US regulators have issued a green light for Sanofi's meningococcal vaccine MenQuadfi for the prevention of invasive meningococcal disease in persons two years of age and older.
“Meningococcal meningitis remains a major global health challenge because it can strike quickly and with devastating effect, taking a life in less than 24 hours. With the ability to help prevent this disease through vaccination, Sanofi believes one case is one too many,” said David Loew, executive vice president, Sanofi Pasteur.
“Approval of this new vaccine in the US represents an important milestone in the ongoing fight to help protect as many people as possible from meningococcal disease.”
MenQuadfi is the only US FDA-approved quadrivalent meningococcal vaccine indicated for persons two through 56 years of age and older, and the first in the country to use tetanus toxoid as a protein carrier.
The approval already allows for protection of an expanded age group, but this could be expanded even further if ongoing Phase III trials investigating the vaccine's use in infants as young as six weeks of age prove successful to better address the worldwide needs for meningococcal disease prevention throughout life.
“Given the severity and unpredictability of meningococcal disease, there is a public health need to ensure immunisation across multiple ages, consistent with US recommendations,” said Corey Robertson, senior director, Scientific and Medical Affairs at Sanofi Pasteur. “MenQuadfi’s pivotal clinical trials demonstrated a high immune response across all four serogroups and provides a new vaccine option to help protect an expanded age group.”
The vaccine is also currently under review in Europe.