Moderna Stock Price, News & Analysis

Moderna has received FDA approval for a second booster dose of its COVID-19 vaccine, mRNA-1273, at a 50 µg dose for adults aged 50+ and immunocompromised individuals over 18. This amendment to the emergency use authorization (EUA) will enable millions to enhance their immunity as the virus evolves, particularly against the BA.2 variant. The decision is supported by data from Israel highlighting the vaccine's safety and efficacy during the Omicron surge. Moderna continues to monitor real-world data and conduct clinical trials for Omicron-specific boosters.

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.