WASHINGTON – Pfizer and its partner BioNTech said their coronavirus disease 2019 vaccine is safe and 90.7 percent effective against symptomatic Covid-19 in children aged 5 to 11.
The companies revealed the data in a document posted Friday ahead of a meeting of advisers to the US Food and Drug Administration (FDA) scheduled for October 26.
Pfizer and BioNTech are applying FDA emergency use authorization (EUA) of a two-dose regimen of their 10-microgram dose for children 5 years to 11 years old.
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 United States.
The FDA's Vaccines and Related Biological Products Advisory Committee is scheduled to meet on October 26 to discuss whether to authorize the vaccine for children.
If authorized, it would be the first Covid-19 vaccine for younger children.
The Pfizer-BioNTech vaccine is currently fully approved for people aged 16 and older and has a EUA for children aged 12 to 15. (Xinhua)