BioNTech/Pfizer COVID Vaccine Gets FDA Approval for Younger Ages

TL;DR

FDA approves BioNTech/Pfizer Omicron vaccine for kids 6mo+, expanding market.

AI Summary

On August 22, 2024, BioNTech SE and Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) approved a supplemental Biologics License Application (sBLA) for their Omicron-adapted bivalent COVID-19 vaccine. This approval allows the vaccine to be used in individuals 6 months of age and older.

Why It Matters

This FDA approval expands the eligible population for the Omicron-adapted bivalent COVID-19 vaccine, potentially increasing vaccination rates and public health protection against the virus.

Risk Assessment

Risk Level: low — The filing is an announcement of regulatory approval, which is generally positive news and does not introduce new risks.

Key Numbers

• 6 months — Minimum Age for Vaccine (The FDA approval now covers individuals from 6 months of age and older.)

Key Players & Entities

• BioNTech SE (company) — Registrant and co-developer of the vaccine
• Pfizer Inc. (company) — Co-developer of the vaccine
• U.S. Food and Drug Administration (company) — Regulatory body that approved the vaccine
• August 22, 2024 (date) — Date of the announcement and FDA approval

FAQ

Filing Documents

• form6-kkp2vaccinefdaapprov.htm (6-K) — 16KB
• ex99_120240822xbntxprxkp2v.htm (EX-99.1) — 85KB
• image_0a.jpg (GRAPHIC) — 32KB
• image_1a.jpg (GRAPHIC) — 69KB
• 0001776985-24-000077.txt ( ) — 241KB

From the Filing

Document UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a16 OR 15d16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 FOR THE MONTH OF AUGUST 2024 COMMISSION FILE NUMBER 001-39081 BioNTech SE (Translation of registrant's name into English) An der Goldgrube 12 D-55131 Mainz Germany +49 6131-9084-0 (Address of principal executive offices) Indicate by check mark whether the registrant files or will file annual reports under cover Form 20F or Form 40F Form 20F Form 40F Indicate by check mark if the registrant is submitting the Form 6K in paper as permitted by Regulation ST Rule 101(b)(1) Indicate by check mark if the registrant is submitting the Form 6K in paper as permitted by Regulation ST Rule 101(b)(7) DOCUMENTS INCLUDED AS PART OF THIS FORM 6-K On August 22 , 2024, BioNTech SE and Pfizer Inc. announced that the U.S. Food and Drug Administration approved the supplemental Biologics License Application for individuals 12 years of age and older (COMIRNATY (COVID-19 Vaccine, mRNA)), and granted emergency use authorization for individuals 6 months through 11 years of age (Pfizer-BioNTech COVID-19 Vaccine) of the companies' Omicron KP.2-adapted 2024-2025 Formula COVID-19 vaccine. The press release is attached hereto as Exhibit 99.1. SIGNATURE Pursuant to the requirements of the Exchange Act, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized. BioNTech SE By s Jens Holstein By s Dr. Sierk Poetting Name Jens Holstein Name Dr. Sierk Poetting Title Chief Financial Officer Title Chief Operating Officer Date August 22, 2024 EXHIBIT INDEX Exhibit Description of Exhibit 99.1 Pfizer and BioNTech Receive U.S. FDA Approval Authorization for Omicron KP.2-adapted COVID-19 Vaccine

View Full Filing

View this 6-K filing on SEC EDGAR