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Pfizer Resubmits Application for COVID-19 Vaccine for Children Under 5

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Pfizer and its partner BioNTech have resubmitted their application to the FDA for emergency use of a three-dose COVID-19 vaccine for children ages 6 months to 4 years. Allegedly from the FDA accepted Pfizer’s application to see the data Wednesday.

“Pfizer and BioNTech have filed a rolling emergency use authorization request with the U.S. Food and Drug Administration,” Pfizer said in an emailed statement.

Pfizer had previously asked the FDA to approve their vaccine for children 6 months to 4 years in February though has withdrawn his application waiting for more data. Pfizer said last week trials showed its three-dose vaccine triggered a strong immune response in children under 5.

Ahead of the expected filing, the FDA said last week that its Advisory Committee on Vaccines and Related Biological Products would do so meet on 15.6 Discussing emergency use authorization applications for Pfizer and Moderna vaccines in children 6 months and older.

Moderna asked for permission End of April. Moderna’s vaccine for children under 5 years old is two doses of its 25 microgram vaccine (a quarter the volume of Moderna’s adult dose). Pfizer contains three 3-microgram doses — one-tenth the adult dose.

“We recognize that parents are anxious to have their young children vaccinated against COVID-19, and while the FDA cannot predict how long it will take to evaluate the data and information, we will honor any EUA request that we as soon as possible using an evidence-based approach,” the FDA said in a statement to ABC News.

The FDA did not immediately respond to a request for comment. The vaccine would need to be approved by the committee before the full FDA, followed by CDC approval.

The information contained in this article is for educational and informational purposes only and is not intended as health or medical advice. Always consult a physician or other qualified healthcare provider with any questions about a medical condition or health goals.

Pfizer Resubmits Application for COVID-19 Vaccine for Children Under 5 Source link Pfizer Resubmits Application for COVID-19 Vaccine for Children Under 5

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