Pneumococcal infection

U.S. FDA Accepts for Priority Review the Supplemental Biologics License Application for Merck’s VAXNEUVANCE™ (Pneumococcal 15-valent Conjugate Vaccine) for Use in Infants and Children

Retrieved on: 
Wednesday, December 1, 2021
FDA, Health, Infectious Diseases, Clinical Trials, Pharmaceutical, Biotechnology, MSD, Regulation of tobacco by the U.S. Food and Drug Administration, Annual report, PCV, NYSE, Medicine, Vaccination, Animal, 23F, Risk, CRM197, Incidence, Anaphylaxis, LinkedIn, Breakthrough therapy, Food, HIV, Infant, Security (finance), Myalgia, Merck & Co., Head, Private Securities Litigation Reform Act, PCV13, Streptococcus pneumoniae, Cancer, Allergy, Headache, Streptococcus, Research, Arthralgia, Phase II, Priority, Infection, MRK, Fatigue, YouTube, News, Coronavirus, Population, Sickle cell disease, Diphtheria, Vaccine, Conjugate vaccine, Twitter, FDA, Life, HIV/AIDS, Patient, Pneumococcal infection, Safety, Immunocompetence, Priority review, SEC, COVID-19, PDUFA, Patent, Instagram, U.S. Securities and Exchange Commission, Immunization, Pharmaceutical industry, Birth control, VAXNEUVANCE (Pneumococcal 15-valent Conjugate Vaccine), Merck, VAXNEUVANCE (PNEUMOCOCCAL 15-VALENT CONJUGATE VACCINE), MERCK

The FDA set a Prescription Drug User Fee Act (PDUFA), or target action date, of April 1, 2022.

Key Points: 
  • The FDA set a Prescription Drug User Fee Act (PDUFA), or target action date, of April 1, 2022.
  • The sBLA is supported by results from Phase 2 and Phase 3 clinical studies in pediatric populations including infants, children, and adolescents.
  • Invasive pneumococcal disease can cause serious and potentially life-threatening infections in infants and children.
  • Do not administer VAXNEUVANCE to individuals with a severe allergic reaction (e.g., anaphylaxis) to any component of VAXNEUVANCE or to diphtheria toxoid.

Affinivax and Astellas Present Safety and Immunogenicity Data from Phase 2 Study of ASP3772, a Novel 24 valent MAPS™ Vaccine for Streptococcus pneumoniae

Retrieved on: 
Monday, July 12, 2021
Medical Supplies, Biotechnology, FDA, Health, General Health, Pharmaceutical, Research, Infectious diseases, Genetics, Science, Clinical trials, Bacteria, Medical specialties, Microbiology, Pneumonia, Gram-positive bacteria, Pathogenic bacteria, Streptococcaceae, Infectious diseases, Streptococcus pneumoniae, Streptococcus, Vaccine, Pneumococcal infection, the ASP3772 Phase 2 Clinical Trial1, Multiple Antigen Presenting System (MAPS™), Affinivax, Inc., Astellas, THE ASP3772 PHASE 2 CLINICAL TRIAL1, MULTIPLE ANTIGEN PRESENTING SYSTEM (MAPS™), AFFINIVAX, INC., ASTELLAS

Affinivax, Inc. ("Affinivax") and Astellas Pharma Inc. (Astellas) announced results from the Phase 2 clinical trial of ASP3772, a novel vaccine candidate targeting Streptococcus pneumoniae.

Key Points: 
  • Affinivax, Inc. ("Affinivax") and Astellas Pharma Inc. (Astellas) announced results from the Phase 2 clinical trial of ASP3772, a novel vaccine candidate targeting Streptococcus pneumoniae.
  • Developed using Affinivaxs proprietary MAPS (Multiple Antigen-Presenting System) platform technology, ASP3772 is designed to offer both B-cell (antibody) and T-cell immune protection against Streptococcus pneumoniae.
  • The FDA decision is informed by the results of the Phase 2 data.
  • In more than 30% of Streptococcus pneumoniae infections, the bacteria are resistant to one or more clinically relevant antibiotics.

Merck Announces Positive Topline Results from PNEU-DIRECTION (V114-027) and PNEU-PLAN (V114-024) Phase 3 Pediatric Studies for V114, Merck’s Investigational 15-valent Pneumococcal Conjugate Vaccine

Retrieved on: 
Thursday, May 20, 2021
Health, Infectious diseases, Clinical trials, General Health, Pharmaceutical, Biotechnology, Pneumonia, Medical specialties, Clinical medicine, Microbiology, Pneumococcal conjugate vaccine, Pneumococcal infection, Vaccine, Pneumococcal vaccine, Streptococcus pneumoniae, Conjugate vaccine, PNEU-DIRECTION, PNEU-PLAN, V114, Pneumococcal Disease, Merck, PNEU-DIRECTION, PNEU-PLAN, V114, PNEUMOCOCCAL DISEASE, MERCK

\xe2\x80\x9cAt Merck, our goal is to expand coverage to new serotypes not targeted by currently available pediatric pneumococcal conjugate vaccines, while maintaining a strong immune response to current vaccine serotypes so as to help sustain progress achieved to date.

