Sanofi’s MenQuadfi® (MAL 23076024ARZ) Approved In Malaysia For Prevention Of Meningococcal Disease

New quadrivalent meningococcal conjugate vaccine approved for use in persons aged 12 months and older. Safety and effectiveness have been evaluated in a series of double-blind, randomised clinical trials.

KUALA LUMPUR, Jan 15 – A new vaccine, MenQuadfi® Meningococcal Conjugate Vaccine by Sanofi, is now approved in Malaysia for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W and Y in persons aged 12 months and older.1

Meningococcal Disease is a Public Health Concern, and Vaccination

Meningitis, a severe infection of the membranes covering the brain and spinal cord remains a public health challenge around the world. Bacterial meningitis is a dangerous form and commonly caused by Neisseria meningitidis (meningococcus), Streptococcus pneumoniae (pneumococcus), Haemophilus influenzae and Streptococcus agalactiae (group B streptococcus) in which infection can be fatal.

Neisseria meningitidis has been responsible for some of meningitis cases in Malaysia. Owing to these and other factors, vaccination is recommended as an effective strategy to reduce the burden of disease.

Currently in Malaysia, meningococcal vaccination is recommended for children and those in high-density environments such as students living in dormitories; it is also required by the health authorities of Saudi Arabia for all pilgrims performing their Umrah and Hajj and those travelling to parts of the world where meningitis outbreaks are common.

“Meningococcal disease can be devastating, causing lifelong disability or even death. The fact that it can strike so quickly, within 24 hours, underscores the importance of prevention. We, at Sanofi are committed to providing safe and effective solutions, and this approval of MenQuadfi® is timely in our ongoing effort to protect a broader population against the threat of meningococcal disease,” said Sri Murali Sivadason, General Manager, Sanofi Vaccines, Malaysia, Singapore and Brunei.

Safety and Efficacy of MenQuadfi®

Over the course of seven Phase 2 and 3 trials involving more than 6,300 subjects aged 12 months and older, MenQuadfi® demonstrated a high immune response across all four serogroups for multiple ages and was well tolerated, with the most common side effects including tenderness and swelling at the injection site, fever, drowsiness and irritability, which were consistent and comparable with those expected after vaccination.2

MenQuadfi® will be commercially available in mid-January 2024 at private clinics and hospitals.

References:

  1. MenQuadfi™ Product Insert.
  2. National Pharmaceutical Regulatory Agency (NPRA), Ministry of Health Malaysia. Technical Evaluation Summary: MenQuadfi – Meningococcal Vaccine, Solution for Injection in 0.5 mL Vial (MAL23076024ARZ). Link.

KKLIU 3344 / EXP 28.5.2024

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