PRESSING PAUSE

Pfizer Hits the Brakes on FDA Approval for COVID Vaccine for Kids Under 5

The company wanted to see more data on how effective three doses would be for children ages 6 months to 4.

Pfizer and BioNTech said Friday they postponed their FDA application for a COVID-19 vaccine for children ages 4 and under, saying they wanted to see more data for a three-dose regimen because they believe “it may provide a higher level of protection in this age group.” “The trial in children 6 months through 4 years of age is ongoing and data on the first two ... doses in this age group are being shared with the FDA on an ongoing basis,” they said in a statement, according to Axios. The companies’ decision led the FDA to postpone its Feb. 15 advisory panel meeting as it awaits the new data, which is expected to arrive in April. Pfizer initially submitted its request to approve the child vaccine earlier this month, though questions arose about the two-dose regime’s effectiveness.