Moderna COVID-19 vaccine

Moderna Reports First Quarter Fiscal Year 2021 Financial Results and Provides Business Updates

Retrieved on: 
Thursday, May 6, 2021

(Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today reported financial results and provided business updates for the first quarter 2021 and highlighted pipeline progress.\n\xe2\x80\x9cIn the first quarter, the Moderna team delivered on its supply commitments to many governments and helped protect more than 100 million people.

Key Points: 
  • (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today reported financial results and provided business updates for the first quarter 2021 and highlighted pipeline progress.\n\xe2\x80\x9cIn the first quarter, the Moderna team delivered on its supply commitments to many governments and helped protect more than 100 million people.
  • The Moderna team and our manufacturing partners are working hard to get as close to 1 billion doses in 2021 as we can.
  • As detected by three distinct serologic assays, antibodies elicited by the Moderna COVID-19 Vaccine persisted through 6 months after the second dose.
  • Moderna owns worldwide commercial rights to mRNA-6981.\nRelaxin (AZD7970): Moderna has regained all rights to the Relaxin development candidate from AstraZeneca.

Moderna Announces New Supply Agreement with Switzerland for 7 Million Booster Vaccine Doses in 2022 and Option for Additional 7 Million Doses

Retrieved on: 
Thursday, May 6, 2021

Purchase under this agreement is subject to regulatory approval of the booster vaccine candidate.

Key Points: 
  • Purchase under this agreement is subject to regulatory approval of the booster vaccine candidate.
  • Today\xe2\x80\x99s announcement follows two earlier agreements between Switzerland and Moderna to supply a total of 13.5 million doses of the COVID-19 Vaccine Moderna.
  • A booster dose of mRNA-1273.351, the Company\xe2\x80\x99s strain-matched booster, achieved higher neutralizing antibody titers against the B.1.351 variant of concern than a booster dose of mRNA-1273.
  • On May 12, the U.S Food and Drug Administration granted the Moderna COVID-19 Vaccine Fast Track designation.

Moderna Announces Positive Initial Booster Data Against SARS-CoV-2 Variants of Concern

Retrieved on: 
Wednesday, May 5, 2021

A booster dose of mRNA-1273.351, the Company\xe2\x80\x99s strain-matched booster, achieved higher neutralizing antibody titers against the B.1.351 variant of concern than a booster dose of mRNA-1273.

Key Points: 
  • A booster dose of mRNA-1273.351, the Company\xe2\x80\x99s strain-matched booster, achieved higher neutralizing antibody titers against the B.1.351 variant of concern than a booster dose of mRNA-1273.
  • We are encouraged by these new data, which reinforce our confidence that our booster strategy should be protective against these newly detected variants.
  • We look forward to sharing data on our multivalent booster candidate, mRNA-1273.211, which combines mRNA-1273 and mRNA-1273.351 in a single vaccine, when available.
  • Today\xe2\x80\x99s update includes preliminary data two weeks following administration of a booster dose of mRNA-1273 or mRNA-1273.351.

Moderna Announces Expansion of its Manufacturing Technology Center in Massachusetts

Retrieved on: 
Tuesday, May 4, 2021

\xe2\x80\x9cWe believe that this investment and expansion at our technology center will allow us to continue to optimize our mRNA products as we explore new pharmaceutical delivery forms such as prefilled syringes and lyophilized products.

Key Points: 
  • \xe2\x80\x9cWe believe that this investment and expansion at our technology center will allow us to continue to optimize our mRNA products as we explore new pharmaceutical delivery forms such as prefilled syringes and lyophilized products.
  • As we grow, we are committed to minimizing our environmental footprint.\xe2\x80\x9d\nThis expansion will support a 50% increase in production of the Moderna COVID-19 Vaccine at Moderna\xe2\x80\x99s manufacturing site, which is expected to ramp up in late 2021 and early 2022.
  • The Moderna Technology Center manufacturing site was named the ISPE Facility of the Future in 2019 and is among the most integrated end-to-end process facilities in the pharmaceutical industry.
  • Digital technology is integrated throughout the site\xe2\x80\x94the entire research, development and production process incorporates advanced robotics, machine learning, artificial intelligence and creative design.

CDC Study Underscores the Critical Need for Real-World Data in Medicine

Retrieved on: 
Tuesday, May 4, 2021

b'AUSTIN, Texas, May 4, 2021 /PRNewswire/ --The New England Journal of Medicine recently published a study on the impact of COVID-19 vaccinations on pregnant people.

Key Points: 
  • b'AUSTIN, Texas, May 4, 2021 /PRNewswire/ --The New England Journal of Medicine recently published a study on the impact of COVID-19 vaccinations on pregnant people.
  • At the heart of the study was the data that expectant individuals provided to the Centers for Disease Control (CDC) using the v-safe after vaccination health checker .
  • The article concluded that "Preliminary findings did not show obvious safety signals among pregnant persons who received mRNA Covid-19 vaccines."
  • Access to this massive amount of real-world health data will improve the quality of decision making critical to the practice of medicine and formulation of public health policy.

