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

https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-provide-update-ongoing-studies-covid-19

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

https://investors.pfizer.com/Investors/News/news-details/2022/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/default.aspx

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

https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-advisory-committee-meeting-discuss-request-authorization-pfizer

Pfizer and BioNTech Seek Authorization of Covid Vaccine for Children Under 5 | Barron’s

https://www.barrons.com/articles/pfizer-and-biontech-seek-authorization-of-covid-vaccine-for-children-under-5-51643754754

COVID vaccine for kids under 5: Doctors, parents demand urgent access

https://www.usatoday.com/story/news/health/2022/01/20/covid-vaccine-kids-under-5-doctors-parents-demand-urgent-access/6576217001/

FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine for Emergency Use in Children 5 through 11 Years of Age | FDA

https://www.fda.gov/news-events/press-announcements/fda-authorizes-pfizer-biontech-covid-19-vaccine-emergency-use-children-5-through-11-years-age

FDA tells Pfizer to seek approval for COVID vaccine for kids under 5