Sanofi’s invasive meningococcal disease vaccine approved for EU use in four serotypes

pharmafile | November 23, 2020 | News story | Research and Development, Sales and Marketing  

Sanofi’s MenQuadfi combination vaccine has secured approval from the European Commission for the prevention of invasive meningococcal disease caused by Neisseria meningitides, it has emerged. The prophylactic is authorised for use in the disease serogroups A, C, W and Y in patients from the age of 12 months.

The decision was supported by data drawn from a seven pivotal Phase 2 and 3 randomised trials incorporating 6,300 healthy participants who received a single dose of the vaccine.

The therapy demonstrated “a high immune response” against all four serogroups, “consistently across all studies”, showing comparable efficacy and safety to other licensed combination vaccines across all patient age groups.

“Meningococcal meningitis can take one’s life in as little as one day and leave survivors with severe permanent disabilities. In Europe, there were more than 3,000 cases of Invasive Meningococcal Disease in 2018, half of them caused by serogroups C, W and Y,” explained Thomas Triomphe, Head of Sanofi Pasteur. “One case is one too many. It is our ambition to make this vaccine available worldwide to further expand protection to as many people as possible. The European Commission’s approval of MenQuadfi takes us one step closer to achieving this goal.”

Sanofi also confirmed that Phase 3 studies are currently ongoing to determine the vaccine’s use in infants as young as six weeks.

Matt Fellows

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