FDA Approves Emergency Use of Pfizer-BioN Tech Vaccine for Children 12-15

The US Food and Drug Administration today approved emergency authorization use of the Pfizer-BioN Tech vaccine for children aged 12-15.

“Today’s action allows for a younger population to be protected from COVID-19, bringing us closer to returning to a sense of normalcy and to ending the pandemic,” Acting FDA Commissioner Janet Woodcock said in a statement.

Pfizer’s two-shot vaccine was authorized in the United States for people 16 years and older last year. Vaccines made by Moderna and Johnson & Johnson are available to those 18 and older.

Five days ago, Canada approved use of the Pfizer-BioNTech shot for children as young as 12. While childrenʻs cases tend to be milder, they can still spread the disease. COVID-19 cases in children also are a growing proportion of cases as more adults are vaccinated.

The United States had nearing 17 million people in the 12 to 15 age group, about 5.3% of the countryʻs population, according to the Kaiser Family Foundation.

In March, Pfizer and BioNTech said their final-stage trial of 2,260 adolescents showed the vaccine was 100% effective in the 12-to-15 age group. The shot produced antibodies exceeding the level seen in vaccinated young adults. Side effects were consistent with those experienced by 16-to-25 year olds.