Sanofi Pasteur Canada receives Health Canada Approval of Menactra® Meningococcal Conjugate Vaccine Indication for Infants starting at 9 months
TORONTO, Dec. 3, 2012
Indication Provides Earlier Protection Against Meningococcal Disease
TORONTO, Dec. 3, 2012 /CNW/ - Sanofi Pasteur, the vaccines division of the Sanofi Group (EURONEXT: SAN and NYSE: SNY), announced today that Health Canada has approved the expansion of the indication for Menactra® (Meningococcal [Groups A, C, Y and W-135] Polysaccharide Diphtheria Toxoid Conjugate Vaccine) down to infants nine months of age.1 Menactra® is a vaccine for the prevention of meningococcal meningitis and meningococcal disease caused by strains A, C, Y and W-135 of the bacteria Neisseria meningitidis, in persons nine months through 55 years old.2
Invasive meningococcal disease is an acute and serious illness caused by the bacterium Neisseria meningitidis.3 In fatal cases, death can occur within 24 to 48 hours after symptoms appear.4 Of those who survive, some (11-19%) may suffer from permanent disabilities, including hearing loss, neurological damage, limb loss and paralysis.5 Meningococcal disease most often occurs in children less than five years of age and peaks again in adolescence.6
"Diagnosis of meningitis can be very difficult, as it mimics the symptoms of flu. Meningitis can lead not only to death, but lifelong health problems including brain damage, loss of limbs and developmental disorders," said Dr. Ron Gold, medical advisor for the Meningitis Research Foundation of Canada. "Approval for use of Menactra® vaccine as early as nine months of age expands our ability to prevent this potentially deadly disease in infants."
Maureen Dennis, parenting expert and founder of WeeWelcome.ca, said, "After speaking with mothers who lost their children to meningitis, I became rather concerned and realized that there was much more to know about this preventable disease. It's unthinkable that an infant can quickly go from their crib to the ICU at Sick Kids, a fate no parent should experience. Parents need to know more about immunization and about meningitis in particular."
Meningitis spreads through close, direct contact.7 Coughing or sneezing, sharing eating utensils, kissing and close physical contact can spread the germs from person to person.8 In Canada meningitis is most prevalent during winter and spring.9 According to the Public Health Agency of Canada, between 2005 and 2010, an average of 197 cases of invasive meningococcal disease was reported annually in Canada, with an average incidence of 0.60 cases per 100,000 population.10
About Menactra® Vaccine
Menactra® (Meningococcal [Groups A, C, Y and W-135] Polysaccharide Diphtheria Toxoid Conjugate Vaccine) is a vaccine indicated for active immunization for the prevention of invasive meningococcal disease caused by N. meningitis strains A, C, Y and W-135 in persons age nine months through 55 years of age.11
Menactra® does not protect against disease caused by strain B, and is not a treatment for meningococcal infections or their complications.12 The length of protection is currently not known.13 As with any vaccine, Menactra® may not protect 100% of vaccinated individuals.14 The amount of time it takes for your body to develop enough antibodies to protect you from meningococcal diseases can vary. It can take several days to a few weeks after your vaccination. Menactra® should not be used in persons with known severe allergy to any of its components or its container. Some persons may experience side effects, which are usually mild and go away within a few days, such as pain, redness or swelling at the injection site, headache, fatigue or drowsiness, lack of appetite.15 Common side effects in infants also include fussiness, and increased crying.16 Allergic reactions may occur.17 A complete copy of the Product Monograph is available at www.sanofipasteur.ca.
Sanofi, a global and diversified healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and Genzyme. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
Sanofi Pasteur, the vaccines division of Sanofi, provides more than 1 billion doses of vaccine each year, making it possible to immunize more than 500 million people across the globe. A world leader in the vaccine industry, Sanofi Pasteur offers the broadest range of vaccines protecting against 20 infectious diseases. The company's heritage, to create vaccines that protect life, dates back more than a century. Sanofi Pasteur is the largest company entirely dedicated to vaccines. Every day, the company invests more than $1.2 million in research and development. For more information, please visit: www.sanofipasteur.ca
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