Kaiser Permanente begins testing Pfizer COVID-19 vaccine candidate on adolescents

Parents of some teenagers in the Sacramento region already have begun signing their children up for trials of the COVID-19 vaccine candidate produced by drugmakers Pfizer and BioNTech.

In a video news conference, Kaiser Permanente announced Friday afternoon that it had begun to administer the Pfizer-BioNTech vaccine candidate to adolescents in Sacramento and Santa Clara as part of the Phase 3 trial..

“We know that teenagers can get infected, and we know that everyone in the world is susceptible to this disease,” said Dr. Nicola Klein, director of the Kaiser Permanente Vaccine Study Center and principal investigator for the trial in Northern California. “Teenagers and younger children are not thought to get as much disease, especially younger children in terms of disease severity, but they do get the disease and they do transmit it. It’s ... really impacted their lives, just like it’s impacted everyone else’s in the world.”

The Pfizer vaccine candidate, more formally known as BNT162b2, comes in two doses, given 21 days apart, and all participants will be monitored for up to two years, Klein said.

The nonprofit health giant said it already gave the shot to San Jose resident Allyson Eisenman, 17, and to students ages 16 and 17 over the past several weeks. Kaiser soon will be seeking dozens of youths ages 12 to 15 years old to participate in the Phase 3 trial.

“I’m missing out on a lot of school stuff,” Eisenman said. “It’s my junior year, and so it’s kind-of an important one. I really wanted to do what I can to help us get out of this and hopefully get back to what will be the new normal.”

Eisenman said that her parents, self-described IT nerd Jeff Eisenman and Kaiser registered nurse Dusta Eisenman, had participated in the Phase 3 trial for adults, and they had only slight flu symptoms for a day.

“I knew that’s probably the worst that would happen to me. I didn’t feel like I was in any danger,” Eisenman said. “Also, I feel like I’d rather have symptoms for a day to prevent from getting (the disease) than to get COVID and be sick for a few weeks.”

Jeff Eisenman said he’d worked for a biotech company previously and knew these sorts of trials had been going on for all kinds of drug candidates and had no qualms about participating in a trial himself or having his daughter participate.

“Someone needs to do it,” he said. “There needs to be volunteers, and this is our chance to contribute.”

Half of trial participants receive a placebo in these trials, Klein said, but the other half get the vaccine candidate. Each dose is tracked with a randomized number, so no physicians or staff know what the patient receives.

The medical teams do take blood samples and send them to Pfizer and BioNTech, Klein said, and they test it and follow through with analysis.

“I don’t know what they (patients) received,” Klein said. ‘They don’t know what they received. And that is really the best way to evaluate how something works .... It’s actually critical for safety that everyone remains what’s considered blinded. ... If there’s any safety outcomes, we wouldn’t say, ‘Oh, it’s because they got the vaccine, or because they got the placebo, this doesn’t matter.’ That’ s not how these trials work.”

Eisenman said that, if she’d gotten the placebo, then nothing would have changed for her but that, if she’d gotten the vaccine candidate and it was actually effective, then she would have gotten the vaccine early.

While a patient’s immune response may later reveal what they got, Klein said, that information is not shared with physicians or staff tracking study results since neither participants nor experimenters know who’s getting a placebo or vaccine candidate.

At this stage in the trials, federal regulators require study sponsors Pfizer and BioNTech to collect information about the safety, immune response and efficacy of their drug candidate.

The companies announced Friday that they had sought emergency use authorization from the U.S. Food & Drug Administration, meaning the vaccine could start being distributed in a small way as early as next month.

Early results from a large study that is still ongoing revealed that the Pfizer-BioNTech vaccine candidate is 95% effective at preventing mild to severe cases of COVID-19, the respiratory illness caused by the new coronavirus.

Want more information about Pfizer trial that Kaiser is conducting on youths? Email vaccinestudycenter@kp.org.