Kaiser enrolling Sacramento, Bay Area children ages 5 to 11 in COVID-19 vaccine trial
Kaiser Permanente is taking part in a pediatric COVID-19 vaccine trial, with dozens of children ages 5 through 11 participating at sites in Sacramento, Oakland and Santa Clara.
The health provider says those three sites combine for about 75 children enrolled in a multinational Phase 2/3 trial for the Pfizer-BioNTech coronavirus vaccine, to evaluate safety and efficacy in that age group.
“I just want other kids and people to know that the COVID vaccine is safe and will get us back to a completely normal life,” Luci Guardino, an 11-year-old participant and daughter of a Kaiser Permanente South Sacramento pediatrician, said during a Zoom news conference Tuesday. “Starting yesterday and this morning, my arm did a feel a little bit heavy, but I don’t feel, like, sick or anything.”
The Northern California trial is being conducted by the Kaiser Permanente Vaccine Study Center and the provider’s research division, both based in Oakland, Kaiser announced this week in a news release.
Pfizer and BioNTech are also sponsors of the study. Pfizer has said it plans to enroll about 4,500 children under 12 years old at dozens of sites across the U.S., Finland, Poland and Spain.
The trial is a randomized double-blind study: Two-thirds of the children will receive the Pfizer vaccine and one-third will receive a placebo, with neither participants nor clinicians knowing who is receiving the vaccine vs. the placebo.
The U.S. Food and Drug Administration granted Pfizer’s vaccine emergency use authorization for ages 16 and older in December and for ages 12 through 15 in May.
Pfizer on its website says that if the clinical trial shows safety and efficacy, it plans to file for emergency use authorization in ages 5 to 11 around September or October. It then generally takes a few more weeks for the FDA to review clinical data and grant that authorization.
Kaiser Permanente, which reports on its website that it has administered more than 2.4 million doses to Northern California patients outside of trial settings, also participated in adult and age 12-to-17 vaccine trials.
Experts say it will almost certainly be necessary to vaccinate large percentages of children in order to achieve herd immunity status for COVID-19, with Pfizer noting that about one-quarter of the global population is under the age of 15.
Children 5 through 11 make up roughly 140,000 of Sacramento County’s nearly 1.6 million residents, according to census data, with about another 100,000 ages 0 to 4. Trials for children 6 months old through 4 years old are up next, Pfizer says.
This story was originally published June 9, 2021 at 7:37 AM.
