In reversal, FDA puts brakes on COVID shots for kids under 5

In reversal, FDA puts brakes on COVID shots for kids under 5

A person is injected with her second dose of the Pfizer COVID-19 vaccine at a Dallas County Health and Human Services vaccination site in Dallas, Thursday, Aug. 26, 2021. Federal health regulators on Friday, Feb. 11, 2022 delayed next week's public meeting to review Pfizer’s COVID-19 vaccine for children under 5, saying they want to see more data. (AP Photo/LM Otero, File)

WASHINGTON (AP) — U.S. regulators have put the brakes on their push to speed Pfizer’s COVID-19 vaccine to children under 5. Friday’s move means another monthslong delay for the shots. The Food and Drug Administration had urged Pfizer to apply before its study was even finished on whether the youngsters needed two shots or three. The agency cited the toll the omicron variant has taken on children. But Friday, the FDA reversed course and said it needed to see how well three shots worked. Pfizer said in a statement that it expected that data by early April.

Photo: A person is injected with her second dose of the Pfizer COVID-19 vaccine at a Dallas County Health and Human Services vaccination site in Dallas, Thursday, Aug. 26, 2021. Federal health regulators on Friday, Feb. 11, 2022 delayed next week’s public meeting to review Pfizer’s COVID-19 vaccine for children under 5, saying they want to see more data. (AP Photo/LM Otero, File)