American pharmaceutical Pfizer and its German partner BioNTech SE have started the clinical trials of its coronavirus vaccine in children under 12, giving an early sign of the next stage of the global immunisation campaign. “Together with our partner BioNTech, we have dosed the first healthy children in a global Phase 1/2/3 continuous study to further evaluate the safety, tolerability, and immunogenicity of the Pfizer-BioNTech COVID-19 vaccine,” news agency AFP quoted the company as saying.
As per the updates posted on the site clinicaltrials.gov, the company is testing three different dosing levels – 10, 20 and 30 micrograms – in a 144-participant Phase I/II trial for use in this age group, with hopes of expanding vaccination to that age range by early 2022.
Pfizer and BioNTech also 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.
After the clinical trial started, the first volunteers in the early-stage trial were given their first injections on Wednesday, Pfizer spokesperson Sharon Castillo said in a statement.
Pfizer is already testing the shots in children aged 12 to 15, and its US emergency authorisation covers people aged 16 and up. With this, Pfizer has joined Moderna and AstraZeneca in testing their vaccines in children as young as 6 months.
While the Pfizer-BioNTech vaccine is being used in 16- and 17-year-olds in the United States, Moderna’s vaccine was cleared for people above age 18.
(With inputs from agencies)