The Novartis Vaccine Unit (Siena) created the first approved product of a new technology, named reverse vaccinology
The European Commission granted on 14 January 2013 a marketing authorization valid throughout the European Union for the first and only broad coverage Meningococcal B vaccine created by Novartis Vaccine Unit, Siena, Italy. This vaccine represents the first approved product of a new technology, named reverse vaccinology and will be useful to produce a robust immune response to N. meningitidis group B. From the European Medicine Agency (EMA) website is possible to read the main information about the safety and the characteristic of the new vaccine such as that this vaccine is available as a suspension for injection in a pre-filled syringe. It contains four proteins which are found on the surfaces of cells of the N. meningitidis group-B bacterium and it is ‘adsorbed’, this means that the proteins are fixed onto a compound containing aluminium, to stimulate a better immune response. Some of the components are made using a method known as ‘recombinant DNA technology’: they are made by another bacterium that has received a gene (DNA) that makes it able to produce them. The effects were first tested in experimental models before being studied in humans. It is used to protect individuals from the age of two months against invasive meningococcal disease caused by one group of the bacterium N. meningitidis (group B). Invasive disease occurs when the bacteria spread through the body causing serious infections such as meningitis (infection of the membranes that surround the brain and spine) and septicaemia (blood infection). MenB vaccine is given by deep injection into a muscle, preferably into the shoulder muscle, or into the thigh muscle in children under two years old. In adults and adolescents aged 11 and over, two injections are given (at an interval of at least one month). In younger children, two injections are given (at an interval of at least two months), except in infants aged between two and five months who receive three injections (at intervals of at least one month). Children under two years old also receive an additional booster dose (at a time point determined by age).