Baylor College of Medicine

My Personal Risk-Benefit Analysis


Dec. 16, 2020


To Members of the Baylor College of Medicine Community:

This has been a truly momentous week, as the nation started mass inoculations against SARS-CoV-2. Up to now, all of our public health efforts have been around containment (which failed spectacularly world-wide) and mitigation. We should all pause to celebrate this event: the first public health intervention taken since the start of the pandemic designed to bring it to an end.

Mitigation is like giving chemotherapy to slow the growth of a cancer that cannot be cured. For the first time we have a path to actually curing our societal cancer.

When the Vaccines and Related Biological Products Advisory Committee (VRBPAC) met last week, they considered a single question: "Based on the totality of scientific evidence available, do the benefits of the Pfizer-Biotech COVID-19 Vaccine outweigh its risks for use in individuals 16 years of age and older?" They performed a risk-benefit analysis. As every probably knows by now, that answer was "yes."

Vaccine supplies will be limited at first, and there is still much we do not know about how it will be distributed. To get a rough guess of where you fall in the expected allocation plans, the New York Times published a useful widget. If you are towards the end of the line, do not worry. Like the annual melt of the Rockies ice pack, our vaccine trickle will soon become a substantial stream, and by the springtime, it will be a flood.

By April, if all goes as expected, I suspect most people who want to be vaccinated will have access to vaccine.

Suddenly, we are all faced with our own VRBPAC-like question: "Does the benefit of vaccination outweigh the risks to me?" Today I want to share my personal risk-benefit assessment.

First, I need to review our recent numbers. We remain in a major surge. We did not experience a major Thanksgiving bump, and there are some encouraging signs.  

The regional R(t) dropped below 1.0 (suggesting viral spread is decelerating) for the first time in several weeks. On an average basis over the past week, new community positive cases actually dropped (2,373 vs 2,040 for the weeks ending Dec. 6 and 13, respectively). This is encouraging, especially given this drop occurred during the time we should be seeing Thanksgiving induced spread. However, it is far, far too early to declare victory.

Numbers are still at near-record highs, and in our June/July surge we saw many examples of one-week dips followed by new-record highs. Our hospital COVID-19 census continues to inch up daily, and hospitals and providers remain on surge footing.

National daily death rates have declined for the past three days, and hard-hit communities like El Paso have seen their case rate numbers fall. Again – to be crystal clear – it is too early to say we are on the declining side of the surge.

Critically, our nascent vaccine rollout will do virtually nothing to impact the current spread. We need to maintain our viral control practices and plan for safe December holidays.

But, back to my personal risk-benefit analysis.

On the risk side, my personal assessment of the risk if very, very low. I will confess, I have confidence the clinical trials process, and in our regulatory approval processes. A collection of our best clinical and scientific minds has looked at the available clinical trial data, put it in the context of decades of experience with rolling out new vaccines, and concluded it is safe and effective.

I have confidence in our own Baylor vaccine scientists and infectious disease experts, who have independently looked at the available data and are comfortable with the vaccine's safety profile. I have also reviewed the data myself, which is publicly available. I encourage you to do the same.

More than 40,000 people received the vaccine in the Pfizer trials. The subjects included people with a range of chronic conditions - diabetes, pulmonary disease, heart disease, hypertension and others. The most common adverse reactions were local soreness at the injection site, headache, muscle pain chills and joint pain. I am not even sure I would classify these as "adverse reactions." They are signs your body is mounting an immune response, which is what a vaccine is designed to do. There were no major adverse reaction reported.

Once actual non-trial vaccine administration began in Great Britain, there were two widely publicized allergic reactions. I have not seen the details reported yet, but both individuals apparently had a history of severe allergic reactions and carried Epi-Pens. At this point, if you have a history of severe allergic reactions (trouble breathing, skin rash) out of an abundance of caution I would suggest you wait to be vaccinated. I believe there will be much more clarity regarding these reactions in the next days to weeks.

In summary, the rate of a significant adverse reaction is very, very low. There have been no deaths, and even the two allergic reactions were easily treated. I am personally very comfortable with this level of risk. However, I am respectful of those who remain cautious. My advice. Wait a month or so. You do not have to get vaccinated today. The vaccine was approved based on the experience of tens of thousands. Within a week, our experience will expand to hundreds of thousands. Within a month, millions. If our experience continues to hold when a million people are vaccinated, I am probably far more likely to be severely injured driving my car to work than I am to experience a major vaccine-related complication.

That is my assessment of my risk. What about my perceived benefit?

Part of my motivation is – as I think it is for most early adopters – at least partially altruistic. I have no major risk factors. I do not want to get the virus, but I am vigilant about my distancing practices and do not necessarily fear contracting it.

However, I do feel – especially as a physician – an obligation to receive the vaccine. In a very small way, I am protecting the more vulnerable in our population. It will require tens of millions of individual small decisions to see this end.

I will confess, much of my motivation – much of my perceived personal benefit – is selfish. I have an 82-year-old father in North Carolina I would like to be able to visit without fear of infecting him. I have a niece and nephew – three-year old twins – I would like to see in person rather than on FaceTime. I have two "pandemic baby" granddaughters that I want to steal from their mothers ever now and then to have small adventures together. I want them to be able to meet and play with other children their ages. I want to go to church on Sunday morning in vivo, instead of on YouTube.

As I write this, it strikes me that this is not particularly revelatory – the pandemic has robbed all of us of something important. Health. Economic security. Companionship. Human connection. Selfishly, I miss my pre-pandemic life, and want it back. My individual decision to receive the vaccine will not get us there, but millions and millions of individual decisions will.

Let's get our lives back.

Stay well.

James T. McDeavitt, M.D.

(Note: I know there are many questions about when vaccines will be available. There is much we do not know, and the situation changes daily. We will continue to push out what we know to the Baylor community, as we know it. Please refer to our on-line FAQs for general information.)

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