COVID-19 vaccines

The Lancet Infectious Diseases Published Data from Sinovac’s Phase I/II Study, World’s First Published Study on Clinical Trial Results of a COVID-19 Vaccine in Healthy Children and Adolescents Aged 3 to 17 Years Old

Retrieved on: 
Wednesday, June 30, 2021

This is the world's first published study on the use of a COVID-19 vaccine for children as young as 3 years old.

Key Points: 
  • This is the world's first published study on the use of a COVID-19 vaccine for children as young as 3 years old.
  • The study enrolled 552 participants, comprised of healthy children and adolescents aged 3-17.
  • From October 31 to December 2, 2020, 72 were enrolled in the phase I clinical study.
  • Between December 12 and December 30, 2020, 480 were enrolled in the phase II clinical study.

Clover and Dynavax Announce Commercial Supply Agreement of Dynavax's CpG 1018 Adjuvant for Clover's COVID-19 Vaccine Candidate

Retrieved on: 
Wednesday, June 30, 2021

Ryan Spencer, Chief Executive Officer of Dynavax commented, "Dynavax is excited for the opportunity to expand our partnership with Clover into an important commercial supply agreement to provide significant amounts of CpG 1018 for combatting the ongoing pandemic.

Key Points: 
  • Ryan Spencer, Chief Executive Officer of Dynavax commented, "Dynavax is excited for the opportunity to expand our partnership with Clover into an important commercial supply agreement to provide significant amounts of CpG 1018 for combatting the ongoing pandemic.
  • Clover's COVID-19 vaccine candidate is the combination of SCB-2019 and two adjuvants, Dynavax's CpG 1018 advanced adjuvant and aluminum hydroxide (alum).
  • Dynavax developed CpG 1018 to provide an increased vaccine immune response, which has been demonstrated in HEPLISAV-B.
  • Dynavax is also advancing CpG 1018 as a premier vaccine adjuvant through research collaborations and partnerships.

Altimmune Announces Update on AdCOVID™ Phase 1 Clinical Trial

Retrieved on: 
Tuesday, June 29, 2021

The Company also provided an update on its T-COVID Phase 1/2 clinical trial to evaluate the potential of T-COVID to prevent clinical worsening in patients with early COVID-19.

Key Points: 
  • The Company also provided an update on its T-COVID Phase 1/2 clinical trial to evaluate the potential of T-COVID to prevent clinical worsening in patients with early COVID-19.
  • The Phase 1 AdCOVID clinical trial is evaluating the safety and immunogenicity of the intranasally administered vaccine candidate in approximately 80 healthy adult volunteers between the ages of 18 and 55.
  • Based on these data, and in view of the highly competitive COVID-19 vaccine landscape, Altimmune is discontinuing further development of AdCOVID beyond the completion of this Phase 1 trial.
  • The immune response to AdCOVID was inferior to that seen in our NasoVAX influenza vaccine trial, commented Scot Roberts, PhD, Chief Scientific Officer at Altimmune.

Moderna Announces Emergency Use Authorization for its COVID-19 Vaccine Granted by Government of India

Retrieved on: 
Tuesday, June 29, 2021

I want to thank the government of India for this authorization, which marks an important step forward in the global fight against the pandemic, said Stphane Bancel, Chief Executive Officer of Moderna.

Key Points: 
  • I want to thank the government of India for this authorization, which marks an important step forward in the global fight against the pandemic, said Stphane Bancel, Chief Executive Officer of Moderna.
  • We are committed to making our COVID-19 vaccine available around the world.
  • Moderna has also received emergency (or other conditional, interim or provisional) authorization for use of its COVID-19 vaccine from health agencies in more than 50 countries and an Emergency Use Listing (EUL) from the World Health Organization (WHO).
  • Modernas COVID-19 vaccine is authorized pursuant to a Registration Certificate and a Permission to Import the vaccine for restricted use in an emergency situation in India, in adults aged 18 years and older.

Moderna Provides a Clinical Update on the Neutralizing Activity of its COVID-19 Vaccine on Emerging Variants Including the Delta Variant First Identified in India

Retrieved on: 
Tuesday, June 29, 2021

Moderna is pursuing a clinical development strategy against emerging variants to proactively address the pandemic as the virus continues to evolve.

Key Points: 
  • Moderna is pursuing a clinical development strategy against emerging variants to proactively address the pandemic as the virus continues to evolve.
  • The Moderna COVID-19 Vaccine is an mRNA vaccine against COVID-19 encoding for a prefusion stabilized form of the Spike (S) protein.
  • Severe allergic reactions, including anaphylaxis, have been reported following administration of the Moderna COVID-19 Vaccine during mass vaccination outside of clinical trials.
  • Individuals who have received one dose of Moderna COVID-19 Vaccine should receive a second dose of Moderna COVID-19 Vaccine to complete the vaccination series.

