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Pfizer-BioNTech Ask FDA to Authorize COVID-19 Vaccine for Children 5 to 11

If authorized, this would be the first coronavirus vaccine authorized for younger children.

Video source: YouTube, TODAY

Pfizer Inc (NYSE: PFE ) and BioNTech SE (Nasdaq: BNTX ) announced Thursday they have asked the US Food and Drug Administration (FDA) to expand their COVID-19 vaccine’s emergency use authorization to cover children ages five to 11. 
If authorized, this would be the first coronavirus vaccine authorized for younger children. Currently, the Pfizer-BioNTech shots are only approved in the US for people ages 16 and up and in the EU for people ages 12 to 15. 

The application was widely expected after Pfizer and BioNTech submitted data last month to the FDA showing that a two-dose regimen of 10 micrograms — a third of the dosage used for teens and adults — is safe and generated a “robust” immune response during a clinical trial in young children. 

The regulator’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) is scheduled to meet on Oct. 26 to discuss the data submitted by Pfizer, and the shots could be approved shortly after that meeting.

"We know from our vast experience with other pediatric vaccines that children are not small adults, and we will conduct a comprehensive evaluation of clinical trial data submitted in support of the safety and effectiveness of the vaccine used in a younger pediatric population, which may need a different dosage or formulation from that used in an older pediatric population or adults," Acting FDA commissioner Dr. Janet Woodcock said in a statement.

Federal health officials are under mounting pressure to act quickly on the application as schools have reopened for in-person learning and the Delta variant has caused a surge in pediatric cases. 

The highly-contagious variant — now the dominant strain in the US — poses a heightened risk to anyone who is not vaccinated, especially the 50 million young children who are not yet eligible. Health experts still consider it uncommon for children to become severely ill from the virus, but being unvaccinated still leaves them vulnerable. 

Peter Marks, the FDA's director of the Center for Biologics Evaluation and Research, which oversees vaccine reviews, told The Associated Press last month that once Pfizer submits its full EUA application, his agency will complete its review “hopefully in a matter of weeks.” He also said he is “very, very hopeful” that vaccinations for 5- to 11-year-olds will be underway by year’s end. 

Meanwhile, Moderna has previously said it anticipates submitting its data to the FDA sometime this fall for use of its vaccine in kids under the age of 12.

Both Pfizer and Moderna are also testing their vaccines in children between the ages of six months and five years old. Data from those trials is expected in late fall of this year.


Source: Equities News

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