Biontech vaccine Is this information helpful to you? Nov 4, 2025 · Two types of COVID-19 vaccines are recommended for use in the United States: mRNA vaccines (Moderna and Pfizer-BioNTech) and a protein subunit vaccine (Novavax). 4 days ago · Pfizer and BioNTech have a phase 3 mishap with their combined COVID-19 and influenza vaccine, handing Moderna an advantage. The company utilizes technology platforms including mRNA -based therapies, targeted therapies, and Dec 10, 2020 · Safety over a median of 2 months was similar to that of other viral vaccines. Dec 18, 2023 · Set-up of first BioNTainer as high-tech manufacturing solution for mRNA medicines is a critical step in establishing a resilient vaccine ecosystem in Africa and future pandemic preparedness BioNTech plans to complete all buildings at the Kigali site and start local training of specialized personnel May 22, 2025 · KP. mRNA technology, used by mRNA COVID-19 vaccines including COMIRNATY, has the potential to streamline vaccine development. Aug 26, 2024 · BioNTech has announced the initiation of global clinical trials for BNT116, an mRNA vaccine for the potential treatment of non-small cell lung cancer (NSCLC). Explore BioNTech's global site network and subsidiaries, integrating capabilities from discovery to delivery to pioneer novel immunotherapies and vaccines. Nov 10, 2020 · He reiterated that BioNTech and Pfizer plan to ask the US Food and Drug Administration to authorize emergency use of the vaccine, with that request coming perhaps as early as next week. For FDA approval, Pfizer and BioNTech Information about reactions and adverse events reported by recipients of the Pfizer-BioNTech COVID-19 Vaccine May 2, 2023 · Vaccine may be stored between 8°C to 25°C (46°F to 77°F) for up to 12 hours prior to first puncture. and the first to be fully approved by the FDA. This shift comes as Pfizer focuses on expanding its pipeline and post-pandemic strategies. What Pfizer-BioNTech/Comirnaty COVID-19 mRNA Vaccine is and what it is used for Pfizer-BioNTech/Comirnaty COVID-19 mRNA Vaccine is a vaccine used for preventing COVID-19 caused by SARS-CoV-2. Balachandran, Director of The Olayan Center for Cancer Vaccines at MSK, explains how this new approach is being developed aiming to treat one of the deadliest cancers. Mar 26, 2021 · MAINZ, GERMANY, March 26, 2021 (GLOBE NEWSWIRE) — BioNTech SE today announced that the European Medicines Agency (EMA) approved the manufacturing of the COVID-19 vaccine drug product at the facility in Marburg. 5 Booster Dose With Pfizer-BioNTech COVID-19 Vaccine, Bivalent – Immunogenicity of a Second Booster Dose in Individuals 12 Years of Age and Older Myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) have occurred in some people who have received mRNA COVID-19 vaccines, including COMIRNATY and Pfizer-BioNTech COVID-19 vaccines. Spikevax. The German company BioNTech partnered with Pfizer to develop and test a coronavirus vaccine known as BNT162b2, the generic name tozinameran or the brand name Comirnaty. Mar 20, 2025 · The emergence of the novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and the subsequent coronavirus disease 2019 (COVID-19) pandemic with the continuous evolution of the virus into variants such as Alpha, Beta, Delta, Omicron and others necessitates an on-going surveillance and evaluation of vaccine effectiveness (VE). This Editorial aims to present an update on the first COVID-19 vaccine to receive full regulatory approval, the Pfizer-BioNTech vaccine, and the implications for real-world public health during the global COVID-19 pandemic and increasing concerns for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants of concern. This study focuses on assessing the real-world Dec 27, 2024 · The logo of BioNTech is pictured at Biontech's research laboratory for individualised vaccines against cancer in Mainz, Germany, July 27, 2023. 