Twin girls at Duke were the first young children in U.S. to receive Pfizer vaccine
Twin 9-year-old girls at Duke Health have become the first young children in the United States to receive the Pfizer-BioNTech vaccine for COVID-19 as part of a clinical study.
The study is the first step in a process that will test the safety and effectiveness of the vaccine in children between the ages of 5 and 12.
Alejandra and Marisol Gerardo received their first vaccinations on Wednesday. Their mother, Dr. Susanna Naggie, is vice dean for clinical research at Duke University School of Medicine, and their father, Charles Gerardo, is chief of emergency medicine.
They are among 48 healthy children — including 12 at Duke — who will receive both shots of the vaccine in what’s known as a Phase 1 clinical trial. The other test sites are at Boston University, Cincinnati Children’s Hospital Medical Center and Johns Hopkins University.
The trial will focus primarily on the safety of the vaccine but also will help researchers determine the proper dose. The 48 children will be divided into three groups of 16 that will get different amounts of the vaccine.
The results of Phase 1 will determine what dose to give children who participate in the next phases of the clinical trial, which will involve more than 2,000 children, including about 100 at Duke.
Dr. Emmanuel “Chip” Walter, a pediatrician who is chief medical officer of the Duke Human Vaccine Institute, said it has a “pretty robust list” of children and parents willing to take part in the studies. Many of the children come from families that took part in the Pfizer vaccine study at Duke last year, which eventually included children as young as 12, Walter said.
“And I think as more and more people get vaccinated themselves, they’re more comfortable with the fact that their children can get vaccinated,” he said in an interview.
Charles Gerardo said the family had talked theoretically about participating in a clinical trial and the girls said they’d be willing. When they learned the Pfizer study needed children under 12, their main concern was whether it would hurt, Gerardo said.
“They’re 9 years old, so obviously they’re going to rely heavily on their parents, both of whom are physicians, to kind of make this decision, so I don’t want to pretend that we didn’t influence the outcome,” he said. “But ultimately it was their decision.”
In addition to the shots, both kids had nasal swabs as well as blood drawn for tests, a first for them both.
“Their arms are a little sore today,” Gerardo said. “But they’re off at gymnastics right now, so it’s not that bad.”
Vaccination and herd immunity
The Pfizer vaccine was the first approved for use in the United States, in December. The Food and Drug Administration authorized its use on an emergency basis, which means the extensive testing the agency normally requires has not been done yet.
The Pfizer vaccine can be administered to teens as young as 16. It takes two doses, given 21 days apart, to be effective.
Walter said if all goes well, the FDA will have what it needs to authorize use of the Pfizer vaccine in children 12 to 15 by the end of the summer and in children ages 5 to 11 by the end of the year. He said getting a vaccine approved for young children cannot only help save their lives but also the lives of others.
“Being able to vaccinate children is an important component of developing herd immunity, or population-level protection, as children make up a significant proportion of our population,” Walter said in a written statement.
As parents, Gerardo and Naggie consider the trial low risk, given that millions of people have now received the Pfizer vaccine. As doctors and researchers, the couple understands the mechanics and importance of the clinical trial.
“We’re in a position to know a lot more, to be a lot more comfortable with it,” Gerardo said. “And ultimately the only way out of this pandemic is through herd immunity and widespread vaccination, and this is something we could do to help move that forward.”
This story was originally published March 25, 2021 at 2:57 PM with the headline "Twin girls at Duke were the first young children in U.S. to receive Pfizer vaccine."
