BioNTech/Pfizer COVID Vaccine Gets EU Panel Recommendation
Ticker: BNTX · Form: 6-K · Filed: 2024-09-20T00:00:00.000Z
Sentiment: bullish
Topics: regulatory-approval, vaccine, covid-19, partnership
TL;DR
EU panel backs BioNTech/Pfizer's updated COVID shot for ages 12+.
AI Summary
On September 20, 2024, BioNTech SE and Pfizer Inc. announced that the Committee for Medicinal Products for Human Use (CHMP) recommended the approval of their Omicron-adapted bivalent vaccine for active immunization to prevent COVID-19 in individuals 12 years of age and older. This recommendation is based on clinical trial data demonstrating the vaccine's efficacy.
Why It Matters
This CHMP recommendation is a significant step towards broader availability of an updated COVID-19 vaccine in Europe, potentially impacting public health strategies and vaccine uptake.
Risk Assessment
Risk Level: low — The filing is an informational update regarding a regulatory recommendation, not a financial event that directly impacts BioNTech's immediate financial standing.
Key Players & Entities
- BioNTech SE (company) — Registrant
- Pfizer Inc. (company) — Collaborator
- Committee for Medicinal Products for Human Use (CHMP) (company) — Regulatory body
- September 20, 2024 (date) — Announcement date
- 12 years of age and older (age_group) — Vaccine indication
FAQ
What is the specific recommendation made by the CHMP?
The CHMP recommended the approval of BioNTech SE and Pfizer Inc.'s Omicron-adapted bivalent vaccine for active immunization to prevent COVID-19.
What is the age group for which the vaccine is recommended?
The vaccine is recommended for individuals 12 years of age and older.
Who announced this recommendation?
BioNTech SE and Pfizer Inc. announced the recommendation from the CHMP.
On what date was this announcement made?
The announcement was made on September 20, 2024.
What is the purpose of the vaccine?
The vaccine is for active immunization to prevent COVID-19.
From the Filing
0001776985-24-000081.txt : 20240920 0001776985-24-000081.hdr.sgml : 20240920 20240920091740 ACCESSION NUMBER: 0001776985-24-000081 CONFORMED SUBMISSION TYPE: 6-K PUBLIC DOCUMENT COUNT: 4 CONFORMED PERIOD OF REPORT: 20240920 FILED AS OF DATE: 20240920 DATE AS OF CHANGE: 20240920 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: 241311833 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-kchmpopinion20sep2024.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 SEPTEMBER 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 September 20, 2024, BioNTech SE and Pfizer Inc. 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 KP.2-adapted monovalent COVID-19 vaccine (COMIRNATY ® KP.2) 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: September 20, 2024 EXHIBIT INDEX Exhibit Description of Exhibit 99.1 Pfizer and BioNTech Receive Positive CHMP Opinion for Omicron KP.2-adapted COVID-19 Vaccine in the European Union EX-99.1 2 a99120240920_chmpopinionpr.htm EX-99.1 Document Exhibit 99.1          Pfizer and BioNTech Receive Positive CHMP Opinion for Omicron KP.2-adapted COVID-19 Vaccine in the European Union • Upon authorization by the European Commission, the Omicron KP.2-adapted COVID-19 vaccine will be available for individuals 6 months of age and older • Data demonstrate that the Omicron KP.2-adapted COVID-19 vaccine generates a substantially improved response against multiple circulating Omicron JN.1 sublineages as did the Omicron JN.1-adapted COVID-19 vaccine authorized by the European Commission in July 2024 • Doses will be ready to ship to applicable European Union member states as soon as possible upon European Commission authorization NEW YORK and MAINZ, GERMANY, SEPTEMBER 20, 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 Euro