Moderna, Inc.
22.6.2022 14:03:42 CEST | ACCESS Newswire | Press release
mRNA-1273.214 Exhibited a Greater Than 5-Fold Boost in Neutralizing Antibodies Against BA.4 and BA.5 Subvariants in Phase 2/3 Study
Data Being Submitted to Regulators and for Peer Reviewed Publication
CAMBRIDGE, MA / ACCESSWIRE / June 22, 2022 / Moderna, Inc., (NASDAQ:MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced new clinical data on its bivalent (Omicron) COVID booster candidate, mRNA-1273.214. One month after administration in previously vaccinated and boosted participants, a 50 µg booster dose of mRNA-1273.214 elicited potent neutralizing antibody responses against the Omicron subvariants BA.4 and BA.5 in all participants regardless of prior infection. Based on this and prior data, the Company is working to complete regulatory submissions in the coming weeks requesting to update the composition of the booster vaccine to mRNA-1273.214.
In today's data, mRNA-1273.214 boosted neutralizing titers against BA.4/BA.5 by 5.4-fold (95% CI: 5.0, 5.9) above baseline in all participants regardless of prior infection, and by 6.3-fold (95% CI: 5.7, 6.9) in the subset of seronegative participants. Neutralizing titers against BA.4/BA.5 were approximately 3-fold lower than previously reported neutralizing titers against BA.1. One month after an mRNA-1273.214 booster, neutralizing geometric mean titers (GMT) against BA.4/BA.5 were 941 (95% CI: 826, 1071) in all participants, and 727 (95% CI: 633, 836) in seronegative participants. For context, prior studies of a third dose of the prototype booster induced neutralizing GMT against BA.1 of 629 (95% CI: 526, 751) and against Delta of 828 (95% CI: 738, 928)[1]. A third dose of the prototype booster was shown to be effective against Delta and BA.1 infection and hospitalization in observational studies [2],[3].
"In the face of SARS-CoV-2's continued evolution, we are very encouraged that mRNA-1273.214, our lead booster candidate for the fall, has shown high neutralizing titers against the BA.4 and BA.5 subvariants, which represent an emergent threat to global public health," said Stéphane Bancel, Chief Executive Officer of Moderna. "We will submit these data to regulators urgently and are preparing to supply our next generation bivalent booster starting in August, ahead of a potential rise in SARS-CoV-2 infections due to Omicron subvariants in the early fall."
Today's data add to results shared earlier this month from the Company's ongoing Phase 2/3 study in approximately 800 participants. Previous results showed a 50 µg booster dose of mRNA-1273.214 met all pre-specified primary endpoints, including superiority in neutralizing antibody GMT against Omicron (BA.1) when compared to a 50 µg booster dose of the prototype booster (mRNA-1273). The bivalent booster was generally well tolerated, with a reactogenicity and safety profile that was consistent with the prototype booster. Moderna believes these data collectively support updating the composition of the Company's booster to bivalent (Omicron) mRNA-1273.214 for the fall.
The Company has already shared these data with regulators and is submitting a manuscript for peer reviewed publication.
About Moderna
In over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna's capabilities have come together to allow the authorized use and approval of one of the earliest and most effective vaccines against the COVID-19 pandemic.
Moderna's mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and auto-immune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past seven years. To learn more, visit www.modernatx.com.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including regarding: the Company's development of a bivalent booster vaccine targeted at the Omicron variant of the SARS-CoV-2 virus (mRNA-1273.214); the ability of mRNA-1273.214 to trigger an antibody response against the Omicron subvariants BA.4 and BA.5; the Company's submission of data to regulators in support of authorization of mRNA-1273.214 as a fall booster; and the safety and tolerability profile of mRNA-1273.214. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna's control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include those other risks and uncertainties described under the heading "Risk Factors" in Moderna's most recent Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) and in subsequent filings made by Moderna with the SEC, which are available on the SEC's website at www.sec.gov. Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna's current expectations and speak only as of the date hereof.
Moderna Contacts
Media:
Chris Ridley
617-800-3651
Vice President, Corporate Communications & Head of Media
Chris.Ridley@modernatx.com
Investors:
Lavina Talukdar
Senior Vice President & Head of Investor Relations
617-209-5834
Lavina.Talukdar@modernatx.com
SOURCE: Moderna, Inc.
View source version on accesswire.com:
https://www.accesswire.com/706099/Moderna-Announces-Bivalent-Booster-mRNA-1273214-Demonstrates-Potent-Neutralizing-Antibody-Response-Against-Omicron-Subvariants-BA4-And-BA5
To view this piece of content from www.accesswire.com, please give your consent at the top of this page.
