Why COVID-19 Vaccines Should Not Be Required for All Americans

BOSTON, MA - AUGUST 30: Anti-vaccine activists hold signs in front of the Massachusetts State House during a protest against Governor Charlie Baker's mandate that all Massachusetts school students enrolled in child care, pre-school, K-12, and post-secondary institutions must receive the flu vaccine this year on August 30, 2020, in Boston, Massachusetts. (Photo by Scott Eisen/Getty Images)

Anti-vaccine activists protest in front of the Massachusetts State House in Boston, Massachusetts. (SCOTT EISEN/GETTY IMAGES)

 

COVID-19 vaccine mandates have become a hotly contested issue, as coronavirus cases and hospitalizations rebound nationwide, driven by the highly contagious delta variant and unswerving vaccine hesitancy. New York City will soon be the first major U.S. city to require proof of vaccination to enter restaurants, gyms, and other indoor public spaces. Dr. Marty Makary, a professor at Johns Hopkins University School of Medicine and editor in chief of MedPage Today, argues that mandating vaccines for "every living, walking American" is not well-supported by science. Moreover, Makary, author of "The Price We Pay: What Broke American Health Care—and How to Fix It," has concerns about the two-dose vaccine regimen for young people.

As told to Lindsay Lyon as part of Two Takes, a U.S. News series examining opinions about key issues. Responses have been edited for length and clarity.

As a physician with a lot of experience dealing with patients who don't follow what we ask them to do, I believe you win more bees with honey than fire.

 

The vaccines are so good at protecting against death from COVID-19 that those who are immune can feel good about living life without worrying about becoming severely ill. Vaccines downgrade the infection to a mild seasonal virus – one we must learn to live with for years to come.

Those who choose not to get vaccinated are making a poor health decision at their own individual risk. They pose no public health threat to those already immune. Would we be so stern toward people making similar or worse health choices to smoke, drink alcohol, or not wear a helmet when riding a bike? Over 85,000 Americans die annually from alcohol, yet we don't have the same public health fervor or requirements to save those lives. Let's encourage vaccination rather than activate the personal liberty culture wars that result in people becoming more entrenched in their opposition.

 

The notion that we have to vaccinate every living, walking American – and eventually every newborn – to control the pandemic is based on the false assumption that the risk of dying from COVID-19 is equally distributed in the population. It's not. We have always known that it's tough for the virus to hurt someone young and healthy. And that's still the case. While vaccine requirements for health care workers make sense, we would never extend those requirements outside of health care for, say, the flu shot. We'd simply state to the public: Those who avoid the flu shot do so at their own risk.

 

Also: Some people already have 'natural immunity – that is, immunity from prior COVID infection. During every month of this pandemic, I've had debates with other public researchers about the effectiveness and durability of natural immunity. I've been told that natural immunity could fall off a cliff, rendering people susceptible to infection. But here we are now, over a year and a half into the clinical experience of observing infected patients, and natural immunity is effective and going strong. And that's because, with natural immunity, the body develops antibodies to the entire surface of the virus, not just a spike protein constructed from a vaccine. The power of natural immunity was recently affirmed in an Israeli study, which found a 6.7 times greater protection among those with natural immunity vs. those with vaccinated immunity.

 

Requiring the vaccine in people who are already immune with natural immunity has no scientific support. While vaccinating those people may be beneficial – and it's a reasonable hypothesis that vaccination may bolster the longevity of their immunity – to argue dogmatically that they must get vaccinated, zero clinical outcome data to back it. As a matter of fact, we have data to the contrary: A Cleveland Clinic study found that vaccinating people with natural immunity did not add to their level of protection.

So instead of talking about the vaccinated and the unvaccinated, we should be talking about the immune and the non-immune. Immunity is something people can test for with a simple antibody test. I would never recommend that anyone intentionally acquire the infection to get natural immunity, but vaccine passports and proof-of-vaccine documents should recognize it.

 

Now, if someone does not have natural immunity from prior infection, they should immediately go out and get the vaccine. I'm pro-vaccine. But the appropriate clinical indication of the vaccine is not an all-or-nothing phenomenon, as we frequently see in American culture and politics.

I'm perplexed at the vitriol directed at folks who are reluctant to get vaccinated. For some, the biggest driver of their hesitancy is the U.S. Food and Drug Administration, which has failed to issue the long-overdue full approval of the COVID-19 vaccines due to stability testing, which has nothing to do with safety.

The goal of our pandemic response should be to reduce death, illness, and disability, but instead, what you're seeing is a movement that has morphed from being pro-vaccine to vaccine fanaticism at all costs.

 

We have robust population immunity in most parts of the U.S. These areas are resilient to the delta variant driving severe illness right now. This stems from a combination of natural immunity and vaccinated immunity. Roughly a third to half of unvaccinated Americans have natural immunity, based on an analysis of California residents. So it does change the outlook.

For example, one study conducted by California this spring found that 38% of Californians and 45% of Los Angeles residents had natural immunity. And this was at a time when vaccine rollout was still too early to account for those numbers. So we're potentially talking about a large portion of the U.S. population who may be immune to COVID and not know it. They should be tested to find out, and we should concentrate our vaccination efforts on people who are not immune.

 

Right now, we do have a group of susceptible, non-immune Americans among whom the delta variant is raging. That's where we need to focus our attention. We have to make the vaccine more available – and easily available – to the non-immune in the U.S. That means going to them: Having walk-up vaccination appointments at routine points of American life.

When it comes to vaccinating healthy kids – and you could argue young people up to 25 – there is a case for vaccination, but it's not strong. The COVID-19 death risk is clustered among kids with a comorbid condition, like obesity. Of the more than 330 COVID-19 deaths in kids under age 25, good preliminary data suggests that most or nearly all appear to be in kids with a pre-existing condition. For kids with concurrent medical conditions, the case for vaccination is compelling. But for healthy kids?

 

The risk of hospitalization from COVID-19 in kids ages 5 to17 is 0.3 per million for the week ending July 24, 2021, according to the Centers for Disease Control and Prevention. We also know that the risk of hospitalization after the second vaccine dose due to myocarditis, or heart muscle inflammation, is about 50 per million in that same age group.

It may be that the standard two-dose regimen is a dose too high and is inducing a strong inflammatory response causing these complications. A single dose of the vaccine may be highly effective in kids, as reported by Tel Aviv University. Researchers there found that one dose was 100% effective in kids ages 12 to 15. Until we get better data, I recommend one dose for healthy kids who have not already had COVID-19 in the past.

 

I'm concerned the CDC hasn't considered whether one dose of the two-dose shots would be sufficient – and safer – for young people. The agency's Advisory Committee on Immunization Practices has vigorously recommended the two-dose vaccine regimen for all children ages 12 and up regardless of whether kids already have immunity. I take issue with that. The data the CDC used on which to base its recommendation is incomplete at best. The agency uses the Yelp of vaccine complications as a data source: a self-reported database of vaccine complications, which haven't been fact-checked by authorities. So the agency may not be fully capturing the extent of vaccine complications from the second dose in some young people.

 

I wish the CDC would tell us more about the deaths of Simone Scott, 19, and Jacob Clynick, 13, both of whom died shortly after getting a second vaccine dose and developed heart inflammation. There have been 19 other deaths in youth under age 25, according to the CDC. Since the clinical trials were not powered sufficiently to detect rare events like these, I want to know more about those deaths before making blanket recommendations.

Researching these events is important when issuing broad guidance about vaccinating healthy kids, including students, who already have an infinitesimally small risk of dying from COVID-19.

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