01. Single-Dose Prefilled Syringe for Individuals 65 Years of Age and Older and Individuals 12 Years Through 64 Years of Age with at Least One Underlying medication page for patients to search for scientific information Jul 14, 2025 · The Pfizer-BioNTech COVID-19 vaccine 2024-2025 Formula is an mRNA COVID-19 vaccine that may help your child develop immunity to SARS-CoV-2, the virus that causes COVID-19. This Sep 25, 2025 · COMIRNATY is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID 19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). hin]; born 19 September 1965 [2]) is a German medical researcher, entrepreneur, and businessman. (Funded by BioNTech and Pfizer; ClinicalTrials. Using a digital data logger (DDL), check and record the temperature daily using one of the options below. 4 days ago · Pfizer is looking to sell its remaining stake in Covid-19 vaccine partner BioNTech. It is not an FDA-approved vaccine. Each vaccine also is approved for younger people with a health condition that raises the risk of serious COVID-19 illness. The WHO’s Emergency Use Listing (EUL) opens the door for countries to expedite their own regulatory approval processes to import and administer the vaccine. § Moderate to severe/critical COVID-19 is defined as PCR-positive (with or without Feb 16, 2022 · 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. In particular cases BioNTech's collaborators are leading specific clinical trials and are acting as Aug 16, 2024 · The companies are evaluating adjustments to the combination vaccine candidate aimed at improving immune responses against influenza B and will discuss next steps with health authorities. Dec 2, 2020 · This constitutes the first Emergency Use Authorization following a worldwide Phase 3 trial of a vaccine to help fight the pandemic. The Pfizer and BioNTech teams came together in a race against the virus, working to design, test, manufacture, Nov 22, 2024 · Learn about the side effects of Pfizer-BioNTech COVID-19 Vaccine (COVID-19 mRNA (Pfizer) vaccine), from common to rare, for consumers and healthcare professionals. The study will evaluate the safety, tolerability, and immunogenicity of 3 different Dec 31, 2020 · The World Health Organization (WHO) today listed the Comirnaty COVID-19 mRNA vaccine for emergency use, making the Pfizer/BioNTech vaccine the first to receive emergency validation from WHO since the outbreak began a year ago. COMIRNATY and the Interim Order authorized Pfizer-BioNTech COVID-19 Vaccine, for use in individuals 12 years of age and older, have the same formulation and can be used interchangeably to provide the COVID-19 vaccination series. 1) for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and older. Oct 21, 2025 · Find out how the COVID-19 vaccines work, how many doses are needed, possible side effects and who shouldn't get the vaccine. During storage, minimize exposure to room light, and avoid exposure to direct sunlight and ultraviolet light. He is the co-founder and CEO of BioNTech, which developed the world’s first mRNA-based vaccine against COVID-19. A clinical trial May 23, 2023 · A personalized mRNA vaccine against pancreatic cancer created a strong anti-tumor immune response in half the participants in a small study. Mar 5, 2025 · The phase 1/2a trial of BioNTech's BNT165e vaccine, involving nearly 180 participants, faces delays as global malaria control efforts struggle with funding and political uncertainties. The study consists of 2 parts: Phase 1: to identify preferred vaccine candidate (s) and dose level (s); Phase 2/3: an expanded cohort and efficacy part. Read this Fact Sheet for information about the Pfizer-BioNTech COVID-19 Vaccine. inactive) for the Pfizer‑BioNTech COVID‑19 vaccine (Comirnaty); official CDC and Pfizer materials in the dataset discuss approvals, formulations, and effectiveness but do not enumerate ingredients in these snippets [1] [2]. Food and Drug Administration (FDA). 1. 2. 1, continued effectiveness and favorable benefit-risk profile consistent with original vaccine The sponsor of a clinical trial is the company, institution or individual that takes responsibility for initiating, managing, and/or financing a clinical investigation. 