FDA to consider COVID-19 vaccine for young kids

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.

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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.

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