About ACCESS Newswire
Subscribe to releases from ACCESS Newswire
Subscribe to all the latest releases from ACCESS Newswire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from ACCESS Newswire
Global Anti-Scam Alliance Launches Scam.org with OpenAI and Key Partners12.3.2026 11:00:00 CET | Press release
AI technology meets on-the-ground expertise from leading organizations across five continents, accessible to billions of consumers in 50+ languages covering 97% of global internet users. AMSTERDAM, NL / ACCESS Newswire / March 12, 2026 / The Global Anti-Scam Alliance (GASA) launched today Scam.org, an AI-powered platform that provides scam education, prevention, detection, reporting, and victim support in over 50 languages, making it a new global hub, accessible to 97% of the world's internet users. Scam.org is powered by partnerships with OpenAI and leading cybersecurity organizations, AnyTech365, CUBE AI,Falkin, Malwarebytes, Netcraft, ReasonLabs, ScamAdviser, Scamnetic, Seraph Secure and Spamhaus. For personal victim support, Scam.org collaborates with other victim support organizations such as AARPin the USA and ANVINT in Brazil. The platform expects more organizations to join, with plans to build an even stronger and broader coalition, creating a world where people are safer from
LiberNovo: From Spring Cleaning to Physical Renewal12.3.2026 09:00:00 CET | Press release
HONG KONG, HK / ACCESS Newswire / March 12, 2026 / As the annual ritual of spring cleaning approaches, a new movement in functional design is shifting the focus from tidying desks to restoring the bodies that sit at them. LiberNovo, a pioneer in health-first design, has announced its spring initiative: a fundamental reimagining of the smart workspace that prioritizes physical fluidity over static organization. New Season, New Standards For decades, office chair ergonomics centered on the "90-degree rule"-a rigid posture that modern research suggests is counterproductive. The true culprit of office fatigue isn't just sitting; it is the lack of movement. Prolonged static positions compress the spine and reduce circulation. LiberNovo's philosophy asserts that a "Spring Reset" is incomplete if it only addresses surface-level clutter while leaving the body in a state of constant strain. Engineering Movement At the core of this movement is the LiberNovo Omni, a chair designed to master Dynam
LiberNovo Omni Wins iF DESIGN AWARD 2026 for Breakthrough Ergonomic Design12.3.2026 09:00:00 CET | Press release
HONG KONG, HK / ACCESS Newswire / March 12, 2026 / LiberNovo is proud to announce that its leading product, the LiberNovo Omni, has won the prestigious iF DESIGN AWARD 2026 in the Product Design - Beauty/Wellness category. The iF DESIGN AWARD is one of the most esteemed design competitions in the world, honoring outstanding design achievements in terms of innovation, functionality, and user experience. Developed to revolutionize the experience of sitting for long periods, the LiberNovo Omni is a product that creates a new category of seating solutions: the Dynamic Ergonomic Chair. The chair doesn't lock people into fixed positions; it accommodates natural body positions and movement throughout the day. This award-winning chair features intelligent ergonomic technologies to enhance user comfort, spinal health, and support movement. These include LiberNovo's innovative Dynamic Support, which automatically adjusts to changing postures, and an adjustable ergonomic framework designed to ens
Tenstorrent Unveils TT-QuietBox(TM) 2, the First RISC-V AI Workstation With a Fully Open-Source Stack to Deliver Teraflop-Class Inference11.3.2026 17:00:00 CET | Press release
Liquid-Cooled Desktop System Runs Models up to 120B Parameters Locally With a Fully Open-Source Stack, Starting at $9,999 SANTA CLARA, CA / ACCESS Newswire / March 11, 2026 / Tenstorrent, the AI computing company led by CEO Jim Keller, today announced TT-QuietBox™ 2 (Blackhole™). This whisper-quiet, liquid-cooled AI workstation runs models up to 120 billion parameters directly at your desk, ships with an entirely open-source software stack from compiler to kernel, and starts at $9,999. It marks the industry's first desktop AI workstation built on RISC-V architecture to deliver teraflop-class inference. The Inference Imperative The timing matters. Inference has quietly overtaken training as the dominant AI workload, now accounting for more than 55% of cloud AI infrastructure spending at $37.5 billion - and it is still accelerating. Yet, developers running these workloads face a stark choice: pay per-token cloud fees that compound as usage scales, or buy hardware locked to proprietary st
Clockwork.io Introduces A New Class of Fault Tolerance to End Failure-Driven GPU Waste in AI Training11.3.2026 14:00:00 CET | Press release
New TorchPass solution addresses a multi-million dollar challenge with AI infrastructure; uses Live GPU Migration to keep large-scale AI training running through hardware failures instead of forcing costly restarts PALO ALTO, CA / ACCESS Newswire / March 11, 2026 / Clockwork.io, the leader in Software-Driven AI Fabrics™- a programmable, vendor-neutral software layer that optimizes large-scale GPU clusters for real-time observability, fault tolerance, and deterministic performance-today announced the general availability of TorchPass Workload Fault Tolerance. This new class of software-driven fault-tolerance eliminates one of the most costly failure modes in large-scale AI training: catastrophic job restarts caused by infrastructure faults. Delivered as a core capability of the Clockwork.io FleetIQ™ platform, TorchPass applies the principles of Software-Driven AI Fabrics to distributed training, using Live GPU Migration to allow workloads to continue running through GPU failures, networ
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom