Pfizer, a foreign manufacturer of a vaccine against Covid-19, said on Tuesday that it will begin testing its vaccine in a larger group of children under age 12 after selecting a lower dose of the shot in an earlier trial stage. The study will involve up to 4,500 kids in the United States, Finland, Poland, and Spain.
Pfizer said it will now test a lower dose on the younger kids based on the safety, tolerability, and immune response generated by 144 children in a Phase 1 study of the two-dose vaccine – that is 10 mg for 5-11 year-olds, and 3 mg for the age group of 6 months to five years of age.
Children over 12 in the US, Canada, and Europe are presently receiving the same dose of the Pfizer-BioNTech vaccine as adults – 30 micrograms.
Dr. Anthony Fauci, a top US infectious disease expert, on Tuesday said decreasing doses in trials on younger children makes sense: “The idea of when you are going from an adult trial with adult doses – we do standard, this isn’t anything unusual, it’s called an age de-escalation and a dose de-escalation study. (flash) And when you get down to the younger children it is not at all unusual to diminish the dose.”
According to the Centers for Disease Control and Prevention, nearly 70 lakh teenagers have received at least one dose of the vaccine in the US. Some health experts say inoculating children is a critical step in controlling the COVID-19 pandemic.
Days ago, the UK’s medicines regulator said the Pfizer/BioNTech vaccine is safe for adolescents aged 12 to 15 following similar assessments in the European Union and the US.
