Sanofi Scores FDA Approval for Quadrivalent Meningitis Vaccine

Sanofi recently announced that FDA approved a biologics license application for a MenQuadfi meningococcal (Groups A, C, Y, W) conjugate vaccine for the prevention of meningitis in individuals two years of age and older.

MenQuadfi is the only FDA-approved quadrivalent meningococcal vaccine indicated for individuals two through 56 years of age and older. It was designed to demonstrate a high immune response across all four serogroups for multiple ages and was well tolerated.

“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,” David Loew, executive vice president of Sanofi Pasteur, said in the announcement.

“Approval of this new vaccine in the U.S. represents an important milestone in the ongoing fight to help protect as many people as possible from meningococcal disease. It is our ambition to make this vaccine available to further expand protection to individuals worldwide.”

MenQuadfi was created to protect an expanded age group. It is the first and only quadrivalent meningococcal vaccine in the US that uses tetanus toxoid as a protein carrier. It will be available in a ready-to-use liquid formulation allowing healthcare providers to avoid vaccine reconstitution.

Sanofi noted that the approval of MenQuadfi builds on its efforts to tackle meningococcal disease, starting with the first monovalent vaccine for Africa in 1974. Since then, Sanofi has worked to extend protection against four of the most prevalent meningococcal disease serogroups with the first quadrivalent vaccine registered in the U.S. 

The approval is based on clinical data from five double-blind, randomized, multicenter Phase 2 and 3 trials that assessed safety and immune responses following vaccination, with nearly 5,000 persons two years of age and older.

The data showed that the vaccine achieved non-inferiority compared with licensed quadrivalent meningococcal vaccines. Four of the studies evaluated the vaccine in individuals without history of a meningitis vaccine, while the other study enrolled individuals who were previously immunized with a quadrivalent meningococcal vaccine.

Against each of the four-meningococcal serogroups, 55.4 percent to 97.2 percent of meningococcal-naïve participants had a vaccine-induced immune response 30 days following vaccination with MenQuadfi. Among individuals previously vaccinated, 92.2 percent to 98.2 percent showed an immune response against each serogroup.

“Given the severity and unpredictability of meningococcal disease, there is a public health need to ensure immunization across multiple ages, consistent with U.S. recommendations,” said Corey Robertson, MD, 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.”

MenQuadfi is expected to be available to providers and pharmacies nationwide in the US for immunization efforts in 2021.

This approval comes over a month after the pharmaceutical company found itself in hot water and agreed to pay $11.85 million to resolve Medicare fraud accusations involving a charity kickback probe. 

Sanofi allegedly helped cover Medicare patients’ out-of-pocket drug costs through an independent charitable foundation, The Assistance Fund (TAF). TAF manages a variety of funds including funds for MS patients that pay co-pays for Lemtrada. The non-profit organization allegedly raised its maximum per-patient grant allocation to $20,000 to accommodate Lemtrada patients. 

The Anti-Kickback Statute prohibits pharmaceutical companies from offering or paying any amount, including money or other items of value, to induce Medicare patients to purchase the companies’ drugs.

“According to the allegations in today’s settlement agreement, Sanofi used a supposed charity as a conduit to funnel money to patients taking Sanofi’s very expensive drug, all at the expense of the Medicare program,” US Attorney Andrew Lelling in Boston said in a statement.