Policy Issue

Policy Watch: COVID-19 Vaccines for Children Under 5

February 22, 2022

More than a year after first being made available to older adults and vulnerable populations, COVID-19 vaccines are not yet available to children younger than five, though authorization may come soon; The Food and Drug Administration (FDA) made an unusual decision in early February but ultimately changed course, bringing relief to some and frustration to others.

In December, Pfizer shared results of a two-dose course for children 6-23 months and 2-4 years old. At that time, the company decided to test the efficacy of a three -dose regimen to see if better results could be achieved. Differences in dosing needs between the two age groups as well as the ability of the Omicron variant to evade vaccine-generated antibodies are leading reasons for testing a third dose.

The FDA made headlines earlier this month when it requested that Pfizer submit the efficacy data for the two-dose course before the results of the three-dose course were available. This was possibly an attempt to get the authorization process underway as the country grappled with the Omicron variant, which was particularly prolific in young children and toddlers.

Within days the FDA changed course again, stating it would wait for the results of a three-dose course before making a decision. This decision brings the FDA in alignment with how these decisions have been made previously, but ignited frustration among researchers, medical professionals, and hopeful parents. The Pfizer vaccine for younger age groups will likely be reviewed in April at the earliest; Moderna may have data for 2-4 year olds as early as March.

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