SAN JOSE, Calif. — Teenagers won't be able to get a COVID-19 vaccine when adults do, because there's not yet proof of safety and efficacy.
But teen volunteers such as San Jose's Allyson Eisenman are bringing it within closer reach, participating in a Kaiser study that could accelerate the vaccine's potential use in young people.
"I really wanted to do what I can help us get out of this" pandemic, said Eisenman,17, "and hopefully get back to what will be the new normal.
"I'm not the best with needles," she confessed. "But it was like any other shot."
Until now, vaccination has focused on adults. Why? It's because they fare worse than adolescents when infected — and also because that's how research is traditionally conducted. Vaccine and drug testing in youth typically starts only after a product is proven completely safe and effective in adults.
Yet pediatricians say it is essential for teens to be included, early on, in COVID-19 vaccine testing. Cases are climbing in young people, they say, with thousands of illnesses and over 100 deaths reported since the pandemic's early days.
Without research, it's not known if they will respond as adults do. Children aren't just miniature adults — they may experience different side effects or require smaller doses.
"We know that teenagers can get infected. We know that everyone 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," she said, "but they do get disease, and they do transmit. It has really impacted their lives, just like it's impacted everyone else in the world."
In September, the American Academy of Pediatrics wrote a letter to the Department of Health and Human Services and Food and Drug Administration urging vaccine research in children.
Allyson and others are enrolled in a trial with Pfizer Inc., the first pharmaceutical company in the United States to receive approval from the FDA to test its vaccine on children as young as 12. The second promising vaccine, made by Moderna, is not yet slated for testing in youth.
Pfizer recently announced preliminary results showing their vaccines appear more than 90% effective, at least for short-term protection against the virus.
The FDA will evaluate the data — collected from adults — in December and could quickly give the go-ahead to distribution of limited, rationed supplies. Youth will be offered the vaccine only after their trial results are analyzed.
Kaiser aims to test the vaccine in 100 youth ages 16 and 17 at its Santa Clara and Sacramento facilities. Over the next several weeks, the trial will be expanded to include 100 younger teens, ages 12 to 15. The overall goal for the Pfizer trial is to enroll a total of 2,000 adolescents.
"We should have a vaccine for children. Children can die of this virus," said Dr. Paul A. Offit, director of the Vaccine Education Center and professor of pediatrics in the Division of Infectious Diseases at Children's Hospital of Philadelphia. "The number of children who died of this virus last year was about the same number as children who died from the flu. And we consider that worthy of prevention."
If immunization rolls out safely in adults, children should not be injected with inactive placebo, added Offit at a Friday briefing at the National Press Foundation. Instead, the study should convert to a so-called "wedge trial," with a steady increase in the number of young volunteers, then comparing their response to that in unvaccinated youth.
Allyson's mother and father, with careers in nursing and information technology, had already been in the vaccine trial and supported Allyson's decision to sign up after experiencing no ill effects other than lethargy.
"This is our chance to contribute to the situation," said Jeff Eisenman in a Friday news briefing.
"We've seen — whether it's measles or polio – that vaccines work," he said. "My opinion is someone needs to do it. There needs to be volunteers."
Because the trial is "placebo-controlled" — with half the participants getting the vaccine and the other half getting an inactive agent — Allyson doesn't know whether she's protected. She was given two doses, 21 days apart.
To be safe, the Branham High School junior still wears a mask and socially distances at her gymnastics practices and during meetings of her Girls Scouts troop.
Once a week, she checks in with Kaiser. She reports her temperature and any symptoms on a Kaiser app. She'll be followed for two years. "It's easy," she said.
"I'm not really a science person," she admitted. "That is definitely my worst subject of my freshman year.
"But the health and safety of those around me is important to me," she said. "And so that's what influenced me to contribute."(c)2020 The Mercury News (San Jose, Calif.) Distributed by Tribune Content Agency, LLC