COVID-19 vaccines

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.

AHF Blasts Bill Gates for Opposing COVID Vaccine Access

Retrieved on: 
Wednesday, May 5, 2021

b"AIDS Healthcare Foundation ( AHF ) sharply criticized Bill Gates, cofounder and former CEO of Microsoft Corporation and cofounder of the Bill and Melinda Gates Foundation, for his opposition to sharing patents for COVID-19 vaccines with the world.

Key Points: 
  • b"AIDS Healthcare Foundation ( AHF ) sharply criticized Bill Gates, cofounder and former CEO of Microsoft Corporation and cofounder of the Bill and Melinda Gates Foundation, for his opposition to sharing patents for COVID-19 vaccines with the world.
  • \xe2\x80\x9cThe COVID-19 pandemic presents a moment that requires all-hands-on-deck, including a temporary suspension of patents on these lifesaving vaccines.
  • For COVID-19, Gates would be wise to pay close attention to lessons learned from the HIV pandemic on how poor countries have been able to access lifesaving ARVs for their populations.
  • WTO members will consider a vote to temporarily waive or suspend all COVID-19 vaccine patents, something AHF has separately urged President Biden and his trade representatives to support.

Adagio Therapeutics Announces ADG20 Phase 1 Data and Initiation of Global Phase 2/3 Clinical Trial of ADG20 for the Prevention of COVID-19

Retrieved on: 
Wednesday, May 5, 2021

Trial initiation is supported bypositive preliminary data from the company\xe2\x80\x99s ongoing Phase 1 trial in healthy volunteers.

Key Points: 
  • Trial initiation is supported bypositive preliminary data from the company\xe2\x80\x99s ongoing Phase 1 trial in healthy volunteers.
  • The Phase 1 trial was designed to evaluate the safety, tolerability, pharmacokinetics and serum SARS-CoV-2 neutralizing antibody levels of various ADG20 dose regimens.
  • Adagio is advancing ADG20 through multiple clinical trials on a global basis.\nAdagio is developing best-in-class antibodies that can broadly neutralize SARS-CoV-2, SARS-CoV and additional pre-emergent coronaviruses.
  • Adagio has secured manufacturing capacity for the production of ADG20 with third-party contract manufacturers through the completion of clinical trials and, if approved by regulatory authorities, through initial commercial launch.

Poll: Blacks Report BDO "Very Helpful" in Vaccine Decision

Retrieved on: 
Tuesday, May 4, 2021

b'CHICAGO, May 4, 2021 /PRNewswire/ -- BlackDoctor.org (BDO) has been leading the charge in COVID-19 vaccine education since the beginning of the pandemic.

Key Points: 
  • b'CHICAGO, May 4, 2021 /PRNewswire/ -- BlackDoctor.org (BDO) has been leading the charge in COVID-19 vaccine education since the beginning of the pandemic.
  • That\'s over two-thirds of over 1600 respondents saying that BDO helped their decision to get vaccinated.
  • BDO polled their audience throughout the pandemic to gauge attitudes and concerns about the vaccines and identified a significant shift.
  • Vaccine hesitancy by Blacks was averaging around 60% but later dropped down to only 22% saying they will not get the vaccine.\nBDO recognized Blacks need information about when, where, and how to get the vaccine.

Emergency Physicians First to Safely Treat Case of Vaccine-Induced Blood Clot with Heparin Alternative

Retrieved on: 
Tuesday, May 4, 2021

The patient was treated on April 13, 2021, the same day that the Centers for Disease Control and Prevention (CDC) announced a pause in the administration of the Johnson & Johnson vaccine.

Key Points: 
  • The patient was treated on April 13, 2021, the same day that the Centers for Disease Control and Prevention (CDC) announced a pause in the administration of the Johnson & Johnson vaccine.
  • "\n"Our experience shows us that these clot reactions are very rare, but they can be treated," said R. Todd Clark, MD, MBA, lead co-author and assistant professor of emergency medicine at the University of Colorado School of Medicine.
  • "Americans can feel comfortable getting vaccinated and should discuss any vaccination concerns with their doctor.
  • Getting vaccinated is a critical step in combatting this pandemic so we can return to our normal lives.

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.

PFIZER REPORTS STRONG FIRST-QUARTER 2021 RESULTS

Retrieved on: 
Tuesday, May 4, 2021

Results from the study are expected to be available in the second half of 2021.\nIn March 2021, Pfizer, the Israel Ministry of Health (MoH) and BioNTech announced real-world evidence demonstrating dramatically lower incidence rates of COVID-19 disease in individuals fully vaccinated with BNT162b2.

Key Points: 
  • Results from the study are expected to be available in the second half of 2021.\nIn March 2021, Pfizer, the Israel Ministry of Health (MoH) and BioNTech announced real-world evidence demonstrating dramatically lower incidence rates of COVID-19 disease in individuals fully vaccinated with BNT162b2.
  • On January 29, 2021, Pfizer and BioNTech signed an amended version of the April 2020 agreement.
  • Under the January 2021 agreement, BioNTech paid Pfizer its 50 percent share of prior development costs in a lump sum payment during the first quarter of 2021.
  • Should known or unknown risks or uncertainties materialize or should underlying assumptions prove inaccurate, actual results could vary materially from past results and those anticipated, estimated or projected.