BioNTech SE — Regulatory Filings 2025

Aug 27, 2025

6-K 1 form6-klp81xadaptedfdaappr.htm 6-K Document created using Wdesk Copyright 2025 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 2025

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 27, 2025, BioNTech SE and Pfizer Inc. announced that the U.S. Food and Drug Administration has approved the supplemental Biologics License Application for the companies’ LP.8.1-adapted monovalent COVID-19 vaccine (COMIRNATY® LP.8.1; COVID-19 Vaccine, mRNA) for use in adults ages 65 years and older, as well as in individuals ages 5 through 64 years with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19 . 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/ Ramón Zapata-Gomez	/s/ Dr. Sierk Poetting
Name: Ramón Zapata-Gomez	Name: Dr. Sierk Poetting
Title: Chief Financial Officer	Title: Chief Operating Officer

Date: August 27, 2025

EXHIBIT INDEX

Exhibit	Description of Exhibit
99.1	Pfizer and BioNTech’s COMIRNATY® Receives U.S. FDA Approval for Adults 65 and Older and Individuals Ages 5 through 64 at Increased Risk for Severe COVID-19