After good Phase III trial results, Novartis announced it will submit Menveo (Meningococcal Group A, C, W135 and Y conjugate vaccine) for infants aged at least two months for approval. Submission for approval will be done in several countries. The company announced the vaccine offers protection against four major serogroups of meningococcal disease at the Infectious Disease Society of America (IDSA) 48th meeting, Vancouver, Canada.
The trial involved over 4,500 infants in several countries and has met its primary endpoints. A significant percentage of vaccinated infants "achieved robust immune response" against meningococcal serogroups A, C, W135 and Y.
Novartis added that the vaccine was generally well tolerated when given on its own or along with other vaccines. Some side effects included drowsiness, bad temper and persistent crying.
Stan Block, MD, FAAP, one of the study investigators said:
In my practice I have seen the devastating effects of meningococcal disease in infants. Meningococcal vaccines are being developed that can provide broad protection against the disease in this vulnerable population.
Menveo is already approved in the USA and Europe for patients aged 11 to 55 years. Pharmaceutical business analysts say it could be a potential blockbuster Novartis was seeking to compensate for drugs that were reaching the end of their patent lives.
Andrin Oswald, Division Head of Novartis Vaccines and Diagnostics, said:
As the most vulnerable age group, infants should be directly protected from this unpredictable and devastating disease. These data are another step in the significant progress Novartis is making toward our goal of protecting all age groups against meningococcal disease.
An sBLA (Biologics License Application) will be submitted to the US FDA at the end of this year, Novartis announced. On approval, Menveo would be the only meningococcal quadrivalent conjugate vaccine for infants over two months of age on the market.
The membranes around the spinal cord and brain are known as the meninges. Meningitis means inflammation of the of the meninges. Meningococcal meningitis is caused by infection with the meningococcal bacterium Neisseria meningitides. Meningococcal disease is the leading cause of bacterial meningitis and sepsis (bloodstream infection).
Five main serogroups - A, B, C, W135 and Y - cause most cases worldwide. Infants have the highest risk of developing meningococcal disease; unfortunately, vaccines are lacking for this age group. According to the CDC (Centers for Disease Control and Prevention) up to 10% of babies less than 12 months old who develop the disease die. Survivors risk serious side effects and complications, such as learning disabilities, deafness, loss of limb(s), and brain damage.
Written by Christian Nordqvist