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 (NASDAQ: MRNA) has announced an amendment to its contract with Gavi to accelerate supply, providing a total of 54 million doses to COVAX in 2021. An additional agreement allows for 20 million doses in Q2 2022, raising the total to 136.5 million doses. Gavi retains options to procure up to 650 million doses through 2022. Deliveries to COVAX AMC countries have commenced, highlighting Moderna's commitment to vaccine accessibility globally.
Moderna announced positive interim results from its Phase 1 study of the quadrivalent flu vaccine candidate, mRNA-1010, showing robust immune responses across all tested doses in both younger and older adults. The Phase 2 study has been fully enrolled, with preparations for a Phase 3 study already in progress. Moderna also introduced two new vaccine candidates, mRNA-1011 and mRNA-1012, aimed at expanding strain coverage. The company is focused on developing a pan-respiratory annual booster vaccine to combat significant health threats posed by respiratory infections.
Moderna, Inc. (Nasdaq: MRNA) announced it will host a live conference call on the Phase 1 interim analysis of its seasonal influenza vaccine candidate, mRNA-1010, on December 10, 2021, at 8:00 a.m. ET. Investors can access the call by dialing 866-922-5184 (domestic) or 409-937-8950 (international), referencing conference ID 8748887. A webcast will also be available on the Moderna website. Since its inception, Moderna has transformed into a leader in mRNA therapeutics, with a diverse clinical portfolio and significant manufacturing capabilities.
Moderna has launched an Artificial Intelligence Academy in collaboration with Carnegie Mellon University, aiming to enhance employee skills in AI and machine learning. This initiative will facilitate immersive learning experiences for Moderna employees at all levels, enabling them to incorporate AI solutions into the company's processes. The program will commence with its first cohort next week, targeting a broader rollout in early 2022. Moderna believes this investment is crucial for expanding mRNA technologies in the coming years.
Moderna (NASDAQ: MRNA) has announced a revised supply agreement with the UK government for up to 60 million doses of its COVID-19 vaccine. The delivery schedule includes 29 million doses in 2022 and 31 million in 2023, with a provision for the UK to increase or decrease orders by 20%. CEO Stéphane Bancel expressed gratitude for the UK government's support, emphasizing ongoing efforts to combat the pandemic. The agreement underscores Moderna's rapid scaling capabilities and its collaborative approach to vaccine distribution.
Moderna (NASDAQ: MRNA) announced updates to its strategy in response to the Omicron variant of SARS-CoV-2. The company is testing three existing COVID-19 vaccine booster candidates, including mRNA-1273 and higher doses (100 µg). Moderna is also developing two multi-valent booster candidates, mRNA-1273.211 and mRNA-1273.213, targeting mutations in the Omicron variant. Additionally, they are advancing an Omicron-specific candidate (mRNA-1273.529). These efforts aim to counteract waning immunity and address concerns regarding the variant's transmissibility and potential immune escape.
Moderna (NASDAQ: MRNA), a leader in messenger RNA therapeutics, has announced its participation in two upcoming virtual investor conferences on December 1. The NASDAQ 45th Investor Conference will take place at 9:30 a.m. ET, followed by the Piper Sandler 33rd Annual Virtual Healthcare Conference at 2:00 p.m. ET. Investors can access live webcasts of both presentations on Moderna's website, where replays will also be available for 30 days. Moderna has significantly advanced in mRNA science, especially in developing COVID-19 vaccines.
Moderna, Inc. (NASDAQ: MRNA) announced that the CDC's Advisory Committee on Immunization Practices (ACIP) has unanimously recommended the use of a booster dose of its COVID-19 vaccine for individuals aged 18 and older, following FDA's Emergency Use Authorization.
This recommendation aims to enhance protection against COVID-19 during the winter months as cases rise. Moderna's CEO, Stéphane Bancel, emphasized the importance of this step in combating the pandemic with their mRNA vaccine.
Moderna (MRNA) announced the FDA has extended emergency use authorization for its COVID-19 vaccine booster at a 50 µg dose for all adults aged 18 and older. This decision allows the booster to be administered to individuals who completed primary vaccination with any approved COVID-19 vaccine. The authorization is seen as critical due to rising COVID-19 cases. The FDA's decision was based on data from a Phase 2 study indicating a significant immune response from the booster dose. The CDC will meet to discuss rollout recommendations.
Moderna has initiated a Phase 2/3 clinical trial for its RSV vaccine candidate, mRNA-1345, with plans to enroll approximately 34,000 participants across multiple countries.
RSV is responsible for significant health issues in older adults and young children but currently lacks an approved vaccine. The Company reports an estimated $3 billion annual medical cost due to RSV in the U.S., with about 177,000 hospitalizations and 14,000 deaths among adults 65 and older annually. The trial aims to evaluate the safety and efficacy of mRNA-1345 in adults over 60, supporting future licensure efforts.