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Vaccines & Immunizations

FDA Grants Fast Track Designation to Meissa Vaccines’ MV-012-968 Vaccine for Respiratory Syncytial Virus

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Meissa Vaccines (“Meissa”), a biotechnology company developing vaccines to prevent viral respiratory infections, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to MV-012-968, an investigational, live attenuated vaccine for protection against respiratory syncytial virus (RSV) infection. The FDA’s Fast Track …

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Moderna Announces Additional Positive Phase 1 Data from Cytomegalovirus 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 positive seven-month interim safety and immunogenicity data after the third and final vaccination in the Phase 1 study of its …

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VBI Vaccines Announces Second Pivotal Phase 3 Study of Sci-B-Vac Meets Primary and Secondary Endpoints

CAMBRIDGE, Mass.–(BUSINESS WIRE)–VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, today reported top-line data from CONSTANT, the second pivotal Phase 3 study, assessing lot-to-lot manufacturing consistency of Sci-B-Vac®, the company’s trivalent hepatitis B (HBV) vaccine, and comparing safety and immunogenicity of …

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FDA Approves Merck’s Ervebo, the First-Approved Vaccine for Prevention of Ebola Virus Disease

KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved ERVEBO® (Ebola Zaire Vaccine, Live) (pronounced er-VEE-boh) for the prevention of disease caused by Zaire ebolavirus in individuals 18 years of age and older. The duration of …

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FDA Approves Sanofi’s Fluzone High-Dose Quadrivalent for Adults 65 Years of Age and Older

PARIS – November 4, 2019 – The U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application for Fluzone® High-Dose Quadrivalent (Influenza Vaccine) for use in adults 65 years of age and older. Fluzone® High-Dose (Influenza Vaccine) was approved by the FDA in 2009 as a trivalent influenza vaccine, including two influenza …

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MSD and 4D Pharma Collaborate to Develop Live Biotherapeutics for Vaccines

LEEDS, England, Oct. 8, 2019 /PRNewswire/ — 4D pharma plc (AIM: DDDD), a pharmaceutical company leading the development of Live Biotherapeutics, today announces that the Company has entered into a research collaboration and option to license agreement with MSD, the tradename of Merck & Co., Inc., Kenilworth, NJ, USA, to …

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FDA Approves Bavarian Nordic’s Jynneos Vaccine for Prevention of Smallpox and Monkeypox Disease in Adults

COPENHAGEN, Denmark, September 24, 2019 – Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) today announced that the U.S. Food and Drug Administration (FDA) has approved JYNNEOS™ (Smallpox and Monkeypox Vaccine, Live, Non-replicating) (MVA-BN®, liquid-frozen) for prevention of smallpox and monkeypox disease in adults 18 years of age and older determined to …

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FDA Grants Priority Review to Merck’s BLA for V920, an Investigational Vaccine for Ebola Zaire Virus

KENILWORTH, N.J.–(BUSINESS WIRE)–Merck, known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) and granted priority review for Merck’s investigational Ebola vaccine (V920), under review for the prevention of disease caused by the Ebola …

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Moderna Announces Positive Phase 1 Results for the First Systemic Messenger RNA Therapeutic Encoding a Secreted Protein

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 positive data in the first analysis of safety and activity in its Phase 1 study evaluating escalating doses of mRNA-1944 …

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FDA Grants Breakthrough Therapy Designation to Janssen’s Investigational Prophylactic Vaccine for Prevention of Respiratory Syncytial Virus in Older Adults

LEIDEN, Netherlands, Sept. 3, 2019 /PRNewswire/ — The Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen) announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for the Company’s investigational prophylactic vaccine for the prevention of respiratory syncytial virus (RSV)-mediated lower respiratory tract disease in …

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