Key Points: 
  • \xe2\x80\x9cAt Merck, our goal is to expand coverage to new serotypes not targeted by currently available pediatric pneumococcal conjugate vaccines, while maintaining a strong immune response to current vaccine serotypes so as to help sustain progress achieved to date.
  • Children under the age of 2 are particularly vulnerable to pneumococcal infection and invasive pneumococcal disease incidence remains highest in the first year of life.
  • Serotypes 22F, 33F and 3 represent a sizeable portion of invasive pneumococcal disease cases in adults and children.
  • This supports the need for robust immune suppression of current vaccine serotypes while also expanding serotype coverage.

H1 2020 Pipeline Review on Meningitis - ResearchAndMarkets.com

Retrieved on: 
Monday, December 7, 2020
Infectious diseases, Pharmaceutical, Health, Medical specialties, Pneumonia, Clinical medicine, Microbiology, Acute pain, Meningitis, Vaccine-preventable diseases, Streptococcus pneumoniae, Pneumococcal infection, Infection

The "Meningitis - Pipeline Review, H1 2020" drug pipelines has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Meningitis - Pipeline Review, H1 2020" drug pipelines has been added to ResearchAndMarkets.com's offering.
  • This report provides an overview of the Meningitis (Infectious Disease) pipeline landscape.
  • Pneumococcal meningitis is another major bacterial cause of meningitis, caused by the bacteria streptococcus pneumonia, while haemophilius influenza is the third, and causes meningitis in infants.
  • Formulate corrective measures for pipeline projects by understanding Meningitis (Infectious Disease) pipeline depth and focus of Indication therapeutics.

Data From Pfizer’s Adult and Pediatric Clinical Trial Programs for 20-Valent Pneumococcal Conjugate Vaccine Presented at IDWeek 2020

Retrieved on: 
Wednesday, October 21, 2020
Infectious diseases, General Health, Pharmaceutical, Health, Vaccines, Health, Pneumonia, Medical specialties, Pneumococcal conjugate vaccine, Pneumococcal vaccine, Pfizer, Meningitis, Vaccination, Conjugate vaccine, Pneumococcal infection, Vaccine, the 20vPnC Clinical Trial Program, 20vPnC

The Phase 3 randomized, double-blind trial (NCT03760146) included 902 adults aged 18 or older with no history of pneumococcal vaccination.

Key Points: 
  • The Phase 3 randomized, double-blind trial (NCT03760146) included 902 adults aged 18 or older with no history of pneumococcal vaccination.
  • Pfizers Phase 3 adult clinical program for 20vPnC includes three studies, which, combined, have enrolled more than 6,000 adult subjects, including populations of vaccine-nave adults and adults with prior pneumococcal vaccination.
  • In 2020, Pfizer initiated the Phase 3 clinical trial program for the pediatric indication for 20vPnC.
  • Impact of the 13-valent pneumococcal conjugate vaccine on pneumococcal meningitis in US children.

The Global Pneumonia Vaccines Market size is expected to reach $9.6 billion by 2025, rising at a market growth of 5.1% CAGR during the forecast period

Retrieved on: 
Monday, July 15, 2019
Medical specialties, Vaccines, Vaccination, Medicine, Pneumonia, Health, Infectious diseases, Pneumococcal vaccine, RTT, Vaccine, Pneumococcal infection, Pneumococcal conjugate vaccine

NEW YORK, July 15, 2019 /PRNewswire/ -- The Global Pneumonia Vaccines Market size is expected to reach $9.6 billion by 2025, rising at a market growth of 5.1% CAGR during the forecast period.

Key Points: 
  • NEW YORK, July 15, 2019 /PRNewswire/ -- The Global Pneumonia Vaccines Market size is expected to reach $9.6 billion by 2025, rising at a market growth of 5.1% CAGR during the forecast period.
  • Pneumococcal disease is common in young children, but older adults are at the greatest risk of serious pneumococcal infections and even death.
  • Pneumonia vaccines are primarily administered to children less than 2-years old and adults aged 65 years and older.
  • However, longer timelines required for pneumonia vaccine production and high costs associated with the development of such vaccines restrain the market growth.