FDA issues 'transformative' authorization of Pfizer's COVID vaccine for children ages 5 to 11

The Food and Drug Administration moved to give Pfizer's COVID-19 vaccine emergency use authorization for American children ages 5 to 11. The Friday decision, which was expected, was heralded as a "watershed moment," "transformative news" for parents, and a "hotly anticipated" milestone in the effort to end the pandemic.

The Pfizer-BioNTech vaccine got the green light from the FDA, and now just needs to be recommended by the Centers for Disease Control and Prevention. That recommendation may come shortly after a Nov. 2 CDC committee meeting.

Roughly 28 million American children will be allowed to be vaccinated once the authorization is finalized, though The Washington Post notes that officials are expecting some level of hesitation from parents who may prefer to wait for full FDA approval or agree with some advisory panelists who argued not all children need the vaccine, because the risk of COVID-19 complications is lower in most kids. However, polling has showed most parents will welcome the vaccine for their children. Stat News notes the Pfizer vaccine was found to be almost 91 percent effective in preventing COVID-19 in kids ages 5 to 11, and didn't cause any serious complications.

"Vaccinating younger children against COVID-19 will bring us closer to returning to a sense of normalcy," said acting FDA Commissioner Janet Woodcock. "Our comprehensive and rigorous evaluation of the data pertaining to the vaccine's safety and effectiveness should help assure parents and guardians that this vaccine meets our high standards."

If and when CDC Director Rochelle Walensky signs off on emergency authorization for the age group next week, providers will be able to begin administering shots same-day.