FDA clears BioNTech (BNTX) LP.8.1 COMIRNATY COVID-19 vaccine for high-risk groups

Rhea-AI Filing Summary

BioNTech SE reports that the U.S. Food and Drug Administration has approved a supplemental Biologics License Application for its and Pfizer’s LP.8.1‑adapted monovalent COVID‑19 vaccine, COMIRNATY LP.8.1. The vaccine is now approved for adults aged 65 and older and for individuals aged 5 through 64 who have at least one underlying condition that puts them at high risk for severe COVID‑19. This expands use of the updated mRNA vaccine in key higher‑risk groups in the United States.

Positive

• U.S. FDA approval of the LP.8.1‑adapted monovalent COMIRNATY COVID‑19 vaccine for adults 65+ and high‑risk individuals 5–64 expands BioNTech’s authorized product offering in key vulnerable populations.

Negative

• None.

Insights

Biopharma regulatory and commercial analyst

U.S. FDA approval broadens BioNTech/Pfizer’s updated COVID-19 vaccine use in high‑risk groups.

The approval of the supplemental Biologics License Application for the LP.8.1‑adapted monovalent COMIRNATY COVID‑19 vaccine gives BioNTech and Pfizer an authorized, updated product specifically tailored to the LP.8.1 lineage. It is approved for adults 65 and older and for individuals 5–64 with at least one high‑risk underlying condition, directly targeting populations most vulnerable to severe COVID‑19 outcomes.

This kind of U.S. FDA approval can be important commercially because it defines who can receive the updated vaccine, helping guide ordering decisions by healthcare providers and public‑health programs. The focus on older adults and high‑risk younger people aligns the product with groups that are often prioritized for vaccination campaigns, which may support continued utilization of the COMIRNATY franchise.

Future information in company communications or subsequent filings may clarify details such as rollout timing, supply, and any impact on revenue contribution from this LP.8.1‑adapted vaccine as vaccination campaigns progress in the United States.

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.

BioNTech SE

By:

/s/ Ramón Zapata-Gomez

By:

/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

FAQ

What did BioNTech (BNTX) disclose in this Form 6-K?

BioNTech reported that the U.S. Food and Drug Administration approved a supplemental Biologics License Application for its and Pfizer’s LP.8.1‑adapted monovalent COVID‑19 vaccine, COMIRNATY LP.8.1, for specific higher‑risk age groups.

Which COVID-19 vaccine was approved according to BioNTech’s 6-K?

The approval covers the LP.8.1‑adapted monovalent COVID‑19 vaccine marketed as COMIRNATY LP.8.1 (COVID‑19 Vaccine, mRNA), developed jointly by BioNTech and Pfizer.

For which age groups is COMIRNATY LP.8.1 now approved in the U.S.?

COMIRNATY LP.8.1 is approved for adults 65 years and older and for individuals aged 5 through 64 who have at least one underlying condition that puts them at high risk for severe COVID‑19.

What is the regulatory milestone highlighted for BioNTech (BNTX)?

The key milestone is U.S. FDA approval of a supplemental Biologics License Application for the LP.8.1‑adapted monovalent COMIRNATY COVID‑19 vaccine for certain high‑risk age groups.

How are BioNTech and Pfizer involved together in this vaccine approval?

BioNTech and Pfizer jointly developed the COMIRNATY LP.8.1 COVID‑19 vaccine, and both companies announced that the U.S. FDA approved the supplemental Biologics License Application for its use in specified high‑risk populations.

Where can investors find more detail on this BioNTech and Pfizer vaccine approval?

More detail is provided in the press release titled “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”, attached as Exhibit 99.1.