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FDA approves meningitis A, C, Y/W-135 vaccine for use in infants as young as 2 months
FDA officials approved the quadrivalent meningococcal conjugate vaccine to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135 in patients aged 2 months through 55 years of age, according to an FDA press release.
The FDA initially approved quadrivalent meningococcal conjugate vaccine A, C, Y /W-135 (Menveo, Novartis) for use in patients aged 11 to 55 years in February 2010 and expanded the approved age range for patients aged 2 to10 years in January 2011. The FDA has now approved an expanded age range for the use of Menveo to include children aged 2 months through 2 years of age.
The manufacturer must complete post-marketing studies that include an open label, descriptive, epidemiological safety surveillance study of the vaccine in children aged 2 months through 23 months of age. The study will include two parts. Part 1 of the study, which will last for 3 years, will begin with the first administration of the vaccine to a child aged 2 through 23 months of age who receives medical care at the site where the study is being conducted. Part 2 of the study will be initiated if there is a recommendation by the Advisory Committee on Immunization Practices for routine use of meningococcal conjugate vaccine in at least one birth cohort within the 2 through 23 months age range, according to the FDA approval letter.
Part 2 will begin with the effective date of the ACIP recommendation, and will continue until 20,000 children are enrolled, or until 1 year has elapsed, whichever occurs last.
Go to FDA.gov to read the complete approval letter.
Perspective
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As I predicted in 2010, the FDA approval of an infant indication for three meningococcal vaccines is now complete. Novartis recently received approval for its MCV4-CRM 197 (A, C, Y, W-135) vaccine (Menveo) for infant series at 2, 4, 6 and 12 months of age, with some catch-up dosing variations. This complements the currently available Hib-MenCY-TT vaccine (MenHibrix, GlaxoSmithKline) administered at 2, 4, 6 and 12 months, along with MenACWY-D (Menactra, Sanofi) available for infants in a 2-dose series at 9 and 12 months.
But as we know too well in pediatrics, FDA approval does not equate with a recommendation from the Advisory Committee on Immunization or the AAP. These advisory groups must now decide whether or not the cost-to-benefit ratio is substantially favorable enough to recommend routine use – which is an onerous and daunting challenge.
Is this too many infant shots? Is there an immune system overload? Not a problem. The three-in-one shot, Pentacel (Sanofi Pasteur), is in full supply again. Pediarix (GlaxoSmithKline) fully complements Hib-MenCY-TT vaccine and reduces the schedule by even one more shot per infant visit, if an infant meningococcal vaccine would be recommended.
A new hexavalent infant vaccine on the horizon would make MenACWY-D and MenACWY-CRM versions even more acceptable. And each of the three meningococcal vaccines was thoroughly studied for signs of immunologic interference or increased adverse events when they were administered concomitantly with the other infant vaccines, such as 13-valent pneumococcal vaccine (Prevnar13, Pfizer), etc. Immune system overload is not an issue.
Effectiveness? The majority of meningococcal disease in infancy is caused by B strain, which is not yet included in any of these vaccines. However, even before the routine use of meningococcal conjugate vaccine (MCV) in preteens/teens, the rate of meningococcal disease in pediatrics had dropped to about a 1,000 cases a year for unknown reasons (probably due to empiric use of ceftriaxone and reduced rates of blood culturing in practice). The meningococcal death rate and severe morbidity in infants is about 10% and 20% respectively, so that annually in the US, approximately 40 deaths and about 80 cases of severe morbidity could be prevented currently with an infant MCV vaccine. Also, this does not account for the likely additional beneficial herd protection effect produced by routine preteen and teen MCV vaccines (we routinely give MCV to all 16- to 18-years-olds).
Costs? Estimates have indicated that cost for the vaccine will approach $400 per four-dose series. Nearly 4 million infants will receive this vaccine annually (95% uptake over time if recommended). Translation: $1.6 billion. If not ACIP recommended, the vaccine uptake and societal costs for the vaccine alone will be paltry.
Medicolegally? Even a lack of recommendation by ACIP will continue to create a heyday for mostly unjustifiable accusations, if an unvaccinated child is affected permanently by meningococcal disease — even if no serotyping is performed.