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    BioNTech

    Also known as BioNTech SE, BNTX

    BioNTech is a German immunotherapy company that developed the Comirnaty COVID-19 vaccine with Pfizer and now concentrates on cancer, including individualized mRNA vaccines.[1][2] It agreed to acquire mRNA rival CureVac, and the exchange offer met its closing conditions in December 2025.[3]

    Editor reviewedStrict sourcingUpdated mRNA and next-gen vaccinesHealth and medicineLife sciences
    Key facts

    BioNTech is an immunotherapy company headquartered in Mainz, Germany.[2] With Pfizer it is the applicant for Comirnaty, the mRNA COVID-19 vaccine also known as BNT162b2.[1][4] It matters because its vaccine was one of the first two authorized mRNA COVID-19 vaccines, and it now runs more than 25 phase 2 and 3 oncology trials.[2][5]

    Platform background

    BioNTech’s COVID-19 vaccine rests on the same two advances as other mRNA vaccines. The first is nucleoside-modified mRNA, which reduces innate immune activation.[6] Karikó and Weissman won the 2023 Nobel Prize in Physiology or Medicine for that work.[7] The second is the four-component lipid nanoparticle used for delivery.[8] Because mRNA is made by in vitro transcription, the same process can in principle be adapted quickly to new sequences. This includes the patient-specific sequences used in individualized cancer vaccines.[9][10]

    Focus areas

    BioNTech describes its work as mRNA cancer immunotherapies, next-generation immunomodulators, antibody-drug conjugates and CAR-T cell therapies. It also develops mRNA vaccine candidates for infectious diseases.[2] It says it runs more than 25 phase 2 and phase 3 oncology trials.[5] Its infectious-disease vaccine work therefore sits alongside a pipeline weighted towards cancer.[2][5]

    Personalised cancer vaccines

    Its individualized mRNA vaccine, autogene cevumeran, is in a phase 2 trial sponsored by Genentech, with BioNTech as collaborator. The trial enrolls about 260 patients with resected pancreatic ductal adenocarcinoma. It tests the vaccine with atezolizumab and mFOLFIRINOX chemotherapy against chemotherapy alone, with disease-free survival as the primary outcome.[11] A competing programme is Moderna and Merck’s intismeran-autogene, which reported positive phase 3 melanoma results in August 2026.[12] Both encode tumour-specific neoantigens in mRNA, an approach described in personalized-neoantigen-vaccines and how cancer vaccines work. Each intismeran dose, for comparison, encodes up to 34 neoantigens chosen from the patient’s tumour sequence.[10]

    CureVac acquisition

    BioNTech agreed to acquire CureVac, another German mRNA developer, in an exchange offer. On 3 December 2025 it announced that about 81.74% of CureVac shares had been tendered and that all closing conditions had been satisfied.[3]

    COVID-19 vaccine in 2025-2026

    The FDA’s first approval letter for Comirnaty is dated 23 August 2021.[13] In August 2025 the FDA approved an updated Comirnaty but limited the label. It now covers people 65 and older and people aged 5-64 with at least one high-risk condition.[1] As a condition, the companies agreed to a placebo-controlled trial in healthy adults aged 50-64.[14] In September 2025 the reconstituted ACIP moved COVID-19 vaccination to individual-based decision-making. A federal court stayed that committee’s votes in March 2026.[15][16] The reasons for and against that approach are covered in the US mRNA policy debate. BioNTech’s main mRNA competitor is Moderna.[4]

    For the 2026-2027 season the FDA advised manufacturers to make monovalent vaccines against the JN.1-lineage XFG variant, after its advisory committee met on 28 May 2026.[17] It approved the 2026-2027 formula of Comirnaty on 27 August 2026, together with updated vaccines from Moderna and Novavax.[18] The eligible groups did not change: everyone 65 and older, and people aged 5-64 with at least one high-risk condition.[19]

    This page describes company activities and regulatory status. It is not medical advice.

    Questions readers ask

    What does BioNTech work on besides COVID-19 vaccines?

    It describes its focus as mRNA cancer immunotherapies, antibody-drug conjugates, CAR-T cell therapies and mRNA vaccines for infectious diseases. It runs more than 25 phase 2 and 3 oncology trials.[2][5]

    Did BioNTech buy CureVac?

    On 3 December 2025 BioNTech said about 81.74% of CureVac shares had been tendered and all closing conditions had been satisfied.[3]

    Who can get the Pfizer-BioNTech COVID-19 vaccine in the US?

    Since August 2025 the FDA label covers people 65 and older and people aged 5-64 with at least one condition that puts them at high risk of severe COVID-19.[1]

    Was Comirnaty updated for 2026-2027?

    Yes. On 27 August 2026 the FDA approved a 2026-2027 formula targeting the XFG variant. The label still covers people 65 and older and people aged 5-64 with at least one high-risk condition.[18][19]

    Sources

    Each numbered claim is a statement we checked against the sources listed with it. Status shows how well established it is.