Moderna Announces Supply Agreement with Gavi for up to 500 Million Doses of COVID-19 Vaccine Moderna for COVAX To Help End COVID-19 Pandemic in Lowest Income Countries

Retrieved on: 
Monday, May 3, 2021

Through this agreement, on behalf of the COVAX Facility, Gavi also retains the option to procure 466 million additional doses in 2022.

Key Points: 
  • Through this agreement, on behalf of the COVAX Facility, Gavi also retains the option to procure 466 million additional doses in 2022.
  • All doses are offered at Moderna\xe2\x80\x99s lowest tiered price, in line with the Company\xe2\x80\x99s global access commitments .\nThis agreement covers the 92 Gavi COVAX Advance Market Commitment (AMC) low- and middle-income countries.
  • On May 12, the U.S Food and Drug Administration granted the Moderna COVID-19 Vaccine Fast Track designation.
  • On November 30, 2020, Moderna announced the primary efficacy analysis of the Phase 3 study of the vaccine conducted on 196 cases.

Moderna Announces Emergency Use Listing Granted by the World Health Organization for its COVID-19 Vaccine

Retrieved on: 
Friday, April 30, 2021

It also enables UNICEF and the PAHO Revolving Fund to acquire the vaccine for distribution to countries in need.

Key Points: 
  • It also enables UNICEF and the PAHO Revolving Fund to acquire the vaccine for distribution to countries in need.
  • On May 12, the U.S Food and Drug Administration granted the Moderna COVID-19 Vaccine Fast Track designation.
  • On December 18, 2020, the U.S. FDA authorized the emergency use of the Moderna COVID-19 Vaccine in individuals 18 years of age or older.
  • Moderna has also received authorization for its COVID-19 vaccine from health agencies in Canada, Israel, the European Union, the United Kingdom, Switzerland, Singapore, Qatar and Taiwan.

Moderna Announces Additional Investments to Increase Global Supply for COVID-19 Vaccine to up to 3 Billion Doses in 2022

Retrieved on: 
Thursday, April 29, 2021

When completed, the investments will also result in an increase in safety stock of raw materials and finished product used to deliver committed volumes.

Key Points: 
  • When completed, the investments will also result in an increase in safety stock of raw materials and finished product used to deliver committed volumes.
  • Currently, the Moderna COVID-19 Vaccine is approved for storage up to 1 month at refrigerated temperatures (2-8\xc2\xb0C) and up to 7 months in a standard freezer (-20\xc2\xb0C).
  • The Moderna COVID-19 Vaccine is also the only authorized mRNA vaccine that does not require on-site dilution.
  • On May 12, 2020, the U.S. FDA granted the Moderna COVID-19 Vaccine Fast Track designation.

Moderna Announces New Supply Agreement with Israel for 2022

Retrieved on: 
Tuesday, April 20, 2021

b'Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced a new supply agreement with Israel for 2022.

Key Points: 
  • b'Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced a new supply agreement with Israel for 2022.
  • Under the terms of this agreement, Israel also retains an option to purchase doses of one of Moderna\xe2\x80\x99s variant-specific vaccine candidates subject to regulatory approval.
  • Today\xe2\x80\x99s announcement follows two earlier agreements between Israel and Moderna to supply a total of 10 million doses of the COVID-19 Vaccine Moderna.
  • \xe2\x80\x9cThis is an important moment for our company as the first firm order for 2022 supply and for the supply of our variant-specific booster vaccine candidates against COVID-19, currently being studied in human clinical trials.

Moderna Announces Clinical Progress from its Industry-Leading mRNA Vaccine Franchise and Continues Investments to Accelerate Pipeline Development

Retrieved on: 
Wednesday, April 14, 2021

Building on its COVID-19 vaccine clinical development experience, the Company plans to invest resources and continue to leverage the power of its mRNA platform to accelerate the development of its mRNA vaccine pipeline.\n\xe2\x80\x9cModerna has one of the world\xe2\x80\x99s largest and most innovative vaccine development pipelines.

Key Points: 
  • Building on its COVID-19 vaccine clinical development experience, the Company plans to invest resources and continue to leverage the power of its mRNA platform to accelerate the development of its mRNA vaccine pipeline.\n\xe2\x80\x9cModerna has one of the world\xe2\x80\x99s largest and most innovative vaccine development pipelines.
  • Examples of these novel viruses include HIV 1 (discovered in 1983), Hepatitis C (1989), H1N1 (2009), and SARS-CoV-2 (2019).\nTo date, Moderna has entered 14 different mRNA vaccine candidates into clinical trials.
  • Clinical data demonstrate that Moderna\xe2\x80\x99s proprietary vaccine technology has been generally well-tolerated and can elicit durable immune responses to viral antigens.
  • mRNA-1345 uses the same lipid nanoparticle (LNP) as Moderna\xe2\x80\x99s authorized Covid-19 vaccine and contains optimized protein and codon sequences.