VBI Vaccines Announces Initial Positive Phase 1 Data for Its eVLP Vaccine Candidate Against COVID-19

Retrieved on: 
Tuesday, June 29, 2021

VBI Vaccines Inc. ( Nasdaq:VBIV ) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today announced positive Phase 1 data from its Phase 1/2 trial of the first of its enveloped virus-like particle (eVLP) COVID-19 vaccine candidates, VBI-2902a, in healthy adults age 18-54 years of age.

Key Points: 
  • VBI Vaccines Inc. ( Nasdaq:VBIV ) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today announced positive Phase 1 data from its Phase 1/2 trial of the first of its enveloped virus-like particle (eVLP) COVID-19 vaccine candidates, VBI-2902a, in healthy adults age 18-54 years of age.
  • The data establish a robust human proof-of-concept, at a low dose without the use of a next-generation adjuvant, demonstrating the potency of the eVLP particulate delivery platform against COVID-19.
  • We look forward to sharing further data as we continue to focus on the development of long-term, effective solutions against COVID-19 and other coronaviruses.
  • VBI is headquartered in Cambridge, Massachusetts, with research operations in Ottawa, Canada, and a research and manufacturing site in Rehovot, Israel.

Global WholeHealth Partners Corp (GWHP-OTC) Acquires Rights to Distribute & Sell a 3rd COVID-19 Vaccine - Moderna

Retrieved on: 
Tuesday, June 29, 2021

As with the Johnson & Johnson 8K filed on June 10, 2021, for the J&J rights, the Company filed on June 16, 2021, for Pfizer and filed for Moderna on June 25, 2021, stating that Effective June 22, 2021, Global WholeHealth Partners Corporation (the Company) was granted the rights from Nunzia Pharmaceutical Inc. (Nunzia) to distribute and sell the Moderna COVID-19 Vaccine.

Key Points: 
  • As with the Johnson & Johnson 8K filed on June 10, 2021, for the J&J rights, the Company filed on June 16, 2021, for Pfizer and filed for Moderna on June 25, 2021, stating that Effective June 22, 2021, Global WholeHealth Partners Corporation (the Company) was granted the rights from Nunzia Pharmaceutical Inc. (Nunzia) to distribute and sell the Moderna COVID-19 Vaccine.
  • The Company will serve as a broker for Nunzia and follow the same sales order processing as used by Nunzia in connection with the distribution and sale of the Vaccine.
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    According to reports: With additional supply agreements under its belt, Moderna now predicts its vaccine will generate $19.2 billion by years end.
  • Investors and security holders are urged to read these documents free of charge on the SEC's web site at http://www.sec.gov .

Kate Cronin to Join Moderna as Chief Brand Officer on July 12

Retrieved on: 
Monday, June 28, 2021

Moderna , Inc., (Nasdaq: MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that Kate Cronin will join Moderna as Chief Brand Officer effective Monday, July 12, 2021.

Key Points: 
  • Moderna , Inc., (Nasdaq: MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that Kate Cronin will join Moderna as Chief Brand Officer effective Monday, July 12, 2021.
  • She will serve on Modernas Executive Committee and report to Chief Executive Officer Stphane Bancel.
  • I am thrilled to welcome Kate to Moderna as our Chief Brand Officer and to the Executive Committee.
  • Kate is joining the team during a time of rapid growth as we continue to scale up.

RedHill Biopharma's Opaganib Inhibits COVID-19 Variants in Preclinical Study

Retrieved on: 
Monday, June 28, 2021

TEL AVIV, Israel and RALEIGH, N.C., June 28, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced preliminary results of a new preclinical study showing potent inhibition of COVID-19 variants of concern by opaganib (Yeliva, ABC294640)[1].

Key Points: 
  • TEL AVIV, Israel and RALEIGH, N.C., June 28, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced preliminary results of a new preclinical study showing potent inhibition of COVID-19 variants of concern by opaganib (Yeliva, ABC294640)[1].
  • Phase 2 study data, opaganib's global 475-patient Phase 2/3 study in hospitalized patients with COVID-19 is fully enrolled and is expected to be completed in the coming weeks.
  • Preliminary results showed potent inhibition of both the Beta and Gamma variants by opaganib at non-cytotoxic doses.
  • This means we expect opaganib to similarly work against other emerging COVID-19 variants, including the Delta (Indian) variant.

RedHill Biopharma's Opaganib Inhibits COVID-19 Variants in Preclinical Study

Retrieved on: 
Monday, June 28, 2021

Phase 2 study data, opaganib's global 475-patient Phase 2/3 study in hospitalized patients with COVID-19 is fully enrolled and is expected to be completed in the coming weeks.

Key Points: 
  • Phase 2 study data, opaganib's global 475-patient Phase 2/3 study in hospitalized patients with COVID-19 is fully enrolled and is expected to be completed in the coming weeks.
  • Preliminary results showed potent inhibition of both the Beta and Gamma variants by opaganib at non-cytotoxic doses.
  • This means we expect opaganib to similarly work against other emerging COVID-19 variants, including the Delta (Indian) variant.
  • The global Phase 2/3 study of opaganib in COVID-19 has previously received four independent DSMB recommendations to continue following unblinded safety reviews and a futility review.