Pfizer and BioNTech recently said they are seeking emergency use authorization from the FDA for their COVID-19 vaccine for children ages 5 to 11.
If authorized, it would be the first COVID-19 vaccine available for younger children.
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.
A recent one published in the American Academy of Pediatrics asked more than 1,745 parents if they were planning to get their kids vaccinated. Among those parents, 28% said they were very likely, 18% said they were somewhat likely, 33% of respondents said they were very unlikely to get their kids vaccinated, and 21% were either somewhat unlikely or unsure.
“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 is a neuroradiologist and has taken part in more than 20 medical trials in his career and says the process of approving a vaccine, particularly, is rigorous as it involves months, if not years, of permits and qualification checks.
The difference in the COVID-19 vaccine trials, he says, is that it involves mRNA, something that has been researched for the better part of the last two decades
“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.
That assurance is what led Rachel Brewer, a doctor of pediatric sports medicine and mother of three, to sign her two oldest daughters up to take part in the childhood vaccine trials in July.
“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.”
According to Brewer, her daughters would go in and get a shot that was either the vaccine or a placebo, and with periodic check-ins each week, they would monitor any side effects between doses.
Twenty-one days after the initial shot in July, they went in for a second shot that, again, was the real vaccine or a placebo.
Brewer says neither daughter has experienced any side effects, which Pfizer and BioNTech say mirror the same ones that adults and teenagers may have experienced after 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.