FDA approves MenQuadfi meningococcal conjugate vaccine
Click Here to Manage Email Alerts
The FDA has recently approved MenQuadfi, 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.
MenQuadfi (Sanofi Pasteur) is the first FDA-approved quadrivalent meningococcal vaccine that uses tetanus toxoid as a protein carrier, the release said. The company expects the vaccine will be available to health care providers and pharmacies in 2021.
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 noninferior 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%). Similar adverse events were observed among adolescents and adults who received a MenQuadfi booster, according to the release.
“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,” Corey Robertson, MD, senior director of Scientific and Medical Affairs at Sanofi Pasteur, said in the release. “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.”
Additional phase 3 trials investigating the safety and efficacy of the vaccine in infants are ongoing, the release said.
Disclosure: Robertson is an employee of Sanofi Pasteur.
Perspective
Back to Top
Kwang Sik Kim, MD
There are already two licensed conjugated meningococcal vaccines for infants and children in the U.S. This vaccine can be used for children at 2 years of age. Still, current recommendations advise initial vaccination at 11 to 12 years of age and a booster dose at 16 years of age.
These quadrivalent vaccines cover serogroups A, C, Y and W. However, serogroup B has been reported to cause outbreaks on college campuses. The meningococcal vaccine directed against serogroup B is available.
People often ask if meningococcal vaccines should be given to young adults who are going off to college. For that particular setting, I would suggest that they receive not only the quadrivalent vaccine but also serogroup B vaccine, which is equally relevant in terms of frequency in relatively high-risk age groups, which are usually infants, adolescents and young adults and older individuals.
Read more about
Click Here to Manage Email Alerts