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New vaccine approved to prevent meningococcal disease
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FDA officials have approved Novartis’ quadrivalent meningococcal conjugate vaccine to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135 in people 11 to 55 years of age.
The meningococcal oligosaccharide diphtheria CRM197 conjugate vaccine (Menveo, Novartis), received approval based on a phase-3 head-to-head clinical trial that compared Menveo to the Sanofi’s Menactra vaccine.
The trial, which was broken into two subsets — adolescents, 11 to 18 years, and adults, 19 to 55 years — measured both the percentage of patients who achieved an immune response as measured by seroresponse and proportions achieving human serum bactericidal antibody titers of one to eight.
Novartis officials said patient response and geometric mean titers (GMT) of circulating antibodies favored the new vaccine, with those tested in serogroup A achieving a GMT of 29 in the new vaccine group versus a GMT of 18 in the previously-licensed vaccine group; 59 versus 47 in serogroup C; 51 versus 18 in serogroup Y, and 87 versus 44 in serogroup W-135.
“Even with early and appropriate treatment, patients can die from meningococcal disease, often within 24 to 48 hours of onset of symptoms. Menveo achieved a higher immune response than the other currently available vaccine, which is very reassuring,” Keith S. Reisinger, MD, Medical Director of Primary Physicians Research, Inc., said in a press release. “With the FDA approval of Menveo, now health care providers in the United States have another option to help prevent this life-threatening invasive disease.”
Novartis officials said are conducting efficacy trials in children from 2 to 10 years. – by Melissa Foster
When a new competitive vaccine becomes available, one must evaluate the following issues to decide whether a practice wishes to switch or to simply add the newer vaccine. It is important to note if there are any differences in issues such as efficacy, immunogenicity, components, dosing schedules, compatibility with other vaccines, duration of protection, adverse events, usage recommendations and costs. Looking at these issues as they relate to Menveo (Novartis) and Menactra (Sanofi) specifically, the following observations can be made:
Efficacy? Too few cases of invasive meningococcal disease occur in the United States to ever meaningfully detect in a clinical trial. Can we use surrogate markers for efficacy like nasopharyngeal carriage? Again, nothing is known about these protein-conjugated vaccines effects on NP carriage, but it could be worth a study to see if the difference is huge or not. (Pediatric NP carriage of meningococcus is about 5% in many observational studies.)
Immunogenicity? Menveo shows superior seroconversion rates and geometric mean titers (GMTs) for three of four strains. The caveat is that for meningococcal disease prevention, we do not have good specific antibody concentrations correlated with protection, like we do for pneumococcus or Haemophilus influenzae type b. Just because one GMT or another is higher, does not necessarily mean a direct superiority in efficacy. Also, in the field, Menactra has been effective in vaccinees, with extremely rare if any cases of disease breakthrough reported. Seroconversion rates seem slightly better for Menveo for three strains, which might be a more important measure than GMTs in my opinion.
Components? Both are quadrivalent vaccines that include strains A, C, Y, W-135; neither has type B. Menveo uses the diphtheria CRM protein conjugate (widely used already in PCV7), whereas Menactra uses non-specific diphtheria protein conjugate. Both are known as effective conjugates.
Doses or dosing schedules? None for adolescents, but so far only Menactra is approved for 2-10 year olds. However, Menveo has also performed numerous studies in this group, and has also shown good antibody seroconversion/concentrations in infants and toddlers, unlike Menactra.
Compatibility with other vaccines? Both have been tested well in adolescents, without any worries.
Duration of protection? Unknown yet. Menactra looks good for five years so far and is coming up on a 10-year anniversary. Menveo is too new to guess.
Adverse events? Very important, but both were commensurate in head-to-head trials. The Guillian-Barre syndrome argument for MCV4 is about to be sent to the graveyard of statistical flukes and scare problems with VAERS reporting.
Recommendations from ACIP or AAP, etc? No differentiating so far.
Costs? Discounts not obvious yet, but likely to be seen with volume orders and package deals, as is the strange custom for new medicines and new vaccines. This is usually the reason a practice chooses between two comparable vaccines.
– Stan Block, MD
Infectious Diseases
in Children Editorial Board