There’s good news on the horizon for parents of unvaccinated kids: Regulators anticipate that COVID-19 vaccines for kids under 12 will be available in a matter of months—potentially before the end of the year. This week, a U.S. Food and Drug Administration (FDA) official said that COVID-19 vaccines could be granted emergency use authorization (EUA) in children younger than 12 by early to mid-winter, NBC News reports.
Children under 12-years-old represent a population that is currently entirely unvaccinated. So making the vaccines available to them would come as a major relief to millions of parents, caregivers, and educators in the U.S. Right now, the Moderna and Johnson & Johnson shots have EUAs for adults over age 18, and in May the FDA announced that the Pfizer/BioNTech vaccine was OK for use in kids as young as 12. But none of the three vaccines currently available in the U.S. have been approved for use in younger children.
The FDA is asking drug manufacturers for more follow-up safety data in this age group than with previous EUA applications. For previous authorizations in adults, the FDA only required two months of follow-up data. But for this younger group, the FDA is requesting four to six months of post-vaccination follow-up data on safety and efficacy in this age group, the official said. (Moderna, Pfizer, and J&J all have trials on children and infants underway; Pfizer told NBC in a statement that their clinical trial data for kids ages 5 to 11 will be ready in September.)
The FDA’s rationale behind collecting safety data for this extended period of time, according to NBC, is that it will speed up the process for getting the vaccines fully approved in kids under 12. Collecting six months of follow-up data would be significant because that’s the minimum length of time drugmakers must monitor clinical trial participants for adverse effects (like long-term side effects or breakthrough infections) in order to receive full FDA approval for a vaccine. The hope is that swiftly issuing full approval after the EUA would boost vaccination rates in kids under 12 by making hesitant parents feel more reassured that the vaccine is safe for their children, the FDA official said.
While kids under 12 generally do not get as sick from COVID-19, they can still become ill enough to require hospitalization and can transmit the virus to others, according to the Centers for Disease Control and Prevention (CDC). It will be essential to distribute COVID-19 vaccines to kids under 12 in order to protect this group, and it will help provide protection to the broader population from the virus through herd immunity. Doing so will also make school, daycare, and other recreational activities safer for kids, families, and educators.
Until younger kids are able to receive the vaccine, the safest way for parents to protect their unvaccinated kids—especially amid the rise of the more infectious delta variant—is still to get vaccinated themselves.
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