The pediatric trial will include children under six months of age, a similar trial launched by the pharmaceutical company Moderna last week.
Mexico City (apro)-The US drugmaker said on Thursday that Pfizer and its German partner BioNTech SE began testing its covid-19 vaccine in children under 12 years of age, hoping to expand the vaccination volume to this age range by early 2022.
Pfizer spokesperson Sharon Castillo said that the first batch of volunteers in the early trial received their first injection on Wednesday.
Pfizer and BioNTech vaccines were 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, after Moderna Inc launched a similar trial last week.
In the United States, only Pfizer and BioNTech vaccines are used for 16- and 17-year-olds. The Moderna drug has been approved for use in people over 18 years of age, and the covid-19 injection has not been approved for use in 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 expand it to a late-stage trial with 4,500 participants. They will test the safety, tolerability and immune response of the vaccine by measuring the level of antibodies 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. (Information from Reuters)