BioNTech SE — Regulatory Filings 2024

Aug 22, 2024

6-K 1 form6-kkp2vaccinefdaapprov.htm 6-K Document created using Wdesk Copyright 2024 Workiva Document

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 6-K

REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a‑16 OR 15d‑16

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 20‑F or Form 40‑F: Form 20‑F ☒ Form 40‑F ☐

Indicate by check mark if the registrant is submitting the Form 6‑K in paper as permitted by Regulation S‑T Rule 101(b)(1): ☐

Indicate by check mark if the registrant is submitting the Form 6‑K in paper as permitted by Regulation S‑T 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.

/s/ Jens Holstein	/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