Moderna Stock Price, News & Analysis

Moderna has signed a new Memorandum of Understanding (MoU) to provide up to 110 million doses of its COVID-19 vaccine to the African Union. Initial deliveries include 15 million doses in Q4 2021 and 35 million doses in Q1 2022. Moderna will supply these doses at its lowest tiered price as part of its global access commitments. The company is also planning to establish a mRNA vaccine manufacturing facility in Africa by 2023, aiming to produce 500 million doses annually, showcasing its commitment to improve vaccine access in low-income countries.

Moderna (Nasdaq: MRNA) announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use has approved a booster dose of its COVID-19 vaccine, Spikevax, at a 50 µg level for individuals aged 18 and older, six months post-primary series completion. This recommendation is based on clinical evidence demonstrating a strong immune response, particularly against variants. The safety profile for the booster dose mirrors that of the second dose. Moderna continues to adapt its mRNA technology to respond to evolving COVID-19 challenges.

Moderna announced positive interim data from the KidCOVE study, evaluating its COVID-19 vaccine, mRNA-1273, in children aged 6 to under 12 years. The trial demonstrated robust neutralizing antibody responses after two 50 μg doses and met primary immunogenicity endpoints. A seroresponse rate of 99.3% was reported, indicating a strong immune response. Moderna plans to submit the results to the FDA and EMA for regulatory review. The safety profile appeared consistent with previous studies, with most adverse events being mild to moderate.

Moderna, Inc. (NASDAQ: MRNA) announced a recommendation from the CDC's ACIP for the use of a booster dose of its COVID-19 vaccine at a 50 µg level for individuals aged 65 and older and those aged 18-64 at high risk. This follows FDA's Emergency Use Authorization for the booster. The ACIP's unanimous vote of 15 members emphasizes the need for additional protection against COVID-19. Moderna estimates that this could lead to up to 1 billion additional doses available for distribution in 2022, enhancing its vaccine supply amid ongoing pandemic challenges.

Moderna announced the FDA's Emergency Use Authorization (EUA) for its COVID-19 vaccine booster dose (mRNA-1273) at a 50 µg level. The EUA is for individuals aged 65 and older, and at-risk individuals aged 18 to 64, with administration recommended at least six months post-primary vaccination. The authorization also allows a booster for those previously vaccinated with other COVID-19 vaccines. The decision is based on strong clinical evidence indicating effective immune response post-booster, with unanimous support from the FDA's advisory committee.

Moderna announced a positive, unanimous vote from the FDA's VRBPAC to recommend Emergency Use Authorization for a 50 µg booster dose of its COVID-19 vaccine (mRNA-1273) for individuals aged 65 and older and high-risk adults aged 18 to 64. This vote may enable up to 1 billion additional doses in 2022. The recommendation was based on strong clinical data demonstrating higher antibody responses against COVID-19 variants. The FDA will consider this recommendation for final authorization, followed by a CDC review.

Moderna, Inc. (NASDAQ: MRNA) will host a live conference call and webcast on November 4, 2021, at 8:00 a.m. ET to discuss its Q3 2021 financial results and provide a corporate update. Interested parties can participate by calling 866-922-5184 (domestic) or 409-937-8950 (international) with conference ID 9177025. A webcast will be available on the Moderna Investors website and archived for a year. Moderna has rapidly advanced its mRNA therapeutics, particularly in COVID-19 vaccines, showcasing significant growth in the biotech field.

Moderna announced a significant agreement with COVAX to supply an additional 176.5 million doses of its COVID-19 vaccine. The doses are priced at an average of less than $10 per 100 µg dose, aligning with Moderna's global access principles. Additionally, the company has requested regulatory authorization for a 50 µg booster dose, which could enhance supply for low-income countries. COVAX has already secured over 210 million doses, with options for further purchases. This partnership aims to promote equitable vaccine access worldwide.

Moderna (NASDAQ: MRNA) is set to invest up to $500 million in building a state-of-the-art mRNA manufacturing facility in Africa. This facility aims to produce up to 500 million vaccine doses annually. The investment reflects Moderna's commitment to expanding its global manufacturing capacity and enhancing its mRNA platform, which has been pivotal in COVID-19 vaccine production. The company plans to begin the site selection process soon. Moderna has delivered over 500 million doses of its COVID-19 vaccine globally to date.