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Pfizer and BioNTech Submit Covid Vaccine Data for Kids 5-11

Added 09-28-21 10:40:05am EST - “The companies said that they would submit a formal request to regulators to allow a pediatric dose of their vaccine to be administered in the United States in the coming weeks.” - Nytimes.com

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Posted By TheNewsCommenter: From Nytimes.com: “Pfizer and BioNTech submit data they say shows shots are safe in 5- to 11-year-olds.”. Below is an excerpt from the article.

Pfizer and BioNTech announced on Tuesday that they had submitted data to the Food and Drug Administration showing that their coronavirus vaccine is safe and effective in children ages 5 to 11.

The companies said that they would submit a formal request to regulators to allow a pediatric dose of their vaccine to be administered in the United States in the coming weeks. Similar requests will be filed with European regulators and in other countries.

Pfizer and BioNTech announced favorable results from their clinical trial with more than 2,200 participants in that age group just over a week ago. The F.D.A. has said that it will analyze the data as soon as possible.

The companies said last week that their vaccine had been shown to be safe and effective in low doses in children ages 5 to 11, offering hope to parents in the United States who are worried that a return to in-person schooling has put youngsters at risk of infection.

About 28 million children ages 5 to 11 would be eligible for the vaccine in the United States, far more than the 17 million of ages 12 to 15 who became eligible for the vaccine in May.

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