1-adapted monovalent COVID-19 vaccine (COMIRNATY ® LP. to help provide protection during the COVID-19 public health emergency, based on initial data from the pivotal Phase 3 clinical trial. The adaptation is Oct 21, 2025 · The 2025-2026 COVID-19 vaccines available in the United States include Moderna, Pfizer-BioNTech and Novavax. Dec 27, 2024 · BioNTech reached settlements with the U. Nov 14, 2025 · Pfizer Inc has significantly reduced its stake in BioNTech SE, more than five years after the two companies developed the successful COVID-19 vaccine. Britain's medicines regulator, the MHRA, says the jab Authorization of Pfizer-BioNTech COVID-19 Vaccine for emergency use in individuals 6 months through 11 years of age to include the 2023-2024 formula. 2. 500 Arcola Road Collegeville, PA 19426 NOTIFICATION SAFETY LABELING CHANGE April 17, 2025 Nov 3, 2022 · Pfizer and BioNTech Initiate Phase 1 Study of Single Dose mRNA-Based Combination Vaccine Candidate for Influenza and COVID-19 16 hours ago · Executive summary Public, provided sources in this search set do not list a complete ingredient breakdown (active vs. 2 billion Pfizer-BioNTech doses have been delivered to more than 120 countries or territories around Visit the website to locate COVID-19 vaccine options including Comirnaty by BioNTech and Pfizer near you. National Institutes of Health and the University of Pennyslvania over royalties related to its Covid-19 vaccine. ). The primary study will evaluate the safety, tolerability, and immunogenicity of the SARS-CoV-2 RNA vaccine candidate (BNT162b2): * As a 30-microgram dose, administered from 1 of 4 manufacturing lots (batches) * As a 20-microgram dose, administered from 1 of the manufacturing lots * As a 2-dose (separated by 21 days Schedule your COVID-19 vaccine at CVS Pharmacy. Mar 5, 2025 · Find patient medical information for Comirnaty (mRNA COVID-19 vaccine) on WebMD including its uses, side effects and safety, interactions, pictures, warnings, and user ratings Oct 24, 2024 · The new shots — one from Moderna, another from Pfizer/BioNTech and a third from Novavax — are available at pharmacies and doctors’ offices across the country, and infectious disease experts hope the reformulated vaccines will help to keep cases from swelling this fall and winter. Nov 4, 2025 · For children ages 6 months–4 years, only Moderna (Spikevax) COVID-19 Vaccine is approved for use; Pfizer-BioNTech COVID-19 Vaccine is no longer authorized for this age group. Each vaccine is also approved for younger people with a health condition that raises the risk of serious COVID-19 illness. The Pfizer–BioNTech COVID-19 vaccine, sold under the brand name Comirnaty, [2][37] is an mRNA-based COVID-19 vaccine developed by the German biotechnology company BioNTech. Explore BioNTech's unique pipeline of innovative therapies and vaccines, including mRNA cancer immunotherapies, next-generation immunomodulators, targeted therapies and infectious disease vaccines. Refer to the protocol-specific pharmacy manual for quantities of initial and subsequent Aug 23, 2021 · COMIRNATY is the first COVID-19 vaccine to be granted FDA approval Approval is based on a comprehensive submission package including six-month efficacy and safety data after second dose More than 1. 5 sublineage and indicated as a single dose for most individuals 5 years of age and older Pre-clinical data show that the updated COVID-19 vaccine generates improved neutralizing antibody responses against multiple circulating Aug 16, 2024 · 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 Feb 19, 2025 · The Story of the mRNA Cancer Vaccine Study in Pancreatic Cancer Here, Dr. The vaccine has now been granted a conditional marketing authorization, emergency use authorization or temporary authorization in a total of more than 60 countries. This is a Phase 3, randomized, observer-blind study in healthy individuals. But crumbling support for cancer and mRNA vaccine research has endangered this promising therapy At BioNTech, we believe that the immune system is the key to addressing cancer, infectious diseases, and other serious diseases. Jul 25, 2025 · (Nasdaq: BNTX, “BioNTech”) announced today