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
Medical Component Specialists to Support Advanced Catheter Innovation at The Catheter R&D Masterclass in Ireland4.5.2026 21:30:00 CEST | Press release
BELLINGHAM, MA / ACCESS Newswire / May 4, 2026 / Medical Component Specialists (MCS), a premier manufacturer of precision medical components, today announced its participation as a supporting organization at The Catheter R&D Masterclass. Hosted by Eyedea Medtech, the highly anticipated event will take place May 28-29, 2026, at the Prototyping and Education Facility in Westport, Mayo, Ireland. The Catheter Systems Lab is an exclusive, dual-purpose educational program designed for senior engineers with over a decade of experience in catheter-based medical device development. Over the course of two days, industry leaders will engage in a deep exploration of catheter design, materials science, structural reinforcement, and end-to-end manufacturing pathways. As a supporting organization, Medical Component Specialists will play a vital role in the event's structured insight and data capture initiatives. The masterclass will facilitate meaningful technical dialogue, allowing MCS to gain direc
Pacific Avenue Capital Partners Enters into Exclusive Negotiations to Acquire ESE World, Amcor's European Waste Container Business4.5.2026 09:30:00 CEST | Press release
LOS ANGELES, CA AND PARIS, FR / ACCESS Newswire / May 4, 2026 / Pacific Avenue Capital Partners ("Pacific Avenue"), a global private equity firm focused on corporate carve-outs and other complex transactions in the middle market, announced today that an affiliate of Pacific Avenue has entered into exclusive negotiations to acquire ESE World (the "Company" or "ESE") from Amcor, one of the world's leading global packaging companies. ESE is the foremost European manufacturer of both plastic and steel waste containers and a provider of associated waste management services. The Company generates approximately €300m of revenues and serves customers across the world from its three manufacturing facilities in Germany (Neuruppin and Olpe) and France (Crissey). Under Pacific Avenue's stewardship, ESE will focus its efforts on meeting the needs of its customers and executing several growth initiatives tied to operational improvement, geographic expansion, and strategic add-on acquisitions. Pacifi
Securitas Acquires CamVision to Expand Packaged and Advanced Security Solutions in Denmark4.5.2026 09:00:00 CEST | Press release
STOCKHOLM, SE / ACCESS Newswire / May 4, 2026 / Securitas has acquired CamVision, a Danish technology driven security specialist with a strong position in retail loss prevention and electronic security solutions. The acquisition strengthens Securitas' ability to deliver reliable and scalable security solutions for micro and small singlesite businesses as well as larger, multisite clients across Denmark. For micro and small businesses, the acquisition enhances Securitas' offering of standardized, packaged security solutions that combine proven technology with dependable service delivery. For larger and multisite clients, it further strengthens Securitas' capability to deliver advanced, technology led security systems designed for complex operational environments. "With the acquisition of CamVision, we strengthen our offering for micro and small business clients, particularly within retail. By combining proven security technology with standardized service delivery, we can offer simpler,
Formerra Appoints Matt Borowiec as Chief Commercial Officer1.5.2026 15:00:00 CEST | Press release
CLEVELAND, OH / ACCESS Newswire / May 1, 2026 / Formerra, a leading distributor of performance materials, today announced the appointment of Matt Borowiec as Chief Commercial Officer (CCO). Borowiec will lead the company's commercial organization to support continued growth and global expansion while strengthening sales execution and customer success. Borowiec is a seasoned executive with over 25 years' experience in operations, commercial and P&L roles across resin manufacturing, specialty compounding, and distribution, including leadership roles at GE Plastics, PolyOne (now Avient), Transcendia, Celanese, and Kinsley Group. With this background, he is well positioned to lead Formerra's commercial strategy at this important time in the company's evolution. "Matt brings a unique combination of producer‑side and distribution experience that positions him well to strengthen alignment between our suppliers, customers, and commercial teams," said Tom Kelly, Chief Executive Officer at Forme
Global Experts call for Paradigm Shift in Medicine, Health and Education to Save Lives and Fight Escalating Health Crisis1.5.2026 14:48:00 CEST | Press release
INNSBRUCK, AUSTRIA / ACCESS Newswire / May 1, 2026 / A global consortium of 64 experts (72 entities, 5 continents) unveiled two coordinated consensus plus policy brief reports, outlining a science‑driven roadmap to confront escalating health crises and to tackle the growing burden of noncommunicable diseases (NCDs-including cardiovascular diseases, cancer, diabetes, etc.: 75% of global deaths; 82% in low-/middle income countries; 90% of all death in European region). The centerpiece is HEAL-Healthy Eating & Active Living, ideally whole‑food plant‑predominant/vegetarian-vegan diets & daily exercise outdoors/active mobility-as the minimum, first‑line standard in health and care. The authors urge immediate action on Prevention-over-Treatment and reforming education and human‑relevant science (drug failure rate from animal studies is 90-95%, and as high as 99.6% for Alzheimer disease), with a rapid shift from disease‑centered reaction to person‑centered, lifestyle‑first cure and care. Figu
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