“We are waiting for the green light from the Italian drug agency Aifa, which should arrive within a year at most. The combined vaccine candidate MenABCWY”, known as the ‘5 in 1’ anti-meningococcal vaccine, “has reached all the 11 primary endpoints of the clinical trial and was well tolerated, with a safety profile consistent with the MenB vaccine and MenACWY. The data demonstrate that the new vaccine is not inferior to the ACWY vaccine nor to the single meningococcal B vaccine, so we expect that the green light for marketing arrives as soon as possible.” Ennio De Gregorio, CEO of GSK Vaccini Italia, said this to Adnkronos Salute, commenting on the positive results of the pivotal phase III clinical study for the 5 in 1 meningococcal vaccine candidate ABCWY, which contains the 5 serogroups of Neisseria meningitides (A, B, C, W and Y) responsible for almost all cases of meningitis in most of the world: to date, no authorized combined vaccine offers protection against these 5 serogroups in a single product.
“Furthermore – continues De Gregorio – we are already working on a second generation ABCWY vaccine which should have an even wider coverage than the previous one and close to almost 100%, but we are still in phase II”.
The GSK center where the vaccine was developed is that of Siena: dedicated to Research and Development, it is close to the Rosia production site. Together they have represented excellence in the panorama of international vaccinia for over 100 years. “It is one of the few sites in the world – underlines the GSK CEO – that deals with the entire life of vaccines, from research and development, to the entire regulatory, production and packaging part of vaccines. Mainly – he specifies – we deal with of vaccines to prevent bacterial infections. We have become an important center of attraction for talents in the world: they want to come and work with us because they know that this is a center of excellence.”
The two Tuscan sites – with over 2,500 collaborators from all over the world and average investments exceeding 60 million per year in plants, machinery and new technologies – constitute a single entity that covers all phases of the development of a vaccine. “The Siena center – remarks De Gregorio – has great scientific expertise especially for vaccines for the prevention of bacterial infections. We have a long tradition with many vaccines that have been developed here especially for the prevention of meningitis, but we work on the prevention of many bacterial infections, in particular that are resistant to antibiotics. This is a very important challenge for the future, because bacteria cause more than 7 million deaths worldwide and this number will increase as bacteria acquire resistance to antibiotics very quickly, so much faster than the industry’s capacity to produce antibiotics. We think that disease prevention through these vaccines can play a very important role, so we are working a lot on this aspect.”
Among the many vaccines developed in the center of Siena, the vaccine against meningococcal B is of particular importance: it is formulated with 4 highly immunogenic antigens which, taken together, have the potential to protect against a wide range of pathogenic strains. GSK Vaccines has identified these components thanks to a pioneering approach, ‘reverse Vaccinology’. Unlike conventional vaccine development methods, reverse vaccine technology allowed GSK to decode the genetic map (i.e. genomic sequence) of meningococcal B and to select proteins with the highest probability of generating broad coverage against meningococcal B.
“The development of the vaccine against meningococcal B infection was a long and complex journey – observes the CEO – because while for other vaccines for the prevention of meningitis we were able to use the capsule, i.e. the external part of the bacterium as antigen, this was not possible for meningococcus B. The sugar (polysaccharide) present on the external capsule of the bacterium – he explains – is in fact identical to a component of the human body and therefore is not recognized as foreign by the immune system, consequently the possible response to the vaccine was very poor and therefore the vaccine did not work. So for meningococcus B it was necessary to use the innovation of genomics and the genetic information of the bacterium to find the right components of the vaccine that could protect not only against some strains of meningococcus B, but from the majority of circulating strains. Constructing a vaccine and demonstrating that it is effective for the protection of all circulating strains – concludes De Gregorio – has been the biggest challenge for researchers. A challenge that we won, however. Meningococcus B has a very important impact on public health: where the vaccine is used, cases of meningitis have been significantly reduced, more than 75%”.