Navigation Links
FDA Approves the First Vaccine to Prevent Meningococcal Disease in Infants and Toddlers
Date:4/22/2011

SILVER SPRING, Md., April 22, 2011 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved the use of Menactra in children as young as 9 months for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135. Menactra already is approved for use in people ages 2 through 55 years.

(Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO)

Meningococcal disease is a life-threatening illness caused by bacteria that infect the bloodstream (sepsis) and the lining that surrounds the brain and spinal cord (meningitis). Neisseria meningitidis is a leading cause of meningitis in young children. Even with appropriate antibiotics and intensive care, between 10 percent and 15 percent of people who develop meningococcal disease die from the infection. Another 10 percent to 20 percent suffer complications such as brain damage or loss of limb or hearing.

Although the rates of meningococcal disease are low in the United States, infants and toddlers are more susceptible to getting this serious illness. Meningococcal disease is particularly dangerous because it progresses rapidly and can cause death within hours. Early symptoms are often difficult to distinguish from influenza and other common illnesses.

"The highest rate of meningococcal disease occurs in children under one 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," said Karen Midthun, M.D., director of FDA's Center for Biologics Evaluation and Research.

The safety of Menactra in children as young as 9 months was evaluated in four clinical studies in which over 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. Occurrence of fever was comparable to other vaccines routinely recommended for young children.

Menactra is given as a two-dose series beginning at 9-months, three months apart; and the study results showed the vaccine produces antibodies in the blood that are protective against the disease.

Menactra was originally approved on Jan. 14, 2005, for use in individuals ages 11 years through 55 years and was approved in October 2007 for children as young as 2 years. Menactra is manufactured by Sanofi Pasteur Inc. of Swiftwater, Pa.

For more information:

Menactra Product Page

http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm176044.htm

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Media Inquiries: Shelly Burgess, 301-796-4651, shelly.burgess@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA


'/>"/>
SOURCE U.S. Food and Drug Administration
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. FDA Approves Lillys Osteoporosis Drug EVISTA(R) (raloxifene HCl) to Reduce The Risk of Invasive Breast Cancer in Two Populations of Postmenopausal Women
2. Health Canada Approves ATRIPLA(R) (efavirenz 600 mg/emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg), the First Once-Daily Single Tablet Regimen for HIV
3. FDA Approves Cymbalta(R) for Maintenance Treatment of Major Depressive Disorder
4. European Commission Approves ATRIPLA(R) (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg), the First Once-Daily Single Tablet Regimen for Virologically Suppressed Adults With HIV-1 Infection
5. FDA Approves MiddleBrooks Amoxicillin PULSYS for Pharyngitis/Tonsillitis in Adolescents and Adults
6. FDA Approves XYZAL(R) (levocetirizine dihydrochloride) Oral Solution for the Relief of Seasonal and Year Round Allergies and Chronic Idiopathic Urticaria
7. UM Maryland Industrial Partnerships Program Approves 18 Collaborative Research Projects, Worth $4.4 Million, Between University Faculty, State Technology Companies
8. U.S. Food and Drug Administration Approves ABILIFY(R) (aripiprazole) for the Acute Treatment of Manic and Mixed Episodes Associated With Bipolar I Disorder in Pediatric Patients (10 to 17 Years of Age)
9. U.S. Food and Drug Administration Approves ORENCIA(R) (abatacept) for the Treatment of Moderate-to-Severe Polyarticular Juvenile Idiopathic Arthritis (JIA) in Patients Six Years and Older
10. FDA Approves HIFU Clinical Trial for Recurrent Prostate Cancer
11. EPA Approves XDS-CALUX(R) as Alternate Dioxin Test Method 4435
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/3/2016)... 2016  As a teenager, an active and athletic ... damaged his heart. He continued enjoying sports and recreation ... Shepherd,s heart was giving out and he was a ... 2013, the Mesa, Arizona resident ... a heart transplant, the SynCardia TAH-t is the only ...
(Date:5/3/2016)... 3, 2016  While you may be familiar with watching a film or TV show in ... ultra-high-definition or 8MP in the Medical Industry.  Ampronix  is a renowned authorized reseller of the ... Photo - http://photos.prnewswire.com/prnh/20160502/362730 ... ... ...
(Date:5/3/2016)... -- Pharmaceutical giant Johnson & Johnson has ... who says its talc-based powder products caused ovarian cancer. ... $5 million in compensatory damages and $50 million in ... ) , This is the second in ... the same court awarded $72 million to the family ...
Breaking Medicine Technology:
(Date:5/5/2016)... ... May 05, 2016 , ... Phycologia ... A (UV-A) for photosynthesis, researchers Juntian Xu and Kunshan Gao tested the magnitude ... pair observed that when photosynthetically active radiation (i.e. the white light in our ...
(Date:5/5/2016)... , ... May 05, 2016 , ... ... organization, announces McLaughlin & Smoak Benefits as the latest addition to its family ... has a dedicated team of compliance, wellness, human resources, and health care consumerism ...
(Date:5/5/2016)... , ... May 05, 2016 , ... ... compensation laws in all U.S. states and certain Canadian provinces is now available ... Workers Compensation Research Institute (WCRI). , The report, Workers’ Compensation Laws ...
(Date:5/5/2016)... ... ... A recent survey by the Midwest Business Group on Health ... use the free preventive care benefits available to them as part of the Affordable ... public and private employers, MBGH found that only 10% of large employers are aware ...
(Date:5/5/2016)... TX (PRWEB) , ... May 05, 2016 , ... Vitenas ... AIA/AAH Healthcare Design Awards, presented by the American Institute of Architects and the Academy ... designed by the renowned Perkins+Will and Harrell Architects, opened to patients in October of ...
Breaking Medicine News(10 mins):