and counter government misinformation.

The latest proposals on placebo testing, it’s being argued, threaten US citizens’ continued access to innovative, up-to-date vaccine technology.

“Requiring placebos for all vaccine trials is a little like making basketball players do tryouts before every game – a waste of everyone’s time and money,” said Shah.