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Why We Volunteered in COVID Vaccine Trials

— A father and son's perspectives

MedpageToday
Photos of Victor Nizet, MD, and his son Oliver receiving the COVID-19 vaccine.

A Doctor's Perspective: Victor Nizet, MD

As a pediatric infectious disease physician who trained in the 1980s and 1990s, I gained plenty of experience caring for infants or children who contracted serious, and sometimes life-threatening, infections because of lack of vaccine access (or first-generation vaccines that worked only in older patients). A few examples include acute epiglottis choking the airway from Haemophilus influenzae; pneumococcal meningitis with severe sequelae such as deafness or cerebral palsy; and fatal measles encephalitis in a recent immigrant. These frightening diseases are now vanishingly rare in communities with high adherence to the pediatric immunization schedule, ensuring one key aspect of health for all children to thrive, pursue their dreams, and reach their full potential.

As a microbiology and immunology researcher, I recognize that emerging infectious disease threats will always be with us, with increasing potential to spread quickly worldwide. Of course, this has been strikingly exemplified by the global public health devastation wrought by the COVID-19 pandemic. Very few countries were able to mobilize quickly and aggressively enough to prevent widespread circulation in the broader population, leading to health, economic, and social disruption and devastation. Early on it became clear that vaccines would be the only pathway to protect the vulnerable, approach herd immunity, and regain a secure foothold toward normalcy.

However, we'd never had a coronavirus vaccine -- would this deadly infectious agent prove as elusive as a cure for the common cold, for which more benign coronaviruses are the frequent culprit?

Fortunately, critical investments were made, and dozens of parallel COVID-19 vaccine discovery programs, ranging from classical technologies to innovative platforms, were launched through a variety of biopharmaceutical, academic, foundation or government initiatives. To many (including me) the most scientifically intriguing among these were the novel mRNA vaccine platforms such as Pfizer/BioNTech and Moderna -- the technology seemed so nimble and versatile, but its promise unfulfilled, as no mRNA vaccine had ever been approved for clinical use.

When I learned through colleagues that the Pfizer/BioNTech COVID-19 vaccine trial was opening a site in San Diego, I didn't hesitate for a second to enroll as a subject. On Aug. 24, 2020, a small needle went into my right arm with a 50% chance that it delivered 30 µg of nucleoside-modified mRNA encoding an optimized full-length SARS-CoV-2 spike glycoprotein, and an equal chance it delivered the placebo. This was repeated 3 weeks later, with no symptoms after each injection. Honestly, going in, when compared to conventional vaccines, I thought that a single mRNA-encoded protein might be the least likely to provoke post-injection side effects like soreness or fevers, and that it might generate more modest levels of immunity. When the results were released in December 2020, I was as stunned as everyone else at the trial results: 95% protection against COVID-19 infection in vaccines -- results that have been confirmed in multiple real-world settings and matched by the similar Moderna technology. When my age group eligibility came up this past January, I was unblinded in the study, learned I was in the placebo group, then crossed over to receive the actual vaccine. And thus, I began the rewarding pathway to high-level immunity, just as the majority of Americans have wisely chosen to do.

A few months later, my family began having a related discussion at the dinner table: Should Oliver, my 15-year-old son, participate in the COVID-19 vaccine trial for kids?

A Teen's Perspective: Oliver Nizet

I was lucky that my school, which teaches students from kindergarten through high school, organized well in response to the COVID-19 pandemic. They followed public health guidelines, got science-based input from the neighboring university, and had good buy-in from parents, teachers, and students. The spring of my freshman year was taught remotely over Zoom, but we had in-person instruction for my whole sophomore year, with daily symptom screening, facemasks, distancing, periodic antigen testing, and a lot of outdoor classrooms (it helps to live in San Diego). A number of students and a few employees got COVID-19 over the course of the year, but this was always from off-campus exposures, and everyone was notified, contact tracing performed, and as far as I know, no infections were spread in the school.

When my dad participated in the COVID-19 vaccine trial last summer, I paid close attention and asked a lot of questions. Three things convinced me that I should participate in the kids' trials. First, a teen's antibody response to vaccines is every bit as good as an adult's. Second, any serious side effects to vaccines always appear in the first few days or weeks after the shot, and millions of adults had already been immunized to COVID-19 without such problems. Finally, even if my risk of severe disease is pretty low, I can protect more vulnerable people by taking myself out of the potential chain of transmission.

When the vaccine trial center became a site for the 12- to 16-year-old age group, I thought, why not sign up and get a head start on my immunity? As it turns out, I got randomized into the placebo group -- similarly to my dad -- so I ended up getting a total of four injections (two during the clinical trial and two once my age group became eligible). I also got to participate in a companion trial of nasal swab self-testing for COVID-19 detection. I'm really glad to be fully protected now and looking forward to visiting my relatives in Sweden this summer who I haven't seen for 2 years. Plus, since I got compensated for being a trial volunteer, I also have a little extra spending money.

A Doctor's Perspective: Victor Nizet, MD

COVID-19 vaccines have undergone intensive safety monitoring, which now extends into the teenage group. Everybody recognizes that COVID-19 is most often a mild disease in children, however, there were sick enough to be hospitalized with COVID-19 in America this past year, and half of these kids had no known risk factors. The rare but frightening multisystem inflammatory syndrome in children (MIS-C) that can strike weeks after COVID-19 infection is quite serious and there is concern that some survivors may experience long-term sequelae. And very importantly, COVID-19 vaccination in our children protects the health of the broader community; fewer overall infections in children and adults means less chance for the virus to mutate and variants to emerge that could prove more dangerous or resistant to the available vaccines and therapies.

I strongly encouraged my son's vaccination, and was proud he volunteered for the trial and learned about informed consent and the true dedication that healthcare professionals give to carefully evaluating the vaccine's efficacy and safety. Soon, families will be able to extend these benefits to their younger children, helping give our country the best chance to open schools and businesses, pursue recreational activities, and travel safely in a post-COVID-19 era.

is Distinguished Professor of Pediatrics and Pharmaceutical Sciences at UC San Diego. Oliver Nizet is a student (just completed 10th grade) at La Jolla Country Day School.