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The Food and Drug Administration on Friday authorized emergency use of Pfizer  (PFE) – Get Pfizer Inc. Report and BioNTech’s  (BNTX) – Get BioNTech SE Sponsored ADR Report Covid-19 vaccine for children ages 5 through 11.

The Pfizer-BioNTech vaccine, which is the first Covid-19 vaccine authorized in the U.S. for children ages 5 through 11, will be administered in a lower-dose, 10 microgram regimen in two shots, 21 days apart, according to a statement from the companies. Individuals 12 years and older receive 30 micrograms of the vaccine.

The FDA based its approval on results from a Phase 2/3 randomized and controlled trial, which included about 4,500 children ages 5 through 11, that demonstrated a favorable safety profile, robust immune responses and a 90.7% vaccine efficacy rate. The FDA’s Vaccine and Related Biological Products Advisory Committee reviewed and recommended the vaccine for children earlier this week.

The Pfizer-BioNTech vaccine is fully approved by the FDA for individuals 16 and over, and is also authorized for emergency use in children aged 12 to 15.

Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices will meet next week to discuss a potential recommendation for the use and rollout of the vaccine to children ages 5 through 11. Pediatric vaccinations are anticipated to start, subject to, and after, CDC endorses the advisory committee recommendation. 

TheStreet RecommendsINVESTINGPfizer-BioNTech Children’s Covid-19 Vaccine Secures FDA Approval11 seconds agoPRESS RELEASESBlythedale Children’s Hospital CEO: Build Back Better For Kids21 minutes agoPRESS RELEASESNew Phase 3 Data Presented At Psych Congress 2021 Showed TV-46000/mdc-IRM Significantly Prolonged Time To Impending Relapse Compared To Placebo In Patients With Schizophrenia25 minutes ago“This is a day so many parents, eager to protect their young children from this virus, have been waiting for,” Pfizer CEO Albert Bourla said in a Friday statement. “Over 6 million children in the U.S. have been diagnosed with Covid-19 since the start of this pandemic, and a high number of young people continue to be infected every week. With this FDA authorization, we have achieved another key marker in our ongoing effort to help protect families and communities, and to get this disease under control.”

BioNTech CEO Ugur Sahin said in a statement that the vaccine will address a need to keep children safe and protected as they return to school.

“Today’s emergency use authorization is supported by clinical data showing a favorable safety profile and high vaccine efficacy in children, underlining its potential to address a current public health need,” Sahin said. “As children 5 through 11 get reacclimated to the new school year, both in and out of the classroom, our goal is to help keep them safe and protected and get them back to normalcy.”

Shares of Pfizer on Friday closed 1.3% higher at $43.74. BioNTech’s stock closed 1.85% lower at $278.73.