Pfizer, BioNTech launch Covid-19 Vaccine Trial in Children Under 12 Years Old

Pfizer Inc and its German partner BioNTech SE have started testing their COVID-19 vaccine in children under 12 years of age, hoping to expand the inoculation to that age range by early 2022, the company said on Thursday.

The first volunteers in the early-stage trial received their first injections on Wednesday, said Pfizer spokeswoman Sharon Castillo.

The Pfizer/BioNTech vaccine was cleared by US regulators in late December for people age 16 and older. Nearly 66 million doses had been administered in the country as of Wednesday morning, according to data from the Centers for Disease Control and Prevention.

The pediatric trial, which will include children up to 6 months, follows a similar trial launched by Moderna Inc last week.

Only the Pfizer/BioNTech vaccine is used in 16- and 17-year-olds in the United States. Moderna’s was approved for people over the age of 18, and no COVID-19 injection in younger children has yet been authorized.

Pfizer and BioNTech plan to initially test the safety of their two-shot vaccine at three different doses (10, 20, and 30 micrograms) in a phase I/II trial of 144 participants.

They plan to expand later to a late-stage trial of 4,500 participants in which they will test the safety, tolerability, and immune response generated by the vaccine, likely by measuring antibody levels in young subjects.

Castillo said companies expect to have data from the trial in the second half of 2021.

Meanwhile, Pfizer has been testing the vaccine in children ages 12 to 15. The company expects to have data from that trial in the coming weeks, Castillo said.