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Vaccines & Immunizations

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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Gilead and Precision BioSciences Collaborate to Develop Therapies Against Hepatitis B Virus Using ARCUS Genome Editing

FOSTER CITY, Calif. & DURHAM, N.C.–(BUSINESS WIRE)–Gilead Sciences (Nasdaq: GILD) and Precision BioSciences announced today that the companies have entered into a strategic collaboration to develop therapies targeting the in vivo elimination of hepatitis B virus (HBV) with Precision’s proprietary genome editing platform, ARCUS. An estimated 257 million people are living with …

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Large Study Finds HPV Vaccination Does Not Negatively Impact Fertility in Adolescents

PORTLAND, Ore., Aug. 21, 2018 /PRNewswire/ — Adolescents who receive recommended vaccinations, including for human papillomavirus (or HPV), have no increased risk of primary ovarian insufficiency, also known as premature menopause, according to a Kaiser Permanente study published today in Pediatrics. Rates of HPV vaccination have lagged behind coverage rates …

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BioNTech Enters Agreement with Pfizer to Develop mRNA-based Vaccines for Prevention of Influenza

MAINZ, Germany & NEW YORK–(BUSINESS WIRE)–BioNTech AG, a rapidly growing biotechnology company focused on precise immunotherapies for the treatment of cancer and infectious disease, today announced that it has entered into a multi-year research and development (R&D) collaboration with Pfizer Inc. (NYSE: PFE) to develop mRNA-based vaccines for prevention of …

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Emergent BioSolutions to Acquire Specialty Vaccines Company PaxVax

GAITHERSBURG, Md., Aug. 13, 2018 (GLOBE NEWSWIRE) — Emergent BioSolutions Inc. (NYSE: EBS) announced today that it has entered into an agreement to acquire PaxVax, a company focused on specialty vaccines that protect against existing and emerging infectious diseases, for an all-cash consideration of $270 million. PaxVax is majority owned …

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FDA Grants Priority Review to Merck’s sBLA for Gardasil 9 for Prevention of HPV-Related Cancers and Diseases

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 accepted for review a new supplemental Biologics License Application (sBLA) for GARDASIL®9 (Human Papillomavirus 9-valent Vaccine, Recombinant), the company’s 9-valent HPV vaccine. The application is seeking …

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FDA Grants PaxVax Fast Track Designation for its Chikungunya Vaccine

REDWOOD CITY, Calif., May 4, 2018 /PRNewswire/ — PaxVax, a leading independent specialty vaccine company, announced today that it has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for its vaccine for the prevention of disease caused by the chikungunya virus. Chikungunya represents a significant public …

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