WASHINGTON, Oct 23 — Pfizer and its partner BioNTech said their COVID-19 vaccine is safe and 90.7 per cent effective against symptomatic COVID-19 in children ages 5 to 11, Xinhua news agency reported.
The companies revealed the data in a document posted Friday ahead of a meeting of advisers to the United States Food and Drug Administration (FDA) scheduled for next Tuesday.
Pfizer and BioNTech are applying FDA emergency use authorisation (EUA) of a two-dose regimen of their 10-microgram dose for children ages 5 to 11. The two doses would be administered three weeks apart.
The data show that the two-dose primary series of the vaccine given to children from 5 to less than 12 years of age confers a high degree of protective efficacy against COVID-19 during a period when the Delta variant of concern predominates in the US.
The FDA’s Vaccines and Related Biological Products Advisory Committee is scheduled to meet on Oct 26 to discuss whether to authorise the vaccine for children ages 5 to 11.
If authorised, it would be the first COVID-19 vaccine for younger children.
The Pfizer-BioNTech vaccine is currently fully approved for people ages 16 and older, and has an EUA for children ages 12 to 15.