FDA Gives Sanofi OK for New Meningococcal Vaccination

Apr 28, 2020

The quadrivalent meningococcal vaccine is indicated persons 2 years of age and older in the United States.

The FDA has approved Sanofi’s meningococcal (groups A, C, Y, W) conjugate vaccine (MenQuadfi) for the prevention of invasive meningococcal diseases in individuals ages 2 years and older, according to a press release.

Sanofi expects MenQuadfi to be available to providers and pharmacies throughout the United States in 2021. It will be available in a ready-to-use liquid formulation, according to Sanofi.

The CDC’s recommendations to protect against meningococcal disease include vaccination at 11 to 12 years of age, with a second dose at 16 years. According to the release, approximately 50% of teens have not received their second dose of the vaccine. This vulnerability may lend itself to the hundreds of annual cases of vaccine-preventable meningococcal disease caused by serogroups B, C, W, Y and subsequent permanent complications, including hearing loss, organ damage, and limb amputation. 

The approval was based on the results from 5 double-blind, randomized, multicenter phase 2 and 3 trials, the latter of which is still ongoing. The studies evaluated the safety and immune response from the vaccine. The trials utilized responses from approximately 5000 individuals 2 years of age and older. Continuing trials are additionally investigating the use of the vaccine in infants as young as 6 weeks old in order to effectively address the global need for preventing meningococcal disease.

Four of the studies analyzed MenQuadfi in meningococcal-naïve individuals, whereas the fifth study included individuals who had been previously immunized with a quadrivalent meningococcal vaccine. In evaluating meningococcal serogroups A, C, W, and Y, 55.4% to 97.2% of meningococcal-naïve trial participants showed a vaccine-induced immune response 30 days after being vaccinated with MenQuadfi. Additionally, 92.2%-98.2% of previously vaccinated participants showed an immune response against each serogroup, according to the results.

The release also announced that MenQuadfi is under regulatory review abroad in Europe as well as other countries in order to support their immunization efforts.

The most common adverse effects of MenQuadfi for first doses were found to be pain at the injection site (25.5% to 45.2%), muscle ache (20.1% to 35.6%), headache (12.5% to 30.2%), and tiredness (14.5% to 26.0%). Booster participants experienced similar effects.

“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. It is our ambition to make this vaccine available to further expand protection to individuals worldwide.”

References:

1. FDA approves MenQuadfiTM, the latest innovation in meningococcal (MenACWY) vaccination. News Release. Sanofi; April 24, 2020. https://www.sanofi.com/en/media-room/press-releases/2020/2020-04-24-07-00-00. Accessed April 28, 2020.

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