For weeks, questions from concerned parents have poured in:
Why isn’t the COVID-19 vaccine approved for children under age 12 yet? When will a vaccine for children be available? Can the vaccine be given off-label?
These are all good questions, and the answers aren’t easy.
After the SARS-CoV-2 virus was identified in late 2019, clinical trials for adults began in mid-March of 2020. Eight months later, Pfizer and Moderna filed for emergency use authorization from the Food and Drug Administration. The EUAs were granted by the agency after prioritized review in December 2020. The process took less than a year, however there was one catch: per standard ethical and safety measures, children were excluded from early studies.
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Immediately after authorization, Pfizer launched pediatric efforts starting with clinical trials for older children in mid-March. This led to an authorization down to age 12 in May, with ongoing trials for younger children through the summer. Moderna also launched pediatric clinical trials, and between the two manufacturers testing is now underway for children of most ages.
Critically, the pediatric studies are necessary to evaluate the efficacy and safety with regard to dosing levels and symptoms as younger children’s bodies function slightly differently than those of adults. For example, the Pfizer studies are testing several dosing levels — 10, 20 and 30 micrograms — across various child age cohorts to determine which is best. This, too, is a standard process, taking months to years depending on the study.
With this in mind, at only about five to six months into these trials, it’s unfair to suggest the pediatric studies are taking too long. In fact, Pfizer has stated it expects to have data for review as early as late September, a goal that could outpace even the 2020 timeline for adult vaccinations.
Many parents are experiencing increased anxiety over how to keep their children safe as schools reopen. It is for this reason that the perceived risk analysis has changed.
What is toxically slow, however, is the rate of adult vaccinations. This heel-dragging has been the main driver for the rapid spread of the delta variant — a mutation of the virus that is better able to infect children. Coupled with leaders refusing to enact precautions despite millions of unvaccinated children who are susceptible, many parents are experiencing increased anxiety over how to keep their children safe as schools reopen. It is for this reason that the perceived risk analysis has changed, leading to what would normally be unsafe calls to hasten or even circumvent rigorous scientific study.
Particularly interesting is that calls to pressure the FDA may be misplaced. Neither Pfizer nor Moderna has submitted pediatric efficacy data for phase 3 studies as of yet. Without this data, it’s difficult for anyone to expedite review, as experts would have insufficient evidence upon which to draw conclusions.
This is likely a main driver for why the timeline of authorization remains slightly murky, and why the American Academy for Pediatrics has issued statements against physicians offering off-label vaccinations to children under 12 — even though off-label use is now technically legal after the Pfizer vaccine, marketed as Comirnaty, was fully approved by the FDA last week. Simply put, without strong pediatric data to lean on, it’s riskier.
To this end, the real pressure should be applied not on FDA officials — the FDA has proven its ability to provide priority review via adult COVID-19 vaccines — but rather on the vaccine manufacturers to release details as soon as possible regarding safety profiles and trial status to date. Certainly the research design should not be compromised, but more information would allay the fears of parents and assist experts in their understanding of the current situation, potentially even allowing for some reconsiderations of off-label use.
For now, it appears parents will need to wait a little bit longer before they can vaccinate their kids, relying on masks and vaccinations for the adults around them. Although the timeline is frustrating, it’s important to appreciate the perceived delay is anything but, and it also serves as a testament to the American public that safety protocols for the vaccine will not be relaxed — not even under political pressure.
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