FDA approves MenQuadfi meningococcal conjugate vaccine
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The FDA has recently approved MenQuadfi (Sanofi Pasteur), a meningococcal conjugate vaccine that protects against serogroups A, C, Y, and W. The approval is for patients aged 2 years and older, according to a press release from the manufacturer.

The approval is based on results of five double-blind, randomized phase 2 and 3 trials that evaluated the safety and efficacy of the vaccine in nearly 5,000 patients aged 2 years and older, the release said. Four trials assessed the vaccine in meningococcal-naive patients; the other trial assessed the vaccine in patients who previously received another quadrivalent meningococcal vaccine.

Results showed that MenQuadfi was non-inferior to other licensed quadrivalent meningococcal vaccines, according to the release. Most meningococcal-naive patients (55.4% to 97.2%) had a vaccine-induced immune response against each of the four serogroups 30 days after vaccination with MenQuadfi. Among adolescents and adults who were previously vaccinated against meningococcal disease, 92.2% to 98.2% had an immune response against each serogroup.

The most common adverse events after the first dose of MenQuadfi included injection site pain (25.5% to 45.2%), muscle ache (20.1% to 35.6%), headache (12.5% to 30.2%) and tiredness (14.5% to 26%).

An additional phase 3 trials investigating the safety and efficacy of the vaccine in infants are ongoing. The company expects the vaccine will be available to health care providers and pharmacies in 2021, the release said.

Source: https://www.sanofi.com/en/media-room/press-releases/2020/2020-04-24-07-00-00
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