New molecular entity: Meningococcal (groups A, C, Y, and W-135) oligosaccharide diphtheria CRM197 conjugate vaccine was approved by FDA to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y, and W-135 in persons aged 2 to 55 years.
A vaccine indicated for active immunization to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y, and W-135 in persons aged 2 to 55 years
In January 2011, meningococcal (groups A, C, Y, and W-135) oligosaccharide diphtheria CRM197 conjugate vaccine (Menveo) was approved by FDA to prevent invasive meningococcal disease caused by N. meningitidis serogroups A, C, Y, and W-135 in persons aged 2 to 55 years. The vaccine results in the production of antibodies directed against the capsular polysaccharides of serogroups A, C, Y, and W-135. The presence of such antibodies has been shown to be protective against the development of invasive meningococcal disease. Meningococcal (groups A, C, Y, and W-135) oligosaccharide diphtheria CRM197 conjugate vaccine does not prevent N. meningitidis serogroup B infections.
Efficacy. The efficacy of meningococcal (groups A, C, Y, and W-135) oligosaccharide diphtheria CRM197 conjugate vaccine in subjects aged 2 to 55 years was assessed by comparing the serum bactericidal antibody (SBA) responses to immunization with meningococcal (groups A, C, Y, and W-135) oligosaccharide diphtheria CRM197 conjugate vaccine to those following immunization with FDA-approved meningococcal quadrivalent conjugate vaccine Menactra (Sanofi Pasteur) in 2 randomized, multicenter, clinical trials. In both trials, the primary end point was hSBA seroresponse for all 4 serogroups (A, C, Y, and W-135) at 28 days after vaccination. For the age groupings of 6 to 10 years (n=1,092), 11 to 18 years (n=1,434). and 19 to 55 years (n=1,312), non-inferiority of Menevo to Menactra for the proportion of subjects with a seroresponse was demonstrated for each of the 4 serogroups. In 2 to 5 year olds (n=1,217), non-inferiority of meningococcal (groups A, C, Y, and W-135) oligosaccharide diphtheria CRM197 conjugate vaccine to Menactra for the proportion of subjects with a seroresponse was demonstrated for serogroups C, W-135, and Y, but not for serogroup A.
Dosing. Use of meningococcal (groups A, C, Y, and W-135) oligosaccharide diphtheria CRM197 conjugate vaccine requires the reconstitution of a MenA lyophilized conjugate vaccine component with a MenCYW-135 liquid conjugate vaccine component immediately before administration. Meningococcal (groups A, C, Y, and W-135) oligosaccharide diphtheria CRM197 conjugate vaccine is administered as a single 0.5 mL intramuscular injection, preferably into the deltoid muscle. For children aged 2 to 5 years at continued high risk of meningococcal disease, a second dose may be administered 2 months after the first dose.
David Calabrese of OptumRx Talks Top Three Drugs in Pipeline, Industry Trends in Q2
July 1st 2020In this week's episode of Tuning Into The C-Suite podcast, MHE's Briana Contreras chatted with David Calabrese, R.Ph, MHP, who is senior vice president and chief pharmacy officer of pharmacy care services company, OptumRx. David is also a member of Managed Healthcare Executives’ Editorial Advisory Board. During the discussion, he shared the OptumRx Quarter 2 Drug Pipeline Insights Report of 2020. Some of the information shared includes the three notable drugs currently being reviewed or those that have been recently approved by the FDA. Also discussed were any interesting industry trends to watch for.
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