Not the Way to Pull Vaccines Back from a “Dangerous Tipping Point”

A response to a JAMA Viewpoint

Peter Marks, the director of the Center for Biologics Evaluation and Research at the FDA, and Robert Califf, the commissioner of the FDA published a “Viewpoint” article in JAMA on January 5th: Is Vaccination Approaching a Dangerous Tipping Point. The Viewpoint is short and certainly worth a read – probably before getting further in this essay.

By my read, the article had two goals. First, it decries the rising anti-vaccine sentiment and falling vaccination rates in the US. Second, it offers recommendations to change this trend.

I had no argument with its first goal. I found the approach to the second goal so disappointing that, after letting it eat at me for a bit, I decided Sensible Medicine was a good place to vent. 

As background, JAMA publishes “Viewpoint” articles in every issue. The journal asks that submissions be “well focused, scholarly, and clearly presented but should not include the findings of new research or data that have not been previously published.”

If you are not the leaders of the FDA, it is not easy to get a Viewpoint published. During the years I was actively publishing in the medical literature, I only got two viewpoints published.¹ These days, at very least, I skim the Viewpoint articles every week. They give a nice summary of opinions (though generally one sided) of important topics in medicine. 

Before my critique, I have to position myself. I am unabashedly pro-vaccine. Little that biomedicine has accomplished comes close to rivaling the benefit of vaccination. Modern vaccines have saved countless lives and changed the course of human history. Hell, I tweeted this on December 22, 2020:

(Of course, if I had it to do again, I would change the title to something like “thanks to vaccines, none of these diseases have killed me.” I’ve had pertussis, dozens of influenzas and, of course, COVID.)

Given my pro-vaccine stance, I agree with Drs. Marks and Califf in decrying the falling vaccine rates in this country. Our vaccines are safe and effective and the fact that we are seeing outbreaks of measles, in people who have ready access to vaccinations, but decline them, is maddening. 

Where I part ways with the authors is in how they believe we should approach raising vaccination rates. They write: 

To counter the current trend, we urge the clinical and biomedical community to redouble its efforts to provide accurate plain-language information regarding the individual and collective benefits and risks of vaccination. Such information is now needed because vaccines have been so successful in achieving their intended effects that many people no longer see the disturbing morbidity and mortality from infections amenable to vaccines. For example, smallpox has been eradicated, and polio has been eliminated from the US, through effective vaccination campaigns. 

This is a reasonable plan if not for the fact that they fail to address the proverbial elephant in the room, COVID boosters. I expect that Dr. Marks and Califf were afraid to go here or that they exist in such a bubble that they no longer talk to patients or primary care doctors. Marks and Califf choose to treat all vaccines the same. This article is like one promoting coronary stenting or statin therapy as appropriate for all patients, in all situations, to the same degree.² The article reads as “trust us, we are doctors, we know what is best” without acknowledging nuance, data, or shared decision making. 

There are people who want nothing to do with vaccines for themselves and their children. I have spent too much time talking to (and tweeting with) this cohort. Some of these people have a poor understanding of science, some extrapolate their mistrust and bad experiences with healthcare to all vaccinations, and some believe in conspiracy theories. None of the them will change their minds based on “accurate plain-language information.” (If you are reading this, and are part of this group, please don’t “@me”. I know I won’t change your mind and you will not change mine. I am sure we agree on lots of other things). 

Most people with whom I interact around vaccines are thoughtful and medically literate. They would never dream of withholding a polio, MMR, or DPT vaccines from their children. When I explain the benefit of the shingles vaccine, they consider it – especially if they have an elderly relative who had shingles. Some choose to accept it, others do not. My patients understand that not all vaccines are the same; they recognize that the individual and community benefit of each vaccine is different. And, as is true in all of medicine, they appreciate -- and should be encouraged to -- weigh the potential harms and benefits of a medical intervention. (I do know we, as humans, are pretty bad at weighing individual risk. But accepting that is the cost of living in a free society.)

Though I am convinced of the safety of the COVID vaccine and know that the initial series saved millions of lives. I, like many of my patients, have questions about the 7^th, 8^th, and 9^th booster (I wish I was exaggerating). I have questions not because of unreasonable skepticism but because we just don’t have robust clinical data that allows me to tell my patients how much a vaccine, after an initial series, will help them. The authors have the gall to show graphs comparing vaccinated and unvaccinated people. This is not the discussion we are having today in clinical medicine. 

Now, don’t get me wrong, COVID remains serious business and we still losing 1500 people each to “COVID related” deaths. We are also not without data that boosters help — I just can’t call it "robust data.”

Like with all medical decisions, we need to be honest with our patients. We do not expect, nor do we want, patients to accept a blanket “do this, it is right” for other interventions; why should we expect that with vaccines?

We have vaccines that are safe, effective, and should be accepted by all — both for their benefit and for the benefit of society. We might even increase uptake of these vaccines with “accurate plain-language information.” We have other vaccines that are safe, but whose benefit may be small or poorly delineated by data.

How do I suggest we increase vaccine uptake?

I think we do it with honesty and transparency. 

“These are the vaccines that have changed life for the better in the 20^th and the 21^st century. If you are hesitant to get these, or give them to your children, you really need to explain you hesitancy to me so that we can discuss it. Not getting these vaccines is a terrible decision.”

On the other hand: 

“These are vaccines whose benefits vary by your personal risk or are supported only by observational or surrogate outcome data. If you would like to do everything that might provide some benefit, take these vaccines. If you are concerned about excessive medical care or are a ‘less is more type’, you might forgo some of these vaccines.” 

Trying to convince all people that all vaccines are the same is not the way to raise vaccination rates, garner trust, or improve public health. Trying to convince all people that all vaccines are the same is probably the way to make people reasonably skeptical of some vaccine be unreasonably skeptical of them all.

Photo by Mika Baumeister

1. Apologies for the shameless self-promotion, I was pretty proud of these two articles. I didn’t keep track but I certainly batter under .500 getting Viewpoints published.

2. H/T to Dr. Mandrola for this analogy.