Earlier this month, Moderna Inc also started a clinical trial of the vaccine in children
And like Moderna Inc, Pfizer/BioNTech's pediatric trial will involve children as young as 6 months, a Reuters report said
Pfizer Inc and German partner BioNTech SE started testing the COVID-19 vaccine in children under 12, the drugmaker said as quoted by a Reuters report. It also mentioned that the first volunteers in the early-stage trial were given their first injections on Wednesday.
With this initiative, the company hopes to expand vaccination to that age range by early 2022. Earlier this month, Moderna Inc also started a clinical trial of the vaccine in children. And like Moderna Inc, Pfizer/BioNTech's pediatric trial will involve children as young as 6 months, the Reuters report said.
Pfizer/BioNTech plans 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.
Later, they plan to 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.
Pfizer spokesperson 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 age 12 to 15. The company expects to have data from that trial in the coming weeks, Castillo said.
The vaccine was authorized by U.S. regulators in late December for people age 16 and older. And till now, nearly 66 million doses of the vaccine had been administered in the United States, as per the 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.