that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorization for the companies’ LP. May 29, 2024 · BioNTech and CEPI aim to enhance local R&D, clinical and commercial-scale manufacturing capacities to develop potential mRNA vaccines in Africa, for Africa CEPI to fund up to $145 million to support BioNTech in broadening the scope of the manufacturing facility in Kigali, Rwanda, aimed at 6 days ago · Vaccines based on mRNA can be tailored to target a cancer patient’s unique tumor mutations. For FDA approval, Pfizer and BioNTech May 2, 2023 · Vaccine may be stored between 8°C to 25°C (46°F to 77°F) for up to 12 hours prior to first puncture. Jul 27, 2022 · Pfizer and BioNTech Advance COVID-19 Vaccine Strategy With Study Start of Next-Generation Vaccine Candidate Based on Enhanced Spike Protein Design The Centers for Disease Control and Prevention (CDC) is issuing Emergency Use Instructions (EUI) to provide information about the use of the 2024-2025 Formula1 COVID-19 vaccine, by Pfizer-BioNTech (Comirnaty2), which is approved (licensed) by the Food and Drug Administration (FDA) for the prevention of COVID-19 in individuals ages 12 years and older. COMIRNATY is Jul 14, 2025 · The Pfizer-BioNTech COVID-19 vaccine 2024-2025 Formula is an mRNA COVID-19 vaccine that may help your child develop immunity to SARS-CoV-2, the virus that causes COVID-19. PEG is a primary ingredient in osmotic laxatives and oral bowel preparations for colonoscopy procedures, an inactive ingredient or excipient in additional medications (including some injectable contraceptives and steroids), and is used in a process called pegylation to improve the therapeutic The FDA amended the EUAs of the Moderna and Pfizer-BioNTech COVID-19 bivalent mRNA vaccines to simplify the vaccination schedule for most individuals. Pfizer and BioNTech are anticipating further regulatory decisions across the globe in the coming days and weeks and are ready to deliver vaccine doses following potential regulatory authorizations or approvals. This allows for a timely response to FDA-recommended updates to the vaccine for emerging strains of the virus that causes COVID-19. Update on Phase 3 Pfizer and BioNTech Combination Vaccine Trial The Phase 3 randomized, observer-blinded study ( NCT06178991 Mar 11, 2021 · The Pfizer-BioNTech COVID-19 Vaccine, which is based on BioNTech proprietary mRNA technology, was developed by both BioNTech and Pfizer. Apr 28, 2021 · The Pfizer-BioNTech vaccine was the first mRNA vaccine to be authorized for emergency use in people. Today, the CDC recommends five COVID-19 vaccines: four mRNA: two from Moderna and two from COMIRNATY ® (COVID‑19 Vaccine, mRNA) IMPORTANT SAFETY INFORMATION You or your child should NOT get COMIRNATY ® (COVID-19 Vaccine, mRNA) if you or your child had a severe allergic reaction after a previous dose of COMIRNATY or any Pfizer-BioNTech COVID-19 vaccine or to any ingredient in these vaccines There is a remote chance that COMIRNATY could cause a severe allergic reaction. Dec 2, 2020 · The UK has become the first country in the world to approve the Pfizer/BioNTech coronavirus vaccine, paving the way for mass vaccination. Moderna COVID-19 vaccine 2025-2026 formulas. COMIRNATY® (COVID-19 Vaccine, mRNA) (2025-2026 Formula) Description 11 DESCRIPTION COMIRNATY (COVID-19 Vaccine, mRNA) is a sterile injectable suspension for intramuscular use. Aug 29, 2024 · BioNTech is also trialling a personalised melanoma vaccine to be delivered alongside Keytruda but is developing another melanoma jab to be used with a checkpoint inhibitor developed by Regeneron. Save this record for 3 years, unless your state/local jurisdiction requires a longer time period. It all began with discoveries in his lab about pancreatic cancer and a global collaboration with Genentech and BioNTech in the middle of the COVID-19 BioNTech SE (/ biːˈɒntɛk / bee-ON-tek; or / baɪˈɒntɛk / bye-ON-tek[3] short for Biopharmaceutical New Technologies) is a German multinational biotechnology company headquartered in Mainz that develops immunotherapies and vaccines, particularly for cancer and