Monday, September 20, 2021

Pfizer Says Vaccine Is Safe & Effective For Children As Young As 5

Opening the door to FDA approval of vaccinations for children between the ages of 5 and 11, Pfizer and BioNTech announced Monday morning that their COVID jab has been found to be just as safe and effective for grade-school children as it is for adults.

NEW YORK AND MAINZ, Germany-(BUSINESS WIRE)- Pfizer Inc. and BioNTech SE today announced results from a Phase 2/3 trial showing a favorable safety profile and robust neutralizing antibody responses in children 5 to 11 years of age using a two-dose regimen of 10 µg administered 21 days apart, a smaller dose than the 30 µg dose used for people 12 and older.

The 10 µg dose was carefully selected as the preferred dose for safety, tolerability and immunogenicity in children 5 to 11 years of age.

"Over the past nine months, hundreds of millions of people ages 12 and older from around the world have received our COVID-19 vaccine. We are eager to extend the protection afforded by the vaccine to this younger population, subject to regulatory authorization, especially as we track the spread of the Delta variant and the substantial threat it poses to children," said Albert Bourla, Chairman and Chief Executive Officer, Pfizer.

"The safety profile and immunogenicity data in children aged 5 to 11 years vaccinated at a lower dose are consistent with those we have observed with our vaccine in other older populations at a higher dose."

The data summarized from this Phase 2/3 study, which is enrolling children 6 months to 11 years of age, was for 2,268participants who were 5 to 11 years of age and received a 10 µg dose level in a two-dose regimen.

Topline readouts for the other two age cohorts from the trial - children 2-5 years of age and children 6 months to 2 years of age - are expected as soon as the fourth quarter of this year.
 

https://www.zerohedge.com/covid-19/pfizer-says-vaccine-safe-effective-children-young-5 

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