On FDA’s Urging Pfizer-BionTech Applies for Vaccine Authorization for Under 5 Years | DrBeen Medical Lectures | Feb 2, 2022 (Video with References)
Pfizer vaccine data was not strong after 2 doses for children under 5 years of age. FDA has urged them to apply for a rolling authorization. Let’s review the data points.
Understanding noninferiority trials – PMC
https://www.ncbi.nlm.nih.gov/labs/pmc/articles/PMC3510268/
Pfizer and BioNTech Provide Update on Ongoing Studies of COVID-19 Vaccine | Pfizer
Pfizer Inc. – Pfizer and BioNTech Initiate Rolling Submission for Emergency Use Authorization of Their COVID-19 Vaccine in Children 6 Months Through 4 Years of Age Following Request From U.S. FDA
Coronavirus (COVID-19) Update: FDA Advisory Committee Meeting to Discuss Request for Authorization of Pfizer-BioNTech COVID-19 Vaccine for Children 6 Months Through 4 Years of Age | FDA
Pfizer and BioNTech Seek Authorization of Covid Vaccine for Children Under 5 | Barron’s
COVID vaccine for kids under 5: Doctors, parents demand urgent access
FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine for Emergency Use in Children 5 through 11 Years of Age | FDA
FDA tells Pfizer to seek approval for COVID vaccine for kids under 5
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