infectious diseases. Uğur Şahin (Turkish: [uˈuɾ ʃaː. STORAGE AND HANDLING Pfizer-BioNTech Bivalent COVID-19 Vaccine with gray caps and gray label borders will be shipped to sites frozen at ultra-cold conditions in thermal containers with dry ice. Aug 22, 2024 · The Pfizer-BioNTech COVID-19 Vaccine is not an FDA-approved vaccine in the United States. Apr 9, 2020 · BioNTech and Pfizer will work together to scale-up manufacturing capacity at risk to provide worldwide supply in response to the pandemic. Nov 10, 2020 · The German company BioNTech, founded by two scientists, has teamed up with Pfizer on a vaccine that was found to be more than 90 percent effective. New York, NY 10001 COVID-19 vaccines from BioNTech and Pfizer, which are based on BioNTech proprietary mRNA technology, were developed by both BioNTech and Pfizer. Jun 5, 2022 · 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. The Pfizer-BioNTech COVID-19 vaccine has been granted Emergency Use Authorization (EUA) for children aged 6 months through 11 years. It relies on the power of nucleic acids found in genetic material, but not the DNA that is uniquely yours. DSpace - World Health Organization DSpace Sep 11, 2023 · This season’s vaccine is tailored to the SARS-CoV-2 XBB. WHAT IS COVID-19? Aug 18, 2022 · This article provides a summary of the interim recommendations for the use of the Pfizer BioNTech (BNT162b2) vaccine against COVID-19 issued by WHO Strategic Advisory Group of Experts on Immunization (SAGE). Nov 13, 2025 · BioNTech (BNTX) stock slips as Pfizer (PFE) plans to sell its remaining stake in the COVID-19 vaccine developer in a transaction worth up to $508M. The EUA permitted essential rollout of vaccine doses across the U. Sep 18, 2023 · BioNTech is initiating a Phase 1/2 clinical trial of the mRNA-based mpox vaccine program, BNT166 The Coalition for Epidemic Preparedness Innovations (CEPI) commits funding of up to $90 million for the development of vaccine candidates Data generated by this partnership will contribute to CEPI’s 100 Dec 31, 2020 · A two-dose regimen of BNT162b2 conferred 95% protection against Covid-19 in persons 16 years of age or older. COMIRNATY (COVID-19 Vaccine, mRNA) is an FDA-approved COVID-19 vaccine made by Pfizer for BioNTech that is indicated for active immunization to prevent COVID-19 in individuals 12 years of age and older. The CDC-issued EUI provide information for . Have the good days finally come to an end? Nov 13, 2025 · Pfizer plans to sell its remaining BioNTech stake through a $508 million block trade, ending a profitable Covid-19 vaccine partnership. BioNTech and Pfizer will also work jointly to commercialize the vaccine worldwide (excluding China, which is already covered by BioNTech’s collaboration with Fosun Pharma) upon regulatory approval. ) Apr 19, 2024 · The Pfizer/BioNTech vaccine is the first COVID-19 vaccine authorized for use in the U. Apr 19, 2021 · In this Snapshot feature, we look at the possible side effects of the Pfizer-BioNTech COVID-19 vaccine, and whether they warrant precaution. Sep 25, 2025 · COMIRNATY is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID 19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). S. As part of the process, EMA has approved the production of the drug substance, the Manufactured for BioNTech Manufacturing GmbH An der Goldgrube 12 55131 Mainz, Germany Marketing Authorization Holder Manufactured by Pfizer Inc. The FDA amended the emergency use authorization (EUA) of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent to provide for a single booster dose in children 6 months through 4 years of age at least 2 Pfizer and BioNTech today announced that two of the companies’ four investigational vaccine candidates from their BNT162 mRNA-based vaccine program (BNT162b1 and BNT162b2) being developed to help protect against SARS-CoV-2 (the virus that causes COVID-19), received Fast Track designation from the U. As immune engineers, we leverage our deep understanding of the human immune system to develop therapies and vaccines that aim to significantly improve standards of care or