Welcome to our dedicated page for Moderna news (Ticker: MRNA), a resource for investors and traders seeking the latest updates and insights on Moderna stock.
Moderna, Inc. reports developments in mRNA medicines, including commercial vaccines, investigational respiratory vaccines, oncology programs and rare-disease candidates. News commonly covers regulatory authorizations and agency interactions for products such as Spikevax, mRESVIA, mNEXSPIKE and mCOMBRIAX, as well as clinical data for seasonal influenza, pandemic influenza and cancer immunotherapy programs including intismeran autogene and mRNA-4359.
Company updates also include quarterly financial results, revenue mix, expense actions, strategic partnerships, scientific meeting presentations and intellectual-property matters tied to Moderna's infectious disease portfolio and broader mRNA technology platform.
Moderna (MRNA) has reported significant advancements in its mRNA pipeline, including successful results from a Phase 2/3 study of its COVID-19 vaccine for children aged 6 months to under 6 years, prompting regulatory submissions. The company is also seeking FDA emergency use authorization for children aged 6 to under 12. Additionally, interim data from a Phase 2 study of its influenza vaccine candidate, mRNA-1010, shows promising immunogenicity. Moderna increased its signed purchase agreements for 2022 to $21 billion, reflecting robust demand for its vaccine products.
Moderna, Inc. (NASDAQ:MRNA) has finalized a strategic partnership with the Australian Federal Government to establish a state-of-the-art mRNA vaccine manufacturing facility in Melbourne. This facility aims to produce up to 100 million vaccine doses annually, targeting respiratory viruses including COVID-19. Construction is set to begin by late 2022 and aims for operational status by 2024. The partnership also includes job creation and support for Australia’s mRNA research ecosystem.
Moderna (NASDAQ:MRNA) released positive interim data from the Phase 2/3 KidCOVE study, showing that two 25 μg doses of mRNA-1273 for children aged 6 months to under 6 years met the primary endpoint, generating robust neutralizing antibody titers similar to adults. The vaccine demonstrated favorable safety and tolerability profiles, with mild adverse reactions primarily after the second dose. Moderna plans to submit for global regulatory approvals for mRNA-1273, including emergency use authorization for children 6 to under 12 years of age.
UMass Chan Medical School has partnered with Moderna (Nasdaq: MRNA) to conduct a study on cytomegalovirus (CMV) transmission in group childcare and educational settings in Worcester and Cambridge. The study, named CMV Transmission and Immune Tracking (CMV TransmIT), aims to analyze how CMV spreads among children and between household members, with the objective to inform potential CMV vaccine development. CMV is a common infection with serious implications, including birth defects, and the research could lead to enhanced prevention strategies. Enrollment is set to begin in fall 2022.
Moderna (NASDAQ:MRNA) announced the launch of two new vaccine development programs. The first is mRNA-1230, a combination respiratory vaccine targeting SARS-CoV-2, influenza, and RSV aimed at older adults. The second is mRNA-1287, a vaccine against four endemic human coronaviruses, which account for 10% to 30% of upper respiratory infections in adults. Moderna aims to address the global burden of respiratory diseases, particularly for older populations. This news underscores Moderna's commitment to expanding its mRNA portfolio and enhancing public health.
Moderna (NASDAQ: MRNA) has signed a new supply agreement with the Swiss Federal Government for seven million doses of its COVID-19 booster vaccine to be delivered in 2023. This adds to a previous agreement for seven million doses in the second half of 2022. CEO Stéphane Bancel emphasized the importance of booster doses in managing infection rates. The vaccine, SPIKEVAX, is authorized for individuals aged 12 and older, contributing to Moderna's robust portfolio in mRNA therapeutics. The company continues to expand its manufacturing capabilities and strategic collaborations.
Moderna, Inc. (MRNA) has submitted a request to the U.S. FDA to amend the emergency use authorization for its COVID-19 vaccine (mRNA-1273) to permit a fourth dose for adults aged 18 and older. The request aims to provide flexibility for healthcare providers and the CDC in administering additional booster doses, particularly for high-risk individuals. This submission relies on recent data from the U.S. and Israel, especially following the emergence of the Omicron variant. Moderna continues to collect real-world data to validate the vaccine's safety and effectiveness.
Moderna has received approval from Health Canada for its mRNA COVID-19 vaccine, SPIKEVAX, for children aged 6 to 11 years. This follows similar authorizations in both Australia and the European Union. The approval is based on data from the Phase 2/3 KidCOVE study, which demonstrated safety and efficacy in over 4,000 children. The vaccine displayed non-inferior antibody responses compared to older age groups. This marks a significant step in expanding vaccination efforts among younger populations.
Moderna, Inc. (NASDAQ:MRNA) has announced a deal with Japan's Ministry of Health to supply an additional 70 million doses of its COVID-19 booster vaccine in the second half of 2022. This agreement could increase the total contracted doses for Japan from 93 million to 163 million. The vaccine has received special approval for use in preventing COVID-19, with booster doses recommended for adults six months after the second dose. The agreement is contingent upon securing the necessary budget from the Ministry.
Moderna (Nasdaq:MRNA) announced the first participant has been dosed in its Phase 1 trial (HVTN 302) for an experimental HIV trimer mRNA vaccine (mRNA-1574). This multicenter, randomized trial aims to assess safety and immunogenicity in approximately 100 HIV-negative adults aged 18 to 55. Moderna's strategy involves using mRNA to induce protective HIV neutralizing antibodies. The trial is sponsored by the Division of AIDS at NIAID and aims to advance Moderna's capabilities in mRNA technology for HIV prevention.