SACRAMENTO, Calif. — When will my kids get a vaccine?
It’s the question that is top of mind for millions of parents now that the Food and Drug Administration has authorized the Pfizer/BioNTech vaccine for 12- to 15-year-olds.
In the Sacramento region, some children likely have already received their two doses. They are part of a pivotal trial that will help bring the COVID-19 vaccine to millions of children across the world.
Davis students Isabella Fahrni, 12, and Leila Farinsky, 13, are both in the Pfizer vaccine trial at Kaiser Permanente. Their parents enrolled them in the trials to help determine how safe and effective the Pfizer vaccine is for children.
Both girls received their first and second shots in January. Neither knows if they received the actual Pfizer vaccine or the placebo, often a saline shot used as a control to test the vaccine’s effectiveness.
“I was really excited for the chance to get the vaccine,” Leila said. “It feels so good to be a part of a big thing, and to know that I am helping people.”
Isabella said the thought of helping bring the vaccine to children around the world was what excited her most about the trial.
In April, Pfizer and BioNTech submitted a request to the FDA to expand its emergency authorization to include vaccines for adolescents.
Pfizer is currently the only vaccine available for people ages 16 and 17.
In the vaccine trials, researchers look at the level of antibodies in participants who received the actual COVID-19 vaccine. Once the trials are complete, researchers can determine if the vaccines will protect children from becoming seriously ill if they are exposed to the virus.
Of the 2,000 young people involved in the Kaiser Pfizer trial across the country, about 139 live in Northern California.
The young people in the Pfizer trial are receiving the same microgram doses as adults, according to Kaiser officials. Half the children receive the actual vaccine; the other half receive the placebo.
The children are blinded in the study, meaning participants in a trial are prevented from knowing information that may somehow influence them.
“They are not going to be unblinded until there is an emergency use authorization,” said Dr. Nicola Klein, a senior research scientist at Kaiser Permanente Northern California and director of the Kaiser Permanente Vaccine Study Center.
With the emergency authorization, Isabella and Leila can now learn if they received the vaccine or the placebo.
“I trust vaccines, and I know they work,” Isabella said. “I know it’s safe for adults, and it was safe in other trials, so it’s safe for me.”
Dr. Ana Rodriguez Fahrni, an oncology doctor at Kaiser South Sacramento, said she felt confident in enrolling her daughter Isabella.
“It’s been over 100 years since we have seen a pandemic,” Fahrni said. “(The virus) is new, but mass vaccinations are not new.”
Isabella said that while the first day after being inoculated may be difficult for some, the payoff is worth it.
“You should do it to help your family, to help your elders, really to do it to keep everyone safe,” Isabella said.
Participants are closely monitored, officials said. Isabella and Leila both began e-diaries after they were inoculated, and will continue writing once a week for the first two years after receiving their shots. Participants also have their antibodies checked every six months. The studies last for two years.
“Symptom diaries” are common in these trials. Dr. Robert Frenck, director of the Vaccine Research Center at Cincinnati Children’s Hospital and investigator for the Pfizer trial at the hospital, told CNN he reviews them. He said kids have reported mild symptoms that typically go away “in a day or two,” including headaches, fatigue and muscle aches.
Isabella and Leila both experienced symptoms similar to those reported in adults.
Isabella’s temperature increased to 99 degrees and she experienced a slight headache. Leila’s temperature rose to 102 degrees for one day after her second shot. She also experienced fatigue, nausea and vomiting.
“I was told my reaction was one of the worst ones in our location,” Leila said.
“I am pretty certain I didn’t get the placebo,” Leila added. “I don’t think the placebo would do that, but I’m not 100% sure.”
Klein said symptoms from a placebo shot may not just be psychological, but physical as well.
“We really monitor the two groups,” she said.
As a doctor, Fahrni receives inquiries from patients about how safe the vaccine is.
“I am always surprised when people ask, ‘Do you think I should get it?’” she said. “Yes, yes, yes. Some ask, ‘Aren’t you scared?’ And I tell them that I even put my 12-year-old on the clinical trial. That’s my selling point.”
Pfizer/BioNTech enrolled nearly 5,000 children between the ages of 6 months and 11 years in their trials. Those results are expected by the end of 2021.
And both Leila and Isabella’s younger siblings are enrolled for future trials for ages 5 to 9; they will begin their own trials in the coming weeks.
Children under the age of 12 will receive smaller doses of the vaccine and placebo.
Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said many younger children may have to wait until early 2022 to receive vaccines, but there are indications that young children could be inoculated sooner.
Moderna, AstraZeneca and Johnson & Johnson either began testing or announced plans to test their vaccines on children.
“My hope is to return to normalcy,” Fahrni said. “If we don’t have people volunteer for trials, it will never happen.”
