Vaccines & Immunizations

Development of COVID-19 Vaccine AZD1222 Expands Into US Phase 3 Clinical Trial Across All Adult Age Groups

WILMINGTON, Del.–(BUSINESS WIRE)–AZD1222 development expanded into a Phase III clinical trial in the US to assess its safety, efficacy and immunogenicity.1 The US trial, called D8110C00001, is funded by the Biomedical Advanced Development Authority (BARDA), part of the office of the Assistant Secretary for Preparedness and Response (ASPR) at the …

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Pfizer and BioNTech Share Positive Early Data on Lead mRNA Vaccine Candidate BNT162b2 Against COVID-19

NEW YORK & MAINZ, Germany–(BUSINESS WIRE)–Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today shared additional Phase 1 safety and immunogenicity data from their ongoing U.S. study of the BNT162 mRNA-based vaccine program against SARS-CoV-2, which has advanced into Phase 2/3 evaluation. The newly released manuscript describes key safety and immunogenicity data …

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ImmunityBio Study Shows Positive T Cell and Antibody Immune Responses to its COVID-19 Vaccine Candidate that Targets Both Spike and Nucleocapsid Virus Proteins

CULVER CITY, Calif.–(BUSINESS WIRE)–ImmunityBio, Inc. a privately-held, clinical-stage immunotherapy company, today announced positive preclinical results for its human Ad5 vaccine candidate that contains both the spike (S) and nucleocapsid (N) SARS-CoV-2 proteins (hAd5 S + N) for preventing COVID-19. The results were published in bioRxiv (“A Next Generation Bivalent Human …

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Moderna Announces Expansion of BARDA Agreement to Support Larger Phase 3 Program for Vaccine Against COVID-19

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Moderna, Inc. (Nasdaq: MRNA), a clinical stage biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced a modification to its contract with the Biomedical Advanced Research and Development Authority (BARDA) for an additional commitment of up …

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Pfizer and BioNTech Announce an Agreement with US Government for up to 600 Million Doses of mRNA-based COVID-19 Vaccine Candidate

NEW YORK & MAINZ, Germany–(BUSINESS WIRE)–Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the execution of an agreement with the U.S. Department of Health and Human Services and the Department of Defense to meet the U.S. government’s Operation Warp Speed program goal to begin delivering 300 million …

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COVID-19 Vaccine AZD1222 Showed Robust Immune Responses in All Participants in Phase I/II Trial

Interim results from the ongoing Phase I/II COV001 trial, led by Oxford University, showed AZD1222 was tolerated and generated robust immune responses against the SARS-CoV-2 virus in all evaluated participants. COV001 is a blinded, multi-centre, randomised controlled Phase I/II trial with 1,077 healthy adult participants, aged 18-55 years. It assessed …

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Pfizer and BioNTech Announce Early Positive Update from German Phase 1/2 COVID-19 Vaccine Study, Including First T Cell Response Data

MAINZ, Germany & NEW YORK–(BUSINESS WIRE)–BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) and Pfizer Inc. (NYSE: PFE) today announced initial data from their ongoing German Phase 1/2, open-label, non-randomized, non-placebo-controlled, dose-escalation trial, that is part of the global mRNA-based vaccine program against SARS-CoV-2. The data are available on an online preprint …

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GSK and CureVac Announce Strategic mRNA Technology Collaboration

GlaxoSmithKline plc (LSE/NYSE: GSK) and CureVac today announced the signing of a strategic collaboration agreement for the research, development, manufacturing and commercialization of up to five mRNA-based vaccines and monoclonal antibodies (mAbs) targeting infectious disease pathogens. The collaboration complements GSK’s existing mRNA capabilities with CureVac’s integrated mRNA platform. mRNA (messenger …

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Tonix Pharmaceuticals Announces Research Collaboration to Develop Precision Medicine Techniques for COVID-19 Vaccines and Therapeutics

NEW YORK, July 16, 2020 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced it has entered into a research collaboration and option agreement with Columbia University focused on studying the immune responses to COVID-19 in healthy volunteers who have …

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Moderna Announces Publication in The New England Journal of Medicine of Interim Results from Phase 1 Study of its COVID-19 Vaccine

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Moderna, Inc., (Nasdaq:MRNA) a clinical stage biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced the publication of an interim analysis of the open-label Phase 1 study of mRNA-1273, its vaccine candidate against COVID-19, in The New …

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