Pfizer and its partner BioNTech said their Covid-19 vaccine is safe and 90.7 percent effective against symptomatic coronavirus in children ages 5 to 11.The companies revealed the data in a document posted on Friday ahead of a meeting of advisers to the 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 of the mentioned age group.
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 October 26 to discuss whether to authorise the jab.
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 aged 12 to 15.
Friday`s announcement comes just days after the White House unveiled a plan to roll out Covid-19 vaccines for children aged from five to 11.
“In anticipation of the FDA`s independent advisory committee meeting on October 26 and the CDC`s (Centers for Disease Control and Prevention) independent advisory committee meeting on November 2-3, today the Biden Administration is announcing a plan to ensure that, if a vaccine is authorized for children ages 5-11, it is quickly distributed and made conveniently and equitably available to families across the country,” the White House said in a statement on Wednesday.
The latest plan “will mobilise a comprehensive effort across the public and private sectors to ensure that we have the supply, the sites, and the support needed to get our nation`s children vaccinated and protected against the virus”, it added.