establish new ones for people worldwide. Temperature Log for Ultra-Cold Vaccine Storage (Celsius) Days 16–31 Store COVID-19 vaccine (Pfizer) between -90°C and -60°C. It also Nov 9, 2020 · Pfizer and BioNTech Announce Vaccine Candidate Against COVID-19 Achieved Success in First Interim Analysis from Phase 3 Study Study Overview Brief Summary This is a Phase 1/2/3, randomized, placebo-controlled, observer-blind, dose-finding, vaccine candidate-selection, and efficacy study in healthy individuals. Jul 12, 2023 · Moderna, BioNTech and others hope that personalized cancer vaccines will soon live up to their potential — even as they work out the wrinkles for the best use of their platform technologies. Moderna, Pfizer-BioNTech and Novavax vaccines are available. Dec 22, 2021 · 1. Pfizer BioNTech COVID-19 Vaccine is authorized for use under an EUA for active immunization for the prevention of COVID-19 caused by SARS-CoV-2 in individuals 16 years of age and older. Feb 16, 2022 · 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. Mar 11, 2021 · The Pfizer-BioNTech COVID-19 Vaccine, which is based on BioNTech proprietary mRNA technology, was developed by both BioNTech and Pfizer. Novavax COVID-19 Vaccine, approved for people ages 12 years and older, is administered as a single dose for initial vaccination. 2 vaccine demonstrates cross-reactive clinical response to LP. But crumbling support for cancer and mRNA vaccine research has endangered this promising therapy Mar 4, 2025 · The FDA has placed a hold on BioNTech’s phase 1/2a trial, pausing the company’s efforts to develop a RNA-based vaccine for malaria prevention. Note: Both the Pfizer-BioNTech and Moderna COVID-19 vaccines contain polyethylene glycol (PEG). The vaccine is claimed to use the same mRNA technology that proved instrumental in Covid-19 vaccines. Here's what is known about how long it will work to offer immunity. 20 Nov 14, 2025 · Pfizer sell 508M stake in BioNTech through an overnight block trade, marking its exit from the COVID-19 vaccine partner's equity. gov number, NCT04368728. Read more here. Centers for Disease Control and Prevention | CDC Nov 3, 2022 · Pfizer and BioNTech Initiate Phase 1 Study of Single Dose mRNA-Based Combination Vaccine Candidate for Influenza and COVID-19 16 hours ago · Executive summary Public, provided sources in this search set do not list a complete ingredient breakdown (active vs. under Emergency Use Authorization (EUA) since December 11, 2020 (as the Pfizer-BioNTech COVID-19 Vaccine). Oct 24, 2025 · The 2025-2026 COVID-19 vaccines available in the United States include Moderna, Pfizer-BioNTech and Novavax. May 10, 2023 · A phase I clinical trial of an adjuvant personalized mRNA neoantigen vaccine, autogene cevumeran, in patients with pancreatic ductal carcinoma demonstrates that the vaccine can induce T cell Oct 11, 2023 · During the COVID-19 pandemic, Pfizer-BioNTech and Moderna successfully developed nucleoside-modified mRNA lipid nanoparticle (LNP) vaccines. 8. Analytical scientists repeatedly test the filtered mRNA to verify its purity and confirm the Mar 5, 2025 · Find patient medical information for Comirnaty (mRNA COVID-19 vaccine) on WebMD including its uses, side effects and safety, interactions, pictures, warnings, and user ratings Centers for Disease Control and Prevention | CDC Jan 11, 2021 · MS onset and severity were lesser in mice treated with the mRNA, non-inflammatory vaccine, without signs of overall immune suppression. BioNTech collaborates with other pharmaceutical companies or institutions (collaborators) to develop certain new medicines. Updated for 2024-2025 to cover Omicron KP. It is approved for use as a 2-dose primary series for the prevention of COVID-19 in individuals 12 years of age and older. The updated mRNA COVID-19 vaccines include Comirnaty and Spikevax, both of which are approved for individuals 12 years of age and older, and the Moderna COVID-19 Vaccine and Pfizer-BioNTech COVID Nov 13, 2025 · Pfizer Inc said on Thursday it sold a part of its stake in German drugmaker BioNTech SE , more than five years after