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Vaccines & Immunizations

VBI Vaccines Announces Positive Top-Line Results from Phase 3 Study of its Investigational Hepatitis B Vaccine Sci-B-Vac

CAMBRIDGE, Mass., June 17, 2019 (GLOBE NEWSWIRE) — VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, today announced positive top-line results from the randomized, double-blind, pivotal Phase 3 study, PROTECT, designed to evaluate the efficacy and safety of a 10 µg …

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FDA Grants Limited Approval of Sanofi Pasteur’s Dengue Vaccine in Children

The U.S. Food and Drug Administration announced today the approval of Dengvaxia, the first vaccine approved for the prevention of dengue disease caused by all dengue virus serotypes (1, 2, 3 and 4) in people ages 9 through 16 who have laboratory-confirmed previous dengue infection and who live in endemic …

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Emergent BioSolutions Announces Interim Results from Phase 2 Study Evaluating its Chikungunya Virus Vaccine Candidate

GAITHERSBURG, Md., April 16, 2019 (GLOBE NEWSWIRE) — Emergent BioSolutions Inc. (NYSE:EBS) today announced results from the interim analysis of its Phase 2 clinical study evaluating the safety and immunogenicity of the company’s chikungunya virus virus-like particle (CHIKV-VLP) vaccine candidate across a series of dosing regimens. The interim analysis has shown that with a …

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Merck Receives Breakthrough Therapy Designation from FDA for V114, Investigational 15-Valent Conjugate Vaccine for Prevention of Invasive Pneumococcal Disease

KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that V114, the company’s investigational 15-valent pneumococcal conjugate vaccine, has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for the prevention of invasive pneumococcal disease (IPD) caused by the …

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Takeda’s Dengue Vaccine Candidate Meets Primary Endpoint in Pivotal Phase 3 Efficacy Trial

CAMBRIDGE, Mass. & OSAKA, Japan–(BUSINESS WIRE)–Takeda Pharmaceutical Company Limited [TSE:4502 / NYSE:TAK] (“Takeda”) today announced that the pivotal Phase 3 trial of its dengue vaccine candidate met the primary efficacy endpoint. This first analysis of the Tetravalent Immunization against Dengue Efficacy Study (TIDES) trial showed that the company’s investigational live-attenuated tetravalent dengue …

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FDA Approves Use of 0.5 mL Dose of Fluzone Quadrivalent in Children as Young as 6 Months of Age

BRIDGEWATER, N.J., Jan. 23, 2019 /PRNewswire/ — The U.S. Food and Drug Administration has approved the use of the 0.5 mL dose of Fluzone®Quadrivalent (influenza vaccine) to include children age 6 through 35 months. Sanofi Pasteur, the vaccine division of Sanofi, will have the 0.5 mL dose, in addition to the 0.25 mL …

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FDA Approves Expanded Use of Adacel Vaccine for Repeat Vaccination

BRIDGEWATER, N.J., Jan. 14, 2019 /PRNewswire/ — The U.S. Food and Drug Administration has approved the expanded use of Adacel® (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis (Tdap) Vaccine Adsorbed) to include repeat vaccination to help protect against tetanus, diphtheria and pertussis. It is now the first and only Tdap vaccine in the …

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FDA Approves Vaxelis, Sanofi and Merck’s Pediatric Hexavalent Combination Vaccine

PARIS and KENILWORTH, N.J. – December 26, 2018 – The U.S. Food and Drug Administration has approved VAXELIS(TM) (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus, Haemophilus b Conjugate [Meningococcal Protein Conjugate] and Hepatitis B [Recombinant] Vaccine) for use in children from 6 weeks through 4 years of age (prior to the 5th …

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Emergent BioSolutions and Valneva Report Positive Phase 1 Results for Their Vaccine Candidate Against the Zika Virus

GAITHERSBURG, Md. and SAINT-HERBLAIN, France, Nov. 19, 2018 (GLOBE NEWSWIRE) — Emergent BioSolutions Inc. (NYSE: EBS) and Valneva SE (VLA) today announced positive interim results for the Phase 1 study evaluating VLA1601, their vaccine candidate against the Zika virus. The highly purified inactivated vaccine candidate, VLA1601, met the study’s primary …

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FDA Grants Breakthrough Therapy Designation to Pfizer’s 20-Valent Pneumococcal Conjugate Vaccine for the Prevention of Invasive Disease and Pneumonia

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE:PFE) announced today that its 20-Valent Pneumococcal Conjugate Vaccine (20vPnC) candidate, PF-06482077, received Breakthrough Therapy designation from the US Food and Drug Administration (FDA) for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae serotypes in the vaccine in adults aged 18 years and …

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