Pfizer Inc. and German partner BioNTech SE have begun testing their COVID-19 vaccine on children under the age of 12, hoping to extend the vaccination to that age range by early 2022, the U.S. drugmaker said Thursday.
The first volunteers in the early stages of the trial were given their first injections on Wednesday, Pfizer spokeswoman Sharon Castillo said.
The Pfizer / BioNTech vaccine was approved by US regulators in late December for people over the age of 16. Nearly 66 million doses of the vaccine have been administered in the United States since Wednesday morning, according to data from the U.S. Centers for Disease Control and Prevention.
The pediatric trial, which will include children under 6 months of age, follows a similar study launched by Modern Inc. last week.
Only Pfizer / BioNTech is used between the ages of 16 and 17 in the United States. The Moderna shot has been removed for those 18 and older, and the COVID-19 vaccine in younger children has not yet been approved.
Pfizer and BioNTech plan to initially test the safety of their two-injection vaccine at three different doses – 10, 20 and 30 micrograms – in a phase I / II trial with 144 participants.
They plan to later expand to a 4,500-trial trial in which they will test the safety, tolerability and immune response generated by the vaccine, presumably by measuring antibody levels in young subjects.
Castillo said that the companies hope to have data from the trial in the second half of 2021.
Meanwhile, Pfizer tested the vaccine on children aged 12 to 15. The company expects data from that survey to be available in the coming weeks, Castillo said.
(Except for the headline, this story was not edited by NDTV staff and is published from a syndicated feed.)