Pfizer Asks FDA For Authorization To Vaccinate Kids Ages 5 To 11 Against Covid
Pfizer's application will be welcome news to many anxious parents, as the number of pediatric cases climb in the U.S. The Food and Drug Administration says it will quickly act on the application, with a meeting tentatively scheduled for Oct. 26. If that timing holds, the shot will not be available to kids until November.
AP:
Pfizer Asks US To Allow COVID Shots For Kids Ages 5 To 11
Pfizer asked the U.S. government Thursday to allow use of its COVID-19 vaccine in children ages 5 to 11 -- and if regulators agree, shots could begin within a matter of weeks. Many parents and pediatricians are clamoring for protection for children younger than 12, today’s age cutoff for the vaccine made by Pfizer and its German partner BioNTech. (Neergaard, 10/7)
Reuters:
Pfizer, BioNTech Ask U.S. Regulators To OK COVID-19 Vaccine For Kids
The application to the U.S. Food and Drug Administration comes as COVID-19 infections have soared in children, hitting their highest point in the pandemic in early September, according to data from the American Academy of Pediatrics. The FDA has set a date of Oct. 26 for outside advisers to meet and discuss the Pfizer application, making it possible for kids to begin receiving the vaccines shortly afterwards. (10/7)
CNBC:
Pfizer Asks FDA To Authorize Covid Vaccine For Kids Ages 5 To 11
The news couldn’t come any sooner for parents anxious to get their children vaccinated as kids start the new school year with the delta variant surging across America. The strain has led to a surge in U.S. hospitalizations, including among young kids who are currently ineligible to get vaccinated. Last month, Pfizer released new data that showed a two-dose regimen of 10 micrograms — a third the dosage used for teens and adults – is safe and generates a “robust” immune response in a clinical trial of young children. It said the shots were well tolerated and produced an immune response and side effects comparable to those seen in a study of people ages 16 to 25. (Lovelace Jr., 10/7)
The New York Times:
Pfizer Asks F.D.A. To Authorize Its Covid-19 Vaccine For Children 5 To 11
Dr. Janet Woodcock, the acting F.D.A. commissioner, said last week that children might require “a different dosage or formulation from that used in an older pediatric population or adults.” Pfizer has proposed giving children one-third of the adult dosage. That might require adding more diluent to each injection or using a different vial or syringe. The company was expected to describe the method it intended to use in its submission to the Food and Drug Administration. (LaFraniere and Weiland, 10/7)
