They seek to expand vaccination to this age range by early 2022
The US drugmaker said on Thursday that Pfizer and its German partner BioNTech SE began testing its Covid-19 vaccine in children under the age of 12, hoping to expand the vaccination volume to that age range in early 2022.
Pfizer spokesperson Sharon Castillo said that the first batch of volunteers in the early trial received their first injection on Wednesday.
The Pfizer/BioNTech vaccine was cleared by U.S. regulatory agencies in late December for people 16 years and older. According to data from the Centers for Disease Control and Prevention, as of Wednesday morning, the country has administered nearly 66 million doses of vaccine.
The pediatric trial will include children under 6 months of age, following a similar trial launched by Moderna Inc last week.
In the United States, only the Pfizer/BioNTech vaccine is used for 16- and 17-year-olds. Moderna has been approved for use in people over 18 years of age and has not been approved to inject Covid-19 into young children.
Pfizer and BioNTech plan to initially test the safety of two doses of the vaccine in three different doses (10, 20 and 30 micrograms) in a phase I/II trial with 144 participants.
They plan to extend it to a late-stage trial with 4,500 participants. They will test the safety, tolerability and immune response of the vaccine by measuring antibody levels in young subjects.
Castillo said the company expects to obtain data from trials in the second half of 2021.
At the same time, Pfizer has been testing the vaccine for children aged 12 to 15. Castillo said the company expects to obtain data from the trial in the coming weeks.