Parents are mad. While grown-ups have been eligible for COVID-19 vaccines for almost a year, there currently aren’t any options for children under 12. This is especially concerning for many parents as the kids return to school amid a nationwide surge in cases.
A Different Process
On September 20, Pfizer/BioNTech released data showing its mRNA vaccine is safe and effective in children aged 5-11. As the Food and Drug Administration (FDA) has fully approved the vaccine for individuals aged 16 and older and Pfizer/BioNTech vaccine is still available to individuals aged 12 to 15 through emergency authorization, why is the approval process taking so long for children?
- More data. Earlier this year, FDA asked Pfizer/BioNTech and the other vaccine developers to provide six months of follow-up data for all clinical trial participants. In comparison, the approval process for adults only required two months of follow-up data.
- More scrutiny. Unlike the emergency use authorization (EUA) for adults, FDA doesn’t just rely on a company’s summary of the clinical trial data for children’s vaccines. The agency looks at individual reports from every child, including data on side effects and blood tests.
- Biological differences. Kids aren’t simply smaller adults. Children have more active immune systems than grown-ups, which means scientists need to ensure they’re providing the right dosage. Pfizer/BioNTech has specifically been testing children aged 5-11 with a two-dose regimen administered three weeks apart. Each dose contains 10 micrograms, which is about a third of the dosage used for individuals aged 12 and up.
Pressure Grows for FDA to Speed Up Timeline
Earlier this year, it appeared that FDA would be able to approve vaccines for children aged 5-11 by early fall, just in time for the start of school. However, signs that the approval timeline would extend first appeared in July when FDA asked Pfizer and Moderna to expand the size of their clinical trials for children to make sure they could detect potentially rare side effects, namely myocarditis, or heart inflammation. These changes caused many health experts to revise their predictions on a timeline for approval for EUA, with some saying that the FDA would not make a decision until winter 2021 or early 2022.
The prospects of a longer timeline combined with a nationwide surge in cases sparked panic among many parents of younger children. While COVID-19 poses a low risk for healthy kids, there is a justifiable concern about immunocompromised children as well as the ability for kids to pass the virus onto vulnerable adults. As a result, some parents are even looking for doctors to skirt the rules and vaccinate their children, while others are signing their kids up for clinical trials, even though it’s unknown whether their child will be receiving the vaccine or a placebo.
Pressure from Pediatricians: The American Academy of Pediatrics (AAP) urged the FDA in an August 5 letter to “continue working aggressively towards authorizing safe and effective COVID-19 vaccines for children under age 12 as soon as possible” due to the threat posed by the Delta variant. Specifically, AAP indicated that a two-month follow-up period to collect safety data is sufficient, as opposed to the six-month period FDA initially requested. AAP also noted that reported cases of myocarditis in children who are receive mRNA vaccines like Pfizer/BioNtech’s are “extremely rare.”
The FDA is listening and took the rare step of publicly responding to the concerns around approving a COVID-19 vaccine for children on September 10. . In addition to vowing to adhere to strict safety standards, FDA stated clinical trials are required to have a “follow-up period for safety data of at least about two months,” indicating a change from the previously requested six-month follow-up period.
The Timeline, Revised
With the FDA apparently open to a shorter follow-up period for safety data, what does the approval timeline look like now? At the the Morgan Stanley Global Healthcare Conference 2021 on September 14, Pfizer CEO Albert Bourla laid out a new estimated approval timeline for children aged 5-11.
- Pfizer to have all safety and immunogenicity date in late September (topline results were released on September 20).
- Pfizer to file for EUA in early October.
- FDA to approve EUA within 3-6 weeks, meaning children aged 5-11 could get their shots as soon as late October or early November.
Bourla also said Pfizer will likely have enough data on how well its vaccine works on children under 5 years of age as early as the end of October, putting that vaccine on the path for EUA by the FDA by the end of the year.
This is reassuring news for parents of kids aged 5-11, to potentially have a vaccine available by Halloween than, say, early 2022. But let’s not get our hopes up as COVID-19 has proven itself to be an incredibly unpredictable virus, and changing conditions could cause scientists and regulators to shift their approval considerations once again.