Clinical Trial Pharmacist Has Unique Perspective on Vaccine Safety

Pharmacist Hetal Patel (right) engages with an infant prior to administering a COVID-19 vaccine at Lebanon Family Pharmacy in Lebanon, Tennessee.

Arthur Wernick, PharmD, wears what he calls a “spacesuit” for his work at True Blue Clinical Research in Tampa, Florida.

While pharmacists have been administering COVID-19 vaccines to pediatric patients in pharmacies around the country, Arthur Wernick, PharmD, has been behind the scenes helping test investigational new COVID-19 vaccines in children. He prepares IV infusions and vaccines for COVID-19 trials at TrueBlue Clinical Research in Tampa, Florida. The experience has given him a valuable perspective on vaccines.

“I have been fortunate enough to be part of the trials where these medications are developed. The patients undergo so much monitoring, for months and months, so that your child can come into a pharmacy and take the shot, and you can go home with peace of mind,” Wernick said.

Wernick is working on pediatric clinical trials of COVID-19 vaccines in development by Novavax and Bavarian Nordic. The Novavax vaccine combines the SARS-CoV-2 spike protein and an adjuvant dubbed Matrix-M, which should boost immune system response to the spike protein. Bavarian Nordic’s vaccine, which uses proprietary capsid virus-like particle technology, is intended to be a universal booster to any prior COVID-19 vaccine.

Wernick works with study participants who have volunteered to receive the vaccine, so he doesn’t encounter much vaccine hesitancy in his daily routine—aside from needle-phobia. But due to his work in clinical research, he knows exactly how he’d address some of the most common reasons parents refuse a COVID-19 vaccine for their children.

In response to the “it came out too fast” argument, Wernick says he doesn’t entirely disagree. He admits that the first COVID-19 vaccine did indeed become available extraordinarily fast, however important steps were not overlooked.

“You always have to start the conversation by listening and letting them know that you understand their feelings,” Wernick said. “They’re right when they say it came out in a very short time, but there was no time [to waste].”

Wernick further emphasizes that the speedy development doesn’t mean the vaccine is unsafe. Clinical trials take as long as they do, he explains, so that the experimental drug can be tested on thousands of people. The number of people who have received COVID-19 vaccines by now has far surpassed the number who participated in clinical trials.

“It’s the largest clinical trial in the history of mankind,” Wernick said.

Given the high numbers of people vaccinated, and the way clinical trials—even expedited ones—are conducted, there’s no doubt in Wernick’s mind that the vaccines are safe. He urges pharmacists to communicate this message to their patients.

“If nothing else, these vaccines are safe. They don’t ever get past Phase 1 [trials] if they are not safe. We would never even learn about the proper dose and the efficacy if we didn’t first prove that they were safe,” explained Wernick.

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Start each vaccine conversation by listening and letting patients know that you understand their feelings.

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To parents who say their children don’t need the vaccine because they’ve already had COVID-19, Wernick says that the virus is constantly changing. Notably, the Bavarian Nordic vaccine being tested by TrueBlue is hoped to protect against multiple variants—both current and future ones—and eliminate or greatly reduce the need to continuously update the vaccine for new variants.

As for the argument that children’s immune systems can fight COVID-19 on their own, Wernick reminds parents that most people’s immune systems are fairly out of practice these days.

“Our immune systems are not what they used to be. We spent all that time at home or masked,” Wernick said. “As soon as we took off our masks, we started getting colds, flu, RSV, and everything else. Tell parents, you don’t want your children to get this virus.”

Resources to help Discuss the Importance of COVID-19 Vaccination and Answer Common Questions are available at APhA’s Vaccine Confident microsite.