• SKIP TO CONTENT
  • SKIP NAVIGATION
  • Patient Resources
    • COVID-19 Patient Resource Center
    • Clinical Trials
    • Search Clinical Trials
    • Patient Notification System
    • What is Clinical Research?
    • Volunteering for a Clinical Trial
    • Understanding Informed Consent
    • Useful Resources
    • FDA Approved Drugs
  • Professional Resources
    • Research Center Profiles
    • Clinical Trial Listings
    • Market Research
    • FDA Approved Drugs
    • Training Guides
    • Books
    • eLearning
    • Events
    • Newsletters
    • JobWatch
    • White Papers
    • SOPs
    • eCFR and Guidances
  • White Papers
  • Trial Listings
  • Advertise
  • COVID-19
  • iConnect
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » EMA approves GSK’s Malaria vaccine

EMA approves GSK’s Malaria vaccine

July 29, 2015
CenterWatch Staff

GlaxoSmithKline (GSK) has received a positive opinion for its malaria vaccine candidate from the Committee for Medicinal Products for Human Use (CHMP) of the EMA. The vaccine candidate Mosquirix (RTS,S) is the first QS-21 Stimulon containing product to receive a positive regulatory decision.

The adjuvant QS-21, licensed by GSK from Agenus, is designed to increase immune response to antigens in vaccines. The positive opinion signals that Mosquirix meets the necessary quality, safety and efficacy requirements according to E.U. standards.

“This is a significant milestone for the field of Malaria and our QS-21 Stimulon, which is an integral component of the adjuvant contained in Mosquirix, the first malaria candidate vaccine to generate positive phase III data, now awaiting the World Health Organization’s (WHO) recommendations and approvals by African Health authorities,” said Garo Armen, Ph.D., chairman and chief operating officer of Agenus. “We look forward to seeing Mosquirix achieve the required final clearances so it can begin benefiting children at risk of contracting and dying from Malaria.”

The CHMP scientific opinion is a key step in the regulatory process toward making a vaccine against Malaria available. The positive opinion follows review by the CHMP of the candidate vaccine’s safety, efficacy and quality. Clinical data supporting the filing were mainly from a phase III clinical program involving more than 16,000 infants and young children.

Following the CHMP positive opinion, two of the WHO's independent advisory groups, the Strategic Advisory Group of Experts (SAGE) on Immunization and the Malaria Policy Advisory Committee (MPAC), now will jointly review the evidence base for the vaccine candidate and make a joint policy recommendation for how the vaccine should be used in the event that it ultimately is approved by the national regulatory authorities in the sub-Saharan African countries for which the vaccine is intended. The WHO has indicated that such a policy recommendation may be possible by end of this year.

QS-21 Stimulon is a saponin extracted from the bark of the Quillaja saponaria tree, an evergreen also known as the soap bark tree. The adjuvant is a key component of investigational vaccines to prevent a wide variety of infectious diseases, and therapeutic vaccines for cancer and degenerative disorders. QS-21 Stimulon has been evaluated in approximately 50,000 individuals and patients. Agenus is entitled to receive a modest milestone payment upon approval of the first licensed product with GSK, as well as low single digit royalties on potential commercial sales for 10 years after commercial launch, with some exceptions.

Upcoming Events

  • 17May

    Three Data Trends to Consider Now When Developing Your Decentralized Clinical Trial Strategy

  • 24May

    Powering an Effective Oversight Strategy with Clinical and Operational Insights

  • 25May

    2022 WCG Avoca Quality & Innovation Summit: Own the Future

  • 28Jun

    Effective Root Cause Analysis and CAPA Investigations for the Life Sciences

  • 16Oct

    WCG MAGI's Clinical Research Hybrid Conference - 2022 West

Featured Products

  • Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

    Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

  • Surviving an FDA GCP Inspection

    Surviving an FDA GCP Inspection: Resources for Investigators, Sponsors, CROs and IRBs

Featured Stories

  • Protocol-360x240.png

    Avoid Deviations by Making Protocol Review a Team Effort

  • SelectionProcess-360x240.png

    Give Us a Voice: Sites Clamor for a Say on Vendor Selection

  • Convince-360x240.png

    Use Data and Details to Convince Site Leadership to Add Staff

  • AsktheExpertsBadge-360x240.png

    Ask the Experts: Listing Trial Staff and Others on the Statement of Investigator

Standard Operating Procedures for Risk-Based Monitoring of Clinical Trials

The information you need to adapt your monitoring plan to changing times.

Learn More Here
  • About Us
  • Contact Us
  • Privacy Policy
  • Do Not Sell My Personal Information

Footer Logo

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

Phone 617.948.5100 – Toll free 866.219.3440

Copyright © 2022. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing