BioNTech & Pfizer Announce Phase 3 Vaccine Trial Results
Ticker: BNTX · Form: 6-K · Filed: 2024-08-16T00:00:00.000Z
Sentiment: neutral
Topics: clinical-trial, vaccine, collaboration
TL;DR
BioNTech and Pfizer dropped Phase 3 vaccine trial results, but details are scarce.
AI Summary
On August 16, 2024, BioNTech SE and Pfizer Inc. announced top-line results from their Phase 3 clinical trial for a combined vaccine. The filing does not provide specific details on the results or any associated dollar amounts.
Why It Matters
This announcement is significant as it pertains to the efficacy and potential market readiness of a new combined vaccine developed by two major pharmaceutical companies.
Risk Assessment
Risk Level: low — The filing is an update on clinical trial results and does not contain immediate financial or operational risks.
Key Players & Entities
- BioNTech SE (company) — Registrant and trial collaborator
- Pfizer Inc. (company) — Trial collaborator
- August 16, 2024 (date) — Date of announcement
FAQ
What were the top-line results of the Phase 3 clinical trial for the combined vaccine?
The filing states that top-line results were announced on August 16, 2024, but does not provide specific details of these results.
Which companies collaborated on this Phase 3 trial?
BioNTech SE and Pfizer Inc. collaborated on the Phase 3 clinical trial.
When was the announcement of the top-line results made?
The announcement was made on August 16, 2024.
What type of vaccine was evaluated in the Phase 3 trial?
The filing refers to a 'combined vaccine'.
Does this filing include financial details related to the vaccine trial?
No, this filing is an update on clinical trial results and does not include specific financial details or dollar amounts.
From the Filing
0001776985-24-000073.txt : 20240816 0001776985-24-000073.hdr.sgml : 20240816 20240816065610 ACCESSION NUMBER: 0001776985-24-000073 CONFORMED SUBMISSION TYPE: 6-K PUBLIC DOCUMENT COUNT: 4 CONFORMED PERIOD OF REPORT: 20240816 FILED AS OF DATE: 20240816 DATE AS OF CHANGE: 20240816 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: 241214098 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-kcombovaccineph23upd.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 AUGUST 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 August 16 , 2024, BioNTech SE and Pfizer Inc. announced top-line results from their Phase 3 clinical trial to evaluate the companies’ combined m RNA vaccine candidate against influenza and COVID-19 in healthy individuals 18-64 years of age . 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: August 16, 2024 EXHIBIT INDEX Exhibit Description of Exhibit 99.1 Pfizer and BioNTech Provide Update on mRNA-based Combination Vaccine Program Against Influenza and COVID-19 in Individuals 18-64 Years of Age EX-99.1 2 ex99_120240816xbntxcombova.htm EX-99.1 Document Exhibit 99.1          Pfizer and BioNTech Provide Update on mRNA-based Combination Vaccine Program Against Influenza and COVID-19 in Individuals 18-64 Years of Age • In a Phase 3 trial, Pfizer and BioNTech’s combination vaccine candidate against influenza and COVID-19 met one of its two primary immunogenicity objectives • The trial did not meet one of its primary immunogenicity objectives of non-inferiority against the influenza B strain despite obtaining higher influenza A responses and comparable COVID-19 responses versus the comparator vaccines • The companies are evaluating adjustments to the candidate and will discuss next steps with health authorities • Pfizer also provides update on its separate Phase 2 second-generation trivalent influenza mRNA vaccine trial which showed encouraging data demonstrating robust immunogenicity against all strains compared to a standard of care influenza vaccine NEW YORK and MAINZ, Germany, August 16, 2024 — Pfizer Inc. (NYSE: PFE, “Pfizer”) and BioNTech SE (Nasdaq: BNTX, “BioNTech”) today announced top-line results from thei