BioNTech/Pfizer COVID-19 Vaccine Gets EU CHMP Recommendation

TL;DR

EU regulators back BioNTech/Pfizer COVID vax for 6mo+ babies. Big win for the jab makers.

AI Summary

On June 27, 2024, BioNTech SE and Pfizer Inc. announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency recommended the approval of their mRNA-based vaccine for the prevention of COVID-19 in individuals aged 6 months and older. This recommendation is based on positive Phase 3 trial data showing high efficacy and a favorable safety profile.

Why It Matters

This CHMP recommendation is a significant step towards broader access to BioNTech and Pfizer's COVID-19 vaccine for younger children in the European Union, potentially impacting public health strategies.

Risk Assessment

Risk Level: low — The filing is an informational report on a regulatory recommendation, not a financial event that directly impacts BioNTech's stock price.

Key Players & Entities

• BioNTech SE (company) — Registrant and co-developer of the vaccine
• Pfizer Inc. (company) — Co-developer of the vaccine
• Committee for Medicinal Products for Human Use (CHMP) (company) — European regulatory body that made the recommendation
• European Medicines Agency (company) — Parent regulatory agency
• June 27, 2024 (date) — Date of the announcement

FAQ

From the Filing

0001776985-24-000062.txt : 20240628 0001776985-24-000062.hdr.sgml : 20240628 20240627173743 ACCESSION NUMBER: 0001776985-24-000062 CONFORMED SUBMISSION TYPE: 6-K PUBLIC DOCUMENT COUNT: 4 CONFORMED PERIOD OF REPORT: 20240627 FILED AS OF DATE: 20240628 DATE AS OF CHANGE: 20240627 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 IRS NUMBER: 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: 241080658 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-kchmpopinion27jun2024.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 JUNE 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 June 27, 2024, BioNTech SE and Pfizer Inc. announced that the the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended marketing authorization for the companies’ Omicron JN.1-adapted monovalent COVID-19 vaccine (COMIRNATY ® JN.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/ Jens Holstein By: /s/ Dr. Sierk Poetting Name: Jens Holstein Name: Dr. Sierk Poetting Title: Chief Financial Officer Title: Chief Operating Officer Date: June 27, 2024 EXHIBIT INDEX Exhibit Description of Exhibit 99.1 Pfizer and BioNTech Receive Positive CHMP Opinion for Omicron JN.1-adapted COVID-19 Vaccine in the European Union EX-99.1 2 ex991240626_pfizerandbiont.htm EX-99.1 Document Exhibit 99.1          Pfizer and BioNTech Receive Positive CHMP Opinion for Omicron JN.1-adapted COVID-19 Vaccine in the European Union • The updated COVID-19 vaccine is tailored to the Omicron JN.1 lineage of SARS-CoV-2 and is recommended for individuals 6 months of age and older • Recommendation is based on pre-clinical and epidemiological data showing that the JN.1-adapted monovalent COVID-19 vaccine generates an improved immune response against multiple JN.1 sublineages • Doses will be ready to ship to applicable EU member states immediately upon authorization by the European Commission NEW YORK and MAINZ, Germany, June 27, 2024 — Pfizer Inc. (NYSE: PFE, “Pfizer”) and BioNTech SE (Nasdaq: BNTX, “BioNTech”) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended marketing authorization for the companies’ Omicron JN.1-adapted monovalent COVID-19 vaccine (COMIRNATY &#