The European Commission granted a marketing authorisation valid throughout the European Union for Trumenba on 24 May 2017. Trumenba is a Pfizer vaccine used to protect individuals from 10 years old against invasive meningococcal disease caused by Neisseria meningitidis group B.
Invasive disease occurs when these bacteria spread through the body causing serious infections such as meningitis and septicaemia. Trumenba contains two components, proteins that are found in the outer coats of Neisseria meningitidis group B bacteria. These proteins are fixed onto a compound containing aluminium, which helps to stabilise them, allowing the immune system to respond to them.
Trumenba has been shown to trigger the production of protective levels of antibodies against Neisseria meningitidis group B in two main studies. The first study involved around 3,600 participants aged 10 to 18 years, and the second study involved around 3,300 young adults between 18 and 25 years of age; none of the participants had previously been vaccinated against N. meningitidis group B. Those taking part were given 3 doses of the vaccine and antibody response against 4 main test strains of the bacteria was measured one month after the last injection. The studies also looked at response to 10 other, secondary strains of N. meningitidis group B.
Antibodies were produced in sufficient quantities to provide protection against the 4 main test strains in between 80 and 90% of those in the first study, depending on the strain; 84% of those given the vaccine had protective antibodies against all 4 strains when tested. In the second study sufficient amounts of antibodies were produced in 79 to 90% of cases, and protective levels of antibodies against all 4 strains were seen in 85% of participants. Antibody responses were also seen against the 10 secondary strains and confirmed the responses seen with the 4 main strains. Supportive studies were also carried out, which showed that 2 doses of the vaccine achieved a broadly similar antibody response to 3 doses, and that even though protective antibody levels declined over time they could be improved by an additional booster dose after both 2- and 3-dose treatments.
The most common side effects with Trumenba are pain, redness or swelling at the site of the injection, headache, tiredness, chills, diarrhoea, nausea, and muscle or joint pain. The available data indicated that Trumenba should provide broad protection against the strains of Neisseria meningitidis group B that are currently found in Europe, whether given in a 3-dose or a 2- dose schedule. As the protection provided seemed to decline over time, a booster dose should be considered in recipients who were thought to be at continued risk of invasive meningococcal disease.