Professor files Human Rights complaint in bid to get Moderna vaccine for his children https://ottawacitizen.com/news/local-news/professor-files-human-right-complaint-in-bid-to-get-moderna-vaccine-for-his-children
MRNA is a better Covid vaccine as compared to Pfizer https://www.science.org/doi/10.1126/scitranslmed.abm2311
HEALTH CANADA AUTHORIZES MODERNA'S COVID-19 VACCINE IN CHILDREN (6-11 YEARS)
2021 was a year of monumental impact and change for Moderna
Moderna entered 2021 with a strong cash position of approximately $5.25 billion. We have used this capital to invest in R&D and scale our development pipeline and manufacturing capabilities to maximize our impact on human health.
As we close our books for 2021, the company’s cash, cash equivalents and investments as of December 31, 2021, were more than $17 billion. We now have the resources to scale our investments and do even more to positively impact human health with mRNA medicines. This is just the beginning.
Moderna is entering 2022 with a remarkable team poised to continue advancing mRNA vaccines and therapeutics into new areas for patients. We have a clear and exciting strategic path to do so, and a strong cash position.
Priority one is our pan-respiratory annual single-dose booster vaccine. Respiratory viruses are a major cause of mortality worldwide, with an estimated 2.7 million deaths in 2015,2 and many millions more hospitalized and sick at home. Building on our continued focus on mRNA-1273, our COVID-19 vaccine, we want to prevent people who are at high risk (e.g., 50 years of age and older, healthcare workers, the immunocompromised) from being hospitalized due to respiratory infection. We will not stop until that goal is achieved.
Priority two is to go after the most important latent viruses and develop first-in-class vaccines against them. We want to protect our fellow human beings from suffering from the long-term damage caused by these viruses. Too many people have the quality of their health impacted because decades before, they were infected with a latent virus. We envision a world where vaccines against all the most important latent viruses are available to all.
Priority three is to bring to market therapeutics based on mRNA-encoded proteins, like our current pipeline in oncology, cardiology, rare genetic diseases and autoimmune diseases.
Priority four is to bring to market innovative therapeutics based on mRNA-encoded gene editing enzymes.
We believe Moderna could become the most impactful healthcare company in the world. A strand of mRNA can bind science, technology and humanity together to build a healthier planet.
MODERNA ANNOUNCES FIRST PARTICIPANT DOSED IN PHASE 2/3 STUDY OF ITS MRNA RESPIRATORY SYNCYTIAL VIRUS (RSV) VACCINE
Moderna expects to enroll approximately 34,000 participants in multiple countries
RSV is a leading cause of severe respiratory illness in older adults (65+) and young children; there is no approved vaccine to prevent RSV
RSV illness in older adults results in an estimated $3 billion in annual medical costs in the U.S. each year
NOVEMBER, 18, 2021
MODERNA ANNOUNCES FIRST PARTICIPANT DOSED IN PHASE 3 PIVOTAL REGISTRATION STUDY OF ITS MRNA CYTOMEGALOVIRUS (CMV) VACCINE
The Phase 3 study, known as CMVictory, will evaluate the safety and efficacy of mRNA-1647 against primary CMV infection in women ages 16-40 years. The Company will seek to enroll approximately 8,000 participants in the study, including 6,900 women of childbearing age, from approximately 150 sites globally, beginning in the U.S. Moderna has set a goal of enrolling a diverse group of U.S. participants into the study, including approximately 42% of participants who are Persons of Color. The ClinicalTrials.gov identifier is NCT05085366. To learn more about eligibility, please click here.
MODERNA ANNOUNCES POSITIVE DATA FROM PHASE 2 STUDY OF MRNA VEGF-A THERAPEUTIC IN PATIENTS UNDERGOING CORONARY ARTERY BYPASS GRAFTING SURGERY
Phase 2a study met the primary endpoint of safety and tolerability; numerical trends observed in endpoints in the heart failure efficacy domains compared with placebo, including increase in LVEF and patient reported outcomes
Results support further investigation of AZD8601 for efficacy and safety in future larger studies
MODERNA AND CARISMA ESTABLISH COLLABORATION TO DEVELOP IN VIVO ENGINEERED CHIMERIC ANTIGEN RECEPTOR MONOCYTES (CAR-M) FOR ONCOLOGY
Collaboration will combine Carisma's engineered macrophage technology with Moderna's mRNA and LNP technologies to generate and develop in vivo CAR-M therapeutics
Multi-year research collaboration funded by Moderna with options for up to twelve targets
Carisma to receive $45 million up-front cash payment and investment by Moderna in the form of a $35 million convertible note
Carisma eligible to receive milestone and royalty payments
MODERNA ANNOUNCES PRESENTATION OF INTERIM DATA FROM PHASE 1 STUDY OF MRNA TRIPLET PROGRAM AT 2021 SITC ANNUAL MEETING
IAVI AND MODERNA LAUNCH TRIAL OF HIV VACCINE ANTIGENS DELIVERED THROUGH MRNA TECHNOLOGY
January 27, 2022 / IAVI, the nonprofit scientific research organization, and biotechnology company Moderna announced today that first doses have been administered in a clinical trial of experimental HIV vaccine antigens at George Washington University (GWU) School of Medicine and Health Sciences in Washington, D.C.
MODERNA ANNOUNCES FIRST PARTICIPANT DOSED IN PHASE 1 STUDY OF ITS MRNA EPSTEIN-BARR VIRUS (EBV) VACCINE
Moderna expects to enroll approximately 270 participants in the U.S.
EBV is a major cause of infectious mononucleosis, which can debilitate patients for weeks to months; there is no approved vaccine to prevent EBV
EBV can also lead to lifelong medical conditions and is associated with an increased risk of developing multiple sclerosis, certain lymphoproliferative disorders, cancers, and autoimmune diseases
Moderna now has a portfolio of two vaccines against latent viruses in the clinic: CMV and EBV
MODERNA RECEIVES FULL U.S. FDA APPROVAL FOR COVID-19 VACCINE SPIKEVAX
Q4 2021 revenues of $7.2 billion; GAAP net-income of $4.9 billion and GAAP diluted EPS of $11.29
Full year 2021 revenues of $18.5 billion; GAAP net-income of $12.2 billion and GAAP diluted EPS of $28.29
Moderna increased its 2022 signed advance purchase agreements to approximately $19 billion, with additional signed options of approximately $3 billion; numerous discussions ongoing with governments for the fall of 2022 and 2023
Moderna received full U.S. FDA approval for COVID-19 vaccine, Spikevax
Moderna announces new bivalent booster candidate (mRNA-1273.214) combining Omicron-specific booster candidate (mRNA-1273.529) and the Moderna COVID-19 vaccine (mRNA-1273)
Company now has 44 programs in development
Moderna announces a new $3 billion share repurchase plan
MODERNA ANNOUNCES MEMORANDUM OF UNDERSTANDING WITH THE GOVERNMENT OF THE REPUBLIC OF KENYA TO ESTABLISH ITS FIRST MRNA MANUFACTURING FACILITY IN AFRICA
Facility to manufacture drug substance with opportunity for fill/finish and packaging capabilities
Moderna investing up to $500 million to produce up to 500 million doses each year for the African continent
Moderna will invest in building mRNA capabilities in Africa
MODERNA ANNOUNCES FIRST PARTICIPANT DOSED IN PHASE 1 STUDY OF ITS HIV TRIMER MRNA VACCINE