Sanofi Pasteur's Meningococcal Vaccine is Prequalified by the World Health Organization - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

Sanofi Pasteur's Meningococcal Vaccine is Prequalified by the World Health Organization


RELATED ARTICLES

More in GMPs/Validation

Sanofi Pasteur, the vaccines division of Sanofi, announced in a press release that one of its quadrivalent vaccines to prevent invasive meningococcal disease has been prequalified by the World Health Organization (WHO). The prequalification procedure accepts Menomune vaccine for purchase by United Nations Agencies, such as UNICEF [The United Nations Children’s Fund].

The purpose of the United Nations prequalification assessment is to provide assurance that candidate vaccines meet WHO recommendations on quality, safety, and efficacy, including compliance with WHO’s recommended standards for GMP and good clinical practice (GCP). This Menomune vaccine prequalification was performed through a streamlined procedure in which WHO worked closely with FDA.

Menomune vaccine is designed for active immunization against invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y, and W-135 for use in persons 2 years of age and older. It is the first quadrivalent meningococcal vaccine prequalified by the WHO.

“The value of a quadrivalent meningococcal vaccine is becoming more and more realized as evidenced by the circulation of the W-135 strain in the western part of the African meningitis belt this past year,” explained Luc Kuykens, MD, MPH, Sanofi Pasteur’s Chief Medical Officer, in the press release. “Menomune is a proven vaccine with a 32-year track record of providing broad protection against this serious disease, so we try to keep a stockpile of the vaccine in case of any outbreaks.”

ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
Which of the following business challenge poses the greatest threat to your company?
Building a sustainable pipeline of products
Attracting a skilled workforce
Obtaining/maintaining adequate financing
Regulatory compliance
Building a sustainable pipeline of products
27%
Attracting a skilled workforce
30%
Obtaining/maintaining adequate financing
10%
Regulatory compliance
33%
View Results
Eric Langer Outsourcing Outlook Eric LangerBiopharma Outsourcing Activities Update
Cynthia Challener, PhD Ingredients Insider Cynthia Challener, PhDAppropriate Process Design Critical for Commercial Manufacture of Highly Potent APIs
Jill Wechsler Regulatory Watch Jill Wechsler FDA and Manufacturers Seek a More Secure Drug Supply Chain
Sean Milmo European Regulatory WatcchSean MilmoQuality by Design?Bridging the Gap between Concept and Implementation
Medicare Payment Data Raises Questions About Drug Costs
FDA Wants You!
A New Strategy to Tackle Antibiotic Resistance
Drug-Diagnostic Development Stymied by Payer Concerns
Obama Administration Halts Attack on Medicare Drug Plans

Click here