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Published On: Mon, Aug 5th, 2013

FDA approves Menveo quadrivalent meningococcal vaccine in children starting as early as two months

The Food and Drug Administration (FDA) approved the expanded age range for Menveo quadrivalent meningococcal vaccine for infants and toddlers from 2 months of age, according to a FDA approval letter.

meningococcus

Neisseria meningitidis
Image/CDC

Menveo, made by Novartis Pharmaceuticals, Inc, is a Meningococcal Group A, C, W-135 and Y conjugate vaccine for the prevention of meningococcal disease caused by four strains of the bacterium Neisseria meningitidis (N. meningitidis).

According to a Novartis news release, “with this expanded indication, pediatricians in the US can now offer a single vaccine for the protection of infants, children and adolescents against four of the five most common serogroups that cause meningococcal disease.”

Infants younger than 7 months old are the most vulnerable age group to meningococcal disease in the US. In their first year of life, infants are more than seven times more likely to contract the disease than 14 to 24 year olds. Of the infants who contract the disease, more than 10 percent will die from it and of those who do survive, approximately one in every five will suffer permanent, devastating side effects, including amputations, hearing loss, paralysis and brain damage.

Prior to this approval, Menveo has been available for use in adolescents and adults (11 – 55 years of age) since February 2010 and in children (2 – 10 years of age) since January 2011.

“Each year, more children in the US die or are left with permanent disability from meningococcal disease than from two other diseases combined that we routinely vaccinate infants against – rotavirus and varicella,” said Dr. Steve Black, Center for Global Health, University of Cincinnati Children’s Hospital. “With the expanded indication for this MCV4 vaccine, we now have the opportunity to help protect our infants against four strains of meningococcal disease earlier, when they are most vulnerable.”

The organization, Meningitis Angels also celebrated the FDA decision.

“We are fooling ourselves if we believe that meningococcal meningitis is just a teen or college disease,” said Frankie Milley, founder and national director of Meningitis Angels. “Even though there is still no approved vaccine in the U.S. to help protect against meningococcal serogroup B infections, the fifth remaining serogroup, this is a huge step in the fight against meningococcal disease in infants.”

“No infant should suffer what some have previously experienced. No parent should have to watch their once perfect child lay in a hospital for months, body rotting away and have to sign papers for doctors to amputate body parts bit by bit. No parent should have to stand helplessly and watch their child literally bleed to death, as I did, from a disease that is preventable with a vaccine,” continued Milley. “When it comes to prevention of deadly disease through vaccination, we all must do the right thing and vaccinate.”

This FDA approval was based on data from three randomized multicenter studies involving more than 8,700 infants, conducted in Australia, Canada, Latin America, Taiwan and the US. The studies demonstrated that Menveo generated a robust protective immune response and was generally well tolerated when administered with other routine pediatric vaccines.

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About the Author

- Writer, Co-Founder and Executive Editor of The Global Dispatch. Robert has been covering news in the areas of health, world news and politics for a variety of online news sources. He is also the Editor-in-Chief of the website, Outbreak News Today and hosts the podcast, Outbreak News Interviews on iTunes, Stitcher and Spotify Robert is politically Independent and a born again Christian Follow @bactiman63

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