Pfizer, BioNTech dispatch COVID-19 antibody trial in kids under 12
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- Source: Reuters
- Date: 26 Mar,2021
Pfizer Inc and German partner BioNTech SE began testing their COVID-19 vaccine in children under 12, with hopes of expanding vaccination to that age range from ancient 2022, the US drugmaker said on Thursday.
The first volunteers in the early-stage trial were given their first shots on Wednesday, Pfizer spokesperson Sharon Castillo said.
The Pfizer/BioNTech vaccine was approved by US regulators in late December for individuals age 16 and older. Nearly 66 million doses of the vaccine was administered in the United States as of Wednesday morning, according to data from the US Centers for Disease Control and Prevention.
The pediatric trial, which will include children as young as 6 months, follows a similar one launched by Moderna Inc last week.
Only the Pfizer/BioNTech vaccine has been used in 16- and 17-year-olds in america. Moderna’s shot was cleared for those age 18 and older, and no COVID-19 vaccine was authorized in younger children yet.
Pfizer and BioNTech plan to initially test the security of the two-shot vaccine at three different dosages — 10, 20 and 30 micrograms — in a 144-participant Stage I/II trial.
They intend to later expand to a 4,500-participant late-stage trial where they will test the safety, tolerability and immune response generated by the vaccine, likely by measuring antibody levels in the young subjects.
Castillo said the companies hope to have data from the trial in the second half of 2021.
Meanwhile, Pfizer has been testing the vaccine in children from age 12 to 15. The company hopes to have data from that trial in the coming weeks, Castillo said.