Novartis has been keen to shout about data published this week in the Journal of the American Medical Association (JAMA) that backs up claims that it has developed the first vaccine to protect infants against the most common meningitis subgroups.
Novartis' tetravalent vaccine, Menveo (MeACWY-CRM), could offer protection against meningococcal serogroups A, C, W-135 and Y in infants as young as two months, potentially filling the gap in the market for the under twos.
While there are other quadrivalent meningitis vaccines available on the market, they have failed to achieve a significant, sustained immune response in infants, and a conjugated vaccine for use in this age group is only available against the C serogroup (and not approved in the US).
The data published in JAMA showed that Menveo was well-tolerated in infants and generated high levels of immunity against the four main serogroups following a standard infant vaccination dosing schedule.
Unlike the currently licensed quadrivalent vaccine, which uses a chemically detoxified diphtheria toxoid as the carrier protein, the Menveo glycoconjugate vaccine uses CRM-197
, a natural, non-toxic mutant of the diphtheria toxin.
The new vaccine also contains an aluminium phosphate adjuvant and uses saccharide chains of different lengths and quantities compared to the existing vaccines.
The study reported in JAMA only involved a relatively small group of 421 infants, too small to draw firm conclusions regarding the safety of the vaccine, and thus further trials will be required.
An editorial in the same edition of JAMA also points out the need to investigate any potential interactions between the vaccine and the heptavalent pneumococcal conjugate vaccine, which also uses CRM-197
as the protein carrier.
The vaccine is currently in multiple Phase III trials involving infants, young children, adolescents and adults, with regulatory submission the EU and US expected over the course of this year.
The product is likely to compete directly with Sanofi Pasteur's quadrivalent vaccines Menactra and Menomune, both of which protect against the same 4 serogroups as Menveo and are currently on the market. GlaxoSmithKline also has a conjugated paediatric vaccine currently in Phase III to protect against the A, C, W and Y serogroups.
Novartis is also in the process of developing a recombinant vaccine to protect against the B serogroup, for which no vaccine is currently available.