Pfizer/BioNTech modified the trial design to evaluate the effect of enhanced needles for children 6 months to 5 years old

On December 17, 2021, Pfizer and BioNTech announced that they will modify a large-scale clinical trial to evaluate their new crown vaccine for children 6 months to 5 years old

This large-scale clinical trial enrolled 4,500 children from 6 months to under 12 years old (regardless of previous evidence of new coronavirus infection), and aimed to evaluate the Pfizer/BioNTech vaccine two-dose vaccination regimen (with an interval of about 21 days) at 3 ages Safety, tolerability and immunogenicity in the group (5 years old to under 12 years old; 2 years old to under 5 years old; 6 months to under 2 years old)

Although the trial is still ongoing and remains blind, the researchers performed a pre-specified immunogenicity analysis on a subset of subjects one month after the second vaccination

In addition, Pfizer and BioNTech have initiated a low-dose level sub-test of 10 µg or 30 µg in approximately 600 cases of 12-17 year-old adolescents to evaluate the safety and immunogenicity of the third dose of the new crown vaccine

Reference materials:

[1] Pfizer And Biontech Provide Update On Ongoing Studies Of Covid-19 Vaccine.

[2] Pfizer Plans To Study A Third Shot For Its Covid-19 Vaccine In The Youngest Kids, Pushing Back Its Timeline Farther.