Pfizer has asked the FDA to authorize its Covid booster shots that target the BA.5 subvariant for ages 5 to 11, before clinical trial results have been published.
The company said its request is based on human data from a similar vaccine that targets the omicron BA.1 subvariant and data from animal studies on the BA.5 shots.
Pfizer’s application comes days after Moderna asked the FDA to authorize its omicron shots for kids ages 6 through 17.
The CDC, in a document published earlier this month, said the shots will likely become available for kids as young as 5 years old in October.
The health agency’s vaccine advisory committee has meetings scheduled for Oct. 19 and 20, where it is expected to review the available data on the boosters for that pediatric age group.
Officials at the FDA and CDC expect the omicron BA.5 shots will provide significantly better protection against infection and disease this fall and winter. But U.S. health officials have acknowledged that in the absence of human data, it’s unclear how much more protection the new vaccines will provide compared with the old ones.