Pfizer Asks FDA To Authorize Covid-19 Vaccine For Children 5 To 11
Topline
Pfizer and BioNTech have asked the Food and Drug Administration (FDA) to grant its Covid-19 vaccine an emergency authorization for children ages five to 11, Pfizer announced Thursday morning.
Key Facts
Five to 11 year-olds did as well on the vaccine as older teens and young adults, the companies said in a late September filing of trial data to the FDA.
The application for emergency use authorization would require the companies to get permanent approval later on, similar to the vaccines’ approval process for older age groups.
Pfizer’s vaccine was authorized on a similar basis for children 12 to 15 in May and in late August was given full approval for people 16 and older.
Children under 18 have become a larger share of Covid-19 cases, representing 16% of cumulative U.S. cases and 27% of cases in the final week of September, according to the American Academy of Pediatrics.
Key Background
Covid-19 vaccines by Moderna and Johnson & Johnson are authorized for people and older. Moderna is in the final stages of a trial of the vaccine in children aged 6 months to 11 years. Former FDA commissioner Dr. Scott Gottlieb told CBS News in September that he expected Pfizer’s vaccine to be approved in October or November.
Big Number
44%. That’s the share of parents of children ages 5 to 11 who said they would likely have their child get the Covid-19 vaccine once eligible, according to an Axios/Ipsos poll from late September. Nearly the same share of parents (42%) said they were unlikely to have their child receive the vaccine.
Further Reading
Pfizer Says Covid-19 Vaccine Works Well In Kids Five To 11 And Is Seeking FDA Authorization (Forbes)
FDA Now Weighing Covid-19 Vaccines For Kids—But Will Parents Let Them Get The Shot? (Forbes)
