The littlest research volunteers arrived at Stanford University on Wednesday, accompanied by their parents, to participate in a pivotal study of the COVID-19 vaccine in very young children.
“We want our kids to be protected from the virus, and not to spread it to others if they do get infected,” said Zinaida Good of Palo Alto, whose 3-year-old son Andel sat still for a shot, then went home to play and take a nap. The family’s 7-month-old baby Soren is scheduled for a shot next month.
The goal of the trial at Stanford Health Care, the only site on the West Coast to test the Pfizer vaccine in children younger than 5, is to identify the strongest dose with the fewest side effects.
As adult vaccinations expand, an increasing number of grownups can socialize, blissfully mask-free. About 75 million American adults are now fully vaccinated.
But children remain unprotected.
The lack of youth vaccines affects the general population, not just individual families, said experts. Because about one-quarter of all Americans are under the age of 18, the nation won’t reach herd immunity without inoculating young people.
“We want to make sure that children have access to vaccines not just for themselves but for the community,” said Dr. Yvonne Maldonado, a Stanford professor of pediatrics and infectious disease and the principal investigator of the trial.
If the research is successful and vaccines are authorized, “the kids will contribute to the community ‘force field’ against COVID,” said Dr. Peter Chin-Hong, a professor of medicine and infectious disease specialist at UC San Francisco, who is not involved in the Stanford research. “We need everyone in the population immunized.”
Chin-Hong, a father of two, said there is an additional concern: Children’s potential vulnerability to new variants.
“COVID is a shape-shifting virus, and there may be a variant in the future that may affect younger individuals,” he said. In Michigan, he noted, the increase of the U.K.’s B.1.1.7 variant is coinciding with a surge of cases in young adults, perhaps through youth sports.
Initially children were thought to be largely impervious to the virus. But statistics prove otherwise. Children make up about 13.5% of U.S. infections. Thousands of children have been hospitalized and nearly 300 have died, said Maldonado.
“We don’t know what the long-term consequences of infection are,” she added.
Vaccines were first tested in adults because elders are more likely to sicken and die, overwhelming hospitals.
Now attention has shifted to youth. Last month, Pfizer announced that its vaccine was safe and effective in adolescents as young as 12. So the vaccine is now being tested in much younger children.
Pfizer’s nationwide trial of 144 children will unfold in phases. It is testing three different doses — 10, 20 and 30 micrograms — in bundles of three different age groups: children ages 5 through 11; ages 2 to 5, and ages 6 months to 2 years. After safety and dosage studies, research will expand into more children and seek signs of efficacy.
Vaccine manufacturer Moderna has also launched a phased trial that will gradually decrease in age, from 11-year-olds to infants.
If results are successful, vaccines may be widely available to older teens by this fall, according to Dr. Anthony S. Fauci, director of the National Institute of Allergy and Infectious Disease. Elementary-school-age children and toddlers may have to wait until early 2022.
Pfizer has already requested an amendment from the U.S. Food and Drug Administration of its Emergency Use Authorization to expand the use of its vaccine to adolescents 12 to 15 years of age, about 2.5 million Californians.
The Stanford trial will not include babies younger than six months because they do not have fully mature immune systems, and rely on their mother’s breast milk for antibodies.
The university reached out to families through Bay Area pediatricians with Packard Children’s Health Alliance. It is still enrolling potential volunteers.
Good and her husband, Otávio, are big believers in the importance of research and data-collecting, she said.
She has a Ph.D. in immunology from Stanford and is now researching the design of engineered cell therapies to attack cancer. Otávio is a computer programmer and inventor who works as a software engineer at Google.
Both are vaccinated, and look forward to the day when the entire family is safe.
“Participating in a clinical trial allows our kids to have access to a vaccine much earlier than if we waited until it was authorized,” she said.
“And it allows us to encourage other families to participate,” she said. “It’s one way for us to do our part.”
They aren’t nervous about risks, she said. “This vaccine has been tested in a large number of adults and teenagers and been shown to be very safe. I’m much more worried about any long-term side effects from getting the virus itself.”
In preparation for Wednesday’s adventure, they offered their son a simple lesson in immunology.
“We told him we think the vaccine will make him not ever get sick from this virus that we’re all now hiding from, with masks and distances,” said Zinaida.
After the shot, Andel was restless after a long morning at a hospital and ready to play, she said. “But I think he understood.”
To learn more about Stanford COVID-19 vaccine trials, go to: https://studypages.com/stanford/covid/home/. Phase 1 of the Pfizer trial started April 14; Phases 2/3 will start on May 17.
It is collecting contact information for potential volunteers through this Stanford research registry: https://redcap.stanford.edu/surveys/?s=D3APEM8HHW