Vaccines

Moderna Announces FDA Advisory Committee Unanimously Votes in Support of Emergency Use for a Booster Dose of Moderna’s COVID-19 Vaccine in the U.S.

10/20/2021

Positive unanimous vote for mRNA-1273 booster at the 50 µg dose level for individuals aged 65 and older as well as individuals aged 18 through 64 at high risk of contracting COVID-19 at least 6 months after completion of the primary series Company estimates that booster at the 50 µg dose level could result in…

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New Duke University-led Study Shows That Vaxart’s Oral COVID-19 Vaccine Candidate Reduces Airborne Transmission of SARS-CoV-2 Infection in Animal Model

10/12/2021

Data published in bioRxiv confirmed previous findings suggesting mucosal vaccines could reduce transmission of airborne viruses such as COVID-19 and flu more than injectable vaccinesStudy suggests mucosal vaccines may protect not only vaccinated, but also unvaccinated animals Excerpt from the Press Release: SOUTH SAN FRANCISCO, Calif., Oct. 7, 2021 /PRNewswire/ — A Duke University-led study published in bioRxiv showed that Vaxart,…

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India’s Bharat Biotech submits data on COVID-19 drug trial in children

10/11/2021

Excerpt from the Press Release: BENGALURU, Oct 6 (Reuters) – Bharat Biotech said on Wednesday it had submitted data from its COVID-19 vaccine trial in children aged 2 to 18 years to India’s drug regulator, becoming the country’s first company to have tested its shot in very young children. The South Asian country is turning…

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VBI Vaccines Announces New Preclinical Data and Initiation of VBI-2905 Clinical Study Targeting Broadened Immunity Against COVID-19 and Variants of Concern

10/04/2021

New preclinical data demonstrate VBI-2905 induced robust neutralizing and antibody binding activity, as a 2-dose course and as a single booster dose, against COVID-19 and variants of concern including Beta and Delta– Data also demonstrate trivalent VBI-2901 induced robust and consistent levels of immunity against the ancestral COVID-19 strain and a panel of variants including…

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COVID-19 Vaccine Developed by Clover Biopharmaceuticals Using Dynavax’s CpG 1018 Adjuvant Meets Primary and Secondary Efficacy Endpoints in Global Phase 2/3 Trial

10/01/2021

– Global Phase 2/3 SPECTRA Trial enrolled over 30,000 adult and elderly participants across 4 continents; 100% of SARS-CoV-2 strains observed in efficacy analysis were variants– 100% efficacy against severe COVID-19 and hospitalizations, and 84% efficacy against moderate-to-severe COVID-19 caused by any strain of SARS-CoV-2– Favorable safety profile; no significant differences in systemic adverse events…

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Elicio Therapeutics Presents Updated Preclinical Data at the 2021 Vaccines Summit Demonstrating that ELI-005, a Lymph Node Targeted Amphiphile Vaccine, Induces Potent Cellular and Humoral Immunity to SARS-CoV-2

09/30/2021

ELI-005, containing the Amphiphile vaccine adjuvant AMP-CpG, induced >25-fold higher antigen-specific T cells in the peripheral blood and exhibited potent killing of antigen-positive targets in vivo that were maintained for >5 months after vaccination Vaccine responses were highly cross-reactive to SARS-CoV-2 variants of concern Antibody responses favored TH1 isotypes with titers 265-fold higher than natural convalescent patient…

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INOVIO Receives Regulatory Authorization to Conduct Phase 3 Efficacy Trial of its COVID-19 DNA Vaccine Candidate, INO-4800, in Mexico

09/29/2021

News follows recent regulatory authorizations to proceed with the trial in Brazil and the PhilippinesINOVIO and partner Advaccine are collaborating on the global Phase 3 trial in regions underserved by COVID-19 vaccines; to focus on Latin America, Asia, and Africa PLYMOUTH MEETING, Pa., Sept. 22, 2021 /PRNewswire/ — INOVIO (NASDAQ:INO), a biotechnology company focused on…

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Arcturus Therapeutics Announces Meeting with President of Vietnam and CEO of Vingroup to Discuss Expansion of COVID-19 Vaccine Collaboration

09/28/2021

SAN DIEGO–(BUSINESS WIRE)–Arcturus Therapeutics Holdings Inc. (the “Company”, “Arcturus”, Nasdaq: ARCT), a leading clinical-stage messenger RNA medicines company focused on the development of infectious disease vaccines and significant opportunities within liver and respiratory rare diseases, today announced that Arcturus’ President & CEO, Joseph Payne, met with the President of Vietnam, Nguyen Xuan Phuc, and the…

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Moderna Announces Health Canada Approves its COVID-19 Vaccine

09/21/2021

Excerpt from the Press Release: CAMBRIDGE, Mass.–(BUSINESS WIRE)–Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced Health Canada has approved the New Drug Submission (NDS-CV) for SPIKEVAX™ (elasomeran mRNA vaccine), which has been known as COVID-19 Vaccine Moderna, for active immunization to prevent COVID-19 in individuals 12 years…

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Moderna Announces Submission of Initial Data to U.S. FDA for Its COVID-19 Vaccine Booster

09/16/2021

mRNA-1273 at 50 µg dose level induced robust antibody responses of more than 40x against the Delta variant (B.1.617.2) CAMBRIDGE, Mass.–(BUSINESS WIRE)–Moderna, Inc. (Nasdaq:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced it has initiated its submission to the U.S. Food and Drug Administration (FDA) for the evaluation of a booster dose…

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