Novartis brings vaccine for meningococcal disease
A recent announcement by pharmaceutical major Novartis should bring cheer and hope to parents of infants suffering from meningococcal disease. Novartis announced it will submit Menveo (Meningococcal Group A, C, W135 and Y conjugate vaccine) for infants aged at least two months for approval.
The vaccine that will be submitted for approval over several countries offers protection against four major serogroups of meningococcal disease at the Infectious Disease Society of America (IDSA) 48th meeting, Vancouver, Canada.
A BLA (Biologics License Application) will be submitted to the US FDA at the end of this year, Novartis announced. On approval, the vaccine would be the only meningococcal quadrivalent conjugate vaccine for infants over two months of age on the market.
The trial involved over 4,500 infants in several countries and a significant per cent of infants achieved robust immune response, says a report by Medical News Today. The vaccine was meant to be well tolerated when given on its own or along with other vaccines. However, some side effects included drowsiness; bad temper and persistent crying were noticed after administration.
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.”
The vaccine 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, further added that “As the most vulnerable age group, infants should be directly protected from this unpredictable and devastating disease”. Up to 10% of babies less than 12 months old who develop the disease die.