Moderna, Inc. - MRNA STOCK NEWS

Moderna (NASDAQ:MRNA) announced that Australia's Therapeutic Goods Administration (TGA) has granted provisional registration for its Spikevax COVID-19 vaccine for children aged 6-11 years. This marks the first regulatory approval for the vaccine in this age group. Data from the Phase 2 'KidCOVE' study showed that the vaccine elicited a strong immune response comparable to that in young adults, with a 99.3% seroresponse rate. The vaccine was well tolerated, supporting its use in this demographic.

Moderna announced its plans to expand its commercial presence in Europe by establishing operations in Belgium, Denmark, the Netherlands, Norway, Poland, and Sweden. This move builds on the company's recent expansion in the Asia-Pacific region. Moderna aims to enhance the delivery of its mRNA vaccines and therapeutics, bolstering its European network where it already has subsidiaries in several major countries. The company has a pipeline of 40 development programs, with 25 in clinical trials, and is working on addressing variants of COVID-19.

Moderna (NASDAQ:MRNA) and Laboratorios Farmacéuticos Rovi (BME: ROVI) have announced a long-term partnership to enhance manufacturing capabilities in Spain. The 10-year agreement includes investments to improve ROVI's facilities in Madrid and other locations, allowing for increased capacity in producing Moderna's COVID-19 vaccine and future mRNA candidates. This collaboration aims to bolster Moderna's production and ROVI's role as a key manufacturer, with expected final details in Q1 2022.

Moderna announces plans to expand its presence in Asia with four new subsidiaries in Malaysia, Taiwan, Singapore, and Hong Kong. This initiative aims to support the delivery of mRNA vaccines and therapeutics, enhancing local operations. The Asia-Pacific region is crucial for Moderna, which has existing operations in Japan, South Korea, and Australia. The company’s broader pipeline includes 40 development programs, with 25 in clinical trials, focusing on addressing various health challenges. In 2021, Moderna shipped 807 million doses of its COVID-19 vaccine globally, including 25% to low- and middle-income markets.

On February 14, 2022, Javara announced a clinical trial for an investigational vaccine, mRNA-1345, aimed at preventing respiratory syncytial virus (RSV) in adults aged 60 and older. This trial, conducted in partnership with Privia Health and Moderna (Nasdaq: MRNA), will enroll approximately 34,000 participants across Fayetteville, Annapolis, and Fort Worth. RSV causes significant health issues, with over 177,000 hospitalizations yearly among older adults in the U.S. The trial aims to evaluate the vaccine's safety and efficacy, addressing the urgent need for preventive measures against RSV.

Moderna (Nasdaq:MRNA) announced that Juan Andres, Chief Technical Operations and Quality Officer, has been elected to the National Academy of Engineering. This honor recognizes his leadership in scaling manufacturing, particularly for the COVID-19 vaccine Spikevax. Under Andres, Moderna's production surged from fewer than 10,000 doses per month in 2019 to approximately 807 million doses in 2021. The Academy's total U.S. membership now stands at 2,388. Moderna continues to expand its global manufacturing presence and pipeline of development programs.

Moderna, Inc. (NASDAQ:MRNA) has announced a new supply agreement with the Colombian government to deliver 10.8 million doses of its COVID-19 vaccine. This follows a previous supply of 10 million doses in 2021. Deliveries are scheduled for 2022, with one million doses in Q1, six million in Q2, and 3.8 million in Q3. Additionally, Moderna has signed a supply agreement with Chile for two million booster doses, pending emergency use authorization. The vaccine, SPIKEVAX, has received emergency use authorization from Colombia’s Invima.

Moderna, Inc. (NASDAQ:MRNA) will hold a live conference call and webcast on February 24, 2022, at 8:00 a.m. ET to discuss its fourth quarter and full year 2021 financial results.

Investors can join the call by dialing 866-922-5184 (domestic) or 409-937-8950 (international), using conference ID 5682797. A webcast will be accessible on the Moderna investor website and archived for one year post-call. Moderna continues to advance its mRNA platform to develop vaccines and therapeutics across various diseases, marking a decade of innovation and partnerships in the biopharmaceutical sector.

Moderna's Spikevax COVID-19 vaccine has received full approval from the U.S. FDA for individuals aged 18 and older. This marks a significant achievement as Spikevax is the company's first product to gain full licensure in the U.S., complementing its existing approvals in over 70 countries, including Canada and the EU. The decision was based on extensive safety and efficacy data, affirming Spikevax's role in combating the pandemic. In 2021, 807 million doses were shipped worldwide, with a significant portion supplied to low- and middle-income countries.