Pfizer announced on Oct. 7 that they have made their formal submission to the FDA for an Emergency Use Authorization for its COVID-19 vaccine for 5-11 year olds. It comes at a time when the coronavirus has infected around 1 million children in the U.S. over the last month. Even though overall new cases have dropped to around 100,000/day, children are now about 26.7% of the new cases, according to the American Academy of Pediatrics accounting of statewide reports.
Pfizer submitted data to the FDA a couple of weeks ago, showing “robust” antibody responses in the Phase 2/3 trials of over 2,200 participants. The dosage level is one-third that of their vaccine for adults. In anticipation of Pfizer’s formal submission, the FDA scheduled its Vaccines and Related Biological Products Advisory Committee to meet on Tuesday, Oct. 26. If past actions are a measure, the FDA would likely meet that week, and the CDC could be ready to move with the vaccine around Nov. 1.
