Recent statements by Pfizer, BioNTech and others indicated that they are seeking FDA emergency use authorization for their COVID-19 vaccine. This vaccine is for children 5 to 11.
If approved, it would be available as the first COVID-19 vaccination for children younger than 5.
In a press release, the companies stated, “…results from a Phase 2/3 trial showing a favorable safety profile and robust neutralizing antibody responses in children 5 to 11 years of age using a two-dose regimen of 10-micrograms administered 21 days apart, a smaller dose than the 30-microgram dose used for people 12 and older.”
Despite the “favorable safety profile,” parents are still hesitant to get their children vaccinated, according to national surveys.
The American Academy of Pediatrics published a survey asking 1,745 parents whether they planned to get their children vaccinated. 28% responded that they believed it was very likely, 18% indicated they thought it was somewhat likely, 33% stated they would not get their children vaccinated and 21% said they weren’t sure.
“Most of the time when these trials are approved nationally, that safety piece is pretty well worked out,” said Dr. Ian Kaminsky M.D.
Dr. Kaminsky, a neuroradiologist, has participated in over 20 medical trials during his career. He says that the approval process for vaccines is particularly rigorous because it requires months or years of permits and qualification checks.
He said that COVID-19 vaccine trials were different because they involved mRNA. This is something that has been extensively researched over the past 20 years.
“I think the time that they took for it didn’t feel rushed to me given the amount of research that has happened in that arena in the many years prior,” said Dr. Kaminsky.
Rachel Brewer, a pediatric sports medicine doctor and mother of three, was able to enlist her two oldest daughters to participate in the July vaccine trials.
“It’s just a moment of ‘wow, this is really cool that we’re doing something to get through the pandemic,’” she said. “Yes, this is like any other medical process and very much what we learn in medical school about how to navigate that safely whether it’s a vaccine, or medicine, or brace, or orthotic. There are so many things we think about how to make safe, and this is just the exact same process as every one of them.”
Brewer said that her daughters would be taken in to get shots. They would either receive the vaccine or a placebo. There would also be weekly check-ins to monitor side effects.
They went back for another shot 21 days after their July shot. This time, it was either the real vaccine or a placebo.
Brewer said that neither daughter experienced side effects. Pfizer, BioNTech and others mirror what teenagers might have experienced after receiving their vaccines.
“Knowing that my kids did this on a voluntary basis—and they even signed their own consent on a kid level—seeing them do that is a pretty cool feeling knowing they’re willing to be a part of science and the process,” the mother said.