Pfizer, BioNTech launch COVID-19 vaccine trial in kids under 12
Pfizer Inc and German partner BioNTech SE began testing their COVID-19 vaccine in children under 12, with hopes of expanding vaccination to that age range by early 2022, the U.S. drugmaker said on Thursday.
The Pfizer/BioNTech immunization was approved by U.S. regulators in late December for individuals age 16 and older. Nearly 66 million dosages of the immunization had been regulated in the United States as of Wednesday morning, according to data from the U.S. Centers for Disease Control and Prevention.
Only the Pfizer/BioNTech vaccine is being used in 16- and 17-year-olds in the United States. Moderna's shot was cleared for those age 18 and older, and no Covid-19 vaccine has been authorized in younger kids yet.
Pfizer and BioNTech plan to initially test the safety of their two-shot vaccine at three different dosages - 10, 20, and 30 micrograms - in a 144-participant Phase I/II trial.
They plan to later expand to a 4,500-participant late-stage trial in which they will test the safety, tolerability, and immune response generated by the vaccine, likely by measuring antibody levels in the young subjects.
Castillo said the companies hope to have data from the trial in the second half of 2021.
Meanwhile, Pfizer has been testing the vaccine in children from ages 12 to 15. The company expects to have data from that trial in the coming weeks, Castillo said.