How safe is safe enough?

There is no reward without risk.

It was my turn. I wasn’t the first, and I certainly won’t be the last, but I had my chance to receive the Pfizer/BioNTech SARS-CoV-2 (aka COVID-19) vaccine.

In a previous post, I discussed reactogenicity—the propensity for certain vaccines to provoke the immune system to cause undesired effects, such as pain at the injection site, body aches or even fevers. Reactogenicity is seen in various vaccines and is not considered an allergy. It is just an effect of the vaccine. Many medications, or even foods, can cause undesired effects. A family member once called me concerned that her urine had turned red. She had eaten a beet salad the night before.

Significant adverse reactions, even life threatening allergic reactions, known as anaphylaxis, are a risk with any medication or vaccination. Already, reports are surfacing of anaphylaxis occurring with the new vaccine—which I just received! The CDC is still investigating the circumstances of these reports, but it is not a complete surprise to hear that a bad reaction, even a potential life threatening reaction, can occur with a new medication or vaccine sent out to millions of people.

It is recommended that people allergic to an ingredient the vaccine not receive the vaccine.

From cdc.gov

But how do you know if you are allergic, especially to ingredients you can’t pronounce? Most of the ingredients in the vaccine are things that we are naturally exposed to all the time, such as cholesterol or various salts. One ingredient has drawn particular scrutiny—polyethylene glycol (PEG).

PEG is most commonly used safely and effectively as a laxative—Miralax. It is also an ingredient in many medications, including interferon and G-CSF. Many brands of artificial tears also have PEG. It is not a new medication. It is also found in some household items. So chances are, a great many of us have been exposed to PEG at one point or another.

Why a handful of people have experienced anaphylaxis so far is unclear—especially since so few people in the vaccine trials did so. There is no recommendation to do any allergy testing for PEG or any other ingredients in the vaccine at this time. The lifetime risk from anaphylaxis from all causes is estimated to be between 0.5% and 2%. For now, the recommendation for all individuals receiving the Pfizer/BioNTech COVID-19 vaccine is that they remain for observation for 15 minutes after administration. For people with a history of anaphylaxis from ANY cause, even food or environmental allergies, the recommendation is to remain for observation for 30 minutes. And for anyone with a history of anaphylaxis to an ingredient in the vaccine—DON’T receive the vaccine!

The risk of serious, even life threatening reaction to this, or any, vaccine raises the question: How safe is safe enough? For those of us on the frontline of caring for COVID-19, as well as older individuals at high risk for death from COVID-19, the risk/benefit analysis falls squarely on the benefit side.

We face risk all the time. Physical risk from food—did you cook your raw chicken well enough, did you wash your hands afterward, as well as the counter and utensils? You don’t want to get salmonella. Or E. coli from lettuce. There are physical risks from various activities like skiing or even playing baseball. And getting in your car—there is always a chance an out-of-control driver will hit you. We live with these risks all the time, and they are familiar to us. We accept the risks associated with these activities, just as we accept the financial risk of starting a business, or the emotional risk of falling in love. We know that without that risk, there is no reward.

Putting an unfamiliar risk, such as a bad reaction from a vaccine, in context is the big challenge facing public health advocates going forward. But this is nothing new. Communicating risk has always been part of the difficult work in public health, whether it is vaccines, safe driving, or mixing firearms and young children in the same home. This has been especially true most recently with measles vaccination.

The individual risk from a vaccine must be weighed against both the individual risk from acquiring the disease AND the societal risk of rampant, unchecked infection in the community. Reframing from ME to WE has been difficult in a society that exalts individualism and a notion of liberty that does not examine or value the externalities of one’s individual decisions. Just as no one has a right to yell “Fire!” in a crowded theater (unless, of course, there is an actual fire), there are certain liberties we must constrain for a functioning society that maximizes liberty for all—including the liberty to live free of COVID-19.

So for now, I will be happy to roll up my sleeve, get the second dose of vaccine in a few weeks, and take on the risk of a reaction. The reward of living a life free from risk of dying from COVID-19, or potentially transmitting it to my loved ones, makes the reward much greater than the risk.