The approval of the quadrivalent meningococcal conjugate vaccine manufactured by Novartis has been expanded to include children aged 2-10 years, but does not yet include infants, the company announced on Jan. 31.
The Food and Drug Administration approved the use of the vaccine for preventing invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135 in children aged 2-10 years of age, according to a statement issued by Novartis. The company markets the vaccine (Meningococcal [Groups A, C, Y and W-135] Oligosaccharide Diphtheria CRM 197 Conjugate Vaccine) as Menveo. It was approved in 2010 for use in adolescents and adults aged 11-55 years.
Novartis application for approval included children down to age 2 months. But the statement said that the FDA had not included this age group in the approval because of concerns raised that the company believes are of a "procedural nature," and that the company plans to resubmit the application for approval with more clinical data on children 2 months to 2 years within a few months.
Approval for the children aged 2-10 years was based on data in a phase III study of 5,297 children in that age group comparing the safety and immunogenicity against the four serogroups contained in the vaccine with those in the other meningococcal vaccine licensed in the United States, according to Novartis. The statement said that the company has agreed to conduct postmarketing studies.
The other meningococcal conjugate vaccine approved in the United States is Menactra, manufactured by Sanofi Pasteur, which is also approved for immunizing people aged 2-55 years against invasive meningococcal disease caused by the four serogroups contained in the vaccine, the same included in Menveo.
In the European Union, where Menveo is known as Meningococcal Group A, C, W135 and Y Conjugate Vaccine, Novartis plans to submit data to support the use of the vaccine in children aged 0-10 years in the first half of 2011, according to the statement. In Canada, the application for use in children 2-10 years has been submitted.