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The meningococcal disease vaccine Menactra is approved for use in children as young as 9 months old, the Food and Drug Administration announced April 22.
Previously, the vaccine was approved for use in people ages 2 through 55 years.
Menactra (Sanofi Pasteur Inc.) is approved for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y, and W-135. Neisseria meningitidis is a leading cause of meningitis in young children. About 15% of people who develop meningococcal disease die from the infection; another 10%-20% experience complications, according to the agency.
"The highest rate of meningococcal disease occurs in children under 1 year of age. With today’s approval, Menactra can now be used in children as young as 9 months of age to help prevent this potentially life-threatening disease," Dr. Karen Midthun, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement issued by the agency.
The safety of Menactra in children as young as 9 months was evaluated in four clinical studies in which more than 3,700 participants received the vaccine. The most common adverse events reported in children who received Menactra at 9 months and 12 months of age were injection-site tenderness and irritability.
Menactra is given as a two-dose series beginning at 9 months, 3 months apart; and the study results showed the vaccine produces antibodies in the blood that are protective against the disease.
The meningococcal disease vaccine Menactra is approved for use in children as young as 9 months old, the Food and Drug Administration announced April 22.
Previously, the vaccine was approved for use in people ages 2 through 55 years.
Menactra (Sanofi Pasteur Inc.) is approved for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y, and W-135. Neisseria meningitidis is a leading cause of meningitis in young children. About 15% of people who develop meningococcal disease die from the infection; another 10%-20% experience complications, according to the agency.
"The highest rate of meningococcal disease occurs in children under 1 year of age. With today’s approval, Menactra can now be used in children as young as 9 months of age to help prevent this potentially life-threatening disease," Dr. Karen Midthun, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement issued by the agency.
The safety of Menactra in children as young as 9 months was evaluated in four clinical studies in which more than 3,700 participants received the vaccine. The most common adverse events reported in children who received Menactra at 9 months and 12 months of age were injection-site tenderness and irritability.
Menactra is given as a two-dose series beginning at 9 months, 3 months apart; and the study results showed the vaccine produces antibodies in the blood that are protective against the disease.
The meningococcal disease vaccine Menactra is approved for use in children as young as 9 months old, the Food and Drug Administration announced April 22.
Previously, the vaccine was approved for use in people ages 2 through 55 years.
Menactra (Sanofi Pasteur Inc.) is approved for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y, and W-135. Neisseria meningitidis is a leading cause of meningitis in young children. About 15% of people who develop meningococcal disease die from the infection; another 10%-20% experience complications, according to the agency.
"The highest rate of meningococcal disease occurs in children under 1 year of age. With today’s approval, Menactra can now be used in children as young as 9 months of age to help prevent this potentially life-threatening disease," Dr. Karen Midthun, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement issued by the agency.
The safety of Menactra in children as young as 9 months was evaluated in four clinical studies in which more than 3,700 participants received the vaccine. The most common adverse events reported in children who received Menactra at 9 months and 12 months of age were injection-site tenderness and irritability.
Menactra is given as a two-dose series beginning at 9 months, 3 months apart; and the study results showed the vaccine produces antibodies in the blood that are protective against the disease.
FROM THE FOOD AND DRUG ADMINISTRATION