Moderna submitted data to the Food and Drug Administration (FDA) on Thursday to get two low-dose shots of the COVID-19 vaccine approved for children younger than 6.
More children were hospitalized with COVID-19 during January’s omicron variant outbreak than at any other time during the pandemic.
The FDA restricted Moderna’s vaccine to adults, citing a concern about a rare heart inflammation side effect in teen boys. The agency said it will publicly debate the evidence next week.
What do the data show? The company study of 6,700 kids ranging from 6 months to 5 years old reported two quarter-strength Moderna shots triggered high levels of virus-fighting antibodies, the same amount proven to protect young adults.
Moderna said the doses were about 40% to 50% effective at preventing symptomatic COVID-19 in children younger than 6. The study did not report any serious side effects, and the shots triggered fewer high fevers than other routine vaccinations.
Pfizer tried to get authorization for a two-dose COVID-19 vaccine for children in this age group last year, but it changed course and decided to work on a three-dose regimen when studies showed two doses were not very effective.
It’s unclear how many parents would agree to giving the COVID-19 vaccine to children so young. Just 28 percent of children ages 5-11 have been fully vaccinated since the FDA authorized the first coronavirus shot for them in October.
This story originally appeared in WORLD. © 2022, reprinted with permission. All rights reserved.