BioNTech/Pfizer Vaccine Gets EMA Nod for 2025-26 Season

Ticker: BNTX · Form: 6-K · Filed: 2025-07-25T00:00:00.000Z

Sentiment: bullish

Topics: regulatory-approval, vaccine, public-health

Related Tickers: BNTX, PFE

TL;DR

EMA's CHMP recommends BioNTech/Pfizer's bivalent COVID vaccine for 2025-26 season.

AI Summary

On July 25, 2025, BioNTech SE and Pfizer Inc. announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommended the approval of their COMIRNATY Original/Omicron BA.4/BA.5 bivalent vaccine for the 2025-2026 respiratory season. This recommendation is based on the vaccine's ability to elicit a strong immune response against currently circulating Omicron subvariants.

Why It Matters

This EMA recommendation is a crucial step towards ensuring broad access to an updated COVID-19 vaccine for the upcoming respiratory season, potentially impacting public health strategies and vaccine availability across Europe.

Risk Assessment

Risk Level: low — This filing is an announcement of a regulatory recommendation, which is generally a positive development with limited immediate downside risk.

Key Players & Entities

FAQ

What specific vaccine was recommended for approval?

The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended the approval of the COMIRNATY Original/Omicron BA.4/BA.5 bivalent vaccine.

Which regulatory body made the recommendation?

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) made the recommendation.

Who are the companies involved in the vaccine development?

BioNTech SE and Pfizer Inc. are the companies involved in the development of the vaccine.

What is the intended use period for the recommended vaccine?

The vaccine is recommended for the 2025-2026 respiratory season.

What is the basis for the CHMP's recommendation?

The recommendation is based on the vaccine's ability to elicit a strong immune response against currently circulating Omicron subvariants.

From the Filing

0001776985-25-000047.txt : 20250725 0001776985-25-000047.hdr.sgml : 20250725 20250725085317 ACCESSION NUMBER: 0001776985-25-000047 CONFORMED SUBMISSION TYPE: 6-K PUBLIC DOCUMENT COUNT: 4 CONFORMED PERIOD OF REPORT: 20250725 FILED AS OF DATE: 20250725 DATE AS OF CHANGE: 20250725 FILER: COMPANY DATA: COMPANY CONFORMED NAME: BioNTech SE CENTRAL INDEX KEY: 0001776985 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] ORGANIZATION NAME: 03 Life Sciences EIN: 000000000 STATE OF INCORPORATION: 2M FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 6-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-39081 FILM NUMBER: 251148980 BUSINESS ADDRESS: STREET 1: AN DER GOLDGRUBE 12 CITY: MAINZ STATE: 2M ZIP: 55131 BUSINESS PHONE: 0049613190840 MAIL ADDRESS: STREET 1: AN DER GOLDGRUBE 12 CITY: MAINZ STATE: 2M ZIP: 55131 6-K 1 form6-kchmpopinion25jul2025.htm 6-K 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 JULY 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 July 25, 2025, BioNTech SE and Pfizer Inc. announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorization for the companies’ LP.8.1-adapted monovalent COVID-19 vaccine (COMIRNATY ® LP.8.1) for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and older. 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: July 25, 2025 EXHIBIT INDEX Exhibit Description of Exhibit 99.1 Pfizer and BioNTech Receive Positive CHMP Opinion for LP.8.1-Adapted COVID-19 Vaccine in the European Union EX-99.1 2 a991250725_covid-19lp81chm.htm EX-99.1 Document Exhibit 99.1          Pfizer and BioNTech Receive Positive CHMP Opinion for LP.8.1-Adapted COVID-19 Vaccine in the European Union • Data indicate that the LP.8.1-adapted COVID-19 vaccine confers improved immune response against currently dominant and emerging sublineages – including the XFG and NB.1.8.1 variants 1 – compared to 2024-2025 COVID-19 vaccine formulations • Upon authorization by the European Commission (EC), the LP.8.1-adapted COVID-19 vaccine will be available for individuals 6 months of age and older • To date, over a billion adults and children around the world have received the Pfizer-BioNTech COVID-19 vaccine, which continues to demonstrate a favorable safety and efficacy profile supported by extensive real-world evidence, clinical, non-clinical, pharmacovigilance and manufacturing data • Doses will be ready to ship to applicable EU member states immediately upon authorization by the European Commission NEW YORK and MAINZ, GERMANY, July 25, 2025 —

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