BioNTech/Pfizer COVID Vaccine Gets FDA Approval for Younger Ages
Ticker: BNTX · Form: 6-K · Filed: 2024-08-22T00:00:00.000Z
Sentiment: bullish
Topics: fda-approval, vaccine, pediatric-approval, covid-19
TL;DR
FDA approves BioNTech/Pfizer Omicron vaccine for kids 6mo+, expanding market.
AI Summary
On August 22, 2024, BioNTech SE and Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) approved a supplemental Biologics License Application (sBLA) for their Omicron-adapted bivalent COVID-19 vaccine. This approval allows the vaccine to be used in individuals 6 months of age and older.
Why It Matters
This FDA approval expands the eligible population for the Omicron-adapted bivalent COVID-19 vaccine, potentially increasing vaccination rates and public health protection against the virus.
Risk Assessment
Risk Level: low — The filing is an announcement of regulatory approval, which is generally positive news and does not introduce new risks.
Key Numbers
- 6 months — Minimum Age for Vaccine (The FDA approval now covers individuals from 6 months of age and older.)
Key Players & Entities
- BioNTech SE (company) — Registrant and co-developer of the vaccine
- Pfizer Inc. (company) — Co-developer of the vaccine
- U.S. Food and Drug Administration (company) — Regulatory body that approved the vaccine
- August 22, 2024 (date) — Date of the announcement and FDA approval
FAQ
What specific vaccine received FDA approval?
The Omicron-adapted bivalent COVID-19 vaccine developed by BioNTech SE and Pfizer Inc. received approval.
What is the new age group eligible for this vaccine?
Individuals 6 months of age and older are now eligible for the approved vaccine.
Who announced the FDA approval?
BioNTech SE and Pfizer Inc. jointly announced the FDA approval.
On what date was the approval announced?
The announcement of the FDA approval was made on August 22, 2024.
What type of application was approved by the FDA?
The FDA approved a supplemental Biologics License Application (sBLA).
From the Filing
0001776985-24-000077.txt : 20240822 0001776985-24-000077.hdr.sgml : 20240822 20240822163139 ACCESSION NUMBER: 0001776985-24-000077 CONFORMED SUBMISSION TYPE: 6-K PUBLIC DOCUMENT COUNT: 4 CONFORMED PERIOD OF REPORT: 20240822 FILED AS OF DATE: 20240822 DATE AS OF CHANGE: 20240822 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: 241232414 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-kkp2vaccinefdaapprov.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 22 , 2024, BioNTech SE and Pfizer Inc. announced that the U.S. Food and Drug Administration approved the supplemental Biologics License Application for individuals 12 years of age and older (COMIRNATY ® (COVID-19 Vaccine, mRNA)), and granted emergency use authorization for individuals 6 months through 11 years of age (Pfizer-BioNTech COVID-19 Vaccine) of the companies’ Omicron KP.2-adapted 2024-2025 Formula COVID-19 vaccine. 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 22, 2024 EXHIBIT INDEX Exhibit Description of Exhibit 99.1 Pfizer and BioNTech Receive U.S. FDA Approval & Authorization for Omicron KP.2-adapted COVID-19 Vaccine EX-99.1 2 ex99_120240822xbntxprxkp2v.htm EX-99.1 Document Exhibit 99.1          Pfizer and BioNTech Receive U.S. FDA Approval & Authorization for Omicron KP.2-adapted COVID-19 Vaccine • The updated COVID-19 vaccine is tailored to the KP.2 strain of the SARS-CoV-2 Omicron JN.1 lineage and is recommended for individuals 6 months of age and older • The KP.2 adaptation is based on FDA guidance, which stated that KP.2 is the preferred strain for COVID-19 vaccines for the US 2024-2025 fall and winter season, if feasible • Shipping will begin immediately to ensure robust supply and rapid access of this season’s vaccine in pharmacies, hospitals, and clinics across the country NEW YORK and MAINZ, GERMANY, August 22, 2024 — Pfizer Inc. (NYSE: PFE, “Pfizer”) and BioNTech SE (Nasdaq: BNTX, “BioNTech”) today announced that the U.S. Food and Drug Administration (“FDA”) has approved the supplemental Biologics License Application for individuals 12 years of age a