both firms formed an alliance that yielded a vaccine to combat the deadly COVID Feb 27, 2024 · The Vaccine study confirmed that the Moderna and Pfizer/BioNTech vaccines are linked in rare cases to myocarditis and pericarditis, conditions involving inflammation of the heart muscle and lining. BioNTech was the regulatory sponsor of the trial and contributed to data interpretation and writing of the manuscript. Dec 21, 2022 · First-in-human study aims to evaluate the safety and immunogenicity of prophylactic herpes virus vaccine candidate BNT163 BNT163 is the first candidate from BioNTech’s infectious disease mRNA vaccine collaboration with the University of Pennsylvania to enter the clinic The program is part of COVID-19 Vaccine, mRNA, Bivalent (Pfizer-BioNTech): learn about side effects, dosage, special precautions, and more on MedlinePlus COVID-19 vaccines from BioNTech and Pfizer, which are based on BioNTech proprietary mRNA technology, were developed by both BioNTech and Pfizer. At the outset of the coronavirus disease 2019 (COVID-19) pandemic, it was clear that a vaccine would be crucial for global health efforts. May 21, 2025 · Our STN: BL 125742/641 BioNTech Manufacturing GmbH Attention: Heather Hufnagel, MS Pfizer Inc. No cost with most insurance. Information on the Pfizer-BioNTech COVID-19 vaccine including ingredients, how it works, how it's given, possible side effects and vaccine safety after authorization. Before that, it was the first COVID vaccine to receive FDA Emergency Use Authorization (EUA) back in December 2020, after the company reported that its vaccine was highly effective at preventing symptomatic disease. May 20, 2025 · Pfizer-BioNTech The Pfizer-BioNTech vaccine (brand name: Comirnaty) was granted full Food and Drug Administration (FDA) approval in August 2021 for people ages 16 and older. May 27, 2021 · Both Pfizer and BioNTech manufactured the vaccine and placebo. This is a Phase 1/2/3, randomized, placebo-controlled, observer-blind, dose-finding, vaccine candidate-selection, and efficacy study in healthy individuals. 07. [3][4] He also serves as chairman of the scientific management board of the Helmholtz Institute for Translational Oncology [de] (HI-TRON), a Mainz May 29, 2024 · BioNTech and CEPI aim to enhance local R&D, clinical and commercial-scale manufacturing capacities to develop potential mRNA vaccines in Africa, for Africa CEPI to fund up to $145 million to support BioNTech in broadening the scope of the manufacturing facility in Kigali, Rwanda, aimed at 6 days ago · Vaccines based on mRNA can be tailored to target a cancer patient’s unique tumor mutations. Restrictions apply. SARS-CoV-2 spike protein expressed by those vaccines Oct 20, 2025 · Pfizer-BioNTech Vaccine Pfizer-BioNTech is an mRNA vaccine, based on a newer approach to making vaccines. Dec 3, 2024 · Background: BNT162b2 RNA-based COVID-19 injections are specified to transfect human cells to efficiently produce spike proteins for an immune response. Safety over a median of 2 months was similar to that of other viral vaccines. 14. Aug 27, 2025 · The FDA approval is based on the cumulative body of evidence supporting the safety and efficacy of the Pfizer-BioNTech COVID-19 vaccine, including clinical trial data supporting the approval for children 5 through 11 years of age. Dec 11, 2020 · The vaccine has been available in the U. A severe 5 days ago · People who are up to date with their COVID-19 vaccine have lower risk of severe illness. Do NOT refreeze thawed vaccine Store vials upright in the tray or box protected from light Track this 12-hour beyond-use time. May 29, 2025 · In 2023, the Food and Drug Administration (FDA) authorized a protein subunit vaccine called Novavax. Jul 23, 2024 · Draft recommendation (text) The Pfizer-BioNTech COVID-19 vaccine is recommended for people 16 years of age and older under FDA’s Biologics License Application (BLA) *Overall efficacy was calculated at ≥7 days after second dose of vaccine among persons without evidence of prior SARS-CoV-2 infection. The vaccines are all approved for people age 65 and older.