Toddler becomes first to get COVID vaccine in new trial
Nathan Galvan has spent nearly his entire life in a pandemic.
At just 16 months old, he has had little opportunity to socialize with anyone outside of his nuclear family. But that could soon change for Nathan, the first child in a Pfizer vaccine study run by Baylor College of Medicine and Texas Children’s Hospital. The study will evaluate the COVID-19 vaccine in children under 2.
Texas Children’s Hospital pediatric transplant surgeon Dr. Thao Galvan gave birth to Nathan in December 2019, just three months before the U.S. declared a national emergency due to COVID-19. News reports about a spreading respiratory virus in Wuhan, China, flashed across the screen as she watched TV in the hospital to pass the time during her recovery from childbirth.
Galvan’s family has faced their own share of worries during the pandemic. As a health care worker, she was so anxious about bringing the virus back to Nathan and his 2-year-old brother, Charlie, she moved out of the house for two months.
“I was terribly scared of contracting the virus and then giving it to my newborn,” Galvan said. When the Pfizer-biontech iteration was authorized for emergency use for health care professionals in December, she rushed to claim a dose — then searched for a clinical trial that could give Nathan the protection she hoped for.
Galvan did not have to look far. She’d originally entered Nathan’s name for a clinical Moderna trial of children under 12, but learned a colleague at Baylor College of Medicine, where she is an assistant professor of surgery, was running a pediatric Pfizer trial.
The trial is evaluating COVID-19 vaccines in children who are 6 months to 2 years old, and another group of children 2 to 11 years old, examining dosage size and adverse reactions. Phase one, which has enrolled fewer than 100 children, is searching for the right balance between a solid immune response in children and minimizing adverse side effects as much as possible.
Once researchers finalize the dosage and confirm children can form strong immune responses, they can proceed with two more phases of the pediatric trial, in which they’ll vaccinate thousands of kids, said Dr. Flor Munoz, the trial’s principal investigator.
“If we can find a dose that is safe, well-tolerated and protects little babies, then we can protect the population,” said Munoz, an associate professor of pediatric infectious diseases at Baylor College of Medicine and infectious disease physician at Texas Children’s Hospital.
If the trials go smoothly, investigators are hopeful the treatment can be available by the end of the year.
Herd immunity
Vaccinating children is key to reducing COVID-19 infections, children’s health experts said.
In Texas, where census data shows 25.5 percent of the population is under 18, immunizing that slice of the state will vastly slow the spread of the virus.
Data indicates youth are now contracting the virus at higher rates; at the end of April 2020, kids made up 3 percent of COVID-19 cases nationwide; as of last week, they made up more than 22 percent of cases, according to the American Academy of Pediatrics.
While children are more likely to have asymptomatic or mild COVID-19 infections, they could still face severe symptoms and die from complications of the virus. Texas Children’s has diagnosed more than 14,000 cases of COVID-19 in youth since last spring.
“It’s difficult to predict which child has severe disease due to COVID,” said
Dr. James Versalovic, interim pediatrician-in-chief at Texas Children’s Hospital. “We have enough data to indicate we can stop the spread by vaccinating children and adolescents.”
Adult vaccine trials focused on how many subjects became sick among both the vaccinated and placebo groups. But now that COVID-19 is more prevalent in the community, the children’s trials will measure efficacy differently: Researchers will instead examine how many antibodies kids produce.
“It’s not being rushed,” Munoz said. “It’s being done very carefully and in a systematic manner that is meeting all the regulatory agencies’ requirements so the vaccines are properly evaluated before they can be used.”
The vaccination process went by just as quickly for Nathan as it did for his mother.
During the second-tolast week of April, a researcher prepared a syringe with 3 micrograms — just a tenth of the adult dose — and pricked Nathan in the thigh, where toddlers routinely receive their shots, since their thigh muscles are larger than their deltoids, lowering the risk of inflammation.
As part of the clinical trial, nurses also measured his height and weight and drew a blood test. After a short observation period, Galvan took him home. While Nathan experienced some hives, he had no other side effects, his mother said.
Gathering data
Medical experts expect the vaccination of kids and teens to boost lagging vaccine rates.
While a vaccine for kids under 12 is still six months to a year away, federal regulators will likely authorize emergency use of the COVID-19 vaccines in adolescents between 12 and 16 years old this month.
“If we’re going to make a really major impact on the transmission and spread of COVID-19, we need to vaccinate children and adolescents because we know they can easily spread the virus,” Versalovic said.