COVID-19 Vaccine(Janssen)

NEW YORK, NY, USA & MAINZ, Germany I September 20, 2024 I 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 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 European Commission will review the CHMP’s recommendation and is expected to make a final decision soon. Following the EC decision, Pfizer and BioNTech’s Omicron KP.2-adapted COVID-19 vaccine will ship to European Union (EU) member states that have specifically ordered this formulation. The CHMP recommendation dated September 19, 2024 is based on the non-clinical and manufacturing data of the Omicron KP.2-adapted vaccine and the clinical and real-world evidence supporting the safety and efficacy of prior formulas of the COVID-19 vaccines by Pfizer and BioNTech. The non-clinical data showed that the KP.2-adapted vaccine generates a substantially improved response against multiple currently circulating Omicron JN.1 sublineages, including KP.2, LB.1, KP.3 and KP.3.1.1, compared with the companies’ Omicron XBB.1.5-adapted COVID-19 vaccine. 1 In July 2024, the EC granted marketing authorization for Pfizer and BioNTech’s Omicron JN.1-adapted COVID-19 vaccine. This authorization was based on evidence showing that the JN.1-adapted COVID-19 vaccine generates a substantially improved response against multiple Omicron JN.1 sublineages, including KP.2, LB.1, KP.3 and KP.3.1.1, as compared with the companies’ Omicron XBB.1.5-adapted COVID-19 vaccine. Pending authorization of the Omicron KP.2-adapted vaccine by the EC, both the Omicron KP.2-adapted vaccine and the Omicron JN.1-adapted vaccine will be available across the EU, though availability will vary based on individual country government requests and national recommendations. In the United States, the U.S. Food and Drug Administration approved the companies’ Omicron KP.2-adapted COVID-19 vaccine for individuals 12 years of age and older and granted emergency use authorization for individuals 6 months through 11 years of age on August 22, 2024. Pfizer and BioNTech will continue to monitor the evolving epidemiology of COVID-19 and remain prepared to develop modified vaccine formulas, as the data support and as regulatory agencies recommend. The COVID-19 vaccines (COMIRNATY ® ) by Pfizer and BioNTech are based on BioNTech’s proprietary mRNA technology and were developed by both companies. BioNTech is the Marketing Authorization Holder for COMIRNATY ® and its adapted vaccines in the United States, the European Union, the United Kingdom, and other countries, and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries. INDICATION, AUTHORIZED USE AND IMPORTANT SAFETY INFORMATION INDICATION COMIRNATY ® (COVID-19 Vaccine, mRNA) is a vaccine for use in people 12 years of age and older to protect against coronavirus disease 2019 (COVID-19). IMPORTANT SAFETY INFORMATION Before getting COMIRNATY, tell your vaccination provider about all of your medical conditions, including if you: Additional side effects that have been reported with COMIRNATY or Pfizer-BioNTech COVID-19 vaccines include: These may not be all the possible side effects of COMIRNATY. Ask your healthcare provider about any side effects that concern you. You may report side effects to the FDA/CDC Vaccine Adverse Event Reporting System (VAERS). The VAERS toll-free number is 1‐800‐822‐7967 or report online to www.vaers.hhs.gov/reportevent.html . In addition, you can report side effects to Pfizer Inc. at 1-800-438-1985 or www.pfizersafetyreporting.com Please click here for full Prescribing Information and Patient Information for COMIRNATY. If it is not currently available via these links, it will be visible as soon as possible as we work to finalize the documents. Please check back for the full information shortly. AUTHORIZED USE Pfizer-BioNTech COVID-19 Vaccine (2024-2025 Formula)* is FDA authorized under Emergency Use Authorization (EUA) to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 6 months through 11 years of age. *Hereafter referred to as Pfizer-BioNTech COVID-19 Vaccine. EMERGENCY USE AUTHORIZATION Emergency uses of COVID-19 vaccines from BioNTech and Pfizer, including Pfizer-BioNTech COVID-19 Vaccine (2024-2025 Formula), have not been approved or licensed by FDA, but have been authorized by FDA, under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) in individuals 6 months of age and older. Emergency uses are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical products under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner. Please see EUA Fact Sheets at www.cvdvaccine-us.com . IMPORTANT SAFETY INFORMATION Additional symptoms, particularly in children, may include: These may not be all the possible side effects. Serious and unexpected side effects may occur. Call the vaccination provider or healthcare provider about bothersome side effects or side effects that do not go away. Report vaccine side effects to the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) Vaccine Adverse Event Reporting System (VAERS). The VAERS toll- free number is 1‐800‐822‐7967 or report online to www.vaers.hhs.gov/reportevent.html . Please include “Pfizer-BioNTech COVID-19 Vaccine (2024-2025 Formula) EUA” in the first line of box #18 of the report form. In addition, individuals can report side effects to Pfizer Inc. at www.pfizersafetyreporting.com or by calling 1-800-438-1985. Please click here for Pfizer-BioNTech COVID-19 Vaccine Healthcare Providers Fact Sheet and Vaccine Recipient and Caregiver EUA Fact Sheet . If it is not currently available via these links, it will be visible as soon as possible as we work to finalize the documents. Please check back for the full information shortly. About Pfizer: Breakthroughs That Change Patients’ Lives At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For 175 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com . In addition, to learn more, please visit us on www.Pfizer.com and follow us on X at @Pfizer and @Pfizer News , LinkedIn , YouTube and like us on Facebook at Facebook.com/Pfizer . About BioNTech Biopharmaceutical New Technologies (BioNTech) is a global next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases. BioNTech exploits a wide array of computational discovery and therapeutic drug platforms for the rapid development of novel biopharmaceuticals. Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor (CAR) T cells, several protein-based therapeutics, including bispecific immune checkpoint modulators, targeted cancer antibodies and antibody-drug conjugate (ADC) therapeutics, as well as small molecules. Based on its deep expertise in mRNA vaccine development and in-house manufacturing capabilities, BioNTech and its collaborators are developing multiple mRNA vaccine candidates for a range of infectious diseases alongside its diverse oncology pipeline. BioNTech has established a broad set of relationships with multiple global and specialized pharmaceutical collaborators, including Biotheus, DualityBio, Fosun Pharma, Genentech, a member of the Roche Group, Genevant, Genmab, MediLink, OncoC4, Pfizer and Regeneron. For more information, please visit www.BioNTech.com . 1 Vaccines and Related Biological Products Advisory Committee June 5, 2024 Meeting Presentation- Pfizer/BioNTech Clinical and Preclinical Supportive Data 2024-2025 COVID19 Vaccine Formula. https://www.fda.gov/media/179144/download. Accessed 23 August 2024 . SOURCE: BioNTech