Pfizer Files Paperwork With FDA To Approve Vaccines For Kids 5-11
FYI, Pfizer and BioNTech requested the expanded use of their vaccine for adolescents 12-15 on April 9 and it was authorized by the FDA on May 10. If the FDA clears the COVID-19 child doses for emergency authorization, the timetable will more than likely be about the same for the 5-11 age group. Once the advisory group wraps up its review, the Centers for Disease Control and Prevention (CDC) will comb through the youth trials and make a final decision. Experts say if the FDA and CDC move fast enough, the vaccine for youngsters could be available by or before November.
The low-dose Pfizer's clinical trials revealed children should get 1/3 of the dose currently being administered to the 12+ age groups. The study involved 2,268 volunteers ages 5 to 11. After they received the second dose, the youngsters developed the same virus-fighting antibody levels teens and young adults get from regular-strength doses.
Another important note, once approved Pfizer is going to manufacture the pediatric vaccine in different packaging. The vials will be specially marked to avoid any mix-ups with dosing.