    1. [1]

      In August 2025 the FDA limited the approved use of Pfizer-BioNTech's Comirnaty to people 65 and older and younger people with at least one condition that puts them at high risk of severe COVID-19. confirmedas of 2025-08-25

    2. [2]

      BioNTech, headquartered in Mainz, Germany, focuses on mRNA cancer immunotherapies, antibody-drug conjugates, CAR-T cell therapies and mRNA vaccines for infectious diseases. confirmedas of 2026-10-10

    3. [3]

      On 3 December 2025 BioNTech announced that about 81.74% of CureVac shares had been tendered in its exchange offer and that all closing conditions for the acquisition had been satisfied. confirmedas of 2025-12-03

    4. [4]

      The first authorized mRNA COVID-19 vaccines, Pfizer-BioNTech's BNT162b2 and Moderna's mRNA-1273, both encode the SARS-CoV-2 spike protein and are formulated in lipid nanoparticles. confirmedas of 2023-03-01

    5. [5]

      BioNTech says it runs more than 25 phase 2 and phase 3 clinical trials in oncology. confirmedas of 2026-10-10

    6. [6]

      Chemically modified nucleosides in synthetic mRNA partially suppress recognition of double-stranded RNA and reduce type I interferon signalling, an innate immune alarm response. confirmedas of 2018-01-12

    7. [7]

      The 2023 Nobel Prize in Physiology or Medicine was awarded to Katalin Karikó and Drew Weissman for discoveries on nucleoside base modifications that enabled effective mRNA vaccines against COVID-19. confirmedas of 2023-10-02

    8. [8]

      Lipid nanoparticles used for mRNA delivery usually contain four components, an ionizable lipid, a PEG-linked lipid, cholesterol and a phospholipid (helper lipid). confirmedas of 2023-03-01

    9. [9]

      mRNA vaccines can potentially be manufactured rapidly, cheaply and at scale, mainly because in vitro transcription reactions give high yields. confirmedas of 2018-01-12

    10. [10]

      Each intismeran dose is a synthetic mRNA encoding up to 34 neoantigens chosen from the mutations in that patient's own tumour. confirmedas of 2026-08-19

    11. [11]

      BioNTech's individualized mRNA cancer vaccine autogene cevumeran is being tested with Genentech in a phase 2 trial of about 260 patients with resected pancreatic cancer, with disease-free survival as the primary outcome. confirmedas of 2026-10-10

    12. [12]

      On 19 August 2026 Merck and Moderna reported that the phase 3 INTerpath-001 trial of intismeran autogene plus pembrolizumab met its primary endpoint of recurrence-free survival and key secondary endpoint of distant metastasis-free survival in resected high-risk melanoma. confirmedas of 2026-08-19

    13. [13]

      The FDA's first approval letter for Comirnaty, the Pfizer-BioNTech COVID-19 vaccine, is dated 23 August 2021. confirmedas of 2026-08-27

    14. [14]

      Under the FDA framework, approval for healthy people requires randomized trials measuring clinical outcomes; Pfizer-BioNTech agreed to a saline placebo-controlled trial in healthy adults aged 50-64. confirmedas of 2025-08-25

    15. [15]

      On 19 September 2025 ACIP voted to recommend COVID-19 vaccination based on individual-based (shared clinical) decision-making for people 6 months and older, and rejected a proposal to require prescriptions. confirmedas of 2025-09-19

    16. [16]

      On 16 March 2026 a federal district court in Massachusetts, in American Academy of Pediatrics v. Kennedy, stayed the 13 ACIP appointments and all votes of the reconstituted committee since June 2025. confirmedas of 2026-03-17

    17. [17]

      After its vaccine advisory committee met on 28 May 2026, the FDA advised manufacturers that 2026-2027 COVID-19 vaccines for the US should be monovalent vaccines targeting the JN.1-lineage XFG variant. confirmedas of 2026-05-29

    18. [18]

      On 27 August 2026 the FDA approved 2026-2027 formula versions of the mRNA vaccines Comirnaty, Spikevax and mNEXSPIKE, which target the XFG variant; Novavax's protein-based Nuvaxovid was also approved for the season. confirmedas of 2026-08-27

    19. [19]

      The 2026-2027 approvals kept the narrower US eligibility set in 2025, covering everyone 65 and older plus younger people with at least one high-risk condition, from age 5 for Comirnaty, 6 months for Spikevax and 12 for mNEXSPIKE. confirmedas of 2026-08-28

    Revision history (2)
    1. Page created.
    2. Added Comirnaty's approval history and the August 2026 approval of the 2026-2027 formula.

    Created Oct 10, 2026. Last reviewed by an editor on Oct 10, 2026. Next scheduled review: Jan 10, 2027.

    Cite this page

    "BioNTech." ContentLora, updated Oct 10, 2026. https://contentlora.com